Impax Pharmaceuticals Initiates Second Phase III Trial of IPX066 in Parkinson's Disease

October 26, 2009

HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 26, 2009-- Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ:IPXL), today announced that it has initiated a multinational Phase III trial of its late-stage drug candidate IPX066 in advanced Parkinson’s disease (PD) patients. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and then sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management. This is the second of two Phase III studies designed to support marketing approval of IPX066 in Parkinson’s disease. Impax Pharmaceuticals previously reported in June the initiation of the first Phase III study of IPX066 in naïve PD patients.

Michael Nestor, divisional president of Impax Pharmaceuticals said: “We are extremely pleased to start the second Phase III study for IPX066. This trial in patients with advanced PD includes significant input from the FDA into the study design.” He added, “Impax Pharmaceuticals looks forward to the successful development of IPX066 and bringing its potential benefits to physicians who treat Parkinson’s and their patients as quickly as possible.”

About the ADVANCE-PD Phase III Study

  • The ADVANCE-PD study ( will evaluate the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients with motor fluctuations.
  • The trial is expected to enroll approximately 420 subjects who will be on treatment for approximately 22 weeks.
  • The trial will be conducted at multiple sites in North America and Europe.
  • The primary endpoint is percentage of “off” time during waking hours.
  • Additional endpoints include total “off” time, total “on” time with no troublesome dyskinesias, Unified Parkinson’s Disease Rating Scale (UPDRS) and clinician and patient reported outcome measures, including quality of life scales.

The ADVANCE-PD trial in patients with advanced PD complements the APEX-PD Study (, which commenced in April 2009 and is currently enrolling levodopa-naïve PD patients. APEX-PD is a randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of IPX066 and is being conducted in North America and Europe. 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 and Philadelphia facilities. For more information, please visit the Company's Web site at:

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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; ability to timely file periodic reports required by the Exchange Act; ability to maintain an effective system of internal control over financial reporting; ability to sustain profitability and positive cash flows; ability to maintain sufficient capital to fund operations; any delays or unanticipated expenses in connection with the construction of our Taiwan facility; ability to successfully develop and commercialize pharmaceutical products; the uncertainty of patent litigation; consumer acceptance and demand for new pharmaceutical products; the impact of competitive products and pricing; the difficulty of predicting Food and Drug Administration (“FDA”) filings and approvals; inexperience in conducting clinical trials and submitting new drug applications; reliance on key alliance agreements; the availability of raw materials; the regulatory environment; exposure to product liability claims; fluctuations in operating results and other risks detailed from time to time in our 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.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Company Contact:
Mark Donohue,
Sr. Director Investor Relations