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Chris DeMuth Jr. is the founder of Rangeley Capital LLC. Rangeley is an investment firm that focuses on event driven, value-oriented investment opportunities. Rangeley Capital and his value investing forum, Sifting the World (StW), search the world for misplaced bets. Rangeley exploits them for... More
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  • Archived GCVRZ Forum 1,014 comments
    Apr 30, 2014 2:48 PM

    Now that this forum has reached 1,000 comments, readers have noticed that it has become slow and ponderous to open (especially on mobile devices). So, if you would like to comment, please do so here instead.

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Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Comments (1014)
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  • HFI
    , contributor
    Comments (1562) | Send Message
     
    Thank you for the new forum! The other one was just getting WAY too laggy.
    30 Apr 2014, 02:50 PM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    Agreed!
    30 Apr 2014, 03:12 PM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Many thanks to Chris Demuth for creating the new forum. I will do my best to try and steer the crowd to this forum for discussion.
    30 Apr 2014, 03:55 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Also thanks for the new forum!

     

    See vrjao's comment on the old forum: http://seekingalpha.co...

     

    The way I interpret these emails is that they wait with selling until reimbursement is arranged. This is very good for us. Unfortunately in Germany universal reimbursement doesn't seem to be possible, at least not any soon. Is that what the IR email says? So I read that they have started selling in Germany anyway, to demonstrate the value of Lemtrada. They hope that some time the AMNOG reverses its policy. So in Germany it's kind of the same situation as in the US.
    30 Apr 2014, 04:00 PM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Given the fact that it looks like Lemtrada will not be reimbursed by public health insurance in Germany, does anyone think that fatally impacts the odds of reaching the $400M milestone? I would suspect that German sales won't get much above $10M-$15M in any quarter.

     

    Germany is likely to be the largest market in the EU for MS, so I am a little worried, but overall, I do expect the milestone to still be hit, with or without significant German sales, primarily because of the size of the Canadian market.
    30 Apr 2014, 04:03 PM Reply Like
  • Keubiko
    , contributor
    Comments (2884) | Send Message
     
    "Given the fact that it looks like Lemtrada will not be reimbursed by public health insurance in Germany,"

     

    This is not a fact at all. What the IR person was confirming is that given alemtuzumab was on the market as Campath previously it is not eligible for the AMNOG drug review process:

     

    http://bit.ly/R4zFR5

     

    That does not mean it won't be covered.

     

    In Germany there are hundreds of "sickness funds" which are the public coverage option - everyone has to join a sickness fund by law. These are non-profit insurance companies but there is a competitive element as people have choice. They may not refuse someone based on a pre-existing condition.

     

    Sanofi is engaging with the sickness funds (i.e. quasi-public non-profit insurance entities) to convince them of the effectiveness of Lemtrada and the cost/benefit analysis (which is s slam dunk in my view).

     

    I think people need to have some patience here. This stuff takes time and you can see why the CVR was structured this way - to allow for ramp-up periods in different markets.

     

    There will be plenty of time to panic in 2015 if the traction isn't there.

     

    Disclosure: Long GCVRZ
    30 Apr 2014, 05:59 PM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Keubiko,
    Thank you for the correction. I jumped to an (incorrect) conclusion. I implied above (and in the previous blog) that if Lemtrada was not covered under the AMNOG process, that it wouldn't be covered by government insurance at all. I wasn't aware of how the sickness funds operated. That makes me feel better... Thanks!!
    30 Apr 2014, 08:39 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Thanks Keubiko! I don't know how you do it but you always seem to have a good answer for our questions.

     

    I think the concern for Germany is that it's the biggest EU Major Market and it's already May. Three months with very little sales, about $5 million. Of course with built up demand the next three quarters could be impressive. I hope Sanofi doesn't have to engage with each sickness fund individually. That could take a while. Maybe there's a few big ones that Sanofi has chosen to get the ball rolling. Or maybe there's a SICK oversight committee that centralizes the effectiveness and cost/benefit analysis.
    1 May 2014, 03:33 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    I also like this find of vjrao: http://bit.ly/R0VW2m
    In this blog I found an interesting data point.

     

    The blogger, from the US, has been treated in Dresden, Germany, apparently with very good results (so far). At the same time another US citizen was treated there as well. She mentions that another 5 people from the US are going to be treated in Dresden in the coming weeks (after April 10 or so). In addition worth mentioning is that she tried to find a doctor in Mexico or Canada but concluded that the infusions have not started yet in these countries.
    30 Apr 2014, 04:06 PM Reply Like
  • JD80
    , contributor
    Comment (1) | Send Message
     
    I tried posting a link to her blog back in March shortly after she started it. In fact I tried twice, but the moderators deleted my comment citing that it wasn't on topic. It will be interesting to see if they delete this comment as well.

     

    At least somebody finally posted the link - it has some interesting information that only patients seeking treatment in foreign countries would know.
    30 Apr 2014, 09:14 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » The link is interesting and on topic. I have no idea what happened last March but certainly would not have deleted a link and wouldn't delete this one.
    1 May 2014, 04:08 AM Reply Like
  • US-Emma
    , contributor
    Comments (39) | Send Message
     
    I am an MS patient who traveled to Germany for Lem in April- story is documented at Lemtrada.blogspot.com

     

    If I can help answer questions I am happy to. I am also a nurse practitioner.

     

    We bough this stock around the time of the trip 4/2014 to hedge against our large outlays to purchase this drug in open markets. I hope that pays out someday but I don't know enough about the lingo to understand what I read here.
    5 Feb 2015, 02:30 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » First of all, I hope that you have all possible success with your health.

     

    Also, I am grateful to have you on this forum. Yours is a valuable perspective.
    5 Feb 2015, 06:24 AM Reply Like
  • US-Emma
    , contributor
    Comments (39) | Send Message
     
    I am sorry that happened. It is never my intention to deny free speech. This 'approval of comments" things is built into blogger & I don't know how to turn it off..

     

    I must have messed up posting your comment.

     

    Many apologies
    10 Feb 2015, 01:48 AM Reply Like
  • drew111
    , contributor
    Comments (514) | Send Message
     
    1,000 comments wow! I just want to say I appreciate everyone's work and continuing research. People here have saved me countless hours of research. Hopefully I will have the opportunity to return the favor in the future.
    30 Apr 2014, 07:33 PM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    This really is a wonderful site, and I, also, appreciate the posts. I am, however, feeling all empty inside, as I missed doing post number 1,000.
    30 Apr 2014, 08:20 PM Reply Like
  • nmecmbtnt
    , contributor
    Comments (124) | Send Message
     
    Thanks Chris -- for blogs, schoolin & articles on this CVR & other securities.

     

    Disclosure: Long GCVRZ.
    30 Apr 2014, 11:13 PM Reply Like
  • earljr1
    , contributor
    Comments (518) | Send Message
     
    Okay everybody, quit thanking him, or he will need to make another forum!
    1 May 2014, 12:41 PM Reply Like
  • HFI
    , contributor
    Comments (1562) | Send Message
     
    Well said haha!
    1 May 2014, 12:45 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » (GCVRZ) Amended Class Action Complaint: http://bit.ly/1nNfGE7
    1 May 2014, 02:56 PM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    http://bit.ly/1jqgHPu

     

    Market share of MS drugs is interesting from perspective that Tecfidera is taking share from all components of the market. Previously, I had thought that the largest source of Lemtrada patients would come from those patients on Tysabri who do not want to incur the risk of PML. These patients will most likely switch to Tecfidera first and then, if they cannot tolerate Tecfidera, will either switch back to Tysabri or switch to Lemtrada when it becomes available. But, there is an overall shift out of ABCR that appears to be going to Tecfidera.

     

    This trend illustrates two points. Patients seem to be more willing to switch therapy to something that is more convenient and are choosing an oral over an injectable. Relapse rate is likely driving the switch. Tecfidera is more efficacious in reducing the relapse rate in comparison to the injectables, but not by a wide margin. The second point is that Tecfidera patients represent the second pool of patients that might actually consider Lemtrada if and when they relapse or if they are intolerant of the rash/gastrointestinal side effects. This will take time to evolve.
    3 May 2014, 08:18 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    A remark in the biogen idec 2013 q3 report confirms this, see also the quoted remark in this sa article: http://bit.ly/1kQ3ge7
    3 May 2014, 10:38 AM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Ruerd, Are you still as bullish as you were in January?

     

    Also is your bull case now based/strengthened on a successful FDA appeal?
    8 May 2014, 04:23 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Bazooooka: I still think this investment offers a good risk/reward. Even if the FDA doesn't approve there is a significant chance on meeting the first and even the second salesmilestone.

     

    @rootbeer: I think that many patients that were on Tysabri for a couple of years were recommended to stop it because of PML risk. At least in The Netherlands. I suppose most of them are on orals now. I suppose many of them will switch to Lemtrada as soon as it's available.
    9 May 2014, 01:42 AM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    In general, I agree. For anything beyond the S400 million milestone, we will need a diagnostic blood test that predicts who will likely develop autoimmune thyroid disease (IL21?).
    Or, we will need a medication that prevents the majority of autoimmune thyroid disease following alemtuzumab (Kepivance?).

     

    http://bit.ly/UAPoWG
    9 May 2014, 10:20 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    From an outside view, psychologically, such a test would be a great, indeed.

     

    But rationally, I don't think it is necessary. The autoimmune thyroid diseases after Lemtrada treatment are minor problems compared to MS. At least when treated, and that's why the monitoring is in place. Yes, they do decrease the quality of life but the side effects of other, less efficacious, drugs seem to decrease life quality as well.

     

    I remember a video interview with a researcher from the Cambridge University. She said that a third of the MS patients gets these other autoimmune thyroid diseases anyway. So most of the 30-40% patients on Lemtrada might have got these thyroid diseases anyway. They might just get it a couple of years earlier.

     

    I could be mistaken though since I can't find the link to that video anymore.
    13 May 2014, 05:22 AM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    Personally, I agree with you. A significant number of risk averse physicians may disagree with you.
    13 May 2014, 03:20 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » The FDA responds to the citizen petition: http://bit.ly/Ss6oAA
    23 May 2014, 11:19 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Did the petition raise a number of points the FDA had not thought about?
    23 May 2014, 12:15 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    I was just joking with my previous comment. This FDA response suggests increased chances on a late approval.

     

    So far the FDA messages came down to "too many side effects" and "no double blind trial = no evidence of efficacy = no approval". Therefore the decision making was simple so far. But now the FDA doesn't want to repeat the 2 points their decision was based on. Instead the FDA acknowledges that Melissa Burdick has raised some "complex issues requiring extensive review and analysis".
    23 May 2014, 01:54 PM Reply Like
  • KL Investment Partners
    , contributor
    Comments (349) | Send Message
     
    Genzyme's Lemtrada Recommended for Reimbursement on NHS by the National Institute for Health and Care Excellence (NICE).

     

    http://bit.ly/1wi1Psd
    27 May 2014, 09:15 PM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    Would sanofi start selling lemtrada in the uk immediately or probably not until the 3rd quarter?
    27 May 2014, 11:48 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    “With this final guidance, the responsibility for treatment decisions with Lemtrada is now handed over to UK healthcare professionals and their patients.”

     

    This statement would suggest that doctors can now prescribe Lemtrada for their MS patients. I would assume that Lemtrada is available in hospital pharmacies so sales can start immediately.

     

    I'm just guessing.
    28 May 2014, 09:24 AM Reply Like
  • pault123
    , contributor
    Comments (90) | Send Message
     
    Genzyme MS drug to become available in the UK
    http://bit.ly/TVMvmz
    28 May 2014, 10:58 PM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    Why would gcvrz drop yesterday after the uk news?

     

    Isn't lemtrada now reimbursable in the uk?

     

    In Germany it is all out of pocket so this uk news should be positive, right?
    29 May 2014, 07:44 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    @bigred2: when the market goes up the price of most CVRs seems to go down.

     

    Was the NICE reimbursement decision a couple of months sooner than expected by some of us?
    29 May 2014, 08:27 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Yes, Ruerd. I think the conventional wisdom was that the NICE decision wouldn't come until October so this is quite a bit sooner than expected. Maybe other European countries will move a little faster than expected.
    29 May 2014, 09:10 AM Reply Like
  • Geusie
    , contributor
    Comments (11) | Send Message
     
    Genzyme’s Lemtrada Resubmission Accepted for Review by FDA
    - Agency action expected in Q4 2014 -
    30 May 2014, 04:05 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    "Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of LemtradaTM (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter."

     

    Only 6 months more to wait for the FDA? I'd like to comment but Chris will delete it so I'll just ask the following: Is the new info that Genzyme gave to the FDA so complicated that the geniuses at the FDA need 6 months to figure it out? I think the FDA is just hoping that someone will find a cure for MS so they don't have to make a decision. Anyway, the first US sale must be completed by the end of 2015 so the US is still potentially in the game. We'll just have to look forward to the Q2 sales data which comes out at the end of July.
    30 May 2014, 07:19 AM Reply Like
  • KL Investment Partners
    , contributor
    Comments (349) | Send Message
     
    It is a positive sign that the FDA has accepted for review Genzyme's Lemtrada re-submission in approximately one month.

