NicOx filed a new drug application with the FDA for its novel osteoarthritis drug naproxcinod, which would be used to treat relief of the disease symptoms, the French biotech announced on Sept. 25. But NicOx still is looking for one or more partners to help market the drug.
Naproxcinod, which is NicOx's lead compound, would be the first drug approved in a new class of anti-inflammatory agents known as CINODs, or cyclooxygenase-inhibiting nitric oxide donators. Naproxcinod is a nitric-oxide-donating form of the anti-inflammatory naproxen.
Unlike COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, which are widely used as symptomatic treatments for osteoarthritis, naproxcinod shows a favorable blood pressure profile.
Though a pooled analysis of three pivotal Phase III trials of naproxcinod showed a significant reduction in systolic blood pressure and diastolic blood pressure compared to naproxen, direct blood pressure readouts from each of the individual Phase III trials reported last year were less clear ('The Pink Sheet' DAILY, Dec. 18, 2008).
The NDA submission contains data from three pivotal Phase III studies, which enrolled more than 2,700 patients with osteoarthritis of the knee and hip. The studies met their three co-primary efficacy endpoints, measuring pain, function and the subject's overall rating of the disease.
A favorable cardiovascular profile would significantly help distinguish naproxcinod from competitors - Pfizer's Celebrex (celecoxib) and Boehringer-Ingelheim's Mobic (meloxicam). Naproxcinod is an oral drug slated to be dosed twice daily at 375 mg or 750 mg. Like other COX-2 inhibitors and traditional NSAIDs, it is intended for chronic use to treat symptoms of osteoarthritis.
But until a regulatory decision for the drug is firmed up, some would-be partners seem to be staying away from signing a commercial agreement, especially given that AstraZeneca gave back rights to the program six years ago ('The Pink Sheet' DAILY, Aug. 6, 2009). This has also led Wall Street analysts to question the drug's market potential.
NicOx eyes specialists in U.S. market
While the FDA reviews the NDA, NicOx is talking to several potential commercial partners. "Our goal is to sign one or more commercialization agreements covering the major pharmaceutical markets by the time of launch, in order to maximize the revenues of naproxcinod," a NicOx spokesman said.
"We are open to signing two or even three deals for North America, Europe and Japan if this approach will generate more value for shareholders," he added.
Though the biotech intends to retain select co-commercialization rights to specialists, the drug maker hopes a U.S. partner would send sales teams to visit mostly primary care physicians, leaving NicOx reps to focus on rheumatologists, orthopedists and pain specialists..
NicOx also plans to submit a marketing authorization application for naproxcinod to the European Medicines Agency in the fourth quarter.
-Carlene Olsen (c.olsen@elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY –Sept 25, 2009
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