Impax Pharmaceuticals Reports Positive Achievements on its Two Leading Brand Product Candidates IPX066 and IPX056

HAYWARD, Calif.--(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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Impax Laboratories, Inc.
Mark Donohue, Sr. Director Investor Relations
215-933-3526
www.impaxlabs.com

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