     

    This contrasts with the original application which the FDA took seven months to accept for review.

     

    Relevant links:

     

    May 2014 -- FDA accepts for review the resubmitted application
    http://bit.ly/1progtb

     

    April 2014 -- Genzyme to resubmit Lemtrada application
    http://bit.ly/1progtf

     

    Jan 2013 - FDA accepts for review the original application
    http://bit.ly/1proeRV

     

    June 2012 - original FDA application
    http://bit.ly/1progJv
    30 May 2014, 10:04 AM Reply Like
  • Keubiko
    , contributor
    Comments (2884) | Send Message
     
    I would note that Genzyme just cranked up hiring for Lemtrada-specific positions in the US:

     

    http://bit.ly/1prsrFh
    30 May 2014, 10:21 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Thanks for the finds. Let me play devil's advocate: they hire these people to sell Lemtrada administered in Canada to US patients.

     

    It seems to be very early to hire these people for selling in the US given the disappointing 6 month review period.

     

    Anyone an opinion on the chances of approval?
    30 May 2014, 11:54 AM Reply Like
  • Keubiko
    , contributor
    Comments (2884) | Send Message
     
    Genzyme has an operating subsidiary in Canada. Pretty much every pharma company does. The operational, labeling, legal, and regulatory environment don't lend themselves well to cross border ops. Not to mention the French language in Quebec.

     

    Also note one of the positions is for the Central Region of the U.S. and another is for:

     

    "US Medical Director, Medical Affairs LEMTRADA MS"

     

    I don't think it's too early to be hiring these folks. They have to be up and running operationally and from a regulatory standpoint.

     

    I now think the chance of US approval is good (60+%). If Genzyme didn't agree they would have gone the appeals route.

     

    The FDA look like buffoons not approving this while every other major country is approving with gusto.

     

    My guess is it gets approved with labeling for 2nd-line therapy.

     

    30 May 2014, 12:03 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Thanks. Suppose that only the first 2 sales milestones will be achieved and that they will be achieved within 4 years if the FDA approves it. Then a 60% chance on approval implies a present value of GCVRZ of about 2.5 (using a discount percentage of over 10%)
    30 May 2014, 12:25 PM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Ruerd,

     

    60% percent chance seems optimistic but surely we are well above 25% (maybe up to 50%) now that the FDA is fast tracking the re-submission and they seemingly gave positive lip service to the citizen's petition.

     

    This looks to be a solid speculative buy below $1 but there is still a good chance this turns into a zero. However I'd coinflip wager 50 cents to win $3+ any day.
    30 May 2014, 06:41 PM Reply Like
  • nmecmbtnt
    , contributor
    Comments (124) | Send Message
     
    Using odds of approval for Lemtrada in the U.S. of 65% before the end of the calendar year. Believe that a $2 price, with such approval, is well within reach. Far more risk without an approval, but still within reach over a longer period.

     

    Also believe the options are currently fairly priced, at $0.50+- with these factors considered.

     

    Your money, your risk, no substitute for your own due diligence & insight.

     

    Disclosure: Long GCVRZ.
    3 Jun 2014, 10:20 AM Reply Like
  • seeking betta
    , contributor
    Comments (759) | Send Message
     
    If they hit the 2nd milestone - assuming FDA approval - then the addl $1 approval milestones also pays, right?
    30 May 2014, 01:22 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    The 2nd sales milestone only pays out the extra dollar if they hit the first sales milestone.
    30 May 2014, 02:12 PM Reply Like
  • seeking betta
    , contributor
    Comments (759) | Send Message
     
    Bud if they miss the first sales milestone - the second can still pay out?
    30 May 2014, 03:41 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Yes but the second one is for much more sales. Most investors probably think FDA approval is necessary for the 2nd sales milestone.

     

    There's a 3rd and a 4th sales milestone as well. See the links in the SA articles on GCVRZ.
    30 May 2014, 04:10 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    In Genzyme's December 30, 2013 press release concerning the FDA's Complete Response Letter, Genzyme says:

     

    "FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Genzyme understands that the conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada in relapsing-remitting MS patients."

     

    So, it looks like there are 2 problems:

     

    Problem #1: The studies were not adequate and well controlled.
    Problem #2: Genzyme did not demonstrate that the benefits of Lemtrada outweigh its serious adverse effects.

     

    This is part of Genzyme's press release on May 30, 2014 regarding their Lemtrada resubmission:

     

    "This resubmission is based on data from the same clinical studies included in the original sBLA, and provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. The company resubmitted the sBLA earlier this month following constructive discussions with the agency."

     

    What are the "supplemental analyses and additional information" that Genzyme submitted?

     

    If you (painfully) read the text of the Amended Class Action Complaint posted by Chris on May 1st, there are 3 important themes that may shed light on what Genzyme resubmitted and whether they will be successful.

     

    1) Management Hype and Misrepresentation
    2) FDA communications to Genzyme
    3) FDA Advisory Committee Voting

     

    Let's address Problem #1:
    The lawsuit states that the FDA for years warned Genzyme that the trials were critically flawed, contained high levels of placebo effect and observer bias which tainted the results and that Genzyme would need to fix these flaws (which it never did). Specifically:

     

    1) On November 21, 2006, the FDA said that "a rater blinded (but not patient blinded) study may be adequate IF THE EFFECT IS LARGE. A totally blinded study is more likely to be found persuasive if the treatment effect is relatively small"

     

    2) On June 29, 2007, the FDA sent a letter to Genzyme stating "FDA strongly recommends that you use a double-dummy placebo control. The acceptability of your rater-blinded study will be a matter of review. If your study results reveal an extremely large effect, then the FDA may potentially accept this rater-blinded design. You should carefully assess ... to determine if the RATER BLIND WAS MAINTAINED.

     

    3) On March 17, 2010, the FDA met with Genzyme and the FDA was concerned by the potential bias introduced by the absence of blinding patients, the possibility of unblinding of EDSS raters, the initiation of alternative MS therapies after the first relapse... The interpretation of the results from the statistical analysis will be challenging and EXTREMELY ROBUST FINDINGS will be necessary to overcome these issues.

     

    4) On January 24, 2011, the FDA said "the lack of double-blinding has consistently concerned us... You need to present data and analyses that evaluate the objectivity of the EDSS and MRI outcomes as well as the relapses.

     

    I think Problem #1 is going to be the hardest to overcome based on the fact that Genzyme ignored the FDA's advice for years. In addition, it's not clear to me that Genzyme is going to be able to massage the statistical data to prove that the studies were well controlled.

     

    Let's address Problem #2: According to the FDA, Genzyme has to demonstrate that the benefits outweigh the serious side effects. I think this Problem will be easier to resolve given the newest MRI data and any other patient study input that Genzyme submitted.

     

    Lastly, a question. Can anybody provide any answers to the question:

     

    What do you think the "supplemental analyses and additional information" was that Genzyme submitted in its May 2014 resubmission to the FDA?
    4 Jun 2014, 03:00 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Part 2: FDA Advisory Committee Voting (All this info is taken from the Amended Class Action Complaint.)

     

    In the days before Genzyme received the Complete Response Letter, the FDA advisory committee voted on 4 questions:

     

    1) By a 11-6 vote, the advisors accepted the view of the FDA staffers that there was "bias" in Genzyme's clinical trials because the company didn't keep patients from knowing whether they were taking Lemtrada or another drug. We indicated our discomfort with the clinical trial as designed, acting deputy director of the FDA's Division of Neurology Products, told the advisors.

     

    I think this vote gave the FDA ammunition to reject Genzyme's Lemtrada application. So the question is, will the same thing happen again? Will Genzyme be able to "remove" the bias? Will the "supplemental analyses and additional information" convince FDA advisors and the FDA that the bias is gone or irrelevant?

     

    This brings us two additional questions:

     

    a) Will the SAME advisory committee be looking at, and voting on, the resubmission data? Or will a new FDA advisory committee be formed?

     

    b) Who in the FDA actually made the decision to reject Lemtrada? Was it one person or is it the goal of the FDA to depersonalize their decisions by just responding "The FDA blah blah blah ...". Thus no one person is responsible for the decisions the FDA makes.

     

    The other 3 questions voted on by the FDA advisory committee were all (mostly) supportive of Genzyme approval but not as a first line treatment.

     

    2) The committee voted 12-6 that Genzyme provided substantial evidence that Lemtrada worked for patients with relapsing MS.

     

    3) The committee voted 17-0 that Lemtrada's safety concerns shouldn't preclude its approval for patients for whom other drugs aren't effective.

     

    4) The committee voted 16-0 that Lemtrada should not be allowed for sale in the US as a so-called first line treatment for newly diagnosed MS patients.

     

    Note that this last vote means that newly diagnosed MS patients would not be contributing to US sales.

     

    So again, it all comes down to the "bias". Will Genzyme's "supplemental analyses and additional information" be enough to overcome the perception of "bias"?
    4 Jun 2014, 08:16 PM Reply Like
  • earljr1
    , contributor
    Comments (518) | Send Message
     
    And how long is a newly diagnosed patient newly diagnosed? I would think not much longer than it takes for the patient and doctor to decide Lemtrada is a good option.
    5 Jun 2014, 10:29 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Sounds like you think some (or many?) doctors will ignore the advice of the FDA and prescribe Lemtrada as a first line treatment even if the FDA only allows Lemtrada to be sold in the US as a second line treatment. Is that normal practice?
    6 Jun 2014, 08:33 AM Reply Like
  • Keubiko
    , contributor
    Comments (2884) | Send Message
     
    This is really a labelling issue. Lemtrada may be labeled/indicated as a first line therapy but doctors are free to prescribe for "off-label" use:

     

    http://bit.ly/Sg0YIf

     

    "The FDA approves a drug for prescription use, and continues to regulate the pharmaceutical industry's promotional practices for that drug through the work of the Office of Prescription Drug Promotion (OPDP, formerly the Division for Drug Marketing, Advertisement and Communication (DDMAC).[3] The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates."

     

    There is no bright line between "first line" and "second line". Generally "second line" is after a "first line" treatment has "failed", but for a degenerative disease like MS there is a lot of gray in terms of when an initial treatment has "failed". In general it may be "use this first and if you are stable we won't move on to a second therapy".

     

    If it gets labelled for second line therapy (my expectation) then fewer docs will prescribe it earlier, no question.

     

    If you talk to neurologists and MS experts there's a difference in philosophy - the "old school" generally feels that you start off with weaker safer meds, and as the disease progresses you get more and more aggressive. However more and more docs (IMHO the forward thinking ones) feel that "time is brain" and MS should be hit hard early to preserve as much brain and quality of life as possible - try to stop the progression in its tracks rather than waiting. The thyroid issues are serious but manageable.

     

    A key point here is that Lemtrada was being used already for MS when it was called Campath - it was approved/labeled/marketed for leukemia but being used *Off Label* for MS. In general most neurologists are well aware of Campath's off label use for MS.

     

    I view Lemtrada as the MS "bazooka" - higher risk but more impactful. With other drugs like Aubagio and Tecfidera ramping up I'm sure many docs would use those first and perhaps Lemtrada as second line.

     

    Of course there is already a huge MS population with RRMS that is already being treated with first line therapies like interferon so there may be a faster ramp as those (particularly those on interferon with RRMS that are getting worse) move to Lemtrada.

     

    This sums it up nicely:

     

    http://bit.ly/15IgmDi
    6 Jun 2014, 10:47 AM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    It is a judgement call. There are no hard rules. For example, about 15% of patients are intolerant of Tecfidera. If a patient is intolerant, a physician does not have to wait until a relapse to recommend an alternative. Since alemtuzumab is first line in the UK, there will be useful information coming out in the next 18 months.
    6 Jun 2014, 10:49 AM Reply Like
  • dh_ellingson
    , contributor
    Comments (19) | Send Message
     
    While searching for more information to better understand this investment I ran across this on the Bloomberg page, "The National Institute for Health and Care Excellence recommended Lemtrada as a cost-effective treatment for adults with relapsing-remitting MS, it said in its final guidance. The drug, which costs 56,360 pounds ($94,500) for a full course of treatment, should be available under the U.K.’s government-funded National Health Service within three months, NICE said."
    This is the first authoritative reference for cost of Lemtrada and thought you would like to know.
    8 Jun 2014, 10:17 PM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Here's the link to the article: http://bloom.bg/1l64L1O
    10 Jun 2014, 06:48 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Thanks for the update. Assuming it was a recent article, we're looking at the beginning of September.
    9 Jun 2014, 04:10 AM Reply Like
  • dh_ellingson
    , contributor
    Comments (19) | Send Message
     
    To support your assumption of Sept of this year, this is a quote from the MS Society web page, "In May 2014, the National Institute for Health and Care Excellence (NICE) issued its final guidance on Lemtrada. It recommended that Lemtrada be prescribed on the NHS in England and Wales for adults with active relapsing remitting MS. ‘Active’ is usually defined as two relapses in the previous two years.

     

    This means that from September 2014, hospitals and NHS Trusts in England and Wales will have to prescribe Lemtrada to all people who are eligible for it and who choose to take it.

