WIRE)--IMPAX Laboratories, Inc. today announced that
IPX056, an investigational extended-release formulation of baclofen, has met its
clinical endpoints in a Phase III study of spasticity in multiple sclerosis
patients. The Company also is providing an update on its brand pharmaceutical
product program, which resides in its IMPAX Pharmaceuticals Division.
In a 173-patient, placebo and active comparator-controlled double blind Phase
III study with a seven-week open label follow on, IPX056 was shown to be
effective versus placebo in reducing spasticity in multiple sclerosis patients.
IPX056 is an extended-release formulation of baclofen, the drug of choice in the
treatment of spasticity, which has the potential to offer improved control of
symptoms and dosing convenience.
“We are very excited with the results of this study,
and are planning to meet with the U.S. Food and Drug Administration (FDA) in the
fourth quarter of this year to discuss the results of this study and determine
the next steps in the submission of a new drug application (NDA) for
IPX056,” said Larry Hsu, Ph.D., president and chief
executive officer of IMPAX Laboratories. “Such
spasticity treatments represent a $1.6 billion market in the U.S. and IPX056 may
fill an unmet medical need in these patients.”
The IMPAX Pharmaceuticals division of IMPAX Laboratories currently has two
products in its development pipeline, directed to neurology as a therapeutic
focus, with four other central nervous system (CNS) specific products undergoing
feasibility assessment. The Company filed an Investigational New Drug
application for IPX066, a controlled-release formulation of Carbidopa/Levodopa
in July 2008, and expects to initiate studies in Parkinson’s disease patients by the end of this year and is targeting
an NDA submission in mid-2011.
Michael Nestor, divisional president of IMPAX Pharmaceuticals said, “We are very pleased with the progress we have made in
advancing our proprietary, brand products and expect to continue this progress
with an expansion in our R&D staff this year. The CNS space is ideally
suited to our core competency in drug delivery, as so many products are
candidates for improved dosing and administration and the market is large and
growing at almost 10% annually, faster than the total U.S. pharmaceutical
market. In addition, the neurology market is readily addressable by a small and
focused sales force, given the concentration of physicians writing
prescriptions. We currently have 66 specialty sales representatives to market
our products, and to serve as a contract force for others,” Mr. Nestor added.
As previously announced on July 31, 2008, Arthur A. Koch, Jr., senior vice
president and chief financial officer of IMPAX Laboratories, will present at the
Bank of America 2008 Specialty Pharmaceuticals Conference today at 9:30 a.m.
Eastern time. The conference will be held at the Southampton Inn, Long Island,
Individuals may listen to the live or an archived presentation made at the
conference, which will be posted in the investor relations section of the
Company’s web site at www.impaxlabs.com. To listen to the live presentation, please
go to the web site 15 minutes prior to its start to register, download, and
install the necessary audio software. This presentation will be archived on the
Company’s web site for 90 days. The Company’s regular Corporate presentation will be updated and posted
on the Company’s web site today as well.
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 brand products. IMPAX markets its generic products through its
Global Pharmaceuticals division and will market its brand 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.
IMPAX Laboratories, Inc.
Larry Hsu, Ph.D. President &
510-476-2000, Ext. 1111
Arthur A. Koch, Jr., Sr. VP &
Mark Donohue, Sr. Director IR
Lippert/Heilshorn & Associates, Inc.