HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL), today announced that data from the
ASCEND-PD Phase III clinical study involving IPX066 will be presented in
a Platform Presentation at the 64th Annual Meeting of the
American Academy of Neurology in New Orleans, Louisiana, held from April
21 to April 28. IPX066 is an investigational, patented extended release
capsule formulation of carbidopa-levodopa (CD-LD) intended for the
treatment of idiopathic Parkinson’s disease. IPX066 is being developed
in collaboration with GlaxoSmithKline (GSK) for territories countries
outside the U.S. and Taiwan.
The presentation information is as follows:
ASCEND-PD Presentation
Title:
Comparison of IPX066, a Novel Investigational Carbidopa-Levodopa (CD-LD)
Extended-Release Formulation, and CD-LD-Entacapone (CLE) in Advanced
Parkinson’s Disease (ASCEND-PD Trial)
Date: April 24, 2012
Time: 2:00 p.m.
Location: New Orleans
Ernest N. Memorial Convention Center
Scientific Session: S02
(Treatment of Parkinson’s Disease)
Abstract Number: S02.005
About the ASCEND-PD study
The ASCEND-PD study is a randomized, double-blind 2-treatment, 2-week
crossover study of IPX066 and CLE (a combination treatment of
carbidopa-levodopa and entacapone, an enzyme inhibitor of levodopa
breakdown), and one of three Phase III studies of IPX066. Study subjects
taking a stable dose of CLE were converted to IPX066 over a six-week
period, then randomized to one of the two treatments (IPX066 or CLE) for
two weeks and then crossed over to the other treatment for an additional
two weeks after a one-week washout with IPX066. The study enrolled 110
subjects, and a total of 84 subjects completed the randomized
double-blind comparative phase of the study. Following the comparative
phase, subjects were enrolled into a six-month open-label extension
study.
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. In December 2011, Impax
filed a New Drug Application (NDA) for IPX066 intended for the treatment
of idiopathic Parkinson’s disease (PD), which is currently undergoing
review by the U.S. Food and Drug Administration (FDA).
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.
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
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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, fluctuations in the Company’s revenues and operating income,
the Company’s ability to successfully develop and commercialize
pharmaceutical products, reductions or loss of business with any
significant customer, the impact of consolidation of the Company’s
customer base, the impact of competition, the Company’s ability to
sustain profitability and positive cash flows, any delays or
unanticipated expenses in connection with the operation of the Company’s
Taiwan facility, the effect of foreign economic, political, legal and
other risks on the Company’s operations abroad, the uncertainty of
patent litigation, increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies, consumer acceptance and
demand for new pharmaceutical products, the difficulty of predicting
Food and Drug Administration filings and approvals, the Company’s
inexperience in conducting clinical trials and submitting new drug
applications, the Company’s ability to successfully conduct clinical
trials, the Company’s reliance on third parties to conduct clinical
trials and testing, the availability of raw materials and impact of
interruptions in the Company’s supply chain, the use of controlled
substances in the Company’s products, disruptions or failures in the
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Company’s reliance on alliance and collaboration agreements, the
Company’s dependence on certain employees, the Company’s ability to
comply with legal and regulatory requirements governing the healthcare
industry, the regulatory environment, the Company’s ability to protect
the Company’s intellectual property, exposure to product liability
claims, changes in tax regulations, the Company’s ability to manage the
Company’s growth, including through potential acquisitions, the
restrictions imposed by the Company’s credit facility, uncertainties
involved in the preparation of the Company’s financial statements, the
Company’s ability to maintain an effective system of internal control
over financial reporting, any manufacturing difficulties or delays, the
effect of terrorist attacks on the Company’s business, the location of
the Company’s manufacturing and research and development facilities near
earthquake fault lines 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.