     

    Decisions about whether Lemtrada will be available in Scotland and Northern Ireland are expected later in 2014." See
    http://bit.ly/1lXJzjJ
    Second issue, can anyone add insight to the trading pattern the last few days? Are these shares subject to manipulation because of the low price and limited number of shares which attracts attention to those who will 'leak false information' to cause price changes? Thanks for any helpful insights.
    19 Jun 2014, 12:04 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    The volume is so low that finding a buyer or seller on the other side of a trade is difficult. Given that the next news event is probably at the end of July (Q2 sales), most people, including me, are concentrating on other areas of the market. A few cents up or down is not going to make much difference to most investors since it seems that most people have established their position for the time being and are waiting for a digital event such as good or poor sales and a decision from the FDA in Q4.

     

    That said, GCVRZ shares are probably subject to manipulation by the market maker and dark pools. When I was buying, I noticed that even if I hit the ask for all the shares offered, there was no change in the Bid/Ask after my purchase. Dark pools are a big problem when deciding when to buy or sell. I encountered the same problem with GPT when it was climbing from $4.80 to $6.20 the first time around. My purchases and sales were visible only to the dark pools and the market maker, an obvious form of manipulation.

     

    Thanks for the update.
    19 Jun 2014, 03:25 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » "I think alemtuzumab is an excellent drug. It's very, very efficacious, and surprisingly well tolerated, considering its potency."

     

    - Dr Martin Wilson
    26 Jun 2014, 04:18 PM Reply Like
  • nmecmbtnt
    , contributor
    Comments (124) | Send Message
     
    Bow for the quote--see also link to source report: http://bit.ly/1izo8Gk
    26 Jun 2014, 05:36 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    I think this doctor was involved in the trials. I hope to see such recommendations from MD's that were not involved in the trials soon. Maybe someone reading this can arrange them.
    27 Jun 2014, 05:34 AM Reply Like
  • Laurent C
    , contributor
    Comments (62) | Send Message
     
    WGMIZ is being aggressively bid:1.69, from about 1.10 one week ago. I wonder what is driving this massive surge. The story is relevant to GCVRZ as the FDA appeal process takes the form of an amended PMA (instead of a DRP) with added scientific evidence, and the result is due in october. The parallel with GCVRZ is clear, one could argue the amended PMA would enable the FDA to approve after their august 2013 refusal without losing face.

     

    Is anyone aware of a new development? Any FDA leakage possible at all?
    27 Jun 2014, 03:43 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    It wouldn't surprise me if there is FDA leakage. Just before the news that Genzyme was going to resubmit the application the price of GCVRZ was bid up very agggresively.

     

    See also this comment on the old forum (and the 2 directly below this one):
    http://bit.ly/1mkwJaB

     

    And I found the downward movement before the critical FDA report in November very suspicious as well. Usually the market increases the implied chances on a positive outcome when the event comes nearby.
    27 Jun 2014, 05:22 AM Reply Like
  • ValGal
    , contributor
    Comments (107) | Send Message
     
    constala,

     

    I have also been wondering about move in WMGIZ. I see no news.

     

    The GCVRZ and WMGIZ stories certainly have parallel themes, but the mechanisms and criteria and technocratic hurdles are quite different.

     

    We are long both.
    27 Jun 2014, 08:03 AM Reply Like
  • BioInvestor2013
    , contributor
    Comments (20) | Send Message
     
    Possible run expected into Sanofi earnings August . 7 .2014 . this stay not longer under $ 1
    28 Jun 2014, 06:51 AM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    Will sales start in France Spain or Italy in q2?

     

    I think we have to wait until q3 or q4 for uk sales.

     

    Germany alone won't be enough?

     

    When is the Scottish independence vote?
    28 Jun 2014, 07:56 AM Reply Like
  • KL Investment Partners
    , contributor
    Comments (349) | Send Message
     
    Genzyme announced today that Lemtrada approved in Argentina for treatment of Multiple Sclerosis.
    30 Jun 2014, 08:05 AM Reply Like
  • 166649
    , contributor
    Comments (382) | Send Message
     
    GCVRZ Sanofi-Aventis's Genzyme’s Lemtrada Approved in Argentina for Treatment of Multiple Sclerosis

     

    Genzyme, a Sanofi company, announces that Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved Lemtrada (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. In addition to Argentina, Lemtrada is approved in the European Union, Australia, Canada, Mexico, Brazil and Guatemala. Lemtrada is currently not approved in the US. Genzyme recently announced that the FDA has accepted for review the co's resubmission of its application seeking approval of Lemtrada. Genzyme expects FDA action on the application in 4Q14.
    30 Jun 2014, 08:11 AM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Lemtrada has been approved in Scotland.

     

    http://on.mktw.net/1j9...

     

    OXFORD, England, Jul 07, 2014 (PR Newswire Europe via COMTEX) -- OXFORD, England, July 7, 2014 /PRNewswire/ --

     

    "Scotland has one of the highest rates of multiple sclerosis in the world, and the approval of Lemtrada in Scotland is an important step forward for people with active RRMS who remain in need of new treatment options. MS treatments have come a long way in the past twenty years and the availability of Lemtrada provides an opportunity for neurologists to offer a new therapy to people with multiple sclerosis," commented Dr. Belinda Weller, Consultant Neurologist, Western General Hospital, Edinburgh.

     

    The Scottish Medicines Consortium (SMC) today published its advice that Lemtradahas been accepted for use within NHS Scotland for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS), with active disease defined by clinical or imaging features.[1]

     

    "RRMS accounts for eighty-five percent of all initial diagnoses in MS. We are pleased that after many years in development, Lemtrada is now available to patients in Scotland. This provides people with MS with an important and innovative treatment option to consider in partnership with their MS specialists," said Amy Bowen, Director of Service Development at the MS Trust.

     

    There are approximately 10,000 people living with MS in Scotland.[2] The majority of people with RRMS experience approximately one or two relapses per year.[3] Around half of all relapses may leave people with lingering problems and disability may accumulate over time.[3],[4]

     

    Lemtrada is the second of Genzyme's treatments for MS to receive approval for use from the SMC and become available for use within NHS Scotland.[1] Lemtrada has also been approved by NICE and is available for NHS patients in England & Wales.[5]

     

    "We are thrilled by today's news that the SMC has approved Lemtrada for NHS use for people with RRMS. At Genzyme, patients at the heart of everything we do and this final milestone brings a treatment option to people with MS that could really reshape the management of their condition. We are also immensely proud of our association with Lemtrada as a home-grown product, developed and pioneered in Cambridge by a team of UK scientists. This reminds us of the UK's position at the forefront of science-led medicine, the importance of industry collaboration which brings global expertise in clinical development and our joint commitment to MS patients," commented Brendan Martin, General Manager for Genzyme UK and Ireland.

     

    About Lemtrada (alemtuzumab)

     

    Lemtrada is a humanised monoclonal antibody therapy which selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has transient impact on other immune cells. The reduction in the level of circulating T and B cells by alemtuzumab and subsequent repopulation may reduce the potential for relapse, which ultimately delays disease progression. Patients treated with Lemtrada had reduced annualised relapse rate compared to patients treated with subcutaneous beta-interferon injected three times per week, and treatment experienced patients were less likely to experience accumulation of their disability. Lemtrada is administered in two short treatment courses. The first treatment course includes one infusion per day for five days (course one). A year later a second course is administered one infusion per day for three days (course two).[6] Lemtrada had been in clinical development for MS for more than 10 years and is supported by an extensive multicentre, multi-country clinical programme.[7],[8],[9] Lemtrada was developed as part of research at the University of Cambridge and more than 1,500 patients received Lemtrada treatment as part of these clinical trials.[7],[8],[9]

     

    EU Indication and Usage

     

    Lemtrada is indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features.[6]

     

    Genzyme have introduced a risk management plan to ensure that Lemtrada is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet for Lemtrada, including the appropriate precautions to be followed by healthcare professionals and patients.[6]

     

    For full prescribing information about Lemtrada, the Summary of Product Characteristics can be found here: http://bit.ly/1j9ls2i +12+mg+concentrate+for...

     

    About Genzyme, a Sanofi Company

     

    Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents ground-breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

     

    About Genzyme in the UK

     

    Genzyme is a significant force in the UK biotechnology sector focused on improving the lives of patients with rare genetic diseases and multiple sclerosis. First established in the UK in 1981, Genzyme employs 450 people at two sites. Genzyme Therapeutics in Oxford is the company's UK commercial base marketing products for the treatment of patients with chronic debilitating diseases. These include genetic diseases such as lysosomal storage disorders (LSDs) - characterised by a lack of enzymes essential to healthy biological processes - and multiple sclerosis - a complex neurological disease affecting the central nervous system. Our portfolio also includes a therapy which aids in the management of thyroid cancer.

     

    References

     

    1. SMC guidance. alemtuzumab, 12mg, concentrate for solution for infusion (Lemtrada(R)) http://bit.ly/1j9ls2k

     

    2. Scottish Public Health Authority. Multiple sclerosis: key points. Available online at http://bit.ly/1j9ls2m [ http://bit.ly/1j9ls2m ] [Accessed December 2013]

     

    3. Multiple Sclerosis Trust. Types of MS. http://bit.ly/1j9lsiB [Accessed October 2013]

     

    4. MS Society UK. Relapsing-Remitting MS (RRMS). http://bit.ly/1j9luHn [Accessed January 2014]

     

    5. National Institute for Health and Care Excellence. Final appraisal determination (FAD). Alemtuzumab for treating relapsing-remitting multiple sclerosis. March 2014

     

    6. Summary of Product Characteristics: Lemtrada. Electronic Medicines Compendium (eMC) http://bit.ly/1j9ls2i +12+mg+concentrate+for... [Last accessed May 2014]

     

    7. Cohen et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a RCT phase III trial. The Lancet 2012; 380: 1069-1078

     

    8. Coles et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a RCT phase III trial. The Lancet 2012; 380: 1829-1839

     

    9. Coles, A.J. Alemtuzumab more effective than interferon b-1a at 5-year follow-up of CAMMS223 Clinical Trial. Neurology 2012; 78: 1069-1078
    7 Jul 2014, 04:16 PM Reply Like
  • riantyk
    , contributor
    Comments (56) | Send Message
     
    this doesnt sound too gd, coming from Genzyme...

     

    "Additional information: budget impact
    The submitting company estimated the population eligible for treatment to be 3,678 in year 1 and 4,129 in year 5. The uptake rate was estimated to be 0.4% in year 1, rising to 13% in year 5. The gross impact on the medicines budget was estimated to be £518k in year 1 and £10.8m in year 5."
    8 Jul 2014, 05:26 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Riantyk: note that this confirms pricing on the lower end of estimations so far: £35,000 or 60,000 USD for a first year treatment.

     

    In year 5, including second treatments, this will be only £20,000 per patient, currently USDGBP=0.58. Translating this to world ex-US these numbers imply about $1 billion of sales in year 5, so not enough for the second sales milestone.
    8 Jul 2014, 01:38 PM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Interesting find, Riantyk. I wonder if we could/should extend the take up rate for Year 1 to other Major Markets??

     

    Source of Riantyk's information: Page 11 of this document --http://bit.ly/1lSjz4T
    8 Jul 2014, 08:30 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Thanks for the link. Note that what I computed from page 11 (see my previous comment) contradicts the pricing table on page 10. The average price per patient from page 11 in year 5 is lower than the lowest of the 2 prices in the table on page 10.
    9 Jul 2014, 02:25 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    If I use the correct pricing, from the table on page 10, then 13% uptake with 41% of the patients eligible means $1.4 billion sales in year 5, world ex-us.
    9 Jul 2014, 03:36 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Last quarter GCVRZ took a tumble from 48 cents to 38 cents after Q1 sales were reported. It recovered the next day on positive 3rd year MRI results.

     

    I'm thinking sales will still be slow in Q2. Anybody think we might drop back to 38 cents again? I have a GTC order for additional shares of GCVRC at 35 cents. I won't be disappointed if the order is filled even though the reason would be because of slow sales. I'm still mostly positive on a Q4 FDA approval.

     

    Lemtrada sales figures should be out in about 3 weeks. I can't wait!
    8 Jul 2014, 06:02 AM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    I might buy more if it falls into the 30 cent range. The long game is how I'm viewing this one.
    24 Jul 2014, 04:40 AM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    Do Scotland sales count as uk sales?

     

    What if the Scottish independence vote is successful?
    8 Jul 2014, 06:38 AM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    My guess is that Scotland would count as UK sales with or without a vote for independence. Does anyone think otherwise?
    8 Jul 2014, 08:31 PM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    What you probably already knew about the Neurology division of the FDA:
    http://bit.ly/1kVXoLu

     

    "Our study finds, notably, considerable variation among the divisions. In fact, the median time for approval at the slowest division is three times as long as the approval time at the fastest. The slowest, the Neurology division, took nearly 600 days to approve a drug, and the two fastest units, Oncology and Anti-Viral, took under 200 days."
    14 Jul 2014, 01:14 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Note also that Neurology has a relatively low workload.

