The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority has awarded a contract worth up to an estimated $231 million to Autralian biotech Biota to advance development of laninamivir, a promising influenza antiviral.

The Biota contract follows a string of awards to biomedical companies by BARDA this year, as part of its efforts for national preparedness and response. The agency has awarded $754 million in three to five year contracts for development of treatments for radiation exposure, smallpox, and influenza.

Flu preparedness has taken top priority, with $661 million in contracts in the past five weeks including $55 million to BioCryst Pharmaceuticals to fund completion of the late-stage development of its neuraminidase inhibitor, intraveous peramivir; and up to $179 million over five years to Novavax and up to $196 million to VaxInnate for the development of their seasonal and pandemic recombinant influenza vaccines.

The Biota five-year milestone-based contract is designed to provide U.S.-based manufacturing and clinical data to support a new drug application in the U.S. for laninamivir, a long-acting neuraminidase inhibitor being developed to both treat and prevent influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza.

Biota says laninamivir is an improvement over first generation neuraminidase inhibitors in that it is more potent and needs to be taken less often. It is currently approved for sale only in Japan where it was launched as Inavir by Daiichi Sankyo in October 2010.

Japanese pharmaceutical companies’ deal making activity shows no signs of abating, despite grave troubles at home in the aftermath of the earthquake and tsunami. This week it was Dainippon Sumitomo Pharma’s turn at bat. The Japanese pharma entered into an exclusive licensing agreement for the development and commercialization of Intercept Pharmaceuticals’ INT-7447, a first-in-class treatment for chronic liver disease in Japan and China. It will first focus on primry biliary cirrhosis and nonalcoholic steatohepatitis. Intercept is currently preparing the drug for a late-stage trial in the U.S. and Europe.

Dainippon Sumitomo will pay Intercept $15 million upfront and up to $300 million in milestone payments, plus tiered double-digit royalties based on sales in Japan and China. It also has an exclusive option to add several other Asian countries to its territory, including Korea and Taiwan, and to pursue additional indications.

Gilead Sciences is looking to academia for novel cancer drugs in a multi-year collaboration with Yale University School of Medicine. The biotech is pledging up to $100 million over ten years toward a multi-disciplinary collaborative research program to search for the genetic basis and underlying molecular mechanisms of many forms of cancer. Yale and Gilead will work together and Yale will have first oprtion to license any inventions that result from the collaboration.

“I am confident this collaboration will lead to important advances in the understanding of the genetic basis of cancer as we collectively seek to develop novel targeted therapies for patients in areas of unmet medical need,” says Norbert Bischofberger, Gilead’s EVP, research and development and chief scientific officer.

Research projects will be chosen by a joint steering committee and Gilead will have an exclusive option to license discoveries arising from the collaboration [see story]. 

Finally, Valeant Pharmaceuticals has taken a $5.7 billion hostile bid for Cephalon directly to shareholders after getting nowhere in private negotiations with Cephalon management. The $73 per share offer represents a 29 percent premium to Cephalon’s 30-day trading average. Valeant said it would begin a solicitation process in the first week of April to replace Cephalon’s current board of directors with its own nominees [see story].

DEALS FOR THE WEEK ENDING APRIL 1, 2011