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.