     

    This paper is a great find. The FDA is treated with their own principles: a scientific analysis of the approval times showing that they work "suboptimal". The paper mentions some severe consequences: deaths from late approvals and potential loss of US leadership in medical research.
    14 Jul 2014, 04:57 PM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    When will 2Q 2014 lemtrada sales be announced?
    22 Jul 2014, 08:12 AM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Sanofi is scheduled to report results on July 31st. I've noticed that they typically report Lemtrada sales on the same day.

     

    http://bit.ly/1A3vA1Y
    22 Jul 2014, 07:53 PM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    One week till sales; however most don't expect much news in the short term. This is a multi-year milestone play for those who are averaged in around 80 cents, give or take. Those trading it short term are likely gambling more than they'd admit and also will likely exit in on a two bit move. I know many that are holding for a Bagger (or bust) though.
    24 Jul 2014, 04:39 AM Reply Like
  • Richard Humphrey
    , contributor
    Comments (75) | Send Message
     
    I might have missed it if someone provided an update before, but it appears that Genzyme has posted quite a few more US based Lemtrada related job openings starting in June and up to as recently as last week.

     

    http://bit.ly/1prsrFh
    24 Jul 2014, 04:54 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    These are not just sales people, but also local "infusion support managers".

     

    When I see this I tend to think that they have got an informal assurance from the FDA that Lemtrada will be approved soon. Does that make sense or is it just wishful thinking?
    25 Jul 2014, 02:34 AM Reply Like
  • ValGal
    , contributor
    Comments (107) | Send Message
     
    I hope you are correct, but I think wishful thinking. First, I think that there will still be continued FDA staff resistance here. Some will no doubt dig their heels in further. Second, I doubt anyone is hinting at how the the political vote that counts (of FDA commissioners) is going to go.

     

    I still think we are less than 50% prob of approval but higher than implied by current price.
    25 Jul 2014, 07:54 AM Reply Like
  • Keubiko
    , contributor
    Comments (2884) | Send Message
     
    I reluctantly agree. I think the odds of U.S. approval are north of 80% now. The "constructive comments from the FDA" is important, as is the fact that every other major company is approving Lemtrada and the simple fact it is an important drug for certain MS patients.

     

    Also, I note that Genzyme/SNY's hiring behavior before the first date was tentative - just a few here and there. This time they are ramping this up with dozens of hires (or more) across the country. Obviously they are confident.

     

    25 Jul 2014, 10:53 AM Reply Like
  • ValGal
    , contributor
    Comments (107) | Send Message
     
    > 80% . . . I am skeptical, but I hope you are correct. We have a pretty large position based on a probability closer to 50/50.
    25 Jul 2014, 05:03 PM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    I'm afraid of confirmation bias but I too dreamed of such a rosy scenario - but then again we are dealing with a government agency, so who really knows how it ends.
    31 Jul 2014, 01:51 AM Reply Like
  • Monolith Investments
    , contributor
    Comments (130) | Send Message
     
    The company resubmitted the application after 'constructive discussions with the FDA'. I am not very familiar with the inner workings of the FDA, but to me the language in the press release seems to imply a higher than 50% chance. I guess only time will tell.
    25 Jul 2014, 09:18 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    If you read the complaints in the lawsuit, one of the key arguments from the plaintiffs is that Sanofi executives were consistently enthusiastic and positive about the prospect of approval for the last 4 years even though they knew, and did not make public, the fact that the FDA repeatedly warned Sanofi (Genzyme) that the trials were "critically flawed" and other FDA criticisms . I, too, was encouraged by the "constructive discussions" comment until I read the lawsuit. The FDA and Genzyme management seem to be living in different dimensions. I'm still long.
    26 Jul 2014, 12:37 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Before the CRL of the FDA in December 2013 there were a couple of days with very high trading volume for GCVRZ. At these days Sanofi probably bought back millions of CVRs.

     

    Just before and after they announced that they were going to resubmit the Lemtrada application the trading volumes were very high as well. Sanofi might have bought some CVRs during these days in the beginning of April. I think the volume was high then.

     

    Such insider buying would be consistent with the new hiring. It would also explain why the shares went up from 0.3 or so to almost 0.6 anyway. I don't think the news of the resubmission alone would have been enough to move the price that much without a big buyer such as Sanofi. I suppose a big buyer like an investment fund would time its purchases better than just buying on the news.

     

    I am looking forward to reading through Sanofi's quarterly results.
    26 Jul 2014, 04:06 PM Reply Like
  • Special Situations and Arbs
    , contributor
    Comments (1399) | Send Message
     
    Ruerd-

     

    Nice comment. You could be very right. It would be somewhat comforting.
    26 Jul 2014, 04:29 PM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    Someone should send this link to Dr. Evelyn Mentari, the nephrologist who said the benefit of alemtuzumab was not worth the risk for MS patients. But renal transplant teams will definitely use it in renal transplant patients.

     

    http://bit.ly/1AypWoA
    30 Jul 2014, 09:34 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Dr. Evelyn K Mentari is available at 301-796-2279 or evelyn dot mentari at fda dot hhs dot gov to discuss her view that MS patients should not have access to alemtuzumab.
    30 Jul 2014, 09:44 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    I have heard that MS patients have higher risks to develop other auto-immune diseases than other people. I wonder whether this is true.

     

    Put it differently: high dosages of alemtuzumab have been used as cancer drug for more than 10 years, labeled as campath. So I wonder what's the risk for these cancer patients on campath getting autoimmune diseases. Is this risk indeed much smaller than for MS patients on alemtuzumab?
    30 Jul 2014, 10:57 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » MS Petition To White House For New Treatment Option: http://bit.ly/1rGO16J
    30 Jul 2014, 01:03 PM Reply Like
  • tkswett
    , contributor
    Comments (67) | Send Message
     
    fyi....Confirmation email from White House takes few minutes to arrive in your email.
    30 Jul 2014, 01:25 PM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    Anyone want to hazard a guess of what Germany's Q2 2014 Lemtrada sales will be?
    30 Jul 2014, 01:45 PM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    How about double 1Q sales or $4m

     

    My question is whether sales have launched in
    the other major countries France, Spain,
    Italy and the United Kingdom .
    30 Jul 2014, 06:27 PM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    I don't know of any product launches in any major market aside from Germany. I think that $8M-$10M in German Product Sales would be a good estimate...
    30 Jul 2014, 06:32 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    I wish I could stay awake long enough to read the press release on Q2 earnings at 1:30am EST and, more importantly, sales figures for Lemtrada. My guess is that sales will be around $8 to $10 million for Germany, matching vjrao's estimate. The bigger question is how many more non-Major market countries will contribute to Q2 sales and will there be any "surprise" sales from Canada or any other Major Market country. The final and most important question for those of us that would like to add to our position is "What will GCVRZ do?" I still have my GTC orders for more GCVRZ in the $30 - $40 range.

     

    And now, I dream. I dream a dream of accelerating Lemtrada sales in 2015 after FDA approval in December. Bonne nuit et bonne chance!
    30 Jul 2014, 10:48 PM Reply Like
  • Geusie
    , contributor
    Comments (11) | Send Message
     
    Q2 Numbers just out for Lemtrada! 6 Mio for Q2, 11 Mio for the first half year!
    31 Jul 2014, 02:46 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    "Second quarter and first-half sales of Lemtrada™ were €6 million and €11 million, respectively."

     

    6 million euros = $8 million.

     

    Pitiful!
    31 Jul 2014, 03:09 AM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Sumi,

     

    Twas not too far from expectations on this board.
    31 Jul 2014, 07:52 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Lemtrada 6 million Euros of Q2 2014 net sales; 11 million Euros of H1 2014 net sales. In Q2, 5 million Euros came from sales to Western Europe and 1 million came from sales in the rest of the world. In H1, 10 million Euros came from sales to Western Europe and 1 million came from sales in the rest of the world.

     

    “Following its approval by the European Commission in September, Lemtrada™ is currently commercially available in a number of countries such as Germany, Nordic countries and Canada with additional launches expected in the second half of 2014. Second quarter and first-half sales of Lemtrada™ were €6 million and €11 million, respectively. In May, the U.S. Food and Drug Administration (FDA) accepted for review the resubmission of the supplemental Biologics License Application (sBLA) seeking approval of Lemtrada™. A six-month review period has been assigned for the Lemtrada™ sBLA.

     

    In April, new magnetic resonance imaging (MRI) data from the Lemtrada™clinical development program were presented at the 66th American Academy of Neurology (NYSE:AAN) Annual Meeting. In Lemtrada™ treated patients from the two Phase III clinical trials (both treatment-naïve patients and patients who had active disease on another therapy), the MRI effects observed after two years were maintained during the first year of the extension study.

     

    In May, the U.S. Food and Drug Administration (FDA) accepted for review Genzyme’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada™ (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period was assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter.

     

    Sanofi took a charge of €132 million mainly reflecting an increase in the fair value of contingent considerations related to the CVRs (€28 million, of which €33 million in Q2 2014) and Bayer contingent considerations (€104 million, of which €92 million in Q2 2014) linked to Lemtrada™.”

     

    - http://bit.ly/1rKgI2w
    31 Jul 2014, 04:26 AM Reply Like
  • Matt Young
    , contributor
    Comments (12) | Send Message
     
    Hi Chris, thanks for the info. Do you read much into their charge due to increase in fair value of CVRs? I suppose this is due to their re-submission to the FDA (which we're increasingly reliant on).
    31 Jul 2014, 07:24 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Yes, due to the FDA progress.
    31 Jul 2014, 07:32 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Link to the abstracts of alemtuzumab papers presented at the 66th American Academy of Neurology Annual Meeting:
    http://bit.ly/1qN3ndT

     

    To access, log in as guest first.
    31 Jul 2014, 08:36 AM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    So Germany is still the only major market with lemtrada sales?

     

    We have to get to $400 million in sales for the $2 payout?

     

    We better get u.s. FDA approval soon!
    31 Jul 2014, 06:53 AM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    Do German insurance companies reimburse for lemtrada or are all German lemtrada patients still paying out of pocket?
    31 Jul 2014, 07:14 AM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    Is anyone able to decompose the charges?

     

    "Sanofi took a charge of €132 million mainly reflecting an increase in the fair value of contingent considerations related to the CVRs (€28 million, of which €33 million in Q2 2014) and Bayer contingent considerations (€104 million, of which €92 million in Q2 2014) linked to Lemtrada™.”
    31 Jul 2014, 09:19 AM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    It sounds like they repurchased some of the CVRs and are writing off the cost.
    31 Jul 2014, 09:36 AM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    I think it is a contingent liability and those CVRs remaining outstanding represent the foundation for the charges, but am not sure. I am wondering in anyone has been able to back into some measures providing insights.
    31 Jul 2014, 09:41 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Bloomberg still reports that there are 238 million rights outstanding which would mean that Sanofi did not purchase any rights in the last 6 months. Don't know how accurate the Bloomberg info is.

     

    Nasdaq reports 249 million rights outstanding which I believe is too high.

     

    Best to look at Sanofi's 10-Q.
    31 Jul 2014, 11:46 AM Reply Like
  • ValGal
    , contributor
    Comments (107) | Send Message
     
    Sonofi must carry the outstanding CVRs on its balance sheet and as they fluctuate in value, it must realize that liability on its balance sheet. This accounting rule creates an odd effect . . . as the chances of Lemtrada improve, Sanofi shows losses. the reason is simple: the CVR liabilities are reflected immediately but the sales of the drug and accompanying profits are delayed.
    31 Jul 2014, 12:12 PM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    Accrual accounting. Matching principle. Periodicity assumption. Must match the cost to the period (income statement). Thank you, all.
    31 Jul 2014, 12:30 PM Reply Like
  • Monolith Investments
    , contributor
    Comments (130) | Send Message
     
    Do people have a view on the expected value of the rights if the FDA approves in December? How much would this impact the probability of achieving the first milestone?
    1 Aug 2014, 12:07 AM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    $1.50 anyone?

     

    Of course as we see with German sales, approval doesn't mean much unless insurance companies reimburse patients for the cost of the drug.

     

    Also new drugs could be introduced during the long the wait for approval which make lemtrada a less appealing treatment alternative.

     

    Without FDA approval the outlook is grim.
    1 Aug 2014, 02:01 AM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    big,

     

    Approval would send the stock up many fold. I'd think right now the market is pricing in approval at 5-10%. I'd think an FDA overturn on this one is much higher - although historically the appeals do offer meager probabilities. Good risk/reward here but realize the risk case means a likely zero on our investment.
    1 Aug 2014, 06:08 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Assuming the FDA approves in December I supposed the value is at least the present value of the first 2 sales milestones ($2 and $4). So it depends on when exactly these payouts will occur and on your discount rate.

     

    My low estimate for the fair value on January 1 2015 is $4.4. This assumes FDA approval, a discount rate of 10%, payout of $2 in July 2016 and payout of $4 in 2018.

     

    I suppose the market won't immediately recognize the value of the second sales milestone when the approval news comes out.

