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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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  • Sanofi's Viehbacher Says Lemtrada Can Still Be A Big Success 40 comments
    Jan 23, 2014 12:30 PM | about stocks: GCVRZ, SNY

    On the morning of January 23, 2014, Sanofi CEO Christopher Viehbacher spoke with Bloomberg TV in an interview in Davos, Switzerland. Previously, on January 14, Bloomberg reported that Sanofi was seeking to reach a compromise with the FDA on the Lemtrada MS drug. This morning, the interviewer commented the Lemtrada was a drug the Viehbacher had hoped to use to gain a fair amount of share in the multiple sclerosis business. The FDA rejected it. How much of a letdown was that?

    According to Viehbacher, it was not something that was a total surprise. When SNY acquired Genzyme, they created a contingent value right recognizing that it was not going to be an easy thing to bring Lemtrada to the market. This is a drug that's been in development for quite some time. That having been said, this is a drug that has been approved by thirty countries around the world. We are seeing patients that have gone five years without a relapse so Sanofi believes that the drug actually is working and it's important for patients and that's why for the first time in my twenty-five years in the industry we're thinking about doing an appeal with the FDA.

    The interviewer asked, realistically, what are the chances that appeal works because if you look at appeals in generally fifteen or twenty percent are successful? Well, it is worth trying, said Viehbacher. We can't possibly go do the new trial so the product comes to the market or it doesn't come to the market. In the rest of the world though the market is a little different. There are more MS patients in Europe than in the US so Lemtrada can still be a big success.

    Disclosure: I am long GCVRZ.

    Additional disclosure: Chris DeMuth Jr is a portfolio manager at Rangeley Capital, a partnership that invests with a margin of safety by buying securities at deep discounts to their intrinsic value and unlocking that value through corporate events. In order to maximize total returns for our partners, we reserve the right to make investment decisions regarding any security without further notification except where such notification is required by law.

    Stocks: GCVRZ, SNY
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Comments (40)
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  • Clayton Rulli
    , contributor
    Comments (3361) | Send Message
     
    I don't think he cares either way. if GCVRZ becomes worthless as the milestone criteria is not met, SNY can still benefit financially from the drug at a later point in time. Hopefully I won't be holding an empty soggy worhtless paper bag only to see SNY benefit years from now.

     

    Disclosure: I own small position in the CVR
    23 Jan 2014, 01:04 PM Reply Like
  • Special Situations and Arbs
    , contributor
    Comments (1263) | Send Message
     
    Interesting Chris. Thanks for posting. What is perplexing to me it that there seem to be so many other drugs (not MS drugs that I speak of necessarily) that have way worse profiles and side effects that are approved. Some of those have killed many people and are still on the market.
    Forgetting my small investment in GCRVZ for a moment, it pains me to know there are a ton of MS sufferers in the US who aren't able to work with their doctors to come up with the best possible treatment for the disease. My good friend's mom has MS and the FDA rejection has been a huge blow to her.
    23 Jan 2014, 01:57 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1094) | Send Message
     
    She should officially emigrate to The Netherlands for just 5 quarters and get the subsidized treatment over there.
    23 Jan 2014, 02:59 PM Reply Like
  • nmecmbtnt
    , contributor
    Comments (124) | Send Message
     
    Maybe she can stay closer to home. Bizwire from two days ago: "Mexico’s national regulatory authority, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations."
    6 Feb 2014, 04:35 PM Reply Like
  • Special Situations and Arbs
    , contributor
    Comments (1263) | Send Message
     
    Good thought Ruerd. Problem is she and many others aren't able to relocate temporarily....for those that can there are many options such as Canada
    23 Jan 2014, 03:01 PM Reply Like
  • Ali Husain
    , contributor
    Comments (2) | Send Message
     
    Funny how he says FDA not approving did not come as a surprise while the information provided here said otherwise.. that it will most likely be approved...
    23 Jan 2014, 09:28 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Apparently it was not a surprise to him. Mr. Viehbacher is fortunate that he does not have to rely on Sanofi (SNY) public disclosures for his information.
    24 Jan 2014, 06:22 AM Reply Like
  • nmecmbtnt
    , contributor
    Comments (124) | Send Message
     
