FDA Safety Concerns About Indevus’ Nebido Could Add 24 Months To Approval Timeline
This article was originally published in The Pink Sheet Daily
Executive Summary
Study to assess safety of hypogonadism therapy's oil-based depot injection could take 18 months.
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Platforms, Payments, Pathways And Pfizer: Business News In Brief
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
Platforms, Payments, Pathways And Pfizer: Business News In Brief
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