Watson seeks approval for generic ulcerative colitis drug
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.
Watson announced that it had filed with the Food and Drug Administration through a subsidiary for melamine delayed-release tablets, a generic version of Shire Development’s Lialda, in the 1.2-g strength. Watson’s filing included a Paragraph IV certification, a legal assertion that Lialda’s patent protection is invalid, unenforceable or won’t be infringed.
In response, Shire and two other companies filed suit against Watson in the U.S. District Court for the Southern District of Florida seeking to prevent Watson from commercializing its drug, alleging that it infringes U.S. Patent No. 6,773,720, which expires in June 2020, according to the FDA. Under laws governing generic drugs, the lawsuit puts a stay of final FDA approval on Watson’s drug for up to 30 months or until the companies settle.
Lialda had sales of about $390 million during the 12-month period ended in March, according to IMS Health.
FDA panel recommends approval for Pfizer RA drug
NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.
Pfizer announced that the FDA Arthritis Advisory Committee voted 8-2 to recommend that the agency approve tofacitinib for moderately to severely active RA. The agency is not required to follow the recommendations of advisory committees, but usually does, and is expected to decide whether or not to approve the drug in August. Pfizer said that, if approved, tofacitinib would be the first new disease-modifying antirheumatic drug for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase, or JAK inhibitors.
"We are pleased with the committee’s positive evaluation of the tofacitinib data and its decision to recommend approval," Pfizer Specialty Care SVP and head of the medicines development group Yvonne Greenstreet said. "The RA patient population needs additional treatment options, and Pfizer looks forward to working with the FDA on next steps as it completes its review of the tofacitinib application."
Mylan boosts EPS guidance
PITTSBURGH — Mylan has increased its 2012 earnings per share guidance range, the generic drug maker said.
The company boosts its EPS guidance range to $2.45 to $2.55 in adjusted diluted earnings per share, up from $2.30 to $2.50 per share. All of Mylan’s other 2012 guidance metrics remain unchanged.
In related news, Mylan also announced that its board of directors has approved the repurchase of up to $500 million of the company’s common stock in the open market.
"As we have said previously, we expect 2012 to be the best year to date in Mylan’s history. The increase in our guidance is a result of our continued strong operational performance," Mylan CEO Heather Bresch said.