HAYWARD, Calif., Aug 25, 2010 (BUSINESS WIRE) -- Impax Pharmaceuticals,the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management. This is the second of two pivotal Phase III studies designed to support a new drug application of IPX066 in Parkinson's disease.
"We are very pleased to have completed enrollment in ADVANCE-PD, the second pivotal trial planned for submission to support our approval in Parkinson's disease," stated Michael Nestor, president of Impax Pharmaceuticals. "This achievement by our dedicated R&D team is an important milestone for IPX066 and for Impax Pharmaceuticals as we plan for potential product launch. We look forward to providing the top line results for this trial in the first half of 2011 and continue to progress toward filing the new drug application in the fourth quarter of 2011."
The ADVANCE-PD study (http://www.advance-pd.com) is a Phase III study of the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients with motor fluctuations. The 22-week trial is being conducted in North America and Europe, and the primary endpoint is percentage of "off" time during waking hours. The trial exceeded its enrollment objective and results are expected in the first half of 2011.
The ADVANCE-PD trial in patients with advanced PD complements the APEX-PD Study (http://www.apex-pd.com) being conducted in levodopa-naïve PD patients, which finished enrollment earlier this year and is ongoing. The ADVANCE-PD and APEX-PD trials follow the earlier announced successful Phase II study of IPX066 in Parkinson's patients.
About IPX066 and Parkinson's Disease (PD)
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 the management of PD. "Off-time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms. 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 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, Philadelphia and Taiwan 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 the Company'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, the effect of current economic conditions on the Company's industry, business, financial position, results of operations and market value of its common stock, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, reductions or loss of business with any significant customer, the impact of competitive pricing and products and regulatory actions on the Company's products, the ability to sustain profitability and positive cash flows, the ability to maintain sufficient capital to fund operations, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the ability to successfully develop and commercialize pharmaceutical products, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, reliance on key alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, exposure to product liability claims and other risks described in the Company's periodic reports filed 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.
SOURCE: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Company Contact:
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 933-3526
http://www.impaxlabs.com