Roche’s GA101 Met Goals in Stage One of Trial to Replace Rituxan

Roche Holding AG (ROG) said a next- generation blood cancer drug met its target in the first stage of a trial that could help the treatment replace top-seller Rituxan in patients with chronic lymphocytic leukemia.

GA101 combined with chemotherapy helped CLL patients live longer without their disease progressing than chemotherapy alone, the Basel, Switzerland-based drugmaker said in an e- mailed statement today. The medicine is a partnership with U.S. biotechnology company Biogen Idec Inc. (BIIB)

Still to come is data comparing GA101 directly with Rituxan. Roche has said it aims to make the new drug the successor to the older medicine in a bid to defend sales from biosimilar competitors after its patent expires. Roche faces a challenge, as there may be a gap between when Roche’s patents start to expire next year and the date that the drugmaker can start selling GA101 to the bigger potential patient groups, Bloomberg Industries analysts wrote in a note in December.

An analysis after the first stage of the CLL trial showed there is a possibility that GA101 will be better than Rituxan, Roche said today.

Like Rituxan, GA101 targets CD20, a type of immune cell that plays a role in non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. People with non-Hodgkin’s lymphoma are the larger group of potential patients for GA101, and Roche is also testing the drug in that patient group.

Full Results

Full results from the trial in CLL patients will be presented at a medical conference, the company said.

Also known by its generic name rituximab, Rituxan generated 6.7 billion Swiss francs ($7.4 billion) in sales last year. Roche’s patents on the medicine expire in 2018 in the U.S. and earlier in Europe. Biogen Idec also helps market the drug in the U.S.

Roche also asked European regulators in December to approve a subcutaneously administered version of Rituxan, which would be a faster way to give patients the drug and thus muster another potential defense against biosimilar copies.

Companies working on copies of Rituxan include Boehringer Ingelheim GmbH, Novartis AG (NOVN), Celltrion Inc. (068270), partners Samsung Electronics Co. (005930) and Quintiles Transnational Corp., and Teva Pharmaceutical Industries Ltd. (TEVA) with Lonza Group AG. (LONN)

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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