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

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 (¹ [See Deal]) 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.

Alkermes eyes competition with Enbrel with platform license deal: Hoping to develop a drug that will compete with Enbrel (etanercept) by offering a longer duration of effect, Alkermes has agreed to a technology licensing deal with Acceleron Pharma. Under the deal, the biotech's first since a September management shake-up returned Richard Pops to the chief executive desk, Alkermes will make a $2 million upfront payment to Acceleron and an $8 million equity investment in the company (³ (Also see "Alkermes Exec Shakeup: CEO Quits, Replaced By Board Chair Richard Pops" - Pink Sheet, 11 Sep, 2009.)). Using Acceleron's proprietary long-acting Fc fusion technology platform Medifusion , Alkermes hopes to extend the duration of ALKS 6931, a tumor necrosis factor receptor-Fc fusion protein in preclinical development for rheumatoid arthritis. In animal models, Alkermes says '6931 has demonstrated a significantly longer half-life than etanercept, a drug that already has booked sales of almost $6 billion for Amgen and Wyeth. Alkermes hopes to file an IND for '6931 during 2010.

Second "complete response" letter for Endo's Nebido leaves U.S. regulatory path unclear: FDA sent Endo Pharmaceuticals a "complete response" letter for its NDA for Nebido (to be known commercially as Aveed in the U.S.) on Dec. 3, requesting further info on the potential of serious adverse events. An oil-based depot injection for men with low testosterone, Nebido has been linked to reports of post-injection anaphylaxis and pulmonary oil microembolism. FDA also said Endo's proposed Risk Evaluation and Mitigation Strategy is insufficient. Although Nebido has been approved in 86 countries and marketed in more than 50 nations in Europe, Asia Pacific and Latin America, this is the second complete response letter from FDA. Indevus Pharmaceuticals, which Endo acquired earlier this year, received a complete response to the initial NDA in June 2008, seeking further study of potential adverse events including coughing episodes and difficulty breathing (⁴ (Also see "FDA Safety Concerns About Indevus’ Nebido Could Add 24 Months To Approval Timeline" - Pink Sheet, 4 Jun, 2008.)). In a Dec. 4 note, Lazard Capital analyst William Tanner suggested the latest letter might send Endo back to square one. "It appears that the safety questions raised in the first CR letter remain unanswered although this latest re-submission included data from more than 14,000 injections in 2,600 patients," he wrote.

Biogen Idec raises its bid for Facet Biotech: The hostile offer was increased by 21 percent, to $493 million, as Biogen called it the "best and final" offer. Facet, however, advised its shareholders not to take any action. The $17.50-a-share, all cash bid is an increase of $3 over Biogen's initial unsolicited offer on Sept. 4. Biogen presented its bid directly to stockholders after its proposal was rejected on Sept. 8 by Facet's board. In its letter to Facet shareholders, Biogen wrote that Facet management "has not provided a superior alternative or a compelling argument for continuing to operate as a stand-alone enterprise." Biogen and Facet have been jointly developing daclizumab for multiple sclerosis and volociximab for cancer since 2005 (⁵ (Also see "You Call That An Offer? Facet Rejects Biogen's Hostile $355 Million Bid." - Pink Sheet, 8 Sep, 2009.)).

Pfizer names new head of U.S. primary care: The drug maker appointed Adele Gulfo as new U.S. president of primary care on Dec. 3. Gulfo is responsible for five regional primary care business units, including commercial operations, marketing, and corporate and government customer relationships. Formerly she was VP for business development and design for launch at AstraZeneca, where she also previously led its cardiovascular business, helping to establish brands such as Crestor . Gulfo will report to Oliver Brandicourt, president and general manager of Pfizer's worldwide primary care business.