HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 26, 2009--
Impax Pharmaceuticals, the brand products division of Impax
Laboratories, Inc. (NASDAQ:IPXL), today announced that it has initiated
a multinational Phase III trial of its late-stage drug candidate IPX066
in advanced Parkinson’s disease (PD) patients. IPX066 is an
investigational extended release carbidopa-levodopa product intended to
rapidly achieve and then sustain effective blood concentrations of
levodopa, potentially improving PD clinical symptom management. This is
the second of two Phase III studies designed to support marketing
approval of IPX066 in Parkinson’s disease. Impax Pharmaceuticals
previously reported in June the initiation of the first Phase III study
of IPX066 in naïve PD patients.
Michael Nestor, divisional president of Impax Pharmaceuticals said: “We
are extremely pleased to start the second Phase III study for IPX066.
This trial in patients with advanced PD includes significant input from
the FDA into the study design.” He added, “Impax Pharmaceuticals looks
forward to the successful development of IPX066 and bringing its
potential benefits to physicians who treat Parkinson’s and their
patients as quickly as possible.”
About the ADVANCE-PD Phase III Study
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The ADVANCE-PD study (www.advance-pd.com)
will evaluate the safety and efficacy of IPX066 versus
immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD
patients with motor fluctuations.
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The trial is expected to enroll approximately 420 subjects who will be
on treatment for approximately 22 weeks.
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The trial will be conducted at multiple sites in North America and
Europe.
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The primary endpoint is percentage of “off” time during waking hours.
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Additional endpoints include total “off” time, total “on” time with no
troublesome dyskinesias, Unified Parkinson’s Disease Rating Scale
(UPDRS) and clinician and patient reported outcome measures, including
quality of life scales.
The ADVANCE-PD trial in patients with advanced PD complements the
APEX-PD Study (www.apex-pd.com),
which commenced in April 2009 and is currently enrolling levodopa-naïve
PD patients. APEX-PD is a randomized, double blind, placebo-controlled
study to evaluate the safety and efficacy of IPX066 and is being
conducted in North America and Europe. The ADVANCE-PD and APEX-PD trials
follow the earlier announced successful Phase II study of IPX066 in
Parkinson’s patients.
About IPX066 and Parkinson’s Disease (PD)
IPX066 is an investigational extended release carbidopa-levodopa product
intended to produce a fast and sustained concentration of levodopa,
potentially improving PD clinical symptom management. IPX066 has the
potential to offer improved and more reliable control of PD symptoms,
leading to clinically meaningful reductions in “off” time, a key
objective in the management of PD. “Off-time” is the functional state
when patients’ medication effect has worn off and there is a return of
Parkinson symptoms. In addition, IPX066 extended release formulation is
designed to reduce dosing frequency, enhancing patient convenience.
Parkinson’s disease is a chronic neurodegenerative movement disorder
affecting an estimated one million people in the U.S. About $1 billion
per year is spent on medications to treat PD in the U.S.
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
Laboratories is headquartered in Hayward, California, and has a full
range of capabilities in its Hayward and Philadelphia 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 Impax’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; ability to timely file periodic reports required by
the Exchange Act; ability to maintain an effective system of internal
control over financial reporting; ability to sustain profitability and
positive cash flows; ability to maintain sufficient capital to fund
operations; any delays or unanticipated expenses in connection with the
construction of our Taiwan facility; ability to successfully develop and
commercialize pharmaceutical products; the uncertainty of patent
litigation; consumer acceptance and demand for new pharmaceutical
products; the impact of competitive products and pricing; the difficulty
of predicting Food and Drug Administration (“FDA”) filings and
approvals; inexperience in conducting clinical trials and submitting new
drug applications; reliance on key alliance agreements; the availability
of raw materials; the regulatory environment; exposure to product
liability claims; fluctuations in operating results and other risks
detailed from time to time in our filings 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.
Impax Laboratories, Inc.
Company Contact:
Mark Donohue,
Sr.
Director Investor Relations
215-933-3526