Comparison of Pharmacokinetics and Pharmacodynamics of Combined Immediate- and Extended-Release (IR+ER) Carbidopa/Levodopa Formulations (VADOVA IR+ER) with IR Carbidopa/Levidopa and Controlled-Release Carbidopa/Levodopa in Parkinson's Disease was presented by lead researchers John Nutt, M.D and Peter A. LeWitt, M.D. The study results concluded that at equivalent carbidopa/levodopa dose level (50/200 mg), the combined immediate- and extended release carbidopa/levodopa preparation produces a more rapid onset of clinical response than controlled release carbidopa/levodopa, without the higher peak plasma levodopa concentrations seen with immediate-release carbidopa/levodopa 2x 25/100. The combined immediate- and extended-release preparation may offer benefits in treating Parkinson's Disease (PD) patients with motor fluctuations.
Bi-layer Formulation Of Carbidopa/Levodopa (IPX054) vs. Standard Carbidopa/Levodopa In Stable PD Patients was presented by Christopher G. Goetz M.D. Vanessa K Hinson, M.D. was a co-investigator of the study. The study compared IPX054, a bi-layer tablet of immediate- and extended-release carbidopa/levodopa (CD/LD) given twice daily vs. standard CD/LD given four times daily in patients with stable PD. The study results concluded that in stable PD patients without troublesome dyskinesia, twice daily IPX054 provided comp arable clinical efficacy to CD/LD given four times daily based on objectively observed assessments. Home-based video provided an objective means to assess motor fluctuations. In this population, substitution with IPX054 maintains CD/LD efficacy and provides ease of administration which may offer improved treatment compliance.
About The Movement Disorder Society
The Movement Disorder Society (MDS) gathers thousands of the field's clinicians, researchers, trainees and industry supporters on an annual basis at its International Congress of Parkinson's Disease and Movement Disorders. This year it was held in Turkey at the Istanbul Convention & Exhibition Centre on June 3-7, 2007. The purpose of the MDS International Congress is to share ideas, encourage interest among all those involved in the care and research of Movement Disorders, to participate in the activities of MDS and to advance the related clinical and scientific discipline. The target audience includes clinicians, researchers, post-doctoral fellows, medical residents and medical students with an interest in the current research and approaches for the diagnosis and treatment of Movement Disorders.
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, possible adverse effects resulting from the delisting of and suspension of trading in IMPAX's stock, the SEC proceeding to determine whether to suspend or revoke the registration of IMPAX's securities under section 12 of the Securities Exchange Act, IMPAX's delay in filing its periodic reports subsequent to its Form 10-Q for the third quarter of 2004, 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.
Larry Hsu, Ph.D. President & CEO
510-476-2000, Ext. 1111
Arthur Koch, CFO, 215-933-0351
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