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  • Seattle Genetics Will Exceed And Immunogen Will Meet Market Expectations [View article]
    I think you're very wrong about Roche, but Roche does have an equity investment in SGEN that dates back over a decade, so if in preclinical work both technologies work roughly as well, they'll go with SGEN's. If you look through all the patents where DM1 is mentioned, it's clear that Roche continues to work with it. I believe you'll see more drugs in the clinic from them, though it's not critical to IMGN.

    The newer partnerships offer terms worth perhaps ten time what IMGN will receive for new drugs from Roche created under the original multi-drug partnership. I'm far more interested in seeing what the drugs from the likes of Novartis, Biotest, etc. do than any additional validation Roche can provide. The AMGN and SNY drugs are under terms that are like those of Roche, of course any success is important, and even a small percentage of a blockbuster drug is still a big number, but look at all the newer partnerships. As long as new partnerships are created, and new drugs are moving toward the clinic from those partnerships, I wouldn't be overly concerned about Roche, or any other single partner.

    Take another look at the N901 failure. Do you realize it's IMGN's very oldest TAP technology. It's the way T-DM1 was originally constituted, but Roche insisted on improvements and several other ways of linking Herceptin were developed before Roche selected the SMCC linker. Don't you think the N901 drug would have been far more effective had it been linked differently. Frankly I thought IMGN should have replaced it with an improved version nearly a decade ago, but when you have a drug progressing slowly, but still progressing, it's hard to stop the trial. Remember, IMGN never spent all that much money supporting N901, they just kept it moving forward slowly just as SGEN kept drugs like SGEN-30 moving forward for years while the likes of 35, 70, etc were advancing. IMGN's far from the only company to advance older technology to maintain investor interest while developing far superior drugs for the future.

    Gary
    Feb 9 01:34 PM | Likes Like |Link to Comment
  • Seattle Genetics Will Exceed And Immunogen Will Meet Market Expectations [View article]
    Here's another article which I believe verify's my thinking that Kadcyla sales haven't grown because Roche simply doesn't have the capacity yet to deliver much more.

    http://bit.ly/1fA8OEX

    In that big Pharma's don't announce what they can, and can't do, I came to this conclusion when I noticed no attempt by Roche to publicize the drug. It's rare to watch commercial TV for an hour without seeing at least on drug being pushed, though the warning of side effects normally takes up most of the commercial. Kadcyla's side effects are generally milder than Herceptin, it should be the off label replacement for Herceptin in almost every application, as the strength of it's label gradually grows as more trials complete. It's not that Roche is keeping it a secret, but if you don't have excess drug capacity to fill new orders, it makes no sense to push for drug you can't deliver.

    I'm sure this will be resolved in the not to distant future, and when it is, Kadacyly sales will take off, and you may just see commercials for it. I know that at my Oncologist's office a few patients are receiving it, but it's also clear that they're not yet being wined and dined by Roche's sales reps. As long as they continue to use Herceptin, and their is no generic competition, they may not push to hard, but the Drs. will become aware of the benefits when they see Herceptin refractory patients getting better than those on Herceptin.

    To the best of my knowledge, IMGN probably has more new linkers that have yet to make the clinic than those already in the clinic. Likewise effector molecules. I'm terrible at reading Patents, but this can be verified by anyone caring to take the time to go through a few years of their Patent.

    Mitch Sayare, their CEO for roughly their first 20 years often said they'd not discuss technologies that were more than a year to 18 months from the clinic. They cannot hide all the patents they file and have approved, but they generally won't speak of them until they, or one of their partners have suggested they're moving a drug forward soon. With many big Pharma partners it's more likely that you don't hear what they're moving forward until they're almost ready to file their IND's.

    Look at GNVC, they almost dissolved the company a few months ago, shares went as low as $.25. The former CFO took over as CEO, announced they'd keep it together, sending the stock back over $1, but virtually a month or so later Novartis presented their Hearing Drug which was partnered 3 years earlier for a review where it was unanimously recommended for IND consideration. The IND's supposed to have been submitted in January, but the milestone is not for submission, it's for acceptance, so Novartis has no requirement to actually say they filed the IND. When GNVC is paid the Milestone, it will clearly get a lot more attention. If the FDA doesn't object to anything Novartis proposes, this could happen any time in roughly the next month as IND acceptance is implied, not declared, if the FDA doesn't say anything in 30 days after filing.

