HAYWARD, Calif.--(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.
Source: Impax Laboratories, Inc.