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Sanofi Message Board

scistats 355 posts  |  Last Activity: 17 hours ago Member since: Apr 5, 2009
  • Gil at GA tech, talking to MDXG?

  • Reply to

    Why does this board exist

    by irby.doug Jul 25, 2015 11:44 AM
    scistats scistats Jul 25, 2015 1:25 PM Flag

    The way ahead is like Icagen, and the estate is worth 5 to 6 PPS until proven otherwise.
    Gil is milking the runway to what appears and inevitable low-level buyout.

  • scistats scistats Jul 5, 2015 8:12 PM Flag

    And France...and by proxy the United States too.

  • scistats scistats Jul 5, 2015 8:08 PM Flag

    That's because Vladimir will be paying good money to Greece to make it a Russian naval base that will project power over Germany soon.

  • Reply to

    Something that bums me out a little

    by ligas3 Jul 3, 2015 11:04 PM
    scistats scistats Jul 4, 2015 2:12 PM Flag

    I just did a quick search for the PR and grabbed what I thought was the whole opt-in description simply to make the point that opt-in is on the table and potentially favorable for GERN.

    I did not claim to post the unabridged SEC filing description, and the part I pasted gets the point across.

    Regardless, Janssen is not going to pay any royalties when they can just buy Geron and also pursue imetelstat combinations showing promise in the literature for other indications. Royalties on MF are not that big a deal, but if Janssen has other indications in mind, a buyout is most likely.

  • Reply to

    Something that bums me out a little

    by ligas3 Jul 3, 2015 11:04 PM
    scistats scistats Jul 4, 2015 1:15 AM Flag

    "In addition, if we exercise the U.S. Opt-In Rights, we will also have a separate co-promotion option, or the U.S. Co-Promotion Option, to provide 20% of the U.S. selling effort with sales force personnel, in lieu of funding 20% of U.S. promotion costs, upon regulatory approval and commercial launch of imetelstat in the United States. Such co-promotion would be conducted under a Janssen prepared promotion plan, and in accordance with a co-promotion agreement to be agreed by us and Janssen at the time of our exercise of the U.S. Co-Promotion Option. We would be responsible for all costs associated with establishing and maintaining our sales force in any conduct of such co-promotion. All product sales would be booked by Janssen. If we do not exercise the U.S. Opt-In Rights upon an affirmative Continuation Decision by Janssen, then all further development and promotion costs beyond the Initial Phase 2 MF Study or Initial Phase 2 MDS Study will be borne by Janssen, we will receive a $65 million milestone payment at the time of the Continuation Decision plus a $70 million payment for Janssen's retention of full U.S. rights, and will be eligible to receive additional potential payments of up to $415 million in development and regulatory milestones, up to $350 million in sales milestones, and tiered royalties ranging from a double-digit up to a mid-teens percentage rate on worldwide net sales in any countries where regulatory exclusivity exists or there are valid claims under the patent rights exclusively licensed to Janssen."

  • Reply to

    Athersys Mentioned in Maxim Report Today

    by wall_street_titan Jul 1, 2015 3:43 PM
    scistats scistats Jul 2, 2015 3:28 AM Flag

    Nice find!
    But, yes, it is a mistake.
    It should be 0-24 hours.

  • scistats scistats Jun 30, 2015 12:00 AM Flag

    Chugai is an oncology company. They have now dropped Athersys for stroke like a hot potato. Get over it.

    Athersys now needs to think strategically which DOES NOT mean going it alone with a second phase 2. This would be pure stupidity.

    Gil can learn a lesson from Geron who had Mayo Clinic run their imetelstat trial first as an IST that was then picked up by Janssen when Mayo proved authoritative efficacy.

    This is how you do it!

    Let Erlanger run the damn stroke trial as an IST until they nail down the early infusion efficacy. This would be both cost effective and definitive. Then, a big dog in cardiovascular, like Abbott, will launch a world-wide phase 2 with hundreds of patients to get orphan status and early market approval.

    Athersys has no money, and the Chugai stroke deal is an absolute stinking pile of #$%$. They are not interested, so get over it. Chugai is not taking this forward. As I said, they are a freaking oncology company that is just going to give Multistem a bad name with their short sighted all or nothing hege bet they just took. They are not the least bit serious about seeing this through.

    What Chugai can do, if they have the sense, is use Multistem for oncology per the systematic review I have posted following Celgene's lead.

  • scistats scistats Jun 28, 2015 2:43 PM Flag

    If Athersys had maintained infusion at 24-36 hours following ischemic stroke, "we'd still be waiting for results".

    What does this say about enrolling the next trial, even with cells available 24/7 and focuing on the 24-36 hour group? Will we still be waiting?

    The problem:
    Erlanger, and other major stroke centers, have rapid response telestroke and very efficient clot removal teams. With this strategy in place, they are eliminating the need for Multistem BASED ON THE STUDY STROKE SCALE CRITERIA because more and more patients are recovering within 24 hours and fewer patients are available that have exceeded the 24 hour mark.

