FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson’s Disease
February 23 2012 - 7:00AM
Business Wire
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for filing the
Company’s New Drug Application (NDA) for IPX066 for the treatment
of idiopathic Parkinson’s disease (PD) submitted to the Agency on
December 21, 2011. IPX066 is a patented extended release capsule
formulation of carbidopa-levodopa (CD-LD). The Prescription Drug
User Fee Date (PDUFA) for a decision by the FDA is October 21,
2012. IPX066 has been licensed to GlaxoSmithKline (GSK) for
countries outside the U.S. and Taiwan for development and
marketing.
IPX066 has undergone extensive clinical development, including
multiple studies in early and advanced PD in the U.S. and in
Europe. The NDA included data from three controlled Phase III
studies and two open label extensions of IPX066 in both early and
advanced PD. IPX066 has been investigated in more than 1,000
subjects.
About IPX066IPX066 is an investigational extended release
capsule formulation of CD-LD which is intended to maintain
consistent plasma concentration of levodopa for a longer duration
versus immediate release levodopa, which may have an impact on
fluctuations in clinical response. It is not approved or licensed
anywhere in the world.
Results from the pivotal phase III studies of IPX066, APEX-PD
(early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD)
have previously been announced. Results of the ASCEND-PD study have
been accepted for presentation to the American Academy of Neurology
April 2012.
About the Impax GSK collaborationImpax Pharmaceuticals
and GSK announced an agreement for the development and
commercialization of IPX066 in December 2010. Under the terms of
the agreement, GSK received an exclusive license to register and
commercialize IPX066 throughout the world except in the U.S. and
Taiwan.
About Parkinson’s DiseaseParkinson’s disease is a chronic
neurodegenerative movement disorder affecting over three million
people in the US, Europe, and Japan.
About Impax Laboratories, Inc.Impax Laboratories, Inc. is
a technology-based specialty pharmaceutical company applying its
formulation expertise and drug delivery technology to the
development of controlled-release and specialty generics in
addition to the development of branded products. Impax markets its
generic products through its Global Pharmaceuticals division and
markets its branded products through the Impax Pharmaceuticals
division. Additionally, where strategically appropriate, Impax has
developed marketing partnerships to fully leverage its technology
platform. Impax is headquartered in Hayward, California, with a
full range of capabilities located in its Hayward, Philadelphia and
Taiwan facilities. For more information, please visit the Company's
Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations
of management. Such statements are based on current expectations
and involve a number of known and unknown risks and uncertainties
that could cause the Company’s future results, performance or
achievements to differ significantly from the results, performance
or achievements expressed or implied by such forward-looking
statements. Such risks and uncertainties include, but are not
limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, the ability to maintain an effective system of internal
control over financial reporting, fluctuations in revenues and
operating income, the ability to successfully develop and
commercialize pharmaceutical products, reductions or loss of
business with any significant customer or a reduction in sales of
any significant product, the impact of competition, the ability to
sustain profitability and positive cash flows, any delays or
unanticipated expenses in connection with the operation of the
Taiwan facility, the effect of foreign economic, political, legal
and other risks on operations abroad, the uncertainty of patent
litigation, consumer acceptance and demand for new pharmaceutical
products, the difficulty of predicting Food and Drug Administration
filings and approvals, the inexperience of the Company in
conducting clinical trials and submitting new drug applications,
the ability to successfully conduct clinical trials, reliance on
alliance and collaboration agreements, the availability of raw
materials, the ability to comply with legal and regulatory
requirements governing the pharmaceutical and healthcare
industries, the regulatory environment, the ability to protect the
Company’s intellectual property, exposure to product liability
claims and other risks described in the Company’s periodic reports
filed with the Securities and Exchange Commission. Forward-looking
statements speak only as to the date on which they are made, and
Impax undertakes no obligation to update publicly or revise any
forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.
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