IMPAX Provides Update On Meeting With FDA To Review Phase III Trial Results For IPX056

Main Category: Multiple Sclerosis
Also Included In: Clinical Trials / Drug Trials
Article Date: 15 Dec 2008 - 3:00 PDT

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IMPAX Laboratories, Inc. announced that it met with representatives of the U.S. Food and Drug Administration (FDA) to review the results of its IPX056 clinical development program and discuss next steps in development leading to submission of a new drug application (NDA). IPX056 is an investigational 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.

As previously announced, IPX056 met its clinical endpoints in a Phase III study of spasticity in multiple sclerosis patients. The randomized, placebo and active comparator-controlled double blind Phase III study enrolled 173 MS patients and included a seven-week open label extension. The primary efficacy endpoint, a reduction in spasticity as measured by Ashworth score following a single dose, was statistically significant for all active treatments, including IPX056 formulations and baclofen, compared to placebo. Results from the open label extension suggest that IPX056 reduced morning stiffness and nighttime awakenings as compared to conventional baclofen in these patients. IPX056 was generally safe and well tolerated in the study.

In the meeting with the FDA, the Company was requested to collect additional longer-term controlled clinical data on the safety and efficacy of IPX056.

Michael Nestor, president of the Impax Pharmaceuticals division of Impax Laboratories, said, "While we are pleased with the results of our Phase III trial, we are disappointed that the FDA has increased its expectation for extended use data since our last meeting with the agency in August 2006. We are currently designing a trial, which the agency has agreed to review as a Special Protocol Assessment (SPA), to collect the data requested by the FDA. We expect to initiate the trial in the second half of next year."

The company is also evaluating the potential need to conduct a pediatric study under the Pediatric Research Equity Act (PREA) which was not invoked at the IPX056 End of Phase II meeting in August 2006. The issue of a pediatric study was first raised by FDA at the most recent meeting. The Company will hold further discussions with the agency on this subject.

"The Phase III results were positive and we gained valuable experience with the effectiveness of IPX056 in reducing symptoms of spasticity in patients with MS. Furthermore, we have insight into some aspects of the product where we believe IPX056 could offer improved control of spasticity symptoms in these patients" said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories.

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 a study in Parkinson's disease patients by the end of this year with completion expected in the second quarter of 2009.

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: http://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, possible adverse effects resulting from the delisting of and suspension of trading in IMPAX's stock, the actual time that will be required to obtain effectiveness of IMPAX's registration statement on Form 10 and resumption of trading in its stock, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's 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.

IMPAX Laboratories, Inc.