* Says FDA accepted its ANDA filling for generic of Oracea
* Says to commercialize product after FDA approval
Sept 21 (Reuters) - 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 trial.
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,” Impax said.
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 Nasdaq.
For the alerts double-click [ID:nWNAB1477] . (Reporting by Anand Basu in Bangalore; Editing by Saumyadeb Chakrabarty)