Emergent to acquire Protien Sciences’ FluBlock, BEVS
ROCKVILLE, Md., and MERIDEN, Conn. Emergent BioSolutions and Protein Sciences have entered into an asset purchase agreement under which Emergent will acquire Protein’s ongoing operation, including FluBlok, a phase III recombinant influenza vaccine candidate, and certain other assets including its Baculovirus Expression Vector System technology.
BEVS is a cell culture-based manufacturing platform used to manufacture FluBlok. The BEVS technology can be applied to develop vaccines and therapeutic candidates to prevent or treat a wide range of diseases. Emergent will also acquire other product candidates. PSC’s other product candidates are based on the BEVS platform and include a SARS vaccine in preclinical development. Also, Emergent acquires a vaccine manufacturing facility. This facility is located in Meriden, Connecticut and includes a 600-liter bioreactor and related upstream and downstream capabilities.
“We are delighted about the opportunity to commercialize the first recombinant cell culture influenza vaccine. We believe that FluBlok will become a strong competitive product in the sizeable and growing seasonal influenza market and that BEVS will provide a unique platform for the development of a novel pandemic influenza candidate. We congratulate the management of PSC in building a manufacturing operation and for bringing FluBlok through a Phase III clinical trial to the point of a BLA submission. Emergent, with the combined resources of PSC, is well positioned to bring this exciting product to the market successfully, based on our product development, regulatory and manufacturing experience,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “The acquisition of FluBlok is consistent with Emergent’s strategy of expanding its product portfolio with a vaccine candidate focused on a major infectious disease.”
FDA approves Teva’s generic Sarafem Pulvules
JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.
The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.
Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.
FDA issues approvable letter for Wyeth osteoporosis drug
WASHINGTON Wyeth Pharmaceuticals received an approvable letter from the Food and Drug Administration for a drug to treat postmenopausal osteoporosis, the company announced Friday.
The FDA requested further analysis concerning stroke and venous thrombosis for the drug, known as bazedoxifene. The FDA made similar requests when Wyeth Pharmaceuticals filed a new drug application in December 2007. The company expects to respond to the new letter by the end of this year.
Wyeth Pharmaceuticals is a division of Wyeth, a global company specializing in pharmaceuticals, consumer healthcare products and animal healthcare products.