Impax Pharmaceuticals Submits New Drug Application for IPX066 in Parkinson’s Disease
December 21 2011 - 8:30AM
Business Wire
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL) today announced the submission of
Impax’s New Drug Application (NDA) for IPX066 to the U.S. Food and
Drug Administration (FDA) for the treatment of idiopathic
Parkinson’s disease (PD). IPX066 is a patented extended release
capsule formulation of carbidopa-levodopa (CD-LD). IPX066 is being
developed in collaboration with GlaxoSmithKline (GSK) for
territories outside the U.S. and Taiwan.
“In just three and a half years, Impax’s brand research and
development team has successfully advanced IPX066 from an
Investigational New Drug (IND) through multiple clinical studies of
efficacy and safety, culminating in our NDA submission,” said
Michael Nestor, president of Impax Pharmaceuticals. “This event
demonstrates our strong internal capability to develop neurology
products to fulfill unmet clinical needs of the PD community.
IPX066 represents a significant commercial opportunity for Impax in
the U.S., which if approved we plan to commercialize with our
specialty neurology sales team.”
IPX066 has undergone extensive clinical development, including
multiple studies in early and advanced PD in the U.S. and in
Europe. As agreed with the FDA, the NDA is being submitted as a
505(b)(2) application and includes data from three controlled Phase
III studies and two open label extensions of IPX066 in early and
advanced PD. In these studies, IPX066 has been studied in about 900
PD subjects. Impax held an end of Phase III meeting with the U.S.
FDA in the third quarter of 2011 and is submitting its NDA
consistent with the guidance it received.
“We are proud to achieve this important milestone in our
development of the brand pharmaceutical business,” said Larry Hsu,
Ph.D., president and CEO of Impax Laboratories, Inc. “This
represents an important part of our strategy to diversify our
business model to branded products, with the objective of improving
long-term shareholder value.”
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 and
other IPX066 data are planned for submission to the American
Academy of Neurology and International Congress of Parkinson’s
Disease and Movement Disorders Conference in April and June 2012,
respectively.
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.
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