Reporters and editors from the Elsevier publication “The Pink Sheet” contributed to this column.
Dapagliflozin Goes to Japan
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, will be developed and commercialized in Japan, AstraZeneca and Bristol-Myers Squibb announced last month. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in phase III clinical trials in several countries, including the United States, to assess its efficacy and safety as a once-daily treatment for type 2 diabetes. The two companies will jointly market the product in Japan, where the drug is currently in phase II trials, sharing all expenses and splitting profits or losses equally. “Bristol-Myers Squibb and AstraZeneca have been working together to develop dapagliflozin for type 2 diabetes for nearly 2 years, [and] this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship,” said Lamberto Andreotti, executive vice president and chief operating officer of Bristol-Myers Squibb. “Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than 6 million people in Japan living with type 2 diabetes.”
Wyeth Buys Thiakis
Madison, N.J.-based Wyeth has agreed to pay $30 million for Thiakis, a privately held London biotech company, the two firms announced last month. Additional milestone-driven payments of up to approximately $120 million are also available to Thiakis' investors. Thiakis' portfolio includes several synthetic gastrointestinal peptides. The company launched a phase I trial of the lead candidate for appetite control, TKS1225, in March. TKS1225 is a potent, long-acting analogue of oxyntomodulin, a naturally occurring peptide hormone involved in regulating food intake. It is thought to work through the GLP-1 receptor and does not cross the blood-brain barrier, an important consideration given the suicidality risks associated with the CB-1 antagonists, another class of obesity treatments.
Bristol-Myers Signs for XL184
Exelixis has signed a deal with long-term partner Bristol-Myers Squibb for its phase III cancer drug XL184, plus an earlier-stage molecule, that will bring in $240 million in assured payments plus a major codevelopment and marketing role. XL184 is a small-molecule inhibitor of MET, VEGFR2, and RET that just entered phase III clinical trials for use in medullary thyroid cancer, for which there is no currently approved treatment. The compound is also in midstage studies for glioblastoma and is being tested for a variety of other tumor types. The second compound, XL281, is a small-molecule RAF kinase inhibitor in phase I development for advanced solid-tumor cancers. In October, GlaxoSmithKline declined to license XL184, probably because it had already licensed a similar compound, XL880, from Exelixis. Under the terms of the licensing agreement with Bristol-Myers, that company will pay Exelixis $240 million in cash upfront, $45 million of it in two installments during the first half of 2009. Exelixis plans to begin “substantial” R&D for both XL184 and XL281 in 2009 and 2010.
Novo Nordisk, VLST Sign Pact
Novo Nordisk has inked a deal with VLST Corp., a Seattle-based biotechnology company, to develop treatments for autoimmune disorders, including diabetes. Under the terms of the agreement, Novo Nordisk and VLST will jointly undertake a research program to identify collaboration targets and develop product candidates. VLST will receive an upfront payment and equity investment totaling about $12 million; the company also is eligible for payments dependent on achieving clinical and regulatory milestones across multiple disease indications, Novo Nordisk said in a statement. Novo Nordisk also will fund the salaries of VLST researchers for the next 3 years, and will provide resources to move product candidates through preclinical development, clinical development, and commercialization. The research collaboration will run for 3 years, with an option to extend the agreement. “VLST's platform technology provides a promising avenue for Novo Nordisk to continue expanding and enhancing its research and development in the field of autoimmune and inflammatory disorders,” said Terje Kalland, senior vice president and head of the biopharmaceuticals research unit at Novo Nordisk. “As Novo Nordisk continues to build its presence in Seattle, the collaboration with VLST marks an important step in our overall strategy to develop therapeutics for autoimmune and inflammatory disorders.”
DexCom CGM Gets European OK
DexCom has received the CE mark in the European Union for SEVEN, the company's 7-day continuous glucose monitoring system, allowing it to market the system in Europe as well as in Asian and Latin American countries that recognize the mark. “We are pleased to have CE mark approval for the SEVEN, and we look forward to working with physicians, nurses, and diabetes educators to bring this important technology to patients around the world,” Terrance H. Gregg, DexCom's president and CEO, said in a statement.