Impax Pharmaceuticals Reports Positive Achievements on its Two Leading Brand Product Candidates IPX066 and IPX056

HAYWARD, Calif.--(BUSINESS WIRE)--Apr 20, 2009 - Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ:IPXL) today announced it has commenced a Phase III trial of IPX066 in Parkinson's Disease (PD) patients based on encouraging interim data collected from the Phase II study in PD patients. It also clarified the U.S. Food and Drug Administration (FDA) requirement for pediatric studies of its investigational medication IPX056.

Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said: “We are very pleased to report these recent achievements, which are important to our long term strategy of investing in developing branded pharmaceutical products. We believe this strategy will augment our generic business and propel our company to the next growth phase by providing longer-life-cycle products with significantly higher margin potential than our generic products.”

IPX066 for Parkinson's Disease

Impax Pharmaceuticals has started enrolling patients in a Phase III trial of its late-stage drug candidate IPX066 in PD patients. 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.

Impax has completed multiple Phase I pharmacokinetic studies in healthy volunteers and will soon complete a open label and active-controlled Phase II study in PD patients. The interim results of this Phase II study have demonstrated consistent signals of superior clinical benefit in both extended pharmacokinetic profile and control of PD motor symptoms compared to conventional carbidopa levodopa.

Based on both confirmatory Phase I and compelling interim Phase II data, the company has commenced enrollment in the first Phase III study, also known as APEX-PD, in PD patients with mild symptoms of PD. The company is conducting this trial under a recent agreement with the FDA through a Special Protocol Assessment (SPA) for the Phase III clinical trial of IPX066 in PD patients.

Impax is planning to commence a second Phase III trial of IPX066 in patients with advanced PD patients later in 2009 or early 2010.

Michael Nestor, divisional president of Impax Pharmaceuticals said: “We are delighted with the efforts of our impressive team headed by Dr. Suneel Gupta which has rapidly advanced IPX066 from an Investigational New Drug (IND) filing (July 2008) to Phase III commencement under SPA in nine months. We are eager to continue the successful development of this product and bring the potential benefits of IPX066 to physicians who treat Parkinson's and their patients as quickly as possible. We continue to work towards our goal of filing a New Drug Application (NDA) in the fourth quarter of 2011.”

Impax plans to submit the Phase II data for presentation at a future clinical meeting.

About the APEX-PD Phase III Study

 

  • The APEX-PD study is a Phase III randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of IPX066 in subjects with PD. The study will evaluate three doses of IPX066 versus placebo in subjects with mild symptoms of PD.
  • The trial is expected to enroll approximately 350 subjects who will be randomized into one of four treatment groups.
  • The trial will be conducted at multiple sites in North America and Europe.
  • The agreed upon primary endpoint is change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III. Additional endpoints include clinical and patient reported outcome measures.

IPX056 for Spasticity

Impax Pharmaceuticals recently held discussions with the FDA related to possible requirement for pediatric clinical studies as part of its potential NDA filing for IPX056. IPX056 is an investigational extended-release formulation of baclofen, the most widely prescribed drug in the treatment of spasticity, which has the potential to offer improved control of symptoms and dosing convenience.

Previously FDA had requested Impax to conduct a pediatric study as part of IPX056 NDA submission under the Pediatric Research Equity Act. In recent discussions with FDA on this issue, the Agency asked Impax to submit a proposed pediatric development plan for IPX056 with the NDA in order to avoid delaying the review and approval of IPX056 for adults. Impax plans to develop an appropriate pediatric development strategy in consultation with its advisors so the pediatric trial can be done independently of the adult indication approval process.

Mr. Nestor said: “We are pleased to have this timely input from the FDA, clarifying next steps in fulfilling the pediatric requirement for IPX056. Significantly, this allows our team to focus on the important work of finalizing the second Phase III trial in Multiple Sclerosis spasticity in adults, which we plan to start in late 2009 or early 2010. We continue to work towards our goal of filing a NDA in the first half of 2012.”

About IPX066 and Parkinson's Disease

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 management of PD. 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 IPX056 and Spasticity

IPX056 is an extended-release formulation of baclofen, the most widely prescribed drug in the treatment of spasticity, which has the potential to offer improved control of symptoms and dosing convenience.

Spasticity is characterized by muscle stiffness and involuntary muscle spasms. It is reported in about two to three million patients in the U.S., occurring commonly in multiple sclerosis, stroke, spinal cord injury, traumatic brain injury and cerebral palsy.

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; 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.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5943497&lang=en

 

 

Contact: Impax Laboratories, Inc.
Mark Donohue, Sr. Director Investor Relations
215-933-3526
www.impaxlabs.com

 

Posted: April 2009

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