    If you look at IMGN's pipeline, you'll see AMGN is close to putting two new drugs in the clinic, yet they're unwilling at this time to reveal what they are. The AMGN drugs were originally developed under a ten year partnership which began in 2000. IMGN doesn't terminate such partnership, they still can license drugs developed during those partnerships. I believe both SNY and Roche could still license additional drugs, and they also have some drugs which are licensed, but not yet elevated to Pre Clinical status. Like Novartis, they might not advise IMGN until they're nearly ready to file the IND.

    As I previously indicated, many IMGN investors thought T-DM1 dead when nothing was said by Genentech about it for many years, finally it became very alive, and it was named Kadcyla as it was being approved. That's the biotech biz.

    Gary
    Feb 2 11:21 PM | 2 Likes Like |Link to Comment
  • Seattle Genetics Will Exceed And Immunogen Will Meet Market Expectations [View article]
    N901-DM1 was made up with IMGN's very oldest TAP linker, they have many others, including the SMCC linker used in Kadcyla which probably would have greatly enhanced the performance of the N901 MAB. Unfortunately, biotechs with limited funds rarely change direction, as long as what they have is showing some forward progress.

    I cannot know if a more up to date version of the N901 conjugate will some day reach trials, or if it's been OBE by other effective drugs, but I have no doubt that if nearly a decade ago such a decision had been made, a better and faster advancing trial could have been created, as the drug would have been much more effective.

    The problem with IMGN's earliest TAP linker was placement and number of effector molecules on each MAB was totally inconsistent. The research IMGN undertook in creating the SMCC and other linkers has permitted much greater control, and thus much better drug design.

    Few of IMGN's newest linkers have yet to enter the clinic. I believe at times they shoot themselves in the foot by offering partners the latest and greatest to test, as clinical testing may be delayed while newer technology is tested to determine if it's more effective than the previously tested linker, or effector molecule.

    Most investors fail to recognize how much time is spent working on drugs you never hear about, as they fail well before even being considered Pre Clinical. Mitch Sayare, the original CEO of IMGN used to say that drugs more than a year and a half from the clinic were not ready for Prime Time, or to put it another way, the company would only discuss drugs thought to be that close. I believe that philosophy still exists today, however Mitch's 1.5 years often took 3 years or more to materialize. I do believe when he said something would happen, it did, but the time frame was rarely on the money. I find this is not inconsistent with many other Biotech Companies, and probably not inconsistent with how most of us live our lives. The expression that I never realized how hard a job was until I had to do it myself generally applies.

    Gary
    Jan 25 06:06 PM | 2 Likes Like |Link to Comment
  • Weighing Out The Seattle Genetics Barbell [View article]
    I wouldn't go so far as to say in N901-DM1 was toxic but rather it was far from the most of the effective way the MAB could be conjugated. Remember, years ago IMGN choose to conjugate C242 with DM4 prior to SKB terminating development of C 242-DM1.

    My point is that IMGN was willing to even challenge its partner with what it believed to be an improvement that wasn't covered under the partnership. They became more conservative when it came to N901-DM1 because they saw potentially approvable, though marginal results.
    Dec 31 09:24 AM | Likes Like |Link to Comment
  • Weighing Out The Seattle Genetics Barbell [View article]
    I think you're very wrong about IMGN, if anything, they have too many linkers. New linkers new effector molecules are offered to partners who are ready or near ready to whom it to the clinic. I believe the results of offering everything they have available may result i delaying files while partners work with the newest linker and effector molecule.

    Drugs in trials are currently using linker and effector molecules which Mitch Sayare used to say are ready for prime time. We will see few years the other linkers and/or effector molecules come into play.
    Dec 30 12:21 AM | 2 Likes Like |Link to Comment
  • Cel-Sci: Immunotherapy Opens New Door To Investors [View article]
    While I really hope you're right, my problem with CVM is that I've seen them say the same thing about Multikine every time some new threat to humanity calls. It usually gets a nice rise in the stock price, and they turn on the printing press.

    Frankly I've been in some stocks that I believe had some drugs which may have been blockbusters, but failed in the likes of Pancreatic cancer and were abandoned. Multikine may be as you suggest, work for head and neck, which took a friend of ours a few years ago.

