Impax Pharmaceuticals Reports Positive Achievements on its Two Leading Brand Product Candidates IPX066 and IPX056
April 20 2009 - 8:47AM
Business Wire
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
- 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.
- The trial is expected to enroll
approximately 350 subjects who will be randomized into one of four
treatment groups.
- The trial will be conducted at
multiple sites in North America and Europe.
- 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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