IMPAX Reports Positive Results in Phase III Trial with IPX056
HAYWARD, Calif.--(BUSINESS WIRE)--Aug 7, 2008 - 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, New York.
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 & CEO
510-476-2000, Ext. 1111
Arthur A. Koch, Jr., Sr. VP & CFO
Mark Donohue, Sr. Director IR
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz
Posted: August 2008