European regulator opens door to Teva, generic cos

Sandoz CEO Jeff George: Looking out five to ten years, I see this as a multi- billion-dollar opportunity.

The European Medicines Agency (EMA) has published draft regulations for biosimilars, opening a market for Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and other generic drug companies that develop generic versions of biological drugs. The regulations will cover monoclonal antibodies, with an estimated biosimilars market of $36.4 billion.

"Bloomberg" reports that three majormonoclonal antibody treatments are scheduled to lose patent protection by 2015: Roche Holding AG’s (SWX: RO) Herceptin for cancer, Biogen Idec Inc. (Nasdaq: BIIB) and Elan Corporation plc’s (NYSE: ELN; ISE: DRX) multiple sclerosis drug Tysabri, and rheumatoid arthritis treatment Remicade, sold by Johnson & Johnson (NYSE: JNJ) and Merck & Co. (NYSE: MRK). Together, these medicines had sales of more than $10 billion in 2009.

"Looking out five to ten years, I see this as a multi- billion-dollar opportunity. Novartis is working on eight to 10 copies of biological drugs.” said Sandoz CEO Jeff George. Sandoz is the generic drugs unit of Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ).

Teva's share closed at $50.31 on Nasdaq on Friday. The share price rose 1.5% in morning trading on the TASE today to NIS 185.60.

Published by Globes [online], Israel business news - - on November 28, 2010

© Copyright of Globes Publisher Itonut (1983) Ltd. 2010

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