--Parkinson's Disease Symptom Scores Reduced 36% over 30 Weeks--
HAYWARD, Calif., Nov 18, 2010 (BUSINESS WIRE) -- Impax Pharmaceuticals,the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced positive top-line results of the APEX-PD Phase III clinical study with IPX066 in Parkinson's disease (PD). IPX066 is a novel extended release carbidopa-levodopa product. The APEX-PD results demonstrate that IPX066 is safe and efficacious when used in patients with early Parkinson's disease.
The trial met its primary efficacy endpoint of change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III score at end of study. The UPDRS Part II measures the activities of daily living and the UPDRS Part III measures motor symptoms of PD. All three doses of IPX066 showed significant improvement compared to placebo (p<0.0001 for all treatments). The mean sum of Parts II and III UPDRS score on IPX066 treatment improved 13.2 units (36%) compared to an improvement of 0.6 units (2%) with placebo treatment, indicating a major improvement in PD symptom severity in early PD patients as a result of IPX066 treatment.
"We are thrilled to report these positive results of the APEX-PD trial demonstrating robust efficacy in early Parkinson's disease across a range of objective and subjective measures for each of the doses tested," stated Dr. Suneel Gupta, Chief Scientific Officer of Impax Pharmaceuticals. "We are working diligently to complete the clinical trial program on schedule and target a New Drug Application (NDA) filing by the end of 2011."
Consistent with the results observed in the UPDRS, IPX066 also demonstrated mean improvements of 72% in both Clinician Global Impression of change (CGI) and Patient Global Impression of change (PGI) compared to improvements of 27% and 34% for placebo in CGI and PGI, respectively (p<0.0001 for both measures at all three dose levels). In addition, IPX066 treatment resulted in an improvement over placebo in quality of life as measured by the Parkinson's Disease Questionnaire (PDQ-39) at week 30 (p<0.02).
The most commonly reported adverse events in the IPX066 treatment arms included nausea, headache, and dizziness which are consistent with carbidopa-levodopa products. The proportion of subjects experiencing adverse events was similar for IPX066 and placebo treated subjects (69% compared to 73%, respectively). No unexpected drug-related serious adverse events were observed in IPX066 treated subjects.
Impax Pharmaceuticals plans to present complete results of the APEX-PD study at an upcoming scientific meeting.
The APEX-PD study was a randomized, double-blind, placebo controlled, parallel group, fixed-dose study comparing 3 doses of IPX066 to placebo in patients with early Parkinson's disease. The study was conducted under a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA) and is part of the IPX066 clinical development plan agreed with the FDA and the European Medicines Agency.
About the Study and the IPX066 Development Program
The APEX-PD study is the first of two pivotal Phase III studies designed to support an NDA for IPX066 in Parkinson's disease. The trial enrolled 381 subjects in North America and Europe who were randomized to receive one of three doses of IPX066 or matching placebo administered orally three times per day for 30 weeks.
In addition, Impax Pharmaceuticals is conducting the ADVANCE-PD study (www.advance-pd.com), 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 ADVANCE-PD trial has completed enrollment and results are expected in the second quarter of 2011.
IPX066 is an investigational extended release carbidopa-levodopa product intended to produce a fast and sustained concentration of levodopa, 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, the IPX066 extended release formulation is designed to reduce dosing frequency, enhancing patient convenience.
About Parkinson's disease (PD).
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 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: 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 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, 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 FDA 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 SEC. 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.
Photos/Multimedia Gallery Available: www.businesswire.com/cgi-bin/mmg.cgi?eid=6517452&lang=en
SOURCE: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Mark Donohue, 215-933-3526
Sr. Director Investor Relations and Corporate Communications