NicOx Says Naproxcinod Partnership, U.S. Filing May Be Delayed
By Albertina Torsoli
June 18 (Bloomberg) -- NicOx SA said its most advanced experimental drug may get a commercial partner and be submitted to U.S. regulators later than the French drugmaker had planned.
The filing with the Food and Drug Administration “is on track for June, July or August” and “it’s very difficult” to make forecasts on when an agreement with one or more potential partners will be reached, Karl Hanks, a spokesman, said in a telephone interview today.
NicOx, based in Sophia Antipolis on the French Riviera, already has partnerships with Pfizer Inc. and Merck & Co. It’s looking for an established drugmaker to help sell naproxcinod, a painkiller that would be its first approved medicine and may garner annual sales of as much as $1 billion, according to Chief Executive Officer Michele Garufi.
Garufi, who co-founded the company in 1996, said in a Jan. 22 interview he was planning to submit naproxcinod to U.S. regulators by the middle of the year and aimed to have a partner before the end of June.
“Discussions are ongoing,” Hanks said today, declining to identify potential partners. “Things are progressing, there is a definite interest but there is also conservatism in some companies.”
NicOx may end up signing accords with two partners, according to Hanks.
“Some of the companies are interested in the U.S. and others are interested in a European deal,” he said. “We may see more than one deal coming through. That seems logical to us at this point in time.”
NicOx has been trying to show that naproxcinod works as well as the standard painkiller naproxen, sold over the counter as Aleve by Bayer AG, and without side effects such as high blood pressure.