The US Food and Drug Administration (FDA) recently extended the Prescription Drug User Fee Act (PDUFA) date for Impax Laboratories, Inc.’s (IPXL - Free Report) New Drug Application (NDA) for Rytary (IPX066). The US regulatory body will now announce its decision by January 21, 2013 instead of October 21, 2012. Importantly, the agency did not ask the company to conduct new studies.
IPX066 is being developed for the treatment of patients suffering from idiopathic Parkinson’s disease. In September this year, Impax had submitted the information on an excipient in IPX066 formulation as requested by the FDA. As the submission of the additional information was within three months of October 21, 2012, the US regulatory body extended the decision date to review the information.
We remind investors that in December 2010, Impax entered into a license, development and commercialization agreement with GlaxoSmithKline plc (GSK - Free Report) for IPX066. As per the terms of the agreement, Glaxo is responsible for the development and commercialization of the candidate outside the US and Taiwan.
The company has already announced results from pivotal phase III studies of IPX066. The studies include APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD).
Currently, the Parkinson’s disease market has players like Novartis AG (NVS - Free Report) and Teva Pharmaceutical Industries Limited (TEVA - Free Report) .
Apart from its lead pipeline candidate IPX066, Impax is also developing IPX159 for the treatment of Restless Legs Syndrome (RLS). The company is currently conducting a phase IIb study of IPX159, results of which is expected in mid-2013.
We currently have a Neutral recommendation on Impax. The stock carries a Zacks #3 Rank (short-term ‘Hold’ rating).