    Maybe.... but it comes off a bit as bluster.
    26 Jan 2014, 08:46 AM Reply Like
  • nmecmbtnt
    , contributor
    Comments (124) | Send Message
     
    Chris,

     

    Do you think there is any subtle alteration or implied relaxation to the T&C of the CVR agreement per the update SNY published: "Status of CVR Product Sales Milestone #1 as of January 16, 2014"?

     

    One clarification from it that stands out: "Note that the timing of Major Market Product Sales for any Qualifying Major Market is determined separately and may be different from that of the others."

     

    The ramp in different Major Market countries may start at different points in time and run for four quarters up to and until December 31, 2016.

     

    I didn't pick this up in a read of the original CVR agreement on Edgar... Did they give themselves some breathing space here to improve the odds of hitting Product Sales Milestone #1 with this clarification?

     

    Tim
    26 Jan 2014, 08:46 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Good question. I read the update consistent with my understanding; it does give them a decent amount of time and some chance of getting to milestone #1.
    26 Jan 2014, 08:49 AM Reply Like
  • bazooooka
    , contributor
    Comments (3591) | Send Message
     
    Nearly 3 years does seem like plenty of time for Europe and the world to ramp up.

     

    However, is there any scenario that would involve new trials for the FDA that could result in testing approval and sales all before 2017? Or is US sales all going to come down to next months appeal?
    26 Jan 2014, 07:33 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Sanofi will not conduct new trials nor should they. The US sales come down to next month's appeal. If the center director endorses the thuggish and arbitrary behavior of her staff, then there will be no sales in the US.
    26 Jan 2014, 07:44 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine -- http://amzn.to/1aXt3HV

     

    Never before have two revolutions with so much potential to save and prolong human life occurred simultaneously. The converging, synergistic power of the biochemical and digital revolutions now allows us to read every letter of life’s code, create precisely targeted drugs to control it, and tailor their use to individual patients. Cancer, diabetes, Alzheimer’s and countless other killers can be vanquished—if we make full use of the tools of modern drug design and allow doctors the use of modern data gathering and analytical tools when prescribing drugs to their patients.

     

    But Washington stands in the way, clinging to outdated drug-approval protocols developed decades ago during medicine’s long battle with the infectious epidemics of the past. Peter Huber, an expert in science, technology, and public policy, demonstrates why Washington’s one-size-fits-all drug policies can’t deal with diseases rooted in the complex molecular diversity of human bodies. Washington is ill-equipped to handle the torrents of data that now propel the advance of molecular medicine and is reluctant to embrace the statistical methods of the digital age that can. Obsolete economic policies, often rationalized as cost-saving measures, stifle innovation and suppress investment in the medicine that can provide the best cures at the lowest cost.

     

    In the 1980s, an AIDS diagnosis was a death sentence, until the FDA loosened its throttling grip and began streamlining and accelerating approval of life-saving drugs. The Cure in the Code shows patients, doctors, investors, and policy makers what we must now do to capture the full life-saving and cost-saving potential of the revolution in molecular medicine. America has to choose. At stake for America is the power to lead the world in mastering the most free, fecund, competitive, dynamic, and intelligent natural resource on the planet—the molecular code that spawns human life and controls our health.

     

    - http://amzn.to/1aXt3HV
    26 Jan 2014, 07:59 AM Reply Like
  • nmecmbtnt
    , contributor
    Comments (124) | Send Message
     
    "According to Viehbacher, it was not something that was a total surprise."

     

    He has to say this and to say it that way. As an officer of the corporation, part of his job is to spin/shape/fashion any adverse news to suggest that it was baked into the calculus. Whether or not he or anyone else was stunned into a slack jawed state by the outcome.