    I'm currently being treated for Acute Lymphoblastic Leukemia, it will probably take over 8 months, much of it in the hospital. I had invested in CVM when it was HIV, and they thought they had the answer to that, I believe that too was Multikine. Of course they may be successful, but having seen them claim that they should be successful against so many things make me think they're a cure searching for a disease. Perhaps some day they'll find it. The problem is they'll either have billions of shares outstanding, or they'll have done multiple reverse splits.

    Gary
    Dec 28 04:23 PM | 1 Like Like |Link to Comment
  • Weighing Out The Seattle Genetics Barbell [View article]
    Stephen,

    While I agree with what you're saying about SGEN, I'd like you to do a comparison with IMGN. I believe if you do, you'll agree with me that the market caps of both companies ought to be much closer to one another.

    My reasoning is based on the likelihood that T-DM1 will not only eventually replace Herceptin, but will greatly expand on it because it's effective for greater percentages of patients with the Her2 identifier, and it sells for substantially more. In time I believe this will be a $10 to $20 million drug. Even with 5% royalties that's a big number. Also look at the pipeline, look at what's being said about advancing certain drugs, look at IMGN's rights to Opt In to the Biotest products.

    I'm not suggesting SGEN's price should fall, just that IMGN is very cheap by comparison.

    Gary
    Dec 27 05:26 PM | 1 Like Like |Link to Comment
  • Aeterna Zentaris: Mispriced $1 Biotech Stock With Limited Downside Risk And Big Upside Potential [View article]
    While I agree with all you're saying, I've learned over time to never quite believe companies won't dilute if they are offered an opportunity to bring in funds. Frankly after the R/S the float is quite low and I expect it to grow, but hopefully not until they get substantially more per share.

    For those who don't know, I'm beginning my second course of eight courses of Chemo for Acute Lymphoblastic Leukemia. The first course went very well, but I was 3 weeks in the hospital, I believe this one will take a week to perhaps 10 days, but we'll see.

    It's amazing how quickly your life can change on a blood test gone sour. I had beautiful numbers when tested less than 3 week prior to the diagnosis.

    Gary
    Dec 26 09:53 PM | Likes Like |Link to Comment
  • ImmunoGen CFO quits [View news story]
    Speculation from investors seems to make it more likely he was fired then he quit. Separation terms were spelled out in his contract.

    Side effects for Tap drugs have generally been mild when compared with other forms of chemo.
    Aug 27 07:25 PM | Likes Like |Link to Comment
  • Seattle Genetics: Positive Read-Through From Roche's Investor Day [View article]
    Ohad,

    I'm surprised you place so much faith in SGEN, and none in IMGN. T-DM1 will earn far more for IMGN once it's approved and Roche starts to market it as the replacement for Herceptin because it's simply much better than Herceptin, and their patents will be running out on Herceptin, so it figures. It may take a few years to reach the $6 billion annually that Herceptin sells, but it won't stop their either as other Her2 positive cancers get into the act.

    Both companies have substantial pipelines, but I believe IMGN will bring 1 to 2 of it's wholly owned drugs into the clinic annually. I don't believe that SGEN has nearly that many preclinical products to bring forward.

    I know you were strong on IMGN a few years ago, while the low royalties with T-DM1 holds down the earnings there, nearly 5% of many billions is still a big number. T-DM1's success has permitted IMGN to gain far better terms in newer partnerships, and post approval they'll get even better.

    Gary
    Feb 13 09:15 PM | Likes Like |Link to Comment
  • 4 Small Cap Biopharmas With Near-Term Catalysts [View article]
    Like many, you stress Perifosine, and ignore a rather broad AEZS pipeline. Let's look at the other near term actions that should boost the stock.

    AEZS-108 should initiate its Phase III Trial any day, it's in the Clinical Trials database with a target of March.

    AEZS-130 should have it's NDA for detection of HGH deficiency filed this quarter. This may be a niche market, but their is no competition as the existing drug has been taken off the market. By mid year we should also see Phase II results for use of this drug in Cancer Cachexia, if this proves to be effective it could be a real game changer.

    AEZS has a number of other drugs in earlier stage trials as well as data from both Perifosine and AEZS-108 in earlier stage trials that show both to be effective in several cancers each. If AEZS had the funding of a major Pharma, both of these drugs would probably be in a few additional Phase III Trials. This could happen with one or both by partnership.

