HAYWARD, Calif., Apr 15, 2010 (BUSINESS WIRE) --Impax Pharmaceuticals,the brand products division of Impax
Laboratories, Inc. (NASDAQ: IPXL), today announced that it has completed
enrollment of its APEX-PD trial. APEX-PD is a multinational Phase III
trial of its late-stage drug candidate IPX066 in subjects with early
Parkinson's disease (PD). IPX066 is an investigational extended release
carbidopa-levodopa product intended to rapidly achieve and sustain
effective blood concentrations of levodopa, potentially improving PD
clinical symptom management. This is the first of two Phase III studies
designed to support marketing approval of IPX066 in Parkinson's disease.
"We are very pleased to have completed enrollment in APEX-PD, meeting an
important milestone for IPX066 and for Impax Pharmaceuticals as we plan
for potential product launch," said Michael Nestor, president of Impax
Pharmaceuticals. "We look forward to revealing the top line results for
this trial in early 2011. We continue to plan to file the new drug
application in the fourth quarter of 2011."
The APEX-PD study is a Phase III randomized, double blind,
placebo-controlled study to evaluate the safety and efficacy of IPX066
in subjects with early Parkinson's disease. The study is evaluating
three doses of IPX066 versus placebo in subjects with mild symptoms of
PD. The trial has met its enrollment goal of 350 subjects who were
randomized into one of four treatment groups.
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, 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, results of operations
and market value of its common stock, the ability to maintain an
effective system of internal control over financial reporting,
fluctuations in revenues and operating income, reductions or loss of
business with any significant customer, the impact of competitive
pricing and products and regulatory actions on the Company's products,
the ability to sustain profitability and positive cash flows, the
ability to maintain sufficient capital to fund operations, any delays or
unanticipated expenses in connection with the operation of the Taiwan
facility, the ability to successfully develop and commercialize
pharmaceutical products, 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, reliance on key 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, 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.
Impax Laboratories, Inc.
Company Contact:
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 933-3526
www.impaxlabs.com