     

    Ala National Lampoon's Christmas Vacation
    Eddie: "You surprised to see us, Clark?"
    Clark: "Oh, Eddie... If I woke up tomorrow with my head sewn to the carpet, I wouldn't be more surprised than I am now."

     

    ;-)
    26 Jan 2014, 08:46 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Is the FDA Ignoring Its Advisers?

     

    The FDA's decision not to approve alemtuzumab (Lemtrada) for use in multiple sclerosis, despite solid votes in favor of the drug's efficacy and safety by an agency advisory committee, has generated fury in the MS community.

     

    Should the FDA pay more attention to its advisory committee recommendations? http://bit.ly/1b0gDlu
    28 Jan 2014, 07:29 AM Reply Like
  • pault123
    , contributor
    Comments (83) | Send Message
     
    Teva rises after FDA OKs higher-dosage Copaxone. Teva's (TEVA) shares were +2.9% premarket after the FDA approved a 40 mg dose of the company's multiple sclerosis drug Copaxone that would be administered three times a week. Teva plans to convert 57% of patients to the new regimen by the year-end from the daily dose of 20 mg. The longer-lasting formulation should help Teva cope with generic competition when Copaxone's patent protection expires in May. The higher-dosage version is protected until 2030. (PR)
    29 Jan 2014, 09:04 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Should be essentially priced in at this point, but Genzyme called around to formally rescind job offers to US MS salesmen today.
    29 Jan 2014, 06:02 PM Reply Like
  • Harlan Kessler
    , contributor
    Comments (60) | Send Message
     
    Lemtrada approved in Mexico

     

    http://bit.ly/1k8SdeT
    4 Feb 2014, 03:49 PM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Hi Chris,

     

    1. I had a wild idea and wondered what you thought of it. I can guess but I'll suggest it to you anyway.

     

    2. Take Abrams Capital Management which owns 31 million rights. I don't know what they paid for the rights but let's say 50 cents so their investment is $16 million. They'd like Lemtrada to reach the First Sales Milestone and receive $62 million. Their profit would be $46 million but, say for instance, at the end of 2016, it looks like Lemtrada sales will fall $20 million short. Sooo, near the end of 2016, they set up a website created to reach MS patients worldwide (or in the relevant markets) that would like to take Lemtrada but don't have insurance or are a US patient that wouldn't mind travelling to Mexico or Canada. They then set up a system that would reimburse doctors directly. This pushes Lematrada over the $400 million sales limit. After spending the $20 million to help MS patients, they have a profit of $26 million vs. a likely loss on their GCVRZ investment. If Abrams paid more than 50 cents for their rights, the benefit for them would be greater.

     

    3. It's win-win. Abrams and MS patients both win. You could argue that Sanofi wins, too, with the free publicity and a stick it to the FDA attitude.

     

    4. Dalton Investments and Whitebox Advisors both own over 16 million GCVRZ rights and might help out if they could benefit too.

     

    Alan
    12 Feb 2014, 05:13 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1094) | Send Message
     
    Great idea!

     

    They can do it even cheaper by setting up a temporary immigration service for MS patients from the US to Europe. In that case I expect the treatment will be reimbursed from insurance policies that are usually mandatory for people living in Europe. So GCVRZ holders would only need to pay the patients flights, accomodation and insurance costs.

     

    Another similar alternative: it might be that offering US patients half of the costs of Lemtrada will be enough to get them on Lemtrada in Canada or Mexico.

     

    Another similar alternative: they don't set up a website but make a deal with a couple of US insurers to reimburse the treatment in Canada or Mexico. I suppose this treatment is costs effective for insurers anyway.
    12 Feb 2014, 05:31 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    Hi Ruerd,

     

    I like all of your ideas. Any one of them would probably work.
    It seems if someone had $100 million or so to invest, they would buy up all the GCVRZ rights (180 million outstanding times 50 cents) and implement one of your or my ideas. At $2 per First Milestone payment, they would earn $360 million from a $90 million investment with some of that profit being used to push Lemtrada sales over the $400 million mark. They'd still have the GCVRZ rights in case the 2nd and 3rd milestones were reached. At that point I think the US would be contributing sales.
    12 Feb 2014, 07:02 AM Reply Like
  • sumikuboanr
    , contributor
    Comments (240) | Send Message
     
