Westchester-based Regeneron Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd., an Israeli producer of generic medicines headquartered in Jerusalem, recently announced a global agreement to develop and commercialize fasinumab, an investigational antibody against nerve growth factor, or NGF, that is in clinical trials by Regeneron as a treatment for osteoarthritis pain and chronic low back pain.
Under the terms of the agreement announced Sept. 20, Teva will pay Regeneron $250 million upfront and share equally in the drug’s global commercial value. The collaborating companies also will equally share ongoing research and development costs of approximately $1 billion.
Dr. George D. Yancopoulos, Regeneron’s chief scientific officer and president of Regeneron Laboratories, said the development of novel pain medicines such as fasinumab “can be one important step in combating the growing opioid epidemic.” The antibody therapy, which Yancopoulos said “represents the culmination of more than 25 years of Regeneron scientific work in neurotrophic factors,” is in Phase 3 clinical trials on patients with osteoarthritis pain and in Phase 2 trials on patients with chronic low back pain.
The companies said fasinumab is a fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in patients with chronic pain conditions, they said.
Michael Hayden, Teva’s president of global research and development and chief scientific officer, said fasinumab “has the potential to provide a treatment option without the concerns of abuse, addiction and misuse of opioids. In the United States alone, it is estimated that 30 million people suffer pain from osteoarthritis and the same number with chronic low back pain.” Those patient numbers for both pain conditions are expected to grow in the low single-digit percentages annually.
The agreement allows Regeneron to receive development and regulatory milestone payments and additional payments from Teva based on net sales. The company, headquartered at the Landmark at Eastview life sciences campus near Tarrytown, will lead global development and U.S. commercialization of the new drug. Regeneron and Teva will share commercialization efforts in the U.S. by utilizing sales teams and marketing expertise from both companies and split profits equally.
In countries outside the U.S. — except for Japan and 10 other Asian countries covered by a previously announced collaboration between Regeneron and Mitsubishi Tanabe Pharma — Teva will be responsible for development and commercialization and pay Regeneron a purchase price, allowing both companies to retain approximately equal shares of fasinumab’s global commercial value over time.
At Teva, “With our commercial footprint, we will be able to widely educate health care providers about this new treatment option when it becomes available,” said Dr. Rob Koremans, Teva’s president and CEO of global specialty medicines.
In late August, Teva Pharmaceuticals USA Inc. announced it will close its plant in Pomona in Rockland County by Feb. 28, 2017, and began layoffs among the plant’s 236 employees. Some research and development operations in Rockland County will be consolidated at the Elizabeth, N.J., facility of Actavis Generics, Allergan plc’s generic drugs business acquired by Teva in August in a $40.5 billion deal.
A Teva spokesperson said the company expected that more than 130 positions will be available at the New Jersey site.