Bristol-Myers Squibb will acquire
Kosan Biosciences, a cancer therapeutics company, for approximately $190 million in cash. The acquisition adds two classes of anticancer agents to BMS's pipeline, novel Hsp90 (heat shock protein 90) inhibitors and epothilones.
“Helping patients prevail against serious disease is paramount at Bristol-Myers Squibb,” said Jim Cornelius, BMS' chairman and chief executive officer. “We pursue innovative science, both internally and externally, that can accelerate the discovery and development of new medicines. Kosan’s technology, coupled with our development and commercialization capabilities, will result in new treatment options for patients, and represents another important milestone in the execution of our strategy to become a next-generation BioPharma leader.”
Helen S. Kim, Kosan’s president and chief executive officer, remarked, “Kosan has evolved from a research platform to a development company, and we have reached a turning point in our growth as an independent company. We believe that this transaction represents a timely opportunity to place our clinical programs and technology assets in the hands of a world-class company with the experience and expertise to bring innovative cancer treatment options to patients in need.”
The two companies have also entered into a separate license agreement under which BMS has an exclusive worldwide license to Kosan’s epothilone compounds and related intellectual property and has been assigned its epothilone IND applications. Under the license agreement, Kosan will receive an initial payment of $25 million and is entitled to milestone payments related to the development of epothilone product candidates and royalty payments on sales of such products.
Eli Lilly and Co. has submitted a sNDA to the FDA seeking approval for a new indication for Cymbalta (duloxetine HCl) for the management of chronic pain. The submission is based on clinical trial results in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previous studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was studied in moderate chronic pain in adults who required daily treatment for an extended period of time.
Cymbalta is currently approved to treat major depressive disorder, generalized anxiety disorder, and the management diabetic peripheral neuropathic pain.
Wyeth's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers has been granted Fast Track designation by the FDA. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes in addition to the seven serotypes included in Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
Fast Track designation is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need. Wyeth plans to submit the BLA on a rolling basis and expects the application to be completed in 1Q09.
The 13-valent pneumococcal conjugate vaccine is being studied in Phase III global trials in both infants and adults.
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