September 25, 2009 / 7:16 AM / 10 years ago

UPDATE 1-NicOx submits naproxcinod application to FDA

* NicOx submitted new drug application to FDA

* NicOx says plans to submit to EMEA in Q4

(Adds background, details, share data)

PARIS, Sept 25 (Reuters) - French biotech firm NicOx (NCOX.PA) on Friday said it had filed for U.S. marketing approval for a potential blockbuster drug that could deal a blow to sales of the Pfizer (PFE.N) medicine Celebrex.

The firm said it had submitted a new drug application to the U.S. Food and Drug Administration (FDA) for the anti-inflammatory drug, its lead product, to treat osteoarthritis on the world’s biggest drugs market.

Some analysts see sales potential of at least $1 billion a year, but others fear it could be hard to get proper reimbursement for the branded drug in the United States.

The company said in a statement it plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) in the fourth quarter of 2009.

These dates are in line with the most recent timetable for the drug’s route to the market on which the financial fortunes of the firm and its share value depends heavily. The firm said earlier this year it has sufficient cash to run the business until the end of 2010.

NicOx said it filed the submission after the successful completion of three pivotal phase 3 studies.

The FDA will now evaluate the data submitted.

“NicOx does not wish to make any claims in regard to naproxcinod’s safety or efficacy prior to its potential approval,” it said in a statement.

NicOx chief executive Michele Gardufi told Reuters in June that the firm expected to sign several partnership agreements for its candidate drug naproxcinod. He said he expected to strike up to five such deals this year or next.

NicOx uses its nitric oxide-donating technology to develop drugs against inflammatory and cardio-metabolic diseases and significantly strengthened its patent portfolio when it bought patents from Nitromed NTMD.O.

Nitric oxide acts as a messenger molecule in the body but certain diseases are linked to a lack of nitric oxide production. NicOx’s technology involves grafting a nitric oxide-donating chemical group onto an existing drug molecule, forming a new chemical entity that can be patented.

In clinical trials NicOx tested naproxcinod against generic naproxen and results showed that patients on naproxcinod did not suffer from higher blood pressure, a common side effect from traditional anti-inflammatories.

The firm recently began the clinical development of cardiovascular compound NCX 6560, which will be compared with a placebo and Pfizer’s cholesterol drug Lipitor, the world’s top selling drug. Results are due in the third quarter.

NicOx had a market value of 467.35 million euros at Thursday’s closing prices and gained 23.7 percent this year. Pfizer has a stake of 2.8 percent in NicOx and Garufi owns 1.5 percent. (Reporting by Marcel Michelson, Helen Massy-Beresford and Caroline Jacobs; Editing by Mike Nesbit)

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