News Of Clinical Hold For Fasinumab Weighs On Regeneron, Teva Shares

Shares of Regeneron Pharmaceuticals, Inc. REGN and Teva Pharmaceuticals Ltd (ADR) TEVA came under selling pressure after the FDA placed the second stage study on chronic low back pain on hold. The companies are involved in developing fasinumab for treating low back pain.

The drug candidate is an investigational Nerve Growth Factor antibody in clinical development for osteoarthritis pain and low back pain. The FDA advised to hold the study and make amendments to the trial protocol following its observation of a case adjudicating arthropathy in a patient, who got high dosage of fasinumab. The patient had an advanced osteoarthritis at trial entry.

Following the regulator's decision, Regeneron indicated it completed an unplanned interim review of results. The company also stopped dosing in the trial. The company indicated that its unplanned analysis demonstrated evidence of efficacy with improvement in pain scores compared to placebo involving a period of 8 and 12 weeks.

Regeneron Chief Scientific Officer, George Yancopoulos, commented, "We look forward to working with global health authorities to advance this important investigational therapy for patients with often difficult-to-treat osteoarthritis pain and chronic low back pain."

Both Regeneron and Teva have collaborated on the development and commercialization of fasinumab. A separate agreement was reached with Mitsubishi Tanable Pharma for the exclusive development and commercial rights in Japan, Korea and nine other Asian nations.

Following the unfavorable news, Regeneron dropped $6.68, or 1.8 percent, to $365 while Teva shed $0.15, or 0.35 percent, to $42.81 in pre-market trading on Monday.