Data on IPX066 APEX-PD Phase III Study for the Treatment of Early Parkinson’s Disease to be Presented at the American Acade...
April 01 2011 - 9:00AM
Business Wire
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL), today announced that IPX066
APEX-PD Phase III clinical study data will be presented in a Late
Breaker Session at the 63rd annual meeting of the American Academy
of Neurology Conference in Honolulu, Hawaii, held from April 9 to
April 16. IPX066 is an investigational extended release
carbidopa-levodopa (CD-LD) product intended to treat the motor
symptoms of Parkinson’s disease.
On November 18, 2010, the Company reported positive top-line
results of the APEX-PD trial. The results demonstrated the safety
and efficacy of IPX066 in patients with early PD. The study met its
primary efficacy endpoint of change from baseline in the sum of
United Parkinson’s Disease Rating Scale (UPDRS) Parts II and III
score at end of study. The study also met several secondary
endpoints including, Clinician Global Impression of change and
Patient Global Impression of change. There were no unexpected
drug-related serious adverse events observed in IPX066 treated
subjects.
The Late-Breaker oral presentation of IPX066 APEX-PD results is
as follows:
Date and Time:April 13, 2011 at
5:00 PM (local time)
Presentation Title and
Number:Double-Blind, Placebo-Controlled Fixed-Dose Trial of
IPX066, a Novel Carbidopa-Levodopa (CD-LD) Extended-Release
Formulation, in Early Parkinson’s Disease (APEX-PD Trial);
LBS.001
Presenter:Rajesh Pahwa, MD,
Professor of Neurology, University of Kansas Medical Center
About the APEX-PD Study
The APEX-PD study was a randomized, double-blind, placebo
controlled, parallel group, fixed-dose study comparing 3 doses of
IPX066 to placebo in patients with early Parkinson’s disease. The
study was conducted under a Special Protocol Assessment agreement
with the US Food and Drug Administration (FDA) and is part of the
IPX066 clinical development plan agreed with the FDA and the
European Medicines Agency.
About IPX066
IPX066 is an investigational CD-LD product with an enhanced
pharmacokinetic profile. The IPX066 pharmacokinetic profile has the
potential to offer reliable control of PD motor symptoms, such as
the reduction in “off time” throughout the day, which has been
observed in preliminary studies of IPX066.
About Our Collaboration with GlaxoSmithKline (GSK) Impax
Pharmaceuticals and GSK announced an agreement for the development
and commercialization of IPX066, outside the United States and
Taiwan, in December 2010. Under the terms of the agreement, GSK
received an exclusive license to sell IPX066 throughout the world
except in the U.S. and Taiwan. Impax will complete the current
Phase III program for IPX066, which includes the ADVANCE-PD
study.
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, and has a full range of
capabilities 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, 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 healthcare industry, 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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