     

    To be more conservative you could also attach a probability to the second sales milestone. If you assume 50% then the minimum estimate for the fair value of the CVR will be slightly above $3 (at January 1, 2015).
    1 Aug 2014, 02:10 AM Reply Like
  • Jack Treme
    , contributor
    Comments (180) | Send Message
     
    Am I correct in understanding that Germany's contribution period runs from Jan 1 2014 to Dec 31 2014, as per the document, "Status of CVR Product Sales Milestone #1 as of January 16, 2014", located at Sanofi's CVR investor page:

     

    http://bit.ly/1ddvwOm ?

     

    If so, then the first milestone faces significant hurdles. As per Chris's article on GCVRZ, Germany has approx 31,200 RRMS patients who wish to seek treatment. Including the other four Major Markets in Europe (UK, France, Spain, and Italy), the total RRMS patients who wish to seek treatment is 96,216. As Chris pointed out in his article, we only need 6% of this population to be actually treated in order to reach the $400MM milestone. (Actually, by my calculation, at $60,000 per first treatment, it is closer to 7%, but close enough.) So, at 6%, this would be 5,772 people treated for all the European Major Markets, including 1,872 for Germany.

     

    Now, Germany thus far has contributed a total of $10MM during the first two quarters of the eligible contribution period (see "Product Sales Statement Q2 2014", also on the above Sanofi webpage). At $60,000 per first treatment, this represents approx 167 people treated in Germany so far. This is obviously a far cry from 1,872; it is doubtful that Germany could make up the difference in the remaining two quarters of their eligible contribution period.

     

    A few points. In Chris's article, he is being conservative and relying only on the five European Major Markets. Clearly, there is going to be some smaller contributions from the Non-Major Markets, as is already showing up in the sales numbers. Also, there is now an increased probability of an FDA approval in the U.S., the sixth and final Major Market. So, the 6 or 7% contribution from the five European Major Markets need likely be less, particularly so if the U.S. is in play. Still, the $10MM/167 treatments so far in Germany is very low and concerning, especially noting that Germany represents a large part (approx a little less than 1/3) of the European Major Markets.

     

    But the main point I want to make here is that something does not seem right about all this. Chris's article seems reasonable to me. A 6 or 7% target of the RRMS patients who wish to seek treatment seems reasonable to me. What does not seem reasonable is that the four calendar quarter period commences immediately after the calendar quarter in which the First Commercial Sale is made in a Major Market. This does not give a long enough chance for word to get out about the wider efficacy of the treatment (for better or worse), as more doctors and patients prescribe and use the drug beyond the limited clinical trials. A new drug (if good) usually takes time to ramp up in the market, as word and further studies get out. It is quite possible that, assuming Lemtrada is good, German annual sales could be significantly higher in the future than it will be now during the current annual eligibility period for the first milestone. But, alas, that won't make any difference for the first milestone. Same can be said of the other Major Markets.

     

    (Chris, I'd be interested in your thoughts on this. In particular, were you expecting a minimum 6% reach of the RRMS treatment seeking population of the European Major Markets within the first year of sales or were you expecting it later? I, myself, failed to properly consider this issue at the time.)

     

    There is one silver lining here. Germany is the only Major Market whose clock has started. So, as word spreads from Germany and other Non-Major markets of a (hopefully) effective drug, the other European Major Markets and the U.S. Major Market (if in play) can ramp up quicker when their annual clock starts, which doesn't have to start till Jan 1 2016 (though will very likely start sooner). Also, if I am reading the above mentioned "Status…" document correctly, the Non-Major markets period will run from April 1 2015 to March 31 2016, which also gives time for them to ramp up sales.

     

    Finally, I recall someone here questioning whether insurance coverage for Lemtrada has started in Germany. If it hasn't, that would be another premature basis on which to have already started Germany's annual clock. Again, just having the annual clock start in a Major Market after the first calendar quarter of the first sale in that Major Market, without letting the medical and patient communities, as well as the drug and insurance companies, get ready and "ramp up", as it were, is not an accurate way to assess annual sales and is unfair to CVR holders. But what do I know. I'm no expert. Maybe this is just the way it is.

     

    On the other hand, and finally (really this time), it may be that we have just grossly overestimated the market for Lemtrada (at least in Germany).
    1 Aug 2014, 03:08 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » I was expecting a minimum 6% reach of the RRMS treatment seeking population of the European Major Markets within the first year of sales. My understanding is that German reimbursements have not yet kicked in.
    1 Aug 2014, 07:48 AM Reply Like
  • vjrao
    , contributor
    Comments (72) | Send Message
     
    My understanding (from a conversation with Sanofi's IR department) is that Lemtrada is not eligible (at all) for reimbursement under Germany's Federal AMNOG program, which is a Federal medical reimbursement plan (think something like Medicare here in the US).

     

    However, Lemtrada can be reimbursed under some of the many SICK insurance plans that are present in Germany. The problem is that Sanofi must negotiate with those SICK plans on a one by one basis in order to secure reimbursement, which will likely not happen in substantial numbers this calendar year.

     

    Disclosure: Long GCVRZ
    1 Aug 2014, 12:16 PM Reply Like
  • Jack Treme
    , contributor
    Comments (180) | Send Message
     
    OK, on the one hand, this is good news. It is an insurance problem. The low German sales numbers should then not be indicative of sales when the other Major Markets start reporting, assuming those markets get their insurance situation straightened out by the time their clock starts.

     

    On the other hand, Germany's contribution to the milestone may be considerably lower than expected. If Vjrao's comment above is right, and there is no or little insurance for German patients currently, then, as Germany's clock ends this year, Germany's contribution will be significantly lower than expected, even if the insurance situation subsequently improves in Germany.

     

    Chris are you saying that the patients are not yet being reimbursed or that Sanofi/Genyzme is not yet being reimbursed? If the former, then it is as Vjrao said and Germany remains a low contributor. If the latter, then are you also saying that we can expect the German sales numbers for the previous quarters to be retroactively increased (or that the reimbursements for the previous quarters to be added to the upcoming quarters)?
    1 Aug 2014, 04:16 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » The patients are not yet being reimbursed.
    1 Aug 2014, 05:08 PM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Chris, where do you now handicap the odds of hitting milestone 1 and 2?

     

    And is it mostly an all or nothing play on the FDA appeal or do you assign a non-trivial percentage to the non-US sales numbers getting over threshold level on their own?
    1 Aug 2014, 06:38 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » The odds of non-US sales numbers getting over threshold level on their own are starting to approach triviality. The odds of hitting milestone 1 and 2 are okay, probably a coin flip, mostly based on the FDA appeal.
    1 Aug 2014, 08:31 PM Reply Like
  • Jack Treme
    , contributor
    Comments (180) | Send Message
     
    Chris, do you say this because of the German insurance situation, and that it may play out like this in some of the other non-US markets?

     

    If, however, the insurance problem is strictly limited to Germany, then by my calculations (see my post below), the sales numbers of the other European Major Markets plus Non-Major markets may be enough to push us past the milestone. But just barely.
    1 Aug 2014, 11:38 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Yes, I say this because I'm nervous that I missed something important about the tempo of their insurance reimbursements starting up (Genzyme might have missed this too, when negotiating the security).
    2 Aug 2014, 08:17 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    It's amazing how creative governments (Australia, Canada, US, Germany) are in denying their civilians the medical care they need.

     

    Only for Germany the clock has started. In Q4 or Q1 the clock will start in the UK and I expect much better sales there.
    2 Aug 2014, 08:33 AM Reply Like
  • Jack Treme
    , contributor
    Comments (180) | Send Message
     
    I will take a stab at some possible scenarios here, now that we have the German numbers. Any suggestions or corrections are welcome, and I'm sure Chris and others could offer a better estimate. A lot of this is based on Chris's article, "Best Ideas For 2014: Long GCVRZ."

     

    Scenario A: Current German run rate is the norm going forward and US FDA approval. First milestone fails.

     

    Germany has $10MM in sales so far for the first half of its annual period. Assume a generous $30MM for the second half. Total Germany: $40MM. Germany is approx 1/3 of EMM (all five European Major Markets). So all EMM sales = $120MM.

     

    US MS population is 400,000, as per various online sources. One can check this, but it seems to make sense as US total population is 314MM and EMM total population is 319MM. The US MS population of 400,000 is roughly same as all EMM MS population (400,900), as per Chris's article. Hence, applying same percentage of RRMS patients, seeking treatment patients, etc. and current German run rate, US sales = EMM sales = $120MM.

     

    Thus, $240MM total for USMM and EMM. That leaves Rest of World Non-Major Markets (NYSE:NMM). I have no idea what this should be, but assume it is not more than either USMM or EMM. Based on that assumption, Total Sales = $360MM. First milestone fails.

     

    What is surprising and concerning here is that even with US FDA approval, the current German run rate is still too low to overcome.
    -----------

     

    Scenario B: Current German run rate is an anomaly (due to lack of insurance or whatever). The actual run rate will be a minimum 6% of RRMS patients wishing to seek treatment, as per Chris's article. No US FDA approval. First milestone likely succeeds, but will be close.

     

    Germany Total Sales = $30MM (being a little more conservative here than in Scenario A). Rest of EMM meets Chris's run rate. If all of EMM met Chris's run rate, we would have $400MM sales, but minus 1/3 for Germany. So EMM sales - Germany sales = $266MM, and EMM sales = $266MM + $30MM = $299MM.

     

    Again, I have no idea what NMM sales should be, but if we assume that it is at least 1/3 of EMM sales, which is much more conservative than Scenario A, then NMM sales = $133MM. And Total Sales = $432MM. Milestone just passes.

     

    Again, bear in mind, that this scenario assumes that the current sales run rate in Germany is an anomaly and will not be seen in other markets. This is a big assumption, but if it really is just an insurance issue, and the other markets straighten out that problem, then it is a safe assumption. Also, notice that Germany's dismal showing is compensated by sales from NMM, which Chris ignored in his model, but which we definitely need in this scenario.
    -----------

     

    Scenario C (our favorite scenario!): Same as Scenario B, but with US FDA approval. First milestone overwhelmingly succeeds.

     

    To get the numbers for this scenario, all we need to do is add the US sales to Scenario B's total sales. From our analysis of Scenario A, we know that US sales should equal EMM sales, under equivalent run rates. Here we are assuming Chris's normal run rate, so EMM (normal run rate) sales = $400MM = USMM sales. And so, Total Sales = $432MM + $400MM = $832MM. First milestone succeeds.
    -----------

     

    In summary, what the above scenarios show is that the US FDA approval is not as critical as the sales run rate. In fact, if we were going strictly by the above scenarios, the FDA approval or disapproval is completely irrelevant, at least for the first milestone. But, of course, this assumes that Chris's model (6 or 7% penetration rate of RRMS patients seeking treatment) is accurate. Nevertheless, Chris, in his article, was not taking into account the FDA approval and still concluded a high probability of success. In reality, things are a bit more murkier, as we all are starting to see with Germany.

     

    What the FDA approval is, in my opinion, an insurance or buffer that can push us over in borderline cases that fail to quite reach the milestone mark. The real scenario may be something between A and B, where some markets exhibit Germany's anomalous sales run rate and some exhibit the 6% RRMS penetration rate. In such a case, the FDA approval may be the deciding factor.

     

    But, again, for me, the real question is what is going on with Germany, and can such a failure be avoided in the other markets. If it is really just an insurance issue that can be addressed before the sales clocks start in those markets, then fine. But if the insurance problem can't be solved in time and/or there are other mitigating reasons for the low sales numbers, then we're in trouble, and even the FDA may not be able to save us, so to speak.
    1 Aug 2014, 11:43 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Jack, your computations are correct except that there are a bit more patients in the NMM and that we should take second year treatments into account in the NMM. NMM could be 170-180MM in scenario B, so total sales 470MM.

     

    I think Germany isn't the only country where reimbusement limits sales. I do expect that reimbursement problems will be over when the clock starts for the NMM in April 2015.
    2 Aug 2014, 09:01 AM Reply Like
  • Jack Treme
    , contributor
    Comments (180) | Send Message
     
    Thanks Ruerd! I was being conservative. That's good to know. Also, good point about the second year treatments.

     

    Also, I want to point out a small error in Scenario B, that I was unable to correct within the edit time window. EMM sales = $266MM + $30MM = $296MM (not $299M), and so Total Sales =$429M (not $432M). It's a trivial difference, but just wanted to point it out.
    2 Aug 2014, 12:44 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Jack, I'm sorry, I didn't check your very first number thorough enough.

     

    400,000 EEM patients - Germans = 300,000 patients.
    Of these 40% have RRMS of which 6% will seek treatment. I vaguely remember that Chris' December article used another safety factor of 0.5 for the number of patients, but I can not check this now. Anyway I don't understand the reason for such a safety factor. Of course the 6% is still a guess.

     

    So the computation for scenario B is:
    EEM sales=300,000*0.4*0.06 * $60,000 +30MM= 462MM
    NMM sales= 200,000 patients *0.4*0.06 * $60,000= 288MM, assuming no second year treatments, which seems a reasonable assumption now.

     

    So total sales could still be 750MM. It depends on the "market share". Since 30% or so is still on the old, less efficacious injectables 6% seems a reasonable estimate. 3% (Chris' estimate with the extra safety factor) might be too low but 4% will still be OK for us.

