News Focus
News Focus
Replies to #70546 on Biotech Values
icon url

rkrw

12/23/08 4:33 PM

#70561 RE: DewDiligence #70546

At least as far as this one goes it looks like Sandoz saw no advantages. My guess would be this one is Epo or Neulasta. I think this is a shrewd decision. mnta/sandoz should stick to areas where they may be the only filer or sole approval.



Item 8.01 Other Events



As previously disclosed, in June 2007, Momenta Pharmaceuticals, Inc. (the “Company”) and Sandoz AG (“Sandoz”) signed a Collaboration and License Agreement (the “2006 Collaboration”) to exclusively collaborate on the development and commercialization of four product candidates. Under the terms of the 2006 Collaboration, the Company and Sandoz agreed to (i) jointly develop, manufacture and commercialize M356, a generic version of Copaxone (glatiramer acetate), worldwide; (ii) expand the geographic markets related to M-Enoxaparin to include the European Union; and (iii) exclusively collaborate on the development and commercialization of two biosimilar products, referred to as M178 and M249.



On December 22, the Company and Sandoz agreed to terminate their collaborative program with regard to M249, primarily due to the commercial prospects for M249, including taking into consideration the number of marketed products that would be competing with M249 at the expected time of launch. Of the $188.0 million in milestone payments that the Company was eligible to receive under the 2006 Collaboration (if all milestones were achieved for the four product candidates), the milestone payments related to M249 totaled $10.0 million. The Company is continuing to collaborate with Sandoz on M356, M-Enoxaparin and M178.



2

icon url

genisi

12/23/08 4:59 PM

#70570 RE: DewDiligence #70546

Perhaps MRK's strategy to run full clinical programs and submit BLAs for its FoBs reflects its view that the FDA will require such pathway anyhow.
Shire is performing a full clinical program for its biosimilar GA-GCB just like it did with Dynepo. TevTropin was filed as an NDA following full clinical studies. But what if phase II studies will not be required at all, or like in Omnitrope's case which was approved after full phase III but no phase II dose ranging and less tox data.
Costs for developing a biosimilar will surely be higher than of a generic drug but possibly (not dramatically) lower than an innovator, imo.