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Pharmas Regeneron and Teva shares hit by FDA order

Monday, October 17, 2016 13:31
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Shares of Regeneron Pharmaceuticals (NASDAQ:REGN) and Teva Pharmaceuticals (NYSE:TEVA) were hit Monday by news of a clinical trial setback for a new pain drug they are co-developing.

US regulators put on hold a clinical trial involving an experimental treatment for chronic low back pain due to safety concerns. Regeneron shares closed down 1.3% at $366.73.

Teva, which is collaborating on the drug, saw its US-listed shares drop during the session although the managed to repair the damage and ended flat at $41.80.

The US Food and Drug Administration had ordered the hold and told Regeneron and Teva to amend the study protocol after observing a case of adjudicated arthropathy – a type of joint disease – in one patient who had osteoarthritis. As a result, Regeneron said it had stopped dosing study patients and was working to design a new study phase that excludes patients with osteoarthritis.

The drug, fasinumab, aims to offer treatment for millions of Americans who suffer from chronic low back pain and osteoarthritis without the use of highly addictive opioids, by targeting proteins that grow nerve cells. Rivals Eli Lilly (NYSE:LLY) and Pfizer (NYSE:PFE) are racing to develop a similar drug, tanezumab, which aims to treat osteoarthritis, back pain and cancer pain, which they aim to submit for approval by 2018.

Story by ProactiveInvestors


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