Impax Pharmaceuticals Completes Enrollment in APEX-PD Phase III Trial of IPX066 in Parkinson’s Disease
April 15 2010 - 9:30AM
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
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To the extent any statements made in this news release contain
information that is not historical, these statements are
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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
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Company’s industry, business, financial position, results of
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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
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