Impax Pharmaceuticals Initiates Second Phase III Trial of IPX066 in Parkinson`s Disease
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HAYWARD, Calif.--(Business Wire)--
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
* 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.
* The trial is expected to enroll approximately 420 subjects who will be on
treatment for approximately 22 weeks.
* The trial will be conducted at multiple sites in North America and Europe.
* The primary endpoint is percentage of "off" time during waking hours.
* 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.
Impax Laboratories, Inc.
Company Contact:
Mark Donohue,
Sr. Director Investor Relations
215-933-3526
Copyright Business Wire 2009
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