The US Food and Drug Administration (FDA) has meted out a severe blow to Regeneron Pharmaceuticals Inc. (REGN) and partner Sanofi-Aventis (SNY) by halting the development of REGN475/SAR164877, which was being developed for treating pain associated with osteoarthritis.
Regeneron stated that no study involving the candidate, aimed to inhibit a protein called nerve growth factor (NGF) associated with pain, is currently underway. Regeneron announced the FDA’s decision via a filing with the Securities and Exchange Commission.
The decision to put the NEGF inhibitor on “clinical hold” arose from safety concerns after a patient developed avascular necrosis of a joint on being treated with a candidate (developed by another company) in the same category.
Avascular necrosis is a serious bone disorder and is responsible for a bone tissue becoming dysfunctional due to insufficient blood supply. Earlier in the year, Pfizer Inc. (PFE) too halted the development of its NGF inhibitor, tanezumab, on being requested by the FDA .The candidate was being developed to treat patients suffering from chronic back pain and diabetes.
Even though the clinical hold placed on the pain candidate is a setback for its pipeline, we remain upbeat about the successful development of its other pipeline candidates. The company’s late-stage development candidates include aflibercept (VEGF trap) for the treatment of cancer, VEGF trap-eye for eye diseases and IL-1 (Interleukin-1) trap for gout.
The successful development and commercialization of the candidates should boost the top line at Regeneron, whose only marketed product is Arcalyst for treating cryopyrin-associated periodic syndromes (CAPS) – a group of rare genetic inflammatory conditions, including familial cold auto-inflammatory syndrome and Muckle-Wells Syndrome. Moreover, the company’s deals with players like Sanofi-Aventis and Bayer AG (BAYRY) have helped bring in funds in the form of upfront and milestone payments.
Currently, we have a ‘Neutral’ recommendation on Regeneron, which is supported by a Zacks #3 Rank (short-term Hold rating).
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