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PDUFA Date Set for October 21, 2012
HAYWARD, Calif.--(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 IPX066
IPX066 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 collaboration
Impax 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 Disease
Parkinson’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.
Source: Impax Laboratories, Inc.