    If someone did buy up all the GCVRZ rights, they could spend $200 million of their profits helping MS patients get Lemtrada and effectively bypass the FDA and "approve" Lemtrada for US patients by getting them to the EU, Canada, or Mexico. I think $200 million would be enough to help all US MS patients.
    12 Feb 2014, 07:35 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » First-of-Its-Kind Treatment for Relapsing-Remitting Multiple Sclerosis Now Available in Canada

     

    Canada NewsWire

     

    MISSISSAUGA, ON, Feb. 27, 2014

     

    MISSISSAUGA, ON, Feb. 27, 2014 /CNW/ - Genzyme, a Sanofi company, today announced the Canadian availability of PrLEMTRADA™ (alemtuzumab) for the management of adult patients with relapsing-remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

     

    LEMTRADA 12 mg has a dosing and administration schedule of two annual treatment courses. The first treatment course of LEMTRADA is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later. LEMTRADA patients require monitoring at regular intervals between treatment courses and for 48 months following the final infusion.

     

    During an extensive, ongoing clinical development program, 80 per cent of RRMS patients who received two treatment courses of LEMTRADA required no further therapy1 and 55 per cent remained relapse-free through the first year of the extension study. Unlike other current disease modifying therapies (DMTs) in which stopping treatment usually results in resumed disease activity, LEMTRADA continues to have a durable effect far beyond the two annual treatment courses. In fact, in more than 70 per cent of clinical trial patients, disability scores improved or remained stable over three years.1

     

    "The approval of LEMTRADA represents an important new treatment option for Canadians living with MS. In clinical trials, LEMTRADA demonstrated impressive effectiveness following two treatment courses for patients with active relapsing MS," said Dr. Anthony Traboulsee, Associate Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health. "Our own experience in treating 35 patients through clinical trials with LEMTRADA has been extremely positive."

     

    LEMTRADA was approved by Health Canada in December 2013. The approval was based on data from the LEMTRADA clinical development program comparing treatment of LEMTRADA to high-dose subcutaneous interferon beta-1a (Rebif®) - which is dosed three times per week - in patients with RRMS who had active disease. In a controlled Phase 3 clinical study, LEMTRADA was more effective compared to Rebif at reducing both the annualized relapse rates (ARR) and the accumulation of disability was significantly slowed in patients given LEMTRADA vs. Rebif.2

     

    In clinical trials, LEMTRADA demonstrated an ARR reduction of 49.4 per cent when compared with Rebif (p<0.0001), and the proportion of relapse-free patients was significantly (p<0.0001) higher in LEMTRADA patients than Rebif (65.4 per cent and 46.7 per cent, respectively). In addition, the risk of sustained accumulation of disability (SAD) over six months was reduced by 42 per cent in patients who received LEMTRADA versus Rebif (p=0.0084).2

     

    "The approval and availability of LEMTRADA represents an important advancement for the MS community," said Dr. Karen Lee, Vice-President, Research, Multiple Sclerosis Society of Canada. "The more treatment options that are available, the more choices Canadians living with MS have to potentially improve their overall quality of life."

     

    In November 2013, Genzyme's AUBAGIO® (teriflunomide) 14 mg was approved by Health Canada as monotherapy for the treatment of patients with RRMS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. The approval was based on efficacy data from two Phase III clinical trials - TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis). In the TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with RRMS. In the TOWER trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0001) and the time to disability progression sustained for 12 weeks (p=0.0442) was statistically significantly reduced versus placebo in patients with RRMS.

     

    "The Canadian approval and availability of LEMTRADA and AUBAGIO represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to MS patients," said Peter Brenders, General Manager, Genzyme Canada. "We are proud of our commitment to long-term leadership and partnership with the MS community."

