HAYWARD, Calif.--(BUSINESS WIRE)--Apr. 20, 2009--
Impax Pharmaceuticals, the brand products division of Impax
Laboratories, Inc. (NASDAQ:IPXL) today announced it has commenced a
Phase III trial of IPX066 in Parkinson’s Disease (PD) patients based on
encouraging interim data collected from the Phase II study in PD
patients. It also clarified the U.S. Food and Drug Administration (FDA)
requirement for pediatric studies of its investigational medication
IPX056.
Larry Hsu, Ph.D., president and chief executive officer of Impax
Laboratories, said: “We are very pleased to report these recent
achievements, which are important to our long term strategy of investing
in developing branded pharmaceutical products. We believe this strategy
will augment our generic business and propel our company to the next
growth phase by providing longer-life-cycle products with significantly
higher margin potential than our generic products.”
IPX066 for Parkinson’s Disease
Impax Pharmaceuticals has started enrolling patients in a Phase III
trial of its late-stage drug candidate IPX066 in PD patients. 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.
Impax has completed multiple Phase I pharmacokinetic studies in healthy
volunteers and will soon complete a open label and active-controlled
Phase II study in PD patients. The interim results of this Phase II
study have demonstrated consistent signals of superior clinical benefit
in both extended pharmacokinetic profile and control of PD motor
symptoms compared to conventional carbidopa levodopa.
Based on both confirmatory Phase I and compelling interim Phase II data,
the company has commenced enrollment in the first Phase III study, also
known as APEX-PD, in PD patients with mild symptoms of PD. The company
is conducting this trial under a recent agreement with the FDA through a
Special Protocol Assessment (SPA) for the Phase III clinical trial of
IPX066 in PD patients.
Impax is planning to commence a second Phase III trial of IPX066 in
patients with advanced PD patients later in 2009 or early 2010.
Michael Nestor, divisional president of Impax Pharmaceuticals said: “We
are delighted with the efforts of our impressive team headed by Dr.
Suneel Gupta which has rapidly advanced IPX066 from an Investigational
New Drug (IND) filing (July 2008) to Phase III commencement under SPA in
nine months. We are eager to continue the successful development of this
product and bring the potential benefits of IPX066 to physicians who
treat Parkinson’s and their patients as quickly as possible. We continue
to work towards our goal of filing a New Drug Application (NDA) in the
fourth quarter of 2011.”
Impax plans to submit the Phase II data for presentation at a future
clinical meeting.
About the APEX-PD Phase III Study
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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 PD. The study will evaluate three doses of IPX066
versus placebo in subjects with mild symptoms of PD.
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The trial is expected to enroll approximately 350 subjects who will be
randomized into one of four treatment groups.
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The trial will be conducted at multiple sites in North America and
Europe.
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The agreed upon primary endpoint is change from baseline in the sum of
Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II and III.
Additional endpoints include clinical and patient reported outcome
measures.
IPX056 for Spasticity
Impax Pharmaceuticals recently held discussions with the FDA related to
possible requirement for pediatric clinical studies as part of its
potential NDA filing for IPX056. IPX056 is an investigational
extended-release formulation of baclofen, the most widely prescribed
drug in the treatment of spasticity, which has the potential to offer
improved control of symptoms and dosing convenience.
Previously FDA had requested Impax to conduct a pediatric study as part
of IPX056 NDA submission under the Pediatric Research Equity Act. In
recent discussions with FDA on this issue, the Agency asked Impax to
submit a proposed pediatric development plan for IPX056 with the NDA in
order to avoid delaying the review and approval of IPX056 for adults.
Impax plans to develop an appropriate pediatric development strategy in
consultation with its advisors so the pediatric trial can be done
independently of the adult indication approval process.
Mr. Nestor said: “We are pleased to have this timely input from the FDA,
clarifying next steps in fulfilling the pediatric requirement for
IPX056. Significantly, this allows our team to focus on the important
work of finalizing the second Phase III trial in Multiple Sclerosis
spasticity in adults, which we plan to start in late 2009 or early 2010.
We continue to work towards our goal of filing a NDA in the first half
of 2012.”
About IPX066 and Parkinson’s Disease
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 management of PD. 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 IPX056 and Spasticity
IPX056 is an extended-release formulation of baclofen, the most widely
prescribed drug in the treatment of spasticity, which has the potential
to offer improved control of symptoms and dosing convenience.
Spasticity is characterized by muscle stiffness and involuntary muscle
spasms. It is reported in about two to three million patients in the
U.S., occurring commonly in multiple sclerosis, stroke, spinal cord
injury, traumatic brain injury and cerebral palsy.
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.
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Source: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Mark Donohue, Sr. Director Investor
Relations
215-933-3526
www.impaxlabs.com