Par buys rights to generic drug for GERD
WOODCLIFF LAKE, N.J. — Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.
Handa, based in Fremont, Calif., sold rights to the regulatory approval application it filed with the Food and Drug Administration for dexlansoprazole capsules, a generic version of Takeda’s Dexilant, in the 60-mg strength.
Par purchased rights to the application for an undisclosed amount and will receive a percentage of profits from sales. Handa is apparently the first company to file for approval of the generic, which would qualify Par for 180 days of market exclusivity once the FDA approves it; Handa is currently involved in a lawsuit concerning the drug in the U.S. District Court for the District of Northern California, and Par will assume control of litigation.
Dexilant has annual sales of about $517 million, according to IMS Health.
Watson launches authorized generic diabetes drug
PARSIPPANY, N.J. — Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.
The generic drug maker launched metformin hydrochloride extended-release tablets, an authorized generic version of Fortamet, made by Shionogi. An authorized generic is a branded drug marketed under its generic name at a reduced price, usually through a third-party company acting under a collaborative agreement with the original branded manufacturer.
The launch of Watson’s product was timed to coincide with the relaunch of a generic version of Fortamet by Lupin. Lupin had received Food and Drug Administration approval for a generic version of the drug in April 2011 and launched it in September of the same year, but in December, Shionogi obtained an injunction that prevented further sales of Lupin’s product.
Fortamet had sales of $82 million during the 12-month period ended in February, according to IMS Health.
AstraZeneca buys Ardea Biosciences for $1.26 billion
SAN DIEGO — Anglo-Swedish drug maker AstraZeneca will buy a San Diego-based biotech company for $1.26 billion, the two said Monday.
Ardea Biosciences is currently developing the drug lesinurad, a drug currently in phase-3 studies for chronic management of hyperuricemia in patients with gout.
"This attractive phase-3 program is an excellent opportunity to leverage AstraZeneca’s global specialty and primary care sales and marketing capabilities," AstraZeneca CEO David Brennan said. "The Ardea team has done a great job developing lesinurad along with a promising next-generation gout program. These compounds have real potential to benefit patients."
The companies said AstraZeneca’s offer of $32 per share for Ardea represented a 54% premium over the price of the company’s stock on Friday.