Third Time’s A Charm? Endo’s Injectable Testosterone Finally Ready For Advisory Cmte.
This article was originally published in The Pink Sheet Daily
FDA says reports of oil embolism and anaphylactic reations with other testosterone injectables also will be part of the discussion during an April 18 meeting of the Reproductive Health Drugs and Drug Safety and Risk Management advisory committees to review Aveed (testosterone undecanoate).
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FDA briefing documents for the advisory committee review of Endo’s Aveed cite the “excessive burden” imposed by any one of the REMS restrictive elements, given the injectable testosterone’s limited additional benefit compared to other available treatment options.
FDA approved the testosterone gel despite concerns about secondary exposure, but Fortesta will be competing against entrenched rivals and a new treatment from Eli Lilly.
Micromet continues spate of good news with option payment from Bayer Schering: Bayer Schering has exercised its one-year option on a preclinical antibody for solid tumors, which will bring Micromet a $7.5 million payment in January. Bayer purchased an option to license the antibody last January (1Elsevier's Strategic Transactions Database, January 2009) and the move initiates a formal collaboration. Micromet discovered the antibody using its BiTE (Bispecific T-cell Engager) technology. Under the deal, Micromet will complete preclinical development and the companies will collaborate on a Phase I program, with Bayer reimbursing Micromet for R&D costs. Bayer assumes full development and commercialization should the antibody enter Phase II, with Micromet eligible to earn up to $426 million in milestones plus up to double-digit royalties on net sales. The agreement follows an October transaction with Sanofi-Aventis in which Micromet received $12 million upfront for a collaboration on BiTE antibodies in an undisclosed cancer indication (2"The Pink Sheet" DAILY, Oct. 29, 2009). Last summer, Micromet also netted $75 million in a follow-on public offering