    Certainly I'll be interested in the recommendation of the trial managers after the peek in the MM Trial, but believe we'll get nothing stronger than a recommendation to continue. Meaningful data rarely comes out of peeks, even if the clinicians are impressed with results to date. The company may get some indication of the clinicians enthusiasm, but not the actual data.

    Look at the whole company, not one drug, and I believe you'll see it ought to be worth far more than it is.

    Gary
    Feb 11 08:19 PM | 1 Like Like |Link to Comment
  • Sentiment Shows Investors Bullish On Aeterna In 2013: Here's Why [View article]
    Two minor things you should know. Perifosine is not wholly owned by AEZS, North America and Europe, two of the largest markets as well as others are still available, but some parts of the world do have partners. The second, which actually could be very big, is that AEZS-130 ought to be completing Phase II Trials in Cancer Cachexia. If Phase II data's positive and the drug's approved for HGH deficiency testing, off label use of the drug could be far greater than it's approved use as their is no approved drug for cancer cachexia. Potentially a niche drug could have blockbuster potential. Currently the Phase II Trial is scheduled to conclude mid-year, before approval even if AEZS should get priority review, so any potential partner would know the true potential of the drug before AEZS finalized a partnership.

    In time, partnerships should be concluded for all the late stage products. Perhaps when AEZS has a substantial revenue stream they'll consider taking drugs worldwide themselves, but without that, at minimum regional partners will be required for much of the world.

    Gary
    Jan 18 01:28 PM | 1 Like Like |Link to Comment
  • Biotech Portfolio Update: 2012 Summary And 2013 Outlook [View article]
    T-DM1's approval may be assumed, but ask yourself what the stock price should be once IMGN's receiving annual royalties in the hundreds of millions. With positive date in gastric cancer, others to follow, I believe T-DM1 could be a $10 billion plus drug in perhaps 5 years netting IMGN nearly half a billion annually. What's a fair price for the stock on that income alone.

    The CEO's speaking at the J.P. Morgan conference and the PR put an emphasis on a new drug from IMGN entering the clinic soon, it seems this drug has many targets and may be bigger than anything currently in the clinic, though all have blockbuster potential IMHO. I think reality is he'll talk about the entire pipeline, but this is the first time this drug is being put under the limelight, so it's the one thing that's new.

    IMGN has a very strong pipeline, though trials advance slowly. If you ignore the entire pipeline, but see T-DM1 replace and expand on Herceptin, as I expect it will, I think you'll see the company should see near triple digits on that alone. It's all about earnings once T-DM1 is approved, while many products failed to live up to expectations, I believe T-DM1 will exceed expectations. As I understand it, IMGN will be paid royalties based on quarterly sales, if correct, it shouldn't take long to see if sales growth isn't impressive. I believe Roche is positioned to market and sell product almost immediately upon notification of approval, we may see royalties announced after the end of the 1st quarter. If they increase dramatically each quarter, what should the stock price be by the end of the year. My estimate is approaching $30.

    Gary
    Jan 6 12:05 PM | Likes Like |Link to Comment
  • Can AEterna Turn A New Leaf In 2013? [View article]
    While I believe you're correct in all you're saying, you're ignoring the potential for tremendous upside growth in many other ways for the company in 2013.

    Partnerships are certainly possibilities for almost instantaneous growth as right now both AEZS-108 and 130 are wholly owned, and much of the world, including North America, is available for Perifosine.

    Another joker in the deck would be the Cancer Cachexia trial with AEZS-130. This drug is only a niche drug when considered for diagnosing HGH deficiency. The drug may have blockbuster potential if the current Phase I/II Trial in Cancer Cachexia produces positive results. Today their is no drug approved for this uncontrolled weight loss which often leads to death well before the cancer would take the patient. It's very possible that for at least some patients the cancer may be put into remission, but the patient passes because of the weakness of other organs caused by tremendous weight loss.

    My point is, you're right, but their are many other catalysts that could take the stock far higher this year.

    Gary
    Jan 5 09:20 PM | 3 Likes Like |Link to Comment
  • Biotech Portfolio Update: 2012 Summary And 2013 Outlook [View article]
    Sorry you're no longer following IMGN or taking a view on AEZS. I believe both these companies will perform well in 2013.

    Have a Happy New Year's all,

    Gary
    Dec 30 05:44 PM | Likes Like |Link to Comment
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