Teva to acquire Taiyo
JERUSALEM — Generic drug maker Teva Pharmaceutical Industries will acquire a privately owned manufacturer of generic drugs based in Japan, Teva said Monday.
Teva announced the purchase of a 57% stake in Nagoya, Japan-based Taiyo Pharmaceutical Industry Co. for $460 million, with plans to extend its offer to purchase all remaining shares of the company.
Taiyo is Japan’s third-largest generic drug company, with sales of $530 million in 2010 and a product portfolio of more than 550 generic drugs, including injectables used in hospitals. Teva president and CEO Shlomo Yanai said the acquisition would position Teva as a leading player in Japan’s quickly growing generics market.
Generic, authorized generic of Amrix launched
PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.
Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.
As the first company to file for Food and Drug Administration approval of a generic version of Amrix, Mylan will have 180 days of market exclusivity in which to compete directly with the branded version, under the provisions of the Hatch-Waxman Act of 1984, the law that created a regulatory approval pathway for generic pharmaceutical drugs.
In related news, Watson subsidiary Watson Pharma has launched an authorized generic of Amrix in the 15-mg and 30-mg strengths, as part of an agreement with Anesta AG, a subsidiary of Cephalon. Under the terms of the nonexclusive sales agent agreement, Anesta manufactures and supplies Watson with all dosage strengths of the authorized generic product.
Victrelis approved by FDA as chronic hepatitis C treatment
SILVER SPRING, Md.— The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.
The FDA announced the approval of Merck’s Victrelis (boceprevir) for patients with the disease. The drug is designed for patients who still have some liver function and have not previously received treatment for chronic hepatitis C infection or have failed previous treatments. The drug is approved for use in combination with the generic drug ribavirin and pegylated interferons, biotech drugs used for treating the disease.
“Victrelis is an important new advance for patients with hepatitis C,” FDA Office of Antimicrobial Products director Edward Cox said. “This new medication provides an effective treatment for a serious disease and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”