Dive Brief:
- Regeneron Pharmaceuticals announced a partnership Tuesday with Teva Pharmaceutical to make what they call a non-addictive consumer option to opioids.
- The plan calls for developing and marketing Regeneron’s fasinumab, a drug that blocks Nerve Growth Factor (NGF), a protein involved in transmitting pain signals.
- Teva says it will pay Regneron $250 million upfront, and share equally in the global commercial value, research and development costs, amounting to a deal worth $1 billion.
Dive Insight:
A collision of numbers tells the story of this deal.
First, it’s the huge numbers of people – 30 million, by Regeneron’s count –who live with osteoarthritis pain, and similar numbers with chronic low back pain. Those populations are expected to grow each year, in what the company calls "low-single digit" percentages.
Opioid prescriptions account for 40% of the chronic pain market, but the drugs are easily abused. Hence, Regeneron says, there’s a singular gap to be filled: alternative pain therapies.
For 25 years, the company worked on the drug fasinumab, although there were setbacks involving an entire class of anti-NGF drugs that resulted in the U.S. Food and Drug Administration temporarily halting testing over concern about safety issues stemming from animal studies.
Once the hold was lifted, Regeneron and other drug companies such as Pfizer and Eli Lilly & Co., got the go-ahead to continue with their studies. Pfizer and Lilly said they would seek FDA approval by 2018 for a type of pain drug also billed as an alternative to opioids, named tanezumab, which would be administered by injection every eight weeks.
In the meantime, Regeneron’s fasinumab is now is being tested in late stage trials for osteoarthritis pain and mid-stage studies for chronic low back pain.
"The development of novel pain medicines, such as fasinumab, can be one important step in combating the growing opioid epidemic," said George Yancopoulos, chief scientific officer of Regeneron.
In May, Yancopoulos disclosed positive results from a placebo-controlled Phase 2/3 study that evaluated fasinumab in patients with moderate-to-severe osteoarthritis pain in their hip or knee who had a history of inadequate pain relief. At 16 weeks, patients treated with all four doses of fasinumab demonstrated statistically significant improvement in pain relief, he said.
Under the terms of its agreement with Teva, Regeneron said it would be eligible to receive development and regulatory milestone payments and additional payments based on net sales. Regeneron said it will lead global development and U.S. commercialization.