Tanezumab

Collectively, SiteOne shareholders could receive as much as $1 billion from the deal, according to Lilly.\n Eli Lilly is expanding its efforts to advance next-generation pain medications. The Big Pharma has penned a deal to acquire SiteOne Therapeutics, primarily for a non-opioid pain asset ready to enter phase 2 trials.Collectively, SiteOne shareholders could receive as much as $1 billion from the deal, Lilly said in a May 27 release, which includes an upfront payment, plus additional biobucks tied to certain milestones.Lilly’s sights are set on STC-004, a sodium channel inhibitor made to block NaV1.8, an ion channel primarily found in the peripheral nervous system and involved in pain sensation.\"The global burden of chronic pain continues to increase and an effective non-opioid treatment remains elusive,\" Mark Mintun, M.D., Lilly’s vice president of neuroscience R&D, said in the release. \"Lilly is eager to continue the development of STC-004 with the outstanding SiteOne team as part of our efforts to advance novel, addiction-free pain therapies.”SiteOne recently tested out STC-004 in a phase 1 trial, finding that a once-daily dose of the drug candidate was well-absorbed and well-tolerated, while also improving pain tolerance, according to a Feb. 4 release.The Bay Area biotech closed a $100 million series C fundraise led by Novo Holdings at the end of last year, with a goal of using the money to advance an early pipeline of pain candidates. In addition to NaV1.8, the company is also exploring other ion channel modulators, such as NaV1.7. Other NaV1.8 inhibitors have hit bumps in the road to replacing opioids. Vertex Pharmaceuticals, a biopharma long on the hunt for non-opioid pain relievers, dropped a pair of NaV1.8-targeting assets back in 2020, and then years later revealed a different inhibitor beat placebo at relieving pain in two phase 3 trials but failed to best the opioid Vicodin.Lilly previously entered a next-gen pain partnership with Pfizer, teaming up with the fellow pharma giant to develop nerve growth factor inhibitor tanezumab. However, the partners ultimately dumped tanezumab after regulators from the FDA and European Medicines Agency rejected it. The candidate had shown the ability to reduce pain in patients with osteoarthritis, but faced concerns over a link to joint damage.

Like many other companies, Regeneron has axed programs from its pipeline, including a cat allergy drug and an NGF inhibitor for chronic pain. The cat’s out of the bag: Regeneron is leaving two drugs behind, including an NGF inhibitor targeting chronic pain and a cat allergy therapy. The culls were announced Nov. 3 in a third-quarter financial update, burrowed deep among third-quarter earnings results, which included a revenue decline of 19% and 11% revenue growth when compared to the third quarter of 2021. The Big Pharma has axed fasinumab, its Teva- and Mitsubishi Tanabe Pharma-partnered NGF inhibitor. The investigational monoclonal antibody was invented by Regeneron in hopes of addressing chronic pain, specifically for patients with osteoarthritis of the knee or hip. The drug has an embattled history, including a 2016 clinical hold from the FDA on a Teva-partnered phase 2b trial in patients with chronic back pain and osteoarthritis of the knee or hip. The agency asked the partners to amend the study protocol after a case of a joint disease was reported in a patient receiving a high-dose of fasinumab. The NGF inhibitor class as a whole has had its share of trouble. In 2011, the FDA put the class on clinical hold over evidence linking the drugs to joint damage and other adverse events, though the stay was lifted a year later. In fall 2021, Eli Lilly and Pfizer called time on their osteoarthritis NGF inhibitor known as tanezumab. In April 2021, after an FDA advisory committee voted against the drug, Teva CEO Kåre Schultz told investors that the vote against it was “definitely a negative for the product class,” adding that nonessential fasinumab costs were on hold pending a decision on whether to file for approval.   Regeneron recognized $44 million in deferred income in the third quarter related to previously received upfront payments and development milestones for fasinumab, Bob Landry, executive vice president and chief financial officer, said during a Nov. 3 earnings call.   The second drug tossed from Regeneron’s pipeline was REGN1908-1909, a multi-antibody therapy for cat-allergic asthmatic patients. The drug, which made it through phase 3 trials, won’t be pawned off to another industry player but instead discontinued fully due to futility, according to the company release.    The Big Pharma’s pipeline still includes about 35 product candidates, Leonard Schleifer, M.D., Ph.D., founder, president and CEO of Regeneron, said on the earnings call, adding that the company continues to focus on investing on internal R&D capabilities and exploring potential collaborations.