Gilead Sciences acquires Pharmasset for $11 billion
FOSTER CITY, Calif. — Drug maker Gilead Sciences will acquire Pharmasset for $11 billion, or $137 per share, Gilead said Monday.
Pharmasset, based in Princeton, N.J., is a drug maker that currently has three treatments for hepatitis C undergoing clinical trials, including PSI-7977, which is in late-stage development.
"The acquisition of Pharmasset represents an important and exciting opportunity to accelerate Gilead’s effort to change the treatment paradigm for HCV-infected patients by developing all-oral regimens for the treatment of the disease, regardless of viral genotype," Gilead chairman and CEO John Martin said. "Pharmasset presented compelling phase-2 data earlier this month further characterizing the strong efficacy and safety profile of PSI-7977."
Impax Labs looks to market generic cancer pain drug
HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.
Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon’s Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can’t be controlled by other drugs.
Impax’s application contained a paragraph IV certification, a legal assertion that one or more patents covering a drug are invalid, unenforceable or won’t be infringed. In response, Cephalon and CIMA Labs filed a patent infringement suit against Impax in the U.S. District Court for the District of Delaware, under the terms of the Hatch-Waxman Act of 1984, the law that created an abbreviated approval pathway for generic pharmaceuticals.
Fentora had sales of about $159 million during the 12-month period ended in September, according to Wolters Kluwer Health.
Mylan granted license to market generic menopause drug
PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.
Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.
The Pittsburgh-based generic drug maker was the first to file for regulatory approval of the drug with the Food and Drug Administration, and as such, will be entitled to 180 days of market exclusivity in which to compete directly with the branded version, after which other generic companies will be able to make their own versions.
Vivelle-Dot had sales of $240 million during the 12-month period ended in September, according to IMS Health. The patch is designed to be applied twice a week, and Mylan plans to sell it in the 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg and 0.1 mg strengths.