Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today reported positive preliminary results in its Phase III clinical trial of Fasinumab for treatment of chronic pain caused by osteoarthritis of the knee or hip. Teva is developing the drug in cooperation with Regeneron Pharmaceuticals.
The trial compared two possible treatments using Fasinumab - subcutaneous injection of a 1 mg dosage every four or eight weeks - to a control group that received a placebo. Teva reported that a primary efficacy assessment in the 16th week showed that the trial had met its two primary endpoints and all of its secondary endpoints. Patients treated with Fasinumab experienced significantly less pain and significantly improved their physical capabilities in comparison with the control group.
"We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program in patients with osteoarthritis of the knee or hip, who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids," said Regeneron president and chief scientific officer Dr. George Yancopoulos.
Teva signed a cooperation agreement with Regeneron two years ago for development and commercialization of the drug. The agreement includes payment of a $250 million advance, and Teva assumed research and development costs estimated at the time at $500 million. Subject to meeting various milestones, Teva will pay its partner $1.9 billion in additional payments under the agreement. Teva recently halted development of the drug at higher dosages because of a questionable risk-benefit profile.
In response, economists at Credit Suisse wrote, "We are encouraged by the reports and are waiting to see additional information, especially in view of the discontinuation of development of the high dosages. It appears that this asset, which is undervalued, could become an upside source for Teva."
Teva, managed by CEO Kare Schultz, has a $22.9 billion market cap. Another of Teva's original drugs, Fremanezumab for treatment of migraine headaches, is in line for a decision about granting marketing approval for it by the US Food and Drug Administration (FDA) one month from now. Fremanezumab is aimed at a very competitive, but also very large, market.
Published by Globes [online], Israel business news - www.globes-online.com - on August 16, 2018
© Copyright of Globes Publisher Itonut (1983) Ltd. 2018