Impax Laboratories Inc. Press Releases (impax)

Impax Pharmaceuticals Submits New Drug Application for IPX066 in Parkinson’s Disease

Wed, 21 Dec 2011 08:30:00 -0500

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced the submission of Impax’s New Drug Application (NDA) for IPX066 to the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic Parkinson’s disease (PD). IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD). IPX066 is being developed in collaboration with GlaxoSmithKline (GSK) for territories outside the U.S. and Taiwan.

“In just three and a half years, Impax’s brand research and development team has successfully advanced IPX066 from an Investigational New Drug (IND) through multiple clinical studies of efficacy and safety, culminating in our NDA submission,” said Michael Nestor, president of Impax Pharmaceuticals. “This event demonstrates our strong internal capability to develop neurology products to fulfill unmet clinical needs of the PD community. IPX066 represents a significant commercial opportunity for Impax in the U.S., which if approved we plan to commercialize with our specialty neurology sales team.”

IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the U.S. and in Europe. As agreed with the FDA, the NDA is being submitted as a 505(b)(2) application and includes data from three controlled Phase III studies and two open label extensions of IPX066 in early and advanced PD. In these studies, IPX066 has been studied in about 900 PD subjects. Impax held an end of Phase III meeting with the U.S. FDA in the third quarter of 2011 and is submitting its NDA consistent with the guidance it received.

“We are proud to achieve this important milestone in our development of the brand pharmaceutical business,” said Larry Hsu, Ph.D., president and CEO of Impax Laboratories, Inc. “This represents an important part of our strategy to diversify our business model to branded products, with the objective of improving long-term shareholder value.”

About IPX066

IPX066 is an investigational extended release capsule formulation of CD-LD which is intended to maintain consistent plasma concentration of levodopa for a longer duration versus immediate release levodopa, which may have an impact on fluctuations in clinical response. It is not approved or licensed anywhere in the world.

Results from the pivotal phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced. Results of the ASCEND-PD study and other IPX066 data are planned for submission to the American Academy of Neurology and International Congress of Parkinson’s Disease and Movement Disorders Conference in April and June 2012, respectively.

About the Impax GSK collaboration

Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.

About Parkinson’s Disease

Parkinson’s disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

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, with a full range of capabilities located 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, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the pharmaceutical and healthcare industries, the regulatory environment, the ability to protect the Company’s intellectual property, 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 Pharmaceuticals Initiates Phase IIb Trial of IPX159 in Restless Legs Syndrome

Mon, 19 Dec 2011 11:30:00 -0500

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).

“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale.

About IPX159

IPX159 is an oral controlled-release formulation of a small molecule that has an established pharmacological and safety profile for non-RLS use outside the U.S. and may represent a novel mechanism of action in RLS. Impax has previously completed a proof of concept study with the molecule in RLS patients.

About Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a condition characterized by an irresistible urge to move ones’ limbs, most commonly the legs, to stop uncomfortable sensations. RLS symptoms generally worsen in the evening, are made worse by rest or inactivity, and commonly cause insomnia and involuntary leg movements during sleep. There are approximately 25 million RLS sufferers in the US.

About Impax Laboratories, Inc.

"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, including the statements under the heading “2011 Financial Outlook,” 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 and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the pharmaceuticals and healthcare industries, the regulatory environment, the ability to protect the Company’s intellectual property, 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 and GSK Announce Positive Topline Results of ASCEND-PD Phase III Study of IPX066 in Advanced Parkinson's Disease

Mon, 15 Aug 2011 08:00:00 -0400

- IPX066 demonstrated statistically significant improvement over carbidopa-levodopa plus entacapone in reducing the percentage of "off time" during waking hours

HAYWARD, Calif. & LONDON, Aug 15, 2011 (BUSINESS WIRE) -- Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) and GlaxoSmithKline (GSK) today announced top-line results of the ASCEND-PD Phase III clinical study of IPX066 versus carbidopa-levodopa plus entacapone (CLE), in patients with advanced Parkinson's disease (PD). IPX066 is an extended release capsule formulation of carbidopa-levodopa (CD-LD) under investigation for the treatment of the motor symptoms of PD.

