Bayer Schering completes acquisition of Novartis’ facility
FRANKFURT, Germany Bayer Schering Pharma has completed its acquisition of one of Novartis’ biologics manufacturing facility in Emeryville, Calif.
Bayer will use the site to manufacture its multiple sclerosis drug Betaseron, also known as Betaferon. Novartis received a one-time payment of $200 million as part of the deal, which was originally announced in March 2007, which involved the transfer of manufacturing responsibility of Betaseron.
Novartis will continue to receive royalty payments based on the net sales of Betaseron until the expiration of the original agreement in October 2008.
Evista gets FDA approval for new use to reduce breast cancer risk
INDIANAPOLIS The Food and Drug Administration has approved a new application for Eli Lilly’s osteoporosis drug Evista. The drug is now indicated as a way to reduce the risk of invasive breast cancer.
The drug’s new use is designed for postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns—osteoporosis and invasive breast cancer,” said Gwen Krivi, vice president of Lilly Research Laboratories.
The approval comes less than a year after the application was submitted to the FDA and also carries a recommendation of the Oncologics Drug Advisory Committee.
Cubist to ask for patent reissue for Cubicin
LEXINGTON, Mass. Cubist Pharmaceuticals is planning on asking U.S. regulators to reissue a patent on the drug Cubicin to block generic competition.
Cubicin is used as a treatment for skin infections and is set to lose its patent in 2016. Cubist is going to ask the U.S. Patent and Trademark Office to correct and reissue a patent regarding the purity level of the compound daptomycin, which is the key ingredient in Cubicin.
On Wednesday, generic manufacturers were allowed to seek approval from the Food and Drug Administration to sell generic versions of the drug. Now, with Cubist seeing corrections from the patent office, the original patent will be removed from the FDA’s registry of information on approved drugs until the mater is handled.