     

    We will know more when they start selling in the UK, where reimbursement is set up already.
    2 Aug 2014, 04:35 PM Reply Like
  • Jack Treme
    , contributor
    Comments (180) | Send Message
     
    Hi Ruerd. Thanks for double checking the numbers. But I think you are using some slightly different assumptions than Chris (and me). (Of course, it doesn't help that you no longer have the article to refer to.)

     

    The number of German patients, by Chris's article (which he got from MS International Federation), are 130,000. So, it is 400,900 - 130,000.

     

    85% was the RRMS rate, but yes, you're right, Chris did cut it by a factor of about 0.5 to 40%. He was just being really conservative (all the more reason the German numbers seem really low).

     

    Also, as a further conservative measure, Chris only assumed that only 60% of the remaining RRMS patients were actually seeking treatment. You left this out of your calculation. Maybe it is another unnecessary conservative factor (Chris did admit that it is a growing percentage as more treatment options become available), but again, all the more reason the German numbers look low.

     

    Finally, as I mentioned in a comment earlier, the final 6% penetration rate really should be 6.9% in order to reach the $400MM mark. But whatever, you can lower the penetration rate and be less conservative about the RRMS rate or seeking treatment rate. The point is that these are all very conservative numbers and we are trying to guess what are the *minimum* number of patients that may be treated.

     

    I have no idea about the NMM patient number, but my estimate of 1/3 of EMM sales may indeed have been too low.

     

    You may actually be right with your less conservative calculations. And that then would be really good, as we don't just squeak by in Scenario B due to Germany's dismal numbers. Again, this assumes that the "blunder" in Germany is an isolated or very limited case. Otherwise, all our calculations, as conservative as they may be or not, will prove to be too high yet.
    2 Aug 2014, 07:51 PM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    Up $0.02 today but yahoo finance says trading volume is only 315,000
    4 Aug 2014, 01:27 PM Reply Like
  • brent999
    , contributor
    Comments (19) | Send Message
     
    315k is the 3mo avg vol - 22k is the day vol @2:11 est
    4 Aug 2014, 02:13 PM Reply Like
  • bigred2
    , contributor
    Comments (73) | Send Message
     
    Yahoo finance lags on the daily volume too - end of day volume was over 561,000
    4 Aug 2014, 10:57 PM Reply Like
  • dh_ellingson
    , contributor
    Comments (19) | Send Message
     
    Regarding end of day price shown on Yahoo, it is wise to check the size of the trade for the last sale. Today there was a flurry of sales in the $0.48 - 50 range, well over 300,000 shares, but the last sale was for $0.46 with only 400 shares at the last second of normal trading. This has been a common practice this last month which I think indicates that someone is intentionally manipulating the price at the end of the day to show lower for the purpose of accumulating at the lowest price. For an investor this is a good sign of positive days ahead.
    4 Aug 2014, 11:54 PM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    I see two extreme possibilities, with very little downside risk, at least at this PPS level, but could be wrong:
    1-FDA approves and PPS increases, significantly.
    2-FDA does not approve, lawsuit proceeds, and any news of favorable legal progress results in a PPS increase, but perhaps only after PPS decline.
    Comments appreciated.
    6 Aug 2014, 09:11 AM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    http://bit.ly/1kOGS5N
    "Lemtrada" mentioned.
    8 Aug 2014, 01:10 PM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    http://bit.ly/1kOJYXC
    8 Aug 2014, 01:30 PM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    That is interesting. My L2 shows someone dumped 70K sh at $0.39 in pre-market today.
    11 Aug 2014, 09:00 AM Reply Like
  • Richard Humphrey
    , contributor
    Comments (75) | Send Message
     
    The trade was done off exchange. It could be a (very) late reported trade, some type of weird basket, or simply a mistake. I wouldn't read too much into it.
    11 Aug 2014, 09:10 AM Reply Like
  • rootbeer
    , contributor
    Comments (321) | Send Message
     
    Interesting comparison of natalizumab vs alemtuzumab This UK clinic feels that alemtuzuimab should be the easy choice in difficult to treat MS patients who are JCV positive.
    Alemtuzumab offers a chance of functional cure in MS with possible autoimmune thyroid disease. No other med offers a chance of cure. No other med seems to generate so much distrust. Why?
    http://bit.ly/1qcXv7t
    15 Aug 2014, 02:00 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    @rootbeer, thanks. This one is also interesting, from the same blog:

     

    Clinical and laboratory data including serial Expanded Disability Status Scale (EDSS) assessments, from all 87 MSers treated with alemtuzumab on investigator-led studies in Cambridge, UK, from 1999 to 2012, were collected.
    .....
    Over a median 7-year follow-up (range 33-144 months), most MSers (52%) required just two cycles of alemtuzumab.
    .....
    Using a 6-month sustained accumulation of disability definition, 59/87 (67.8%) of MSers had an improved or unchanged disability compared with baseline. By an area under the curve analysis, 52/87 (59.8%) MSers had an overall improvement or stabilisation of disability.
    .....
    Alemtuzumab is associated with disease stabilisation in the majority of MSers with highly active RRMS over an average seven-year follow-up. No new safety concerns arose over this extended follow-up.

     

    http://bit.ly/1oBjJEK

     

    Also note that more than 2 treatments (48%) apparently makes sense, at least in Cambridge (UK), if relapses continue.
    15 Aug 2014, 03:31 PM Reply Like
  • pault123
    , contributor
    Comments (90) | Send Message
     
    Maybe some day Lemtrada will get approved.
    -------------
    FDA approves Biogen Idec’s multiple sclerosis drug
    http://bit.ly/1m6Jp6s
    16 Aug 2014, 09:24 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Paul (and Brad): this Biogen drug is a minor modification of an old and pretty ineffective drug. Won't make a big difference for the patients.
    17 Aug 2014, 04:25 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » 2 signatures to go; please help:

     

    http://1.usa.gov/1qN0FoB
    20 Aug 2014, 04:17 PM Reply Like
  • US Investor
    , contributor
    Comments (135) | Send Message
     
    Signed and forwarded to few folks
    20 Aug 2014, 09:47 PM Reply Like
  • platonicbomb
    , contributor
    Comments (1610) | Send Message
     
    It says 99K left to go...
    20 Aug 2014, 10:01 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » I meant 2 to get it up on the White House website. Yes, the rest are for the public to sign it or not. But now that it is over 150, it is more readily accessible: http://1.usa.gov/1liwh3v.
    20 Aug 2014, 10:03 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Thanks a lot Chris, and those US citizens who signed! I hope you will get lots of other signatures.

     

    Only now I see that this is the website of the President and his staff, I couldn't find the usual link with "about us". What a great site!
    21 Aug 2014, 04:06 AM Reply Like
  • HFI
    , contributor
    Comments (1562) | Send Message
     
    I signed.
    21 Aug 2014, 02:07 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Thank you, Wilson.
    21 Aug 2014, 02:18 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    I am sending messages to my social media contacts. This is an example message, please copy and send it to your contacts.

     

    The FDA has turned down a very effective MS medicine, based on unjustified criticisme on the trials and excessive risk aversion. So far this drug has been approved in Canada, Europe, Australia, Mexico, Argentina and Brazil. I expect that it will be available anywhere but probably not in the US.

     

    If the FDA doesn't approve this drug then thousands of patients will die in the US. Therefore Chris DeMuth Jr. is asking the White House to get alemtuzumab approved. Can you please help the MS patients by signing his petition?

     

    The link is: http://1.usa.gov/1qN0FoB
    21 Aug 2014, 04:29 AM Reply Like
  • milkchaser
    , contributor
    Comments (1015) | Send Message
     
    Excellent letter. I will use it. One tiny criticism: criticism does not have an e at the end.
    21 Aug 2014, 06:35 AM Reply Like
  • riantyk
    , contributor
    Comments (56) | Send Message
     
    while I am also vested in this CVR, I think the phrase "thousands of patients will die in the US" is incorrect, and might in fact dent the credibility of this appeal. MS is chronic disease, plus there are multiple therapies around. personally I'll sum up Lemtrada as "revolutionary" "convenient" "effective" and "cost-efficient". perhaps quote a few UK NICE paragraphs on ICER as well :)
    21 Aug 2014, 11:46 AM Reply Like
  • Manoj Madhavan
    , contributor
    Comments (177) | Send Message
     
    GCVRZ seems to have found a "floor" around $0.50. As sales from the 31 approved countries keep coming in, the floor is getting validated. Sanofi management indicated on the latest earnings call that the second half of the year will be better than the first half. This is logical as the sales force, care providers and payer networks ramp up gradually after launch and as positive feedback is received from patients who have had success with the product.

     

    A 10% to 30% pop in the price of the CVR is expected as we get closer to the FDA date (November 2014).
    This pop is going to be driven mostly by greed and hope. Anyone willing to wait 3 months should be able to make an easy 10% provided he or she sells before the FDA decision.
    Thoughts?
    28 Aug 2014, 05:20 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Manoj, you said: "As sales from the 31 approved countries keep coming in, the floor is getting validated. Sanofi management indicated on the latest earnings call that the second half of the year will be better than the first half."

     

    Lemtrada sales from 1H 2014 were so bad that 2H 2014 will obviously be better that 1H 2014. If sales are $12 million in 2H 2014, that would be very bad but still better than 1H 2014. I wouldn't trust much of what Sanofi management says. They've been way overly optimistic and many people got burned trusting management.
    29 Aug 2014, 11:41 PM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    I agree w.r. to the anticipated upward drift and measures. What PPS would you anticipate if/when FDA approves? Are most likely to sell into any rally? Over-reaction to the upside?
    28 Aug 2014, 08:22 PM Reply Like
  • Manoj Madhavan
    , contributor
    Comments (177) | Send Message
     
    AJHolley1957
    If the FDA approves this drug, the 400MM milestone is very reachable. I would expect the PPS to move up closer to $2 (say $1.8 or $1.9). Also, even if there is an FDA rejection, there is a high probability that the PPS does not fall below $0.5. (of course, there will be a short term drop right after FDA rejection if it occurs)
    Why do I say this?
    - Chance of appeal by Sanofi
    - Sales from 31 approved countries
    - Patients and their families in the US willing and able to travel to Canada and/or Europe to get Lemtrada treatment
    29 Aug 2014, 08:33 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    I think you are a little optimistic if the FDA rejects. An appeal would take a year. In that case, the US might fall out of the Major Market window for sales. If the FDA rejects in December, I would expect GCVRZ to drop to the low 20 cent range.
    29 Aug 2014, 11:29 PM Reply Like
  • Jorge_Soriano
    , contributor
    Comments (263) | Send Message
     
    I agree, if FDA rejects, this is when I will just take my losses and move on. However, I am hanging in there right now and hoping the "coin toss" goes in our favor!
    30 Aug 2014, 08:14 PM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Manoj,

     

    Most here think that appeal odds are well under 10% and I'd suspect non US sales have a worse chance than that. A rejection takes this thing down another 50%. However with an acceptance - we can have a double or triple plus.
    31 Aug 2014, 07:57 AM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    Any conjecture on FDA decision dates?
    29 Aug 2014, 02:02 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Reducing salt intake is more effective than some MS drugs?

     

    "Salt is bad for people with multiple sclerosis

     

    People with multiple sclerosis who eat a diet high in salt may face more complications than those who don't, according to the latest edition of the Journal of Neurology, Neurosurgery & Psychiatry.

     

    The study observed 70 patients with MS over two years and found the patients who ate a lot of food with salt were 3.4 times more likely to develop a new lesion than those who consumed low-salt diets.

     

    The results suggest those who are suffering from MS should find ways to lower the amount of sodium in their diet."
    29 Aug 2014, 11:24 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Peter Huber may Save Your Life: http://bit.ly/1A1XsjW

     

    Peter Huber’s The Cure is the Code is likely the best nonfiction book in years if quality is measured by the potential to improve important social policy. Huber compellingly shows how twenty-first century medicine can lengthen life and improve its quality, if only we can get rid of the twentieth century mindset of government control at the FDA and in the Obama administration. Huber does not write as a political polemicist, but as scientist, demonstrating that the model of medical treatment and discovery on which current law rests does not comport with the revolutionary nature of modern molecular and genomic medicine.

     

    Huber concedes that, at one time, a more collectivized medicine made some sense. Early in the last century, highly contagious infectious diseases imposed substantial risks to society as a whole. Government was then right to impose a centralized regime that could order improvements in drinking water and insist on universal vaccinations. For such diseases, the FDA’s method for testing efficacy through randomized trials also worked, because generally the drugs for infectious diseases focused on stopping microbial invaders and worked the same in everyone’s body.

     

    But in the West, infectious diseases are now largely contained. Increasing longevity now requires progress against diseases generated in large measure by our own bodies, like cancer, heart problems, and neurological disorders. Fortunately, science, with the help of genomics, can conquer these diseases by diagnosing and fixing their causes at a molecular level. But the cures for what the lay public understands to be a single disease, like breast cancer, will often differ radically depending on the patient and perhaps even her personal environmental history.