The primary endpoint of this double blind crossover study was the percentage of "off time" during waking hours as measured by patient diary. "Off time" is the functional state when patients' medication effect has worn off and there is a return of the motor symptoms of PD. Patients entered the study with a baseline "off time" of 36.1% (5.9 hours), and at the end of the randomized IPX066 treatment phase patients had "off time" of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for CLE (p<0.0001). This represents a 33.5% decrease in percent "off time" for IPX066 from baseline vs. a 10% decrease for CLE.

"Impax Pharmaceuticals and GSK are excited to report these positive results for the ASCEND-PD trial which demonstrate an 84 minute improvement in "off time" over CLE therapy with a corresponding increase in "on time" without troublesome dyskinesia," stated Dr. Suneel Gupta, Impax Pharmaceuticals' chief scientific officer. "Consistent with our earlier ADVANCE-PD Phase III study findings, this study also demonstrates that IPX066 provides efficacy across a range of clinically meaningful measures in advanced PD. We are also pleased that the secondary endpoints supported the conclusion from the primary endpoint."

During the double blind crossover period of this trial the adverse event (AE) rate for IPX066 was 20% compared to 14% for CLE. After randomization two serious treatment-emergent adverse events were reported with both occurring on IPX066 therapy (sciatica and dehydration) and none on CLE. The most common AEs reported for IPX066 included: insomnia, confusional state, and dyskinesia (each event was reported by 3 subjects). The most common AE reported for CLE was: fall (reported by 2 patients on CLE).

Impax plans to submit these data as part of its New Drug Application (NDA) for IPX066 to the FDA, which is planned for the fourth quarter of 2011. GSK plans to file the marketing authorization application for IPX066 in the European Union in 2012.

Full results from the ASCEND-PD study will be presented at an upcoming scientific meeting.

About the ASCEND-PD study

The ASCEND-PD study is a randomized, double-blind 2-treatment, 2-week crossover study of IPX066 and CLE (a combination treatment of carbidopa-levodopa and entacapone, an enzyme inhibitor of levodopa breakdown), and one of three Phase III studies of IPX066. Study subjects taking a stable dose of CLE were converted to IPX066 over a six-week period, then randomized to one of the two treatments (IPX066 or CLE) for two weeks and then crossed over to the other treatment for an additional two weeks after a one-week washout with IPX066. The study enrolled 110 subjects, with 91 subjects entering the randomized comparative phase of the study. A total of 84 subjects completed the randomized double-blind comparative phase of the study. Following the comparative phase, subjects were enrolled into a six-month open-label extension study.

About IPX066

Results from the pivotal phase III studies of IPX066, ADVANCE-PD (in advanced PD) and APEX-PD (in early PD) have previously been announced and presented at the American Academy of Neurology and International Congress of Parkinson's Disease and Movement Disorders Conference in April and June 2011, respectively. Open-label extension studies for subjects who have completed the ADVANCE-PD and APEX-PD are ongoing.

About the Impax GSK collaboration

About Parkinson's Disease

Parkinson's disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

"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 and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the pharmaceutical and healthcare industries, the regulatory environment, the ability to protect the Company's intellectual property, 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.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.For more information, visit GlaxoSmithKline at www.gsk.com.

GlaxoSmithKline Forward-Looking Statement
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2010.

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SOURCE: Impax Laboratories, Inc.

Impax Enquiries:
Mark Donohue, 215-558-4526
or
GlaxoSmithKline Enquiries:
UK Media enquiries:
David Mawdsley, (020) 8047 5502
or
Stephen Rea, (020) 8047 5502
or
Sarah Spencer, (020) 8047 5502
or
Janet Morgan, (020) 8047 5502
or
David Daley, (020) 8047 5502
or
US Media enquiries:
Nancy Pekarek, 919-483-2839
or
Mary Anne Rhyne, 919-483-2839
or
Kevin Colgan, 919-483-2839
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Sarah Alspach, 919-483-2839
or
European Analyst/Investor enquiries:
Sally Ferguson, (020) 8047 5543
or
Gary Davies, (020) 8047 5503
or
Ziba Shamsi, (020) 8047 3289
or
US Analyst/ Investor enquiries:
Tom Curry, 215-751 5419
or
Jeff McLaughlin, 215-751-7002

