Millions of people in the U.S. suffer from chronic forms of pain, but the treatment options aren’t great. Regeneron Pharmaceuticals is locked in a race with Eli Lilly and Pfizer to develop an alternative, and today the Tarrytown, NY, company just got a big chunk of cash to speed the way forward.
Teva Pharmaceutical (NYSE: TEVA) is paying Regeneron (NASDAQ: REGN) $250 million up front for partial rights to fasinumab, an antibody drug being developed as a treatment for lower back pain and pain associated with osteoarthritis. The two companies will now split the U.S. rights to fasinumab as well as its remaining clinical development costs, which include an ongoing Phase 3 trial in osteoarthritis and a mid-stage study in chronic lower back pain.
Teva will also get rights to the drug outside the U.S., but not in a number of Asian countries such as Japan, South Korea, and Taiwan—rights to fasinumab in those countries are already held by Mitsubishi Tanabe Pharma through a September 2015 deal with Regeneron.
Teva could pay Regeneron another $460 million in downstream payments if fasinumab hits a variety of development and regulatory targets, and up to $1.9 billion in additional payments if the drug hits some unspecified sales figures.
About 30 million people in the U.S. have osteoarthritis pain, and a similar number have chronic lower back pain, according to Regeneron. Yet opioids can lead to addiction problems, and non-steroidal inflammatory drugs can cause safety problems when taken chronically.
One approach that’s garnered much attention over the years as a potential alternative is using a drug to block the activity of nerve growth factor (NGF), a protein involved in pain signaling. Regeneron’s fasinumab works this way, as does a rival drug from Pfizer and Eli Lilly called tanezumab, and several years ago NGF blockers were heralded as a new potential blockbusters for drugmakers. But then concerns about the drugs’ safety emerged. Between 2010 and 2012, the FDA halted several ongoing studies of NGF blockers—among them Regeneron’s drug, Pfizer and Lilly’s tanezumab, and Johnson & Johnson’s fulranumab, due to reports that they were actually exacerbating joint damage, among other issues. The holds were lifted just last year, freeing development of the drugs.
Pfizer and Lilly currently lead the race to market, thanks in part to dwindling competition. The pair inked a $1.8 billion deal in 2013 to co-develop tanezumab, and aim to win FDA approval of their drug in 2018. J&J, which had licensed fulranumab from Amgen, stopped development of the drug in April and returned its rights to the Thousand Oaks, CA, company. AstraZeneca and AbbVie are also no longer developing rival anti-NGF drugs. That leaves Regeneron, which has now aligned itself with Teva and Mitsubishi.
Regeneron announced positive top-line results from a placebo controlled, Phase 2/3 trial of fasinumab in osteoarthritis in May, though questions remain regarding the long-term safety of fasinumab and NGF blockers in general. Regeneron has been enrolling patients in a large, long-term safety study in osteoarthritis, which should produce data in 2018. Data from its mid-stage study in low back pain should come next year.