     

    Huber explains why the new science of personalized medicine requires a revolution in government health care policy. The FDA’s traditional trials will miss many life-saving treatments if different drugs or combinations of drugs work only in small numbers of people. In addition, molecular and genomic science today is always adding to general medical knowledge not linked to any particular drug. As a result, the FDA should shift from “frequentist” to Bayesian probability analysis and legalize drugs that can be justified by combining this general information with an understanding of how the drug works. To be sure, this process will require the kind of risk-adjusted judgments bureaucrats like to avoid, but the alternative is to keep patients from enjoying the benefits of the scientific frontier.

     

    Molecular and genomic medicine also means that further medical progress requires unlocking information about the distinctive biological makeups of patients themselves. But Huber points out that federal law places many barriers not only between patients and drug companies, but between doctors and those companies.

     

    Finally, with its top-down enthusiasm for determining the best general practices for patients, Obamacare is also out of step with an ever-more personalized medicine. The treatment that is generally effective for many may well not be effective on you, but general rules—the stuff of law—will crowd out the individualized treatment—the stuff of new medicine. And centralizing health care policy in the federal government will discourage drug companies from investing even in this new golden age, because they may fear that the government will use its power to prevent them from getting a market return on their investment. And when they do get drugs to market, political demagogues will be aided and abetted in expropriating their profits, because drugs targeted at a few people will often require high individual prices to pay for the high cost of research.

     

    Huber’s solution is more freedom in health care policy—more freedom for doctors and patients to collaborate with one another, more freedom for the seriously ill to take risks that to choose cures that will advance medical knowledge, and more freedom for the wealthy to spend money on cutting-edge treatment that ultimately redounds to everyone’s benefit. In medicine today, information is power and there is no better device than the market for gathering dispersed bits of information, bringing them together, and making new knowledge available in usable form as fast as possible. If the next President has any sense, he or she will make Huber his medical czar so he can euthanize the monster of current federal health regulation.
    2 Sep 2014, 01:49 PM Reply Like
  • cfishnc
    , contributor
    Comments (24) | Send Message
     
    Seems you miss the point that most of the countries that approved Lemtrada have socialized medicine. Words like freedom are nice but it comes down to what is working. The FDA at times seems to work with the insurance companies. The FDA could have been looking at cost (austerity) as well as effectiveness when they looked at Lemtrada. You know looking out for inusrance companies and not the people.
    6 Sep 2014, 11:46 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    cfishnc: total costs of Lemtrada treatments are almost certainly much less than those of other modern treatments (e.g. Tecfidera, Gilenya, Aubagio) since Lemtrada does not need to be administered as often as the other medicines.

     

    Moreover costs for society are less since it is at least as efficacious as competing drugs. The reports written for the NICE approval in the UK confirm this.
    6 Sep 2014, 04:17 PM Reply Like
  • cfishnc
    , contributor
    Comments (24) | Send Message
     
    Ruerd
    I agree with what you say. From what I see Lemtrada works. I was trying to make a point that Single Payer (socialized medicine) also works.
    The article above criticized the affordable care act like it was to blame for Lemtrada's denial by the FDA.
    I sold my shares a a day or two ago after reading the above article.
    So this is my last post. I am thinking the FDA if they do approve will put so many limitations on the drug (ex investigational and experimental) just words but its all insurance companies need to loophole there way out of not paying for something that does work. Kind regards
    10 Sep 2014, 02:20 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    cfishnc, best of luck then, hope you sold for a profit.

     

    BTW whether any post approval restrictions of the FDA would harm sales or not has been discussed on this forum and on Chris' GCVRZ archived forum as well.
    10 Sep 2014, 03:50 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Genzyme continues MS drug rollout across EU: http://bit.ly/1tXW16i
    Lemtrada and Aubagio now available in Republic of Ireland
    Genzyme's plans to grow its multiple sclerosis business in Europe continued with the launch of two new treatments in the Republic of Ireland.
    The company, which serves as the biotech arm of French pharma firm Sanofi, today launched the injectable Lemtrada (alemtuzumab) in the country just weeks after oral multiple sclerosis (MS) treatment Aubagio (teriflunomide) hit the market.
    Lemtrada will be made available to adults with active relapsing-remitting multiple sclerosis (RRMS), in accordance with its approval from the EC. It is to be given as an intravenous infusion in two annual treatment courses.
    Aubagio is also available for adults with active RRMS, although it is one of several new MS treatments that come in an oral formulation, offering greater convenience to patients. It is to be taken once daily.
    According to Genzyme, there are 8,000 people in Ireland with MS and around 85% will be affected by RRMS.
    The launch of Lemtrada follows a recommendation in July this year from the National Centre for Pharmacoeconomics (NCPE), which provides guidance on what drugs should be reimbursed on Ireland's healthcare system to the Health Service Executive (HSE).
    By contrast, Aubagio was turned down by the NCPE in June with after its assessment found that the drugs cost was not justified by its benefits.
    However, in a conversation with PMLiVE, Henry Featherstone, director of public affairs at Genzyme UK & Ireland confirmed that Genzyme has since held discussions with the HSE and they have agreed that the drug can be reimbursed in Ireland.
    As for where the drugs fit on the MS treatment pathway, Featherstone said that the broad indications for both products allowed doctors to discuss suitable options with patients. Further down the line, however, it's possible that Aubagio will be better suited as a first-line treatment for people with MS, while Lemtrada will be reserved for more aggressive forms of the disease.
    "We hope to have these treatments available to as many people with MS as possible," Featherstone told PMLiVE. "We passionately believe in these products."
    Backing Featherstone's belief, both drugs are making headway in western Europe where Lemtrada had revenues of €10m for the first six months of the year and Aubagio had revenues of €38m.
    It's a different story for Lemtrada in the US, however, as the drug was turned down by the FDA at the start of 2014, much to the shock of Genzyme and Sanofi.
    The decision, which was based on concerns over the drug's safety, drew criticism from the healthcare community and dozens of US doctors added their name to an open letter to the FDA to appeal the negative guidance.
    2 Sep 2014, 04:36 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    MS patient Emma Parker discusses the results of the UK long term research (see also my comment 38696145 above or http://bit.ly/1rR8GJI):

     

    http://bit.ly/1nCatvb
    6 Sep 2014, 08:41 AM Reply Like
  • riantyk
    , contributor
    Comments (56) | Send Message
     
    http://1.usa.gov/P2wJUv

     

    FDA transcript "It (Rebif) was approved on the basis of two pivotal studies, 1 placebo controlled and 1 rater-blinded study versus Avonex. In fact, it was that rater-blinded study that was considered sufficient to overcome Avonex's orphan exclusivity."

     

    If that were the case, why is FDA now fighting so hard against alemtuzumab's trial design?

     

    Another source of information:
    http://bit.ly/1uF8qKP

     

    "The EVIDENCE† study was a head-to-head trial that compared Rebif with Avonex for an average of 64 weeks. Rebif 44 mcg was given to 339 people 3 times per week under the skin, with injections at least 48 hours apart. Avonex 30 mcg was given to 338 people once per week into the muscle."
    7 Sep 2014, 12:28 PM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    Genzyme to Feature Multiple Sclerosis Pipeline and Present New Data on Aubagio and Lemtrada at ECTRIMS– Genzyme Pursuing Innovative Approaches for Investigational Treatments Targeting Relapsing and Progressive Forms of MS –– More Than 25 Oral and Poster Presentations Reinforce the Breadth and Depth of Genzyme’s MS Clinical Development Programs –
    BUSINESS WIRE 8:00 AM ET 9/8/2014
    Symbol Last Price Change
    SNY 55.76up 0 (0%)
    QUOTES AS OF 04:02:55 PM ET 09/05/2014
    CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi(SNY) company , announced today that its multiple sclerosis pipeline, which includes a new generation of investigational treatments in early development, will be featured during the 30thCongress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) being held in BostonSept. 10-13. The company will also present this week 26 oral and poster presentations from its MS franchise, including four-year results from the Lemtrada™ (alemtuzumab) extension study,12-year MRI data for Aubagio®(teriflunomide), and data from the Aubagio TOPIC study, which was recently published in The Lancet Neurology.

     

    In addition to its marketed therapies, Genzyme has an MS R&D pipeline focused on investigational treatments to address unmet needs for relapsing and progressive forms of MS through research in selective immunomodulation, neuroprotection and remyelination.

     

    Key Genzyme MS programs and collaborations in clinical and preclinical development include:

     

    Vatelizumab – An investigational anti-VLA-2 humanized monoclonal antibody currently in a Phase II trial for relapsing forms of MS, in partnership with Glenmark Pharmaceuticals.
    GZ402668 – A next-generation investigational anti-CD52 humanized monoclonal antibody currently approaching Phase I clinical development.
    Discovery and research programs evaluating agents promoting remyelination, as well as agents targeted at central nervous system innate immune cells to provide neuroprotection.
    Collaborations with academic medical centers such as Brigham and Women’s Hospital to identify correlative biomarkers of disease progression, and with Cleveland Clinic to explore strategies to address neurodegeneration, a hallmark of progressive MS.
    “Since FDA approval of once-daily oral Aubagio two years ago, Genzyme has continued to advance the understanding and treatment of MS by addressing important unmet medical needs for people living with the disease. Between clinical trials and commercial use in more than 40 countries, approximately 30,000 patients have now been treated with Aubagio,” said Genzyme President and CEO David Meeker. “With Lemtrada, we have also made significant progress with approvals in more than 30 countries. With our differentiated marketed therapies and a varied pipeline focusing on innovative treatment approaches and underserved MS patients with progressive disease, we are uniquely positioned to bring long-term value to the MS community.”

     

    Presentations on Aubagio and Lemtrada at ECTRIMS are as follows, along with information about Genzyme-sponsored activities.

     

    Aubagio:

     

    Long-term MRI outcomes from patients treated with teriflunomide: results from a phase 2 extension study. (Poster Session 1 – P079; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Efficacy of teriflunomide in patients with early stage MS: analysis of the TOPIC study using 2010 McDonald diagnostic criteria. (Poster Session 1 – P095; Sept. 11; 3:30 – 5:00 p.m. EDT)
    MRI outcomes in patients with early multiple sclerosis treated with teriflunomide: subgroup analyses from the TOPIC phase 3 study. (Poster Session 1 – P040; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Evaluating the effect of teriflunomide in subgroups defined by prior treatment: pooled analyses of the phase 3 TEMSO and TOWER studies. (Poster Session 1 – P046; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Teri-PRO: study design and US patients’ baseline characteristics. (Poster Session 1 – P078; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Effect of teriflunomide on lymphocyte and neutrophil counts: pooled analyses from four placebo-controlled studies. (Poster Session 1 – P060; Sept. 11; 3:30 – 5:00 p.m. EDT)
    The efficacy of teriflunomide is evident before steady state plasma concentrations are reached. (Poster Session 1 – P058; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Pooled safety analyses from the teriflunomide clinical development program. (Poster Session 1 – P097; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Pregnancy outcomes for female patients and partners of male patients in the teriflunomide clinical development program (Poster Session 2 – P846; Sept. 12; 2:45 – 4:15 p.m. EDT)
    Teriflunomide mechanism of action: linking preclinical evidence to clinical efficacy and safety (Poster Session 2 – P959; Sept. 12; 2:45 – 4:15 p.m. EDT)
    Lemtrada:

     

    Disease-free outcomes with alemtuzumab: 3-year follow-up of the CARE-MS studies. (Oral platform presentation – FC1.4; Sept. 12; 8:15 – 9:15 a.m. EDT)
    Alemtuzumab improves MRI outcomes in treatment-naive active relapsing-remitting multiple sclerosis patients: 3-year follow-up from CARE-MS I. (Oral platform presentation – FC2.2; Sept. 12; 8:15 – 9:15 a.m. EDT)
    Alemtuzumab improves MRI outcomes in relapsing-remitting multiple sclerosis patients who relapsed on prior therapy: 3-year follow-up of CARE-MS II. (Poster Session 1 – P103; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Efficacy and safety of alemtuzumab in treatment-naive patients with relapsing-remitting ms: four-year follow-up of the CARE-MS I study. (Poster Session 1 – P090; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Efficacy and safety of alemtuzumab in patients with relapsing-remitting ms who relapsed on prior therapy: four-year follow-up of the CARE-MS II study. (Poster Session 1 – P043; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Improvement in MRI outcomes across subgroups with alemtuzumab versus interferon beta-1a in treatment-naive relapsing-remitting multiple sclerosis. (Poster Session 1 – P039; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Alemtuzumab improves MRI outcomes regardless of subgroup versus interferon beta-1a in relapsing-remitting MS patients who relapsed on prior therapy. (Poster Session 1 – P075; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Alemtuzumab reduces disease activity in treatment-naive patients with highly active relapsing-remitting multiple sclerosis. (Poster Session 1 – P088; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Alemtuzumab improves quality of life in relapsing-remitting multiple sclerosis patients who relapsed on prior therapy: three-year follow-up of CARE-MS II. (Poster Session 1 – P044; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Cost-effectiveness of alemtuzumab vs subcutaneous interferon beta-1a for the treatment of active relapsing-remitting multiple sclerosis: a payer perspective. (Poster Session 1 – P013; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Greater cost savings associated with disability improvement in patients treated with alemtuzumab versus interferon beta-1a. (Poster Session 1 – P011; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Anti-murine CD52 therapy provides anti-inflammatory and neuroprotective effects in EAE. (Poster Session 1 – P388; Sept. 11; 3:30 – 5:00 p.m. EDT)
    Defining clinical meaning of patient reported outcomes with disability assessment in multiple sclerosis: an analysis of the CARE-MS II study. (Poster Session 2 – P802; Sept. 12; 2:45 – 4:15 p.m. EDT)
    Pregnancy outcomes in the alemtuzumab MS clinical development program. (Poster Session 2 – P842; Sept. 12; 2:45 – 4:15 p.m. EDT)
    Management of infusion-associated reactions in alemtuzumab-treated relapsing-remitting multiple sclerosis patients. (Poster Session 2 – P880; Sept. 12; 2:45 – 4:15 p.m. EDT)
    Analysis of data from RRMS alemtuzumab-treated patients in the clinical program to evaluate incidence rates of malignancy. (Poster Session 2 – P868; Sept. 12; 2:45 – 4:15 p.m. EDT)
    Abstracts are available on the ECTRIMS website.