Impax Pharmaceuticals Completes Enrollment in ASCEND-PD Phase III Trial of IPX066 in Parkinson's Disease

Tue, 26 Jul 2011 08:00:00 -0400

90 subjects randomized in comparative trial of IPX066 to carbidopa-levodopa and entacapone

Results expected in late August

HAYWARD, Calif., Jul 26, 2011 (BUSINESS WIRE) -- Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that it has completed enrollment in the ASCEND-PD trial. ASCEND-PD is a multinational Phase III comparative study of IPX066 to carbidopa-levodopa and entacapone in subjects with advanced Parkinson's disease (PD). IPX066 is an investigational extended release capsule formulation of carbidopa-levodopa (CD-LD) intended to treat the motor symptoms of Parkinson's disease. IPX066 is being developed in collaboration with GlaxoSmithKline (GSK) outside the US and Taiwan.

"We are extremely pleased to have completed enrollment in ASCEND-PD, which is the third Phase III trial of IPX066 in PD subjects," stated Suneel Gupta, chief scientific officer of Impax Pharmaceuticals. "The study compares IPX066 to another commonly used medication in advanced PD, and is intended to provide further safety and efficacy data on IPX066."

Impax plans to provide the top line results for this trial in late August of this year and continues to progress toward filing the new drug application in the fourth quarter of 2011.

About the ASCEND-PD Study

The ASCEND-PD study is a supportive Phase III study to compare the efficacy and safety of IPX066 to Carbidopa-Levodopa and Entacapone (CLE,) in subjects with advanced Parkinson's disease. The trial is randomized, double-blind 2-treatment, 2-period crossover study of IPX066 and CLE. Study subjects currently taking a stable dose of CLE were enrolled into a six-week conversion onto IPX066 and then randomized to one of the two treatments for two weeks and then crossed over to the other for an additional two weeks. The study enrolled 110 subjects, with 90 subjects entering the randomized comparative phase of the study. The primary efficacy parameter is the percent "off time" during waking hours based on the subject PD diaries. Following the comparative phase, subjects were able to enroll in a six-month open-label extension phase.

About IPX066

IPX066 is an investigational extended release capsule formulation of CD-LD with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD motor symptoms.

Impax Pharmaceuticals has previously announced the successful completion of two pivotal phase III trials in advanced PD subjects (ADVANCE-PD) and in early PD patients (APEX-PD). Open-label extension studies for subjects who have completed the ADVANCE-PD, APEX-PD, and ASCEND-PD studies are also ongoing. The Company plans to file a New Drug Application for IPX066 in PD in the fourth quarter of 2011.

About Our Collaboration with GlaxoSmithKline (GSK)

Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066, outside the United States and Taiwan, in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.

About Parkinson's Disease

Parkinson's Disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

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: 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 and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements, the regulatory environment, the ability to protect the Company's intellectual property, 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
215-558-4526
http://www.impaxlabs.com

Impax Pharmaceuticals Awarded Michael J. Fox Foundation Grant for Ongoing Research of IPX066 for Parkinson's Disease

Thu, 14 Jul 2011 08:00:00 -0400

HAYWARD, Calif., Jul 14, 2011 (BUSINESS WIRE) -- Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), has been awarded funding of up to $400,000 by The Michael J. Fox Foundation for ongoing clinical research of the Company's investigational carbidopa-levodopa extended release (CD-LD ER) product IPX066, which is intended to treat the motor symptoms of Parkinson's disease (PD).

The funding will support a planned dosing conversion study of CD-LD ER to IPX066, to be followed by an open-label extension safety study of IPX066 in subjects with advanced PD.

"One of our priorities is to improve symptomatic treatments for patients today," said Brian Fiske, Ph.D., director of research programs at the Michael J. Fox Foundation. "IPX066 holds promise as a potentially useful future treatment option for PD. By collaborating with Impax Pharmaceuticals to develop additional clinical data about IPX066, we hope to gather important information for physicians treating PD and their patients."

