SUPPLIER NEWS — Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), a drug for treating symptoms of menopause, 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.
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.
Par Pharmaceutical has completed its acquisition of Anchen Pharmaceuticals, the generic drug maker said. Par announced plans in August to acquire Irvine, Calif.-based Anchen for $410 million, consisting of a loan and cash it already had. A privately owned company, Anchen has about 200 employees and more than 72,000 sq. ft. of manufacturing and warehouse space, Par said.
Drug maker Gilead Sciences will acquire Pharmasset for $11 billion, or $137 per share, Gilead said. 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.
After being unanimously recommended for approval by a FDA panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals. Eylea (aflibercept) is used to treat patients with wet age-related macular degeneration, a leading cause of vision loss and blindness.
The wet form of AMD includes the growth of abnormal blood vessels, which can leak fluid into the central part of the retina, also known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs. The drug was recommended for approval back in June by the Dermatologic and Ophthalmic Drugs Advisory Committee.