Genentech, Biogen Idec cancer therapy study yields positive results
NEW ORLEANS A combination of a biotech drug with a chemotherapy treatment helped patients with chronic lymphocytic leukemia survive longer than the chemotherapy treatment alone, according to late-stage clinical trial results presented Monday at the annual meeting of the American Society of Hematology in New Orleans.
Roche subsidiary Genentech and Biogen Idec announced results of an 817-patient phase 3 study comparing therapy with Rituxan (rituximab) and fludarabine and cyclophosphamide chemotherapy with FC chemotherapy alone in patients with previously untreated CLL. Of the patients, 87.2% of those who received Rituxan and FC were alive after more than three years of follow-up, compared with 82.5% of those who only took FC chemotherapy.
“Rituxan was the first targeted B-cell therapy approved for cancer in the U.S., and these new data once again illustrate Rituxan’s ability to improve patient outcomes,” Biogen Idec SVP oncology research and development Greg Reyes said in a statement. “These three-year data are exciting for people living with CLL.”
Valeant to acquire Laboratoire Dr. Renaud
ALISO VIEJO, Calif. U.S. drug maker Valeant Pharmaceuticals International will acquire a Canadian cosmeceutical company, Valeant announced Monday.
Valeant Canada will purchase Laval, Quebec-based Laboratoire Dr. Renaud for C$21.8 million, leasing a 45,000-sq.-ft. manufacturing plant for topical products. Dr. Renaud has annual sales of $10.4 million, and the acquisition is expected to be completed in 2010.
“This acquisition is part of our continued efforts to build a leading dermatology business by adding respected brand names in our select regions,” Valeant chairman and CEO J. Michael Pearson stated. “Laboratoire Dr. Renaud enjoys a high degree of loyalty from esthetic clinics and spas, and we believe that Valeant will gain immediate entree into the cosmeceutical market in Canada. With exclusive access to a world class topical manufacturing plant and a successful sales and marketing infrastructure, we also have the ability to launch select U.S. dermatology products into Canada and further expand our reach in dermatology.”
FDA warns GSK’s HIV drug may increase risk of heart attack
ROCKVILLE, Md. The Food and Drug Administration and GlaxoSmithKline have warned healthcare professionals of the risk of heart attack and buildup of cholesterol in patients taking a drug used to treat HIV.
The FDA released an alert Thursday announcing that it had modified the prescription information for the drug Lexiva (fosamprenavir calcium) to note that some patients taking the drug have experienced increases in cholesterol, a condition known as dyslipidemia, and recommend that patients undergo cholesterol and triglyceride testing before and during therapy with the drug.
In other news, the agency warned of possible birth defects among babies born to women who take the epilepsy drug valproate sodium and related drugs during pregnancy, including defects of the head and face and circulatory systems. Valproate sodium and related drugs are mostly available as generics, and Abbott Labs markets them under brand names such as Depacon (valproate sodium injection) and Depakote (divalproex sodium tablets).