    Multistem has to be given to ALL patients no later than 24 hours, and the enrollment size has to be larger to distinguish that the subgroup that normally does not recover with standard of care alone recovers with Multistem. Or that Multistem enhances recovery of the majority of all patients beyond standard of care.

    Multistem is an insurance policy for stroke victims:
    Then, we have to get dose costs down to below 5 thousand USD to justify dosing everyone who has a stroke.

    Doing this may be justifiable considering the cost burden of taking care of one incapaciated person runs into the millions. We need economies of scale here, and this means everyone gets a little Multistem to make it work. Think of Multistem as an insurance policy that cannot survive if standard of care recovery pateints do not also enroll. If Japan gets this and all patients undertand they may be the ones who need it, Athersys might just pull this thing off. But, it is going to take a collective effort on the part of Japan. In this sense, Japan is the best place in the world to achieve this.

  • scistats scistats Jun 28, 2015 3:13 AM Flag

    There are two sides to Athersys management, greed and pride. Greed pays inflated salaries and bonuses while pride actually wants to make a medical contribution.

    Perhaps is was greed that resulted in a change in the protocol to speed things up ? The extension to 48 was the kiss of death, but even 36 hours is too long.

    As far as needing to increase enrollment numbers for stroke, I already gave references about stroke variability and samples size calculations. Because of this, a small trial, even dosing at less than or equal to 24 hours, could eat ATHX's lunch. With stroke, you either go big or go home. I hope Chugai gets this and understands that 36 hours is too long.

    Lonza will take care of cell expansion, and the MAPC advantage will make it rise to the top for oncology applications. Apceth's dose was not high enough, as seen in their ASCO abstract. I think they will need Athersys' Multistem in addition to tweeking their system.

    Biggest mistake Athersys ever made...
    Before (Updated 2011_09_16)
    single infusion 24-36 hours following ischemic stroke

    After (Updated 2011_10_24)
    single infusion 1-2 days (24-48 hours) following ischemic stroke


    10:30 AM
    Overcoming Comparability and Scale-Up Challenges in Cell Therapy Production

    Robert DeansRobert Deans, Ph.D., EVP, Regenerative Medicine, Athersys, Inc.

    Advancing cell therapeutics to commercialization requires adapting early pilot scale clinical manufacturing to a scale meeting commercial expectations. Improvements and scaling cell processing can involve radical shifts in bioreactor format, often moving from 2D planar culturing to microcarrier based bioreactor formats. A case study will be presented for comparability analysis involving MultiStem®, an adherent adult stem cell product, in commercialization for cardiovascular and CNS indications.

  • Mesenchymal stem cells as vectors for lung cancer therapy.
    Respiration. 2013;85(6):443-51
    Lungs for Living Research Centre, University College London, London, UK

  • If Chugai and Athersys really are ignoring oncology...we have a major problem.

  • Athersys and Chugai getting beat!!!!!!!

    We also expect to initiate a Phase I/II trial for the allogeneic off-the-shelf version of Agenmestencel-T (Agenmestencel-L) in Q4 2015

  • Therapy loaded Multistem: Off-the-shelf for targeting tumors or metastases

    Yes Chugai and Athersys are playing catch-up, but Multistem has advantages.

  • scistats scistats Jun 25, 2015 12:04 AM Flag

    Multistem will be off-the-shelf engineered for targeting tumors or metastases at economies of scale that bring quality patient treatment at rock bottom prices.


    apceth begins Agenmestencel-T Phase II clinical trial in gastrointestinal cancer patients
    Published on March 27, 2015

    Successfully Completed Phase I Clinical Study and Regulatory Approval Enable World’s First Genetically-Engineered Cell Therapy to Enter Phase II

    apceth, a global leader in engineered cell therapies, today announced the successful completion of the Phase I and initiation of the Phase II part of its ongoing monocentric Phase I/II clinical trial TREAT-ME 1 with the engineered cell therapeutic product Agenmestencel-T, at the Klinikum Grosshadern in Munich. To the company’s knowledge, this is the first time that a genetically engineered Mesenchymal Stem Cell (MSC) treatment has successfully completed a Phase I clinical trial and been approved to initiate a Phase II trial. The first patient in the Phase II trial has already been treated.

    apceth’s proprietary Agenmestencel-T next-generation MSC therapy is based on cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified, and re-infused into the patient. The cells specifically target tumors or metastases, and, upon reaching the target tissue, the cytotoxic gene product is selectively activated, increasing local efficacy with reduced systemic toxicity.

  • scistats scistats Jun 24, 2015 3:05 PM Flag

    I think a lot of people, like dr_sumitchawla, who used to follow ATHX felt the stroke analysis was a stretch. I think there is something there myself, but Gil needs to dial back to no later than 24hr infusion and the next trial has to have massive enrollment to statistically prove anything because of spontaneous recovery and clot removal advancements that keep improving daily. So, maybe another stroke trial might happen, but Chugai seems to want to say, "it not you its me" for stroke. I think they want Multistem for cancer myself.

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