* Says FDA accepted its ANDA filling for generic of Oracea
* Says to commercialize product after FDA approval
Sept 21 Drugmaker Impax Laboratories Inc's
(IPXL.O) unit said its experimental drug to treat late-stage
Parkinson's disease showed positive results in a mid-stage
Impax said its drug IPX066 reduced Parkinson's patients'
"off" time, a key objective in the management of the disease,
during waking hours by 2 hours compared to current standard of
care Bristol-Meyers Squibb's (BMY.N) Sinemet.
Separately, the company said it initiated a challenge of
the patents listed by Galderma Laboratories on Oracea -- a drug
used to treat inflammatory lesions.
Galderma is a joint-venture between Swiss food maker Nestle
NESN.VX and French cosmetics company L'Oreal (OREP.PA).
Impax said the U.S. Food & Drug Administration accepted for
filing its abbreviated new drug application (ANDA) containing a
paragraph IV certification for a generic version of Oracea.
"Once the ANDA is approved by FDA, Global Pharmaceuticals,
Impax's generic division, will commercialize the product,"
Last week, the Research Foundation of State University of
New York, New York University and Galderma Laboratories filed
suit for patent infringement against Impax.
Shares of Impax were flat at $8.89 in morning trade on
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(Reporting by Anand Basu in Bangalore; Editing by Saumyadeb