NicOx urged to delay naproxcinod partnering talks
This article was originally published in Scrip
NicOx has been urged to wait for a response from the European Medicines Agencybefore partnering out its lead product naproxcinod amid healthy first-half results.
Piper Jaffray analysts said that the anti-inflammatory candidate, which was turned down by the US FDA earlier this month (scripintelligence.com, 23 July 2010), was "unlikely to be able to get attractive deal terms given that the FDA's negative response reduces the likelihood of partners paying significant upfronts before the EMA response".
NicOx is seeking approval for naproxcinod in Europe for the treatment of signs and symptoms of primary osteoarthritis. A CHMP opinion is expected by the middle of next year.
The FDA recommended conducting one or more long-term studies to assess the cardiovascular and gastrointestinal safety of naproxcinod, following its refusal. However, the analysts believe such trials would be large and expensive and that NicOx is unlikely to have sufficient resources to complete them. They suggest that a potential problem could also arise from naproxcinod's long development timeline, which could result in the product being on the market for only a short time before its patents expire.
NicOx's cash and equivalents stood at €128.4 million at the end of the first half, down from €148.3 million at the same time last year.
Revenues jumped from €1.1 million in the first half of 2009 to €7.4 million in the same period this year, due to the initial licence payment received from Bausch & Lomb. NicOx signed a licensing agreement that granted the eye-care specialist exclusive worldwide rights to develop and commercialise NCX 116, a nitric oxide-donating prostaglandin F2α-analogue, earlier this year (scripintelligence.com, 3 March 2010).
NicOx's net loss increased by €300,000 to €27.5 million, driven by an 8% rise in R&D costs to €26.9 million and a 42% rise in selling expenses to €6.2 million. Administrative expenses were flat at €3.2 million.
The firm's CEO Michele Garufi said: "We will collaborate closely with both regulatory authorities in the coming months. We will also focus on securing potential licensing agreements for naproxcinod in Europe and the rest of the world."