MAYNE WINS GERMAN APPROVAL FOR GENERIC CANCER DRUG

Mayne Pharma announced it has received marketing approval for its generic oxaliplatin product in Germany, which is one of the largest oxaliplatin markets, according to the company. The product completed the mutual recognition program in July and has now received marketing approval in 13 European countries and Australia.

Mayne has begun to sell its version of oxaliplatin in six European markets including the UK. Mayne's launch of the drug in the UK last month has been highly successful, the company said.

A UK high court in May found in favor of Mayne in relation to patents for its oxaliplatin products. Additionally, a German court has ruled that the process used to manufacture the active ingredient in Mayne's oxaliplatin does not infringe on patents belonging to sanofi-aventis, which makes the brand drug Eloxatin. Sanofi-aventis has appealed both rulings.

Oxaliplatin is a core anticancer product used in the treatment of stage III adjuvant and metastatic colorectal cancer, according to Mayne. The drug generates annual worldwide sales of approximately $1.6 billion, the company said, citing IMS Health.