Teva settles patent suit with Ortho-McNeil-Janssen
JERUSALEM Teva Pharmaceutical Industries has announced its settlement of its patent infringement lawsuit over its generic version of a popular contraceptive.
Teva said it has entered into a definitive agreement with Ortho-McNeil-Janssen to settle the suit in the U.S. District Court for the District of New Jersey related to Teva’s generic Ortho Tri-Cyclen Lo. Under the terms of the settlement, Teva will obtain a release for past sales of its generic product, in exchange for an undisclosed royalty payment. Teva also will obtain a license to re-enter the market on December 31, 2015, or earlier in certain circumstances.
The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho’s patent.
FDA approves additional use for Forteo
ROCKVILLE, Md. The Food and Drug Administration has approved a new use for an osteoporosis drug, the agency announced Wednesday.
The FDA said it approved Eli Lilly & Co.’s drug Forteo (teriparatide) as a treatment for glucocorticoid-induced osteoporosis in adults with high risk for fracture.
Since 2002, the drug has included a boxed warning – the FDA’s highest warning – about the risk of bone cancer in patients taking it. Because patients with GIO may be younger than the ones who usually take Forteo, the warning will be updated, the agency said.
Wyeth reports mixed results for Q2
MADISON, N.J. Drug maker Wyeth had mixed fortunes during second quarter 2009, according to a financial report released Thursday.
The company reported a 13% increase in diluted earnings per share, but also a 4% decrease to $5.7 billion in global net revenue, though global net revenue increased by 2% when excluding the adverse effects of foreign exchange rates.
Wyeth also reported mixed results for its top-selling products. Sales of the antidepressant Effexor (venlafaxine hydrochloride) decreased by 25% for the quarter, though the children’s pneumococcal vaccine Prevnar (pneumococcal 7-valent conjugate vaccine [diphtheria CRM197 protein]) had a 13% sales increase, while the autoimmune disease drug Enbrel (etanercept) had a 7% increase in U.S. and Canadian sales.
“Wyeth’s results reflect the ongoing strength of our biotechnology and vaccine franchises Enbrel and Prevnar and our nutritionals products, all of which performed strongly around the world,” Wyeth CEO Bernard Poussot said in a statement. “Execution of our medical innovation strategy led to positive revenue growth in constant dollar terms.”
The company’s acquisition by Pfizer, announced earlier this year, received overwhelming support from Wyeth shareholders, the company said, with 98% of votes cast in favor. The acquisition is expected to close at the end of third quarter or during fourth quarter 2009.