FDA approves Mylan’s epilepsy generic
PITTSBURGH The Food and Drug Administration has approved a generic version of an epilepsy drug made by Mylan, the company announced Friday.
The generic drug maker received FDA approval for its levetiracetam tablets in the 1,000-mg strength. The company already markets the drug in the 250-mg, 500-mg and 750-mg strengths.
The drug is a generic version of UCB Pharma’s Keppra. Levetiracetam in the 1,000-mg strength had sales of $136 million during the 12-month period ended Sept. 30, according to IMS Health.
PhRMA admits new members
WASHINGTON An organization representing the country’s pharmaceutical companies has admitted seven new members.
The Pharmaceutical Research and Manufacturers of America announced Tuesday that the new member companies would support the organization’s push for healthcare reform.
“The addition of these member companies is a testament to the hard work PhRMA has been doing over the years, which has attracted enormous new talent to our ranks,” PhRMA chairman and AstraZeneca CEO David Brennan said. “We welcome the new companies with open arms and look forward to working with them on one of the most important issues of our lifetime – healthcare reform.”
The new companies are: Cubist Pharmaceuticals, Lexington, Mass.; OSI Pharmaceuticals, Melville, N.Y.; Alexion Pharmaceuticals, Cheshire, Conn.; Ferring Pharmaceuticals, Parsippany, N.J.; Talecris Biotherapeutics, Raleigh, N.C.; Vifor Pharma, Basking Ridge, N.J.; and Xoma, Berkeley, Calif.
Lilly outlines innovation strategy, reviews pipeline for 2010
NEW YORK Eli Lilly & Co. will pursue an innovation-based strategy to compete and serve patients, the drug maker said Thursday at its annual meeting with its investment company.
The Indianapolis-based drug maker boasts a pipeline of more than 60 potential drugs in clinical development, including 25 in phase 2 and phase 3 studies. It expects to have 10 in phase 3 studies in 2011 and launch two new medicines per year beginning in 2013.
“In 2009, Lilly has once again exhibited strong performance in a tough environment, and we’ve continued with a series of actions aimed at speeding innovation to patients and delivering greater value to our customers,” Lilly president and CEO John Lechleiter said. “Through these actions and more, we are transforming Lilly to compete and to win in an ever more demanding and challenging environment.”
Lilly’s situation stands in contrast with those of many other large drug makers, such as Pfizer and Merck & Co., which have pursued big-ticket acquisitions of Wyeth and Schering-Plough Corp. to stave off the effects of patent expirations on top-selling products and weak pipelines.
“We see a divergence of strategies among our peers to deal with these challenges, including the wave of consolidation this year,” Lechleiter said. “Many companies are seeking to lower risk by reducing their focus on innovative medicines. This is not our path.”