* FDA panel recommends against approval
* Drug has potential, but not enough data-FDA panel
* FDA expected to make final decision by July 23
(Adds comments from panelist and FDA, background, share price,
By Susan Heavey
SILVER SPRING, Md., May 12 NicOx SA's (NCOX.PA)
arthritis drug should not be approved until there is more data
to prove it is safe, a U.S. Food and Drug Administration
advisory panel said on Wednesday.
The French biotech company wants the FDA's approval to
market its first product, a non-steroidal anti-inflammatory
drug (NSAID) called naproxcinod, to treat patients with
osteoarthritis with the claim that it has fewer heart risks
than some other drugs.
In a 16-1 vote against approval, the panel said that data
from the company's small trials was not sufficient to support
safe use of the drug, which may be widely used by older people
with other health problems who are likely to be taking other
medications. One panelist abstained.
The biotech had been planning to partner with a larger drug
maker to market the product.
The FDA will weigh the panel's recommendation before making
its final decision, expected by July 23. It often follows
"It's really something that's at the margins," panel member
Robert Harrington, a Duke University Medical Center
cardiologist, said of the drug. While "there's actually a lot
to be hopeful about," the company's data simply did not meet
FDA's standards, he said.
The FDA's panel of outside medical experts agreed that more
options were needed to treat the growing number of people with
arthritis, a painful joint disease.
NicOx told the FDA's panel that naproxcinod was an improved
version of naproxen, a widely used NSAID that can increase
blood pressure and cause stomach problems. The company said
naproxcinod did not cause such side effects because of its
nitric oxide-releasing properties.
Such a claim would set the drug apart from dozens of
over-the-counter and prescription pain relievers, including
AstraZeneca Plc (AZN.L) (AZN.N) and Pozen Inc's POZN.O
recently-approved naproxen-based drug Vimovo.
Nonprescription strength naproxen is sold over the counter
as Bayer AG's (BAYGn.DE) Aleve.
Naproxcinod would also compete against Pfizer Inc's (PFE.N)
Celebrex, another type of pain medicine known as a COX-2 drug.
Panelists echoed FDA staff concerns that the biotech's
clinical trials did not prove its drug had a significant heart
"There is some tantalizing data that may suggest that there
may be a protective effect ... but that will take long-term
studies to determine," said panel chairwoman Kathleen O'Neil, a
pediatric rheumatologist at the University of Oklahoma College
Most of the panelists agreed that NicOx's drug appeared to
be more effective than a sugar-pill but was not necessarily
shown to be as effective as naproxen.
FDA officials at the meeting called the company's data
NicOx officials said they would continue talking with the
FDA and would not withdraw their application. They said they
were heartened that the panel noted the need for additional
medications and that the drug was more effective than a
"We remain convinced that this drug is viable," said
Elizabeth Robinson, a co-founder of NicOx and president of the
NicOx Research Institute. The company is also seeking approval
(Reporting by Susan Heavey)