     

    Genzyme Symposium

     

    “Emerging Trends in MS Pathophysiology: The Role of Mitochondria”

     

    Date: Wednesday, Sept. 10 at 5:30 p.m.

     

    Location: Veteran’s Memorial Auditorium, 2nd floor, Hynes Convention Center

     

    Genzyme Plenary

     

    “Approaching the Cause of MS”

     

    Date: Thursday, Sept. 11 at 9:00 a.m.

     

    Location: Veteran’s Memorial Auditorium, 2nd and 3rd floors, Hynes Convention Center

     

    Genzyme Challenge Event
    Genzyme will engage the community in interactive events are intended to bring to life some of the most common symptoms of MS – including vision impairment, cognitive challenges, and fatigue – and help participants better understand some of the challenges that people living with MS may face. For every person who participates in the experience, Genzyme will pledge volunteer hours that will be given back to the MS community. Visit the Prudential Center on Wednesday September 10 and Thursday September 11 to participate in the dynamic experiences.

     

    About Aubagio ® (teriflunomide)
    Aubagio is approved in the United States, European Union, Australia, Argentina, Brazil, Canada, Chile, Columbia, Honduras, Mexico, New Zealand, Russia, South Korea, Switzerland, Turkey and Ukraine, with additional marketing applications under review by regulatory authorities globally.

     

    Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.

     

    About Lemtrada™ (alemtuzumab)
    Lemtrada is approved in the European Union, Australia, Canada, Mexico, Brazil, Argentina, Chile and Guatemala. Lemtrada is currently not approved in the United States. The U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its application seeking approval of Lemtrada, and Genzyme expects FDA action on the application in the fourth quarter. Marketing applications for Lemtrada are also under review in other countries. Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up.

     

    Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.

     

    Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue.

     

    About Genzyme, a Sanofi Company
    Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi(SNY) company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at http://www.genzyme.com.

     

    Genzyme® and Aubagio® are registered trademarks and LemtradaTM is a trademark of Genzyme Corporation.

     

    About Sanofi(SNY)
    Sanofi (SNY), a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi(SNY) has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi(SNY) is listed in Paris and in New York .

     

    Sanofi Forward Looking Statements

     

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi(SNY), that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi(SNY), including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi(SNY) does not undertake any obligation to update or revise any forward-looking information or statements.

     

    Source: Genzyme
    8 Sep 2014, 08:03 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Thanks, would be interested to know more about poster sessions P013 and P388, dealing with the cost effectivenes of alemtuzumab.
    8 Sep 2014, 11:45 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » At Four Years, Treatment Effect Maintained in More Than Two-Thirds of Patients Who Received Genzyme’s Lemtrada in Pivotal Studies: http://bit.ly/1BtZagE

     

    - In approximately 70 percent of patients, disability scores improved or remained stable for an additional two years beyond the two-year pivotal multiple sclerosis studies -

     

    - Approximately 70 percent of patients treated with Lemtrada did not receive a third course of treatment through the second year of the extension –

     

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today positive interim results from the second year of the extension study of Lemtrada™ (alemtuzumab) for multiple sclerosis.

     

    In this analysis, relapse rates and sustained accumulation of disability remained low among patients who had previously received Lemtrada in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, Lemtrada was given as two annual courses, at the start of the study and 12 months later. Approximately 70 percent of patients who received Lemtrada in the pivotal studies did not receive further treatment with Lemtrada through the second year of the extension study. No new safety signals were identified. These data will be presented today at the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) meeting in Boston.

     

    “These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability,” said Dr. Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge. “The majority of patients continued to experience reduced disease activity, even though their last Lemtrada treatment was three years earlier.”

     

    Extension Study Results

     

    The Phase III trials of Lemtrada were randomized, two-year pivotal studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with relapsing-remitting multiple sclerosis who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).

     

    More than 90 percent of the patients who were treated with Lemtrada in the Phase III trials enrolled in the extension study. These patients were eligible to receive additional treatment with Lemtrada in the extension study if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions.

     

    The following interim results are from the second year of the extension study for patients who previously received Lemtrada in the two-year pivotal studies:

     

    In year four, the annualized relapse rates for patients who received Lemtrada in CARE-MS I and CARE-MS II were 0.14 and 0.23, respectively. These rates were comparable to the annualized relapse rates for those patients who received Lemtrada in the pivotal trials.
    Through year four, 74 percent of patients in CARE-MS I and 66 percent in CARE-MS II had improved or stable disability as measured by the Expanded Disability Status Scale (EDSS).
    Through year four, 83 percent and 76 percent of patients who received Lemtrada in the pivotal trials, respectively, did not experience six-month sustained accumulation of disability – meaning they did not experience a worsening of their disability that persisted for six continuous months in the four years of observation.
    Approximately 70 percent of patients treated with Lemtrada in the pivotal studies did not receive a third course of treatment in years three and four.

     

    “MS is a devastating disease and patients remain in need of new treatment options that may offer greater efficacy. These new data reinforce the transformative potential of Lemtrada,” said Genzyme President and CEO, David Meeker, M.D. “It is encouraging to see the durable efficacy and manageable safety of Lemtrada maintained two years into the extension study.”

     

    Safety results from the second year of the extension study were reported. No new risks were identified. As previously reported, there were two deaths in the extension study. One was from sepsis and the other was presumed accidental and deemed unrelated to study treatment. Over four years, approximately 2 percent of patients treated with Lemtrada in the pivotal trials developed immune thrombocytopenia (ITP), all of whom responded to treatment. Patient monitoring for autoimmune disorders is incorporated in all Genzyme-sponsored trials of Lemtrada.

     

    The most common side effects of Lemtrada are infusion associated reactions (headache, rash, pyrexia, nausea, fatigue, urticaria, insomnia, pruritus, diarrhea, chills, dizziness, and flushing), infections (upper respiratory tract and urinary tract), and thyroid disorders. Autoimmune conditions (including immune thrombocytopenia, other cytopenias, glomerulonephritis and thyroid disease) and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will help support early detection and management of these identified risks.
    11 Sep 2014, 03:38 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Thanks for the update.

     

    How many extension studies are there? So there are now 2 phase III extension studies, one for 3 years, one for 4 years. And there is a phase II extension study with a follow up for many more years. Is that correct?

     

    These studies seem to have very good results but don't have a comparison group. The 4-year study (above) seems to indicate relapse rates remain constant at a low level after year 2. Any idea whether these results will impress the FDA? Are the results good enough to ignore the fact that there was no placebo group?

     

    To estimate future revenue I would be interested to know how many percent of the patients have received 3 treatments and how many have received 4 treatments.

     

    I suppose approval will trigger the first 2 sales milestones but if many patients take more than 2 treatments the other 2 milestones could be achieved as well.
    11 Sep 2014, 06:01 AM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Ruerd,

     

    Are you still optimistic on approval? Big volume and no movement of late. Suggests that there is a lot of stock supply. I wonder if that is just trader exhaustion or something else.
    12 Sep 2014, 06:11 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    Bazooooka: approval or not, that is the big question indeed. I suppose the very long term research results and the results from the 4-year extension have increased the chances on approval. But by how much?

     

    Let's hope for the best.
    12 Sep 2014, 06:26 AM Reply Like
  • Anthony Cataldo
    , contributor
    Comments (854) | Send Message
     
    At this point, I continue to hold. My cost is a tiny bit below $0.31 PPS. Assuming FDA approval, how many are likely to hold v. sell into any upside over-reaction? Alternatively, are many likely to sell into any rally, wait a bit, and attempt to repurchase at a lower PPS? Comments appreciated.
    11 Sep 2014, 06:32 AM Reply Like
  • Medellin85
    , contributor
    Comments (13) | Send Message
     
    You shouldn't be so concerned with the label on whether it will be or not be indicated as first line therapy. No MS specialist will prescribe it as first line. This drug will be saved for patients who have failed current therapies such as injectables and orals.
    The drug carries many risks vs other options on the market. Keep in mind MS Specialist will always seek a balance between efficacy and patient safety. As long as there are options which provide efficacy with a safer profile, Lemtrada will not be used. By default Lemtrada is going to be saved as alast resort. I don't know how this impacts your calculations but mine say Lemtrada will be a niche drug and by no means a billion dollar drug.
    11 Sep 2014, 09:25 PM Reply Like
  • Manoj Madhavan
    , contributor
    Comments (177) | Send Message
     
    5.2 million CVR's were traded today! And yet, the price did not move up or down. I wonder if Sanofi was among the buyers today.

     

    For the newbies in the forum, a reminder - Sanofi can buy the CVRs in the open market and does not have to file with the SEC each time they do so.

     

    From their latest 20-F (period ending Dec 2013):

     

    "we are not prohibited from acquiring the CVRs, whether in open market transactions, private transactions or otherwise and we have already purchased CVRs on several occasions"

     

    "In November 2011, Sanofi obtained the necessary corporate authorizations to purchase any or all of the outstanding Contingent Value Rights ("CVR") and subsequently purchased CVRs in 2011. In 2012 following a tender offer initiated in September 2012 on the basis of the same corporate authorization, Sanofi purchased an additional 40,025,805 CVRs (for a total consideration of approximately $70 million). In 2013, Sanofi purchased an additional 10,928,075 CVRs (for a total consideration of approximately $9 million). As of December 31, 2013, 238,275,333 CVRs were outstanding out of 291,313,510 issued at the time of the Genzyme acquisition."
    11 Sep 2014, 10:27 PM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Manoj,

     

    Sure seems like they could get them at a good price and average down compared to those old purchases above $1.

     

    I'm more surprised that the recent volume didn't affect the pps.
    12 Sep 2014, 06:13 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    There's a good reason the price didn't move. There was a big seller in the 49 to 50 cent range. I bought 50K more shares in 10K allotments. I started my first buy at 50 cents, the second at 49.5 cents, the third at 49 cents, the fifth at 49 cents and the last at 48.5 cents. All 5 times my order was executed immediately with no change in the bid or ask. A big seller was sitting there selling on every order to buy.

     

    I got the 50K but could have gotten it a little cheaper if I knew there was a big seller there. That's why dark pools are so unfair. There's no way to tell what the real supply and demand is so individuals and others are at a big disadvantage.

     

    That said, if Lemtrada is approved by the FDA, I really won't care that I didn't get the best price. I'll be happy. If it isn't approved, the price won't matter much either. I'll be sad.
    12 Sep 2014, 08:51 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1202) | Send Message
     
    GCVRZ seems to be a 100 dollar bill on the street, ready to be picked up. On the other hand there is the current price and the trading dynamics. It could be, maybe like last November, that someone knows a bit more than most of us.
    12 Sep 2014, 09:03 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » Sanofi Posts Promising Trial Results for MS Drug: http://bit.ly/1m0L9nq
    12 Sep 2014, 04:18 PM Reply Like
  • Laurent C
    , contributor
    Comments (62) | Send Message
     
    also surprising is the price action on WMGIZ, where FDA amended PMA decision is expected 26 Oct and price inches up fairly regularly, recent high 2.14 versus 1.60 this summer and 1.03 in June. attracting more bids as the decision looms; not like GCVRZ.
    13 Sep 2014, 09:50 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » WMGIZ has worked out well so far this year. It is the core holding of my most successful portfolio on Motif Investing: http://bit.ly/1nSTpRC
    13 Sep 2014, 10:09 AM Reply Like
  • bazooooka
    , contributor
    Comments (3684) | Send Message
     
    Chris,

     

    Does your allocation percentages on Motif reflect your relative bullishness on the different holdings? Seems like a large percentage for WMGIZ.
    13 Sep 2014, 05:09 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (10624) | Send Message
     
    Author’s reply » No my allocation percentages on Motif are silly and should not be taken too seriously or read into too much. That being said, I like WMGIZ since I set it up and have high hopes for that right. They are worse than Genzyme at dealing with the FDA (!!!) and it could go either way. I like GCVRZ somewhat more. Sizing is key on these but the EV is + (I think). -C