Clinical hold for Regeneron/Teva anti-NGF

Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said FDA placed a clinical hold on a Phase IIb study of fasinumab ( REGN475) after a case of adjudicated arthropathy occurred in an advanced osteoarthritis patient who received a high dose of the back pain candidate. The partners said a planned Phase III study to treat chronic low back pain will exclude patients with advanced osteoarthritis.

Last month, Teva paid Regeneron $250 million up front to share ex-Asian rights to fasinumab, a mAb against nerve growth factor. Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) has rights in 11 Asian countries, including Japan, South Korea and Taiwan (see BioCentury Extra, Sept. 20). ...