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Teva Licenses Pain Relief Antibody for $1.25 Billion

Nerve cells illustration

(commonfund.nih.gov)

20 September 2016. Teva Pharmaceutical Industries is licensing from biotechnology company Regeneron Pharmaceuticals an engineered antibody that targets proteins supporting pain signals. The agreement could bring Regeneron, in Tarrytown, New York as much as $1.25 billion in licensing fees and R&D reimbursements, more in milestone and royalty payments.

The deal involves fasinumab, a synthetic antibody that addresses a specific protein, nerve growth factor, or NGF supporting development and survival of nerve cells transmitting pain, temperature, and touch sensations. New drugs are needed to replace opioid pain relievers responsible for a growing epidemic of abuse and overdoses. The companies cite data from market research company Decisions Resources Group that 30 million people in the U.S. live with osteoarthritis pain, and a similar number with chronic low back pain, many at moderate to severe levels.

Fasinumab binds to NGF and blocks its signals, reducing pain sensitization. Regeneron says its preclinical tests show other nerve cell signals are not affected by the drug. Other preclinical tests, however, show fasinumab and similar experimental drugs addressing NGF have toxic effects on the sympathetic nervous system that activates fight-or-flight responses in some lab animals. Those results led FDA in December 2012 to suspend testing of anti-NGF drugs with humans until the toxicity questions were resolved.

FDA later lifted its suspension, allowing Regeneron in mid-2015 to begin an intermediate- and late-state clinical trial of fasinumab with individuals experiencing moderate or severe knee or hip pain from osteoarthritis. The company reported its first results of the trial in May 2016, showing participants receiving 4 doses of fasinumab over 12 weeks, with pain measured on a 10-point standard rating scale at 16 weeks. The results show participants receiving fasinumab at 4 different dosage levels experienced less pain compared to baseline measures than individuals receiving a placebo. Occurrences of adverse events — joint pain, tingling sensations, numbness, and swelling — were similar for treatment and placebo groups.

The deal calls for Regeneron to lead further development of fasinumab and commercialization in the U.S., while both companies will share sales and marketing responsibilities in the U.S. Teva, based in Israel, will lead commercialization of fasinumab outside the U.S., except for Japan, Korea and 9 other Asian countries where Regeneron and Mitsubishi Tanabe Pharma Corp. already have a licensing agreement. China is not one of 9 countries.

The agreement gives Regeneron an initial licensing fee of $250 million from Teva, as well as payments of about $1 billion covering continuing research and development of fasinumab. Regeneron is also eligible for development and regulatory milestone payments, and royalties based on net sales.

Regeneron is recruiting participants for intermediate- and late-stage clinical trial of fasinumab among individuals with chronic lower back pain, as well as a long-term safety and efficacy study of the drug with people having knee or hip pain from osteoarthritis.

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