The US Food and Drug Administration (FDA) recently extended the
Prescription Drug User Fee Act (PDUFA) date for
Impax Laboratories, Inc.
) 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.
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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
We remind investors that in December 2010, Impax entered into a
license, development and commercialization agreement with
) 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
Teva Pharmaceutical Industries Limited
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).