     

    LEMTRADA is supported by a comprehensive and extensive clinical development program that involved 1,188 patients, resulting in 2,363 patient-years of safety follow-up.

     

    A New Standard in Patient Support
    As LEMTRADA patients require monitoring at regular intervals between treatment courses and for 48 months following the final infusion, Genzyme is providing every patient with a unique, comprehensive and free patient support program. The MS One to One™ program will offer comprehensive support services, including: counseling, pre-treatment testing, coordination of infusion appointment and location, post-treatment monitoring at the patient's preferred location (lab, infusion centre or in-home), delivery of test results directly to patient's healthcare provider, patient education and compliance services, as well as reimbursement navigation and other financial assistance. Staffed by dedicated MS nurses and highly trained representatives, MS One to One™ can provide support for individuals living with MS who are receiving Genzyme MS therapies, their health care providers, family and loved ones. Please consult your healthcare provider for more information.

     

    The most common side effects of LEMTRADA are infusion-associated reactions (headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills and flushing) and infections (nasopharyngitis, urinary tract and upper respiratory tract). Serious infections and autoimmune conditions, including thyroid disease, cytopenias, and kidney disease can occur in patients receiving LEMTRADA. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks.

     

    About MS in Canada
    With 100,000 Canadians living with MS and three people newly diagnosed every day,3 Canada has the highest rate of MS in the world.4 As most people are diagnosed with relapsing MS in their 20s and 30s,5 MS is the most common neurological disease affecting young adults in Canada.3

     

    As a debilitating disease, MS symptoms can include: blurred or loss of vision, poor coordination, slurred speech, extreme fatigue, diminished mobility of the arms or legs, problems with memory and concentration, and bladder and bowel dysfunction.5

     

    About LEMTRADA™ (alemtuzumab)
    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, altering the immune system in a way that potentially reduces MS disease activity.

     

    About AUBAGIO® (Teriflunomide)
    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 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 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.ca.

     

    About Sanofi
    Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi 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 is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

     

    Genzyme®, LEMTRADA™ and AUBAGIO® are registered trademarks of Genzyme Corporation. All rights reserved.

     

    WEB Video Preview and Download link:

     

    http://bit.ly/1fullpk

     

    TIME OF POSTING: 8:00 a.m. ET

     

    DATE OF POSTING: February 27, 2014

     

    All video can be viewed by clicking on the link. Broadcast quality video is available for download by accredited journalists. Please contact video@newswire.ca for access.

     

    References
    _______________________
    1 Genzyme. Effect of Genzyme's LEMTRADA™ Maintained in Patients Beyond Two-Year Pivotal MS Studies. Available at: http://bit.ly/1fullpo. Accessed on February 7, 2014.
    2 Coles AJ et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. The Lancet. 2012 Nov 24;380(9856):1829-39. Available at: http://bit.ly/1fulokN. Accessed on February 6, 2014.
    3 Multiple Sclerosis Society of Canada. About MS. Available at: http://bit.ly/1fulokR. Accessed on January 24, 2014.
    4 MS-UK. Ethnic groups, geographical regions and MS. Available at: http://bit.ly/1fulnNV. Accessed on January 24, 2014.
    5 Genzyme. Multiple Sclerosis (MS) infographic.

     

    SOURCE Genzyme

     

    Read more: http://bit.ly/1fulokU
    27 Feb 2014, 03:16 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1094) | Send Message
     
    Great news! Does this mean it's reimbursed in Canada as well?

     

    Something else: I wonder how many MS patients live in Canada. Is it 100,000, a prevalence twice as high as in the UK, or, more likely, 50,000, a number backed by an old scientific paper.

     

    For the GCVRZ payouts it would be better if it was 100,000, but I doubt it. Since it's such a big difference it would be great if someone can find out more about this. Which number are you using in your probability calculations?
    27 Feb 2014, 03:58 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1094) | Send Message
     
    According to the link below there were 93,535 MS patients in Canada in 2010-2011. Reassuring, although I would need a confirmation to trust this number more.

