Regeneron Pharmaceuticals Inc. will give a Japanese pharmaceutical company exclusive rights to develop and commercialize for the Asian market Regeneron”™s antibody drug for musculoskeletal pain in a collaboration that could earn the biotech company in Greenburgh a total of $325 million.
In a deal announced Oct. 1, Mitsubishi Tanabe Pharma Corp. will develop fasinumab, Regeneron’s nerve growth factor antibody in late-stage development for pain control, and market it in Japan, Korea and nine other Asian countries, excluding China.
“Pain is one of the most common causes of disability, suffering and productivity loss across the world, and yet current treatments have limited efficacy, hold the risk of abuse or have other serious side effects,” said Dr. Leonard S. Schleifer, president and CEO of Regeneron, in the announcement. He said Mitusbishi Tanabe “has proven experience marketing biologics for rheumatology and pain management and thus is an ideal partner in Asia.”
Fasinumab is a fully human monoclonal antibody that was shown to safely reduce pain in a clinical study in osteoarthritis, Regeneron officials said. The new drug however, was put on partial clinical hold in late 2012 by the U.S. Food and Drug Administration, limiting duration of trials in osteoarthritis to 16 weeks.
The FDA action, which applied to the Regeneron therapy and other investigational new drugs that target nerve growth factor (NGF), was prompted by reports of toxicity in the sympathetic nervous systems of mature animals being treated with other NGF antibodies.
Regeneron will receive up to $55 million in up-front and other near-term payments from Mitsubishi Tanabe. The Osaka-based pharmaceutical research company agreed to pay up to $170 million additionally in research and development reimbursements and at development milestones.
Regeneron officials said the company will receive a significant portion of any potential profits from fasinumab sales in the Asian market. Regeneron is also eligible for additional one-time purchase price adjustment payments totaling up to $100 million based on specified annual net sales.