     

    http://bit.ly/1fukWJp
    27 Feb 2014, 04:03 PM Reply Like
  • Keubiko
    , contributor
    Comments (2743) | Send Message
     
    MS prevalence in Canada is very high, about 2 to 2.5x that of the US. 100,000 is the number. Rule of thumb 40% of those would be RRMS.

     

    Canada has about 10% of the US population about 25% of the MS patients as the US.

     

    Will help a lot.
    27 Feb 2014, 04:08 PM Reply Like
  • bazooooka
    , contributor
    Comments (3591) | Send Message
     
    Chris,

     

    Any word on the FDA appeal?
    27 Feb 2014, 05:25 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Nope. Not that I am aware of.
    27 Feb 2014, 05:25 PM Reply Like
  • greystark
    , contributor
    Comments (84) | Send Message
     
    How easy is it for someone in the US to get this treatment in Canada?
    1 Mar 2014, 03:47 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1094) | Send Message
     
    See also the video interview with the Canadian MD.

     

    http://bit.ly/1etrrdT

     

    "Superior to the best treatments available today"
    He also mentions the benefit that patients don't need to use any medicins for most of the time, and the possibility of a cure with alemtuzumab.
    28 Feb 2014, 02:55 AM Reply Like
  • bigred2
    , contributor
    Comments (72) | Send Message
     
    Why is gcvrz down so much today?
    28 Feb 2014, 01:37 PM Reply Like
  • Andrew Williams
    , contributor
    Comments (326) | Send Message
     
    Fyi

     

    FDA has posted the transcript to the Advisory Committee meeting.

     

    http://1.usa.gov/P2wJUv
    5 Mar 2014, 10:04 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » SNY repurchased 10.9 million GCVRZ CVRs at an average price of $0.78 for a total cost of 8.6 million.

     

    - http://bit.ly/1lFWB5V
    7 Mar 2014, 01:46 PM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1094) | Send Message
     
    Great! Page F-74 of the 20-F, BTW. I hope the investment will be just as good for us as they seem to expect it will be for them.

     

    These numbers mean that they repurchased just before you wrote your December article on GCVRZ or that they already started to repurchase when it was still $2 and that they averaged down.

     

    10.9 million shares is a lot so I think Sanofi followed the second path. In that case they bought most of the CVRs at current prices.
    7 Mar 2014, 03:30 PM Reply Like
  • bazooooka
    , contributor
    Comments (3591) | Send Message
     
    Chris, do we have any clue when they made these purchases? Were they averaging down after they knew their original purchases were underwater or do you suspect this was largely a new position that reflected the subsequent AdCom meeting and low price from early November?
    8 Mar 2014, 10:12 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » My understanding is that it was the latter.
    9 Mar 2014, 07:43 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Cullman doctor and patient, whose mothers died from MS, speak out against FDA rejection of new drug: http://bit.ly/N3zuTu
    11 Mar 2014, 10:25 AM Reply Like
  • kuttajoukowski
    , contributor
    Comments (5) | Send Message
     
    Can anyone comment if bayer's $1.25bn (20-35% ) co promote fee is net off the product sales calculation in CVR agreement? Plain reading off the cvr agreement pg 9 makes it clear distribution fees are net off Product sales calculation. Is Bayer's co promote fee a "distribution fee"?
    12 Mar 2014, 10:07 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (9641) | Send Message
     
    Author’s reply » Product licenses for alemtuzumab and multiple sclerosis: http://bit.ly/Oq6PZU
    14 Mar 2014, 11:18 AM Reply Like
  • Ruerd Heeg
    , contributor
    Comments (1094) | Send Message
     
    Thanks for the link! Note the text "on behalf of 70 signatories" (listed in the appendix (pdf)).

     

    Still I don't think any patient action will increase the minimal chances of FDA approval.

     

    Bad for the MS patients in the US because new MS medicines being tested now may be less effective or have more side effects than many people think now, and these tests might not be adequate and well controlled either.
    14 Mar 2014, 05:55 PM Reply Like
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