"We appreciate the support and recognition of The Michael J. Fox Foundation as we further advance the development of IPX066 for Parkinson's disease," said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc.

About IPX066

IPX066 is an investigational CD-LD ER product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD motor symptoms, such as the reduction in "off time" throughout the day, which has been observed in studies of IPX066.

Impax Pharmaceuticals has successfully completed two required phase III trials in advanced PD patients (ADVANCE-PD) and early PD patients (APEX-PD). With the completion of these studies, the Company is working diligently to file a New Drug Application in the fourth quarter of 2011. The Company is also conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, and an Open-Label Extension study for subjects from the ADVANCE-PD and APEX-PD studies is also ongoing.

About The Michael J. Fox Foundation

As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding over $240 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.

For more information, visit: http:///mail.hostaccount.com/owa/redir.aspx?C=08fe787753354c3e818c262c9a12f1ba&URL=http:%2f%2fwww.michaeljfox.org; http://www.facebook.com/michaeljfoxfoundation.

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 and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on 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, the ability to protect the Company's intellectual property, 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.
Mark Donohue
Sr. Director, Investor Relations and Corporate Communications
(215) 558-4526
http://www.impaxlabs.com

Data on IPX066 ADVANCE-PD and APEX-PD Phase III Studies to be Presented at the International Congress of Parkinson's Disease and Movement Disorders Conference

Wed, 01 Jun 2011 08:00:00 -0400

HAYWARD, Calif., Jun 01, 2011 (BUSINESS WIRE) -- Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that IPX066 ADVANCE-PD and APEX-PD Phase III clinical study data will be presented in Poster Sessions at the 15th International Congress of Parkinson's Disease and Movement Disorders Conference in Toronto, Canada, held from June 5 to June 9. IPX066 is an investigational extended release carbidopa-levodopa (CD-LD) product intended to treat the motor symptoms of Parkinson's disease.

The Poster Sessions of IPX066 ADVANCE-PD and APEX-PD results are as follows:

ADVANCE-PD Presentation
Title: Double-blind, Controlled Trial of IPX066, a Novel Carbidopa-Levodopa Extended-Release Formulation, in Advanced Parkinson's Disease (ADVANCE-PD Trial)
June 8, 2011
Time: 1:30 p.m. to 3:00 p.m.
Location: South Building, Level 800, Hall E
Abstract Number: LB9
Presenter: Robert A. Hauser, MD, Professor of Neurology, Molecular Pharmacology, and Physiology and Director of the Parkinson's Disease & Movement Disorders Center at the University of South Florida

APEX-PD Presentation
Title: Efficacy and safety of IPX066, a New Carbidopa-Levodopa (CD-LD) Extended-Release Formulation, in LD-Naïve Early Parkinson's Disease (APEX-PD Trial)
June 7, 2011
Session Title: Poster Session II
Time: 9:00 a.m. to 6:00 p.m., authors present from 1:30 p.m. to 3:00 p.m.
Location: South Building, Level 800, Hall E
Abstract Number: 407
Presenter: Rajesh Pahwa, MD, Professor of Neurology, University of Kansas Medical Center
June 9, 2011
Tour Title: Guided Poster Tour 13
Parkinson's disease: Clinical trials
Time: 1:30 p.m. to 3:00 p.m.
Location: South Building, Level 800, Room 808
Presenter: Rajesh Pahwa, MD, Professor of Neurology, University of Kansas Medical Center

About the ADVANCE-PD Study

The ADVANCE-PD study is a randomized, double-blind, active-control, parallel-group Phase III study of the safety and efficacy of IPX066 versus IR CD-LD in advanced PD patients with motor fluctuations. The trial enrolled 471 subjects in North America and Europe of which 393 subjects were randomized to participate in the 13-week comparison of IPX066 versus IR CD-LD. Prior to randomization, subjects on a stable IR CD-LD dose regimen entered a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

The ADVANCE-PD results demonstrated that IPX066 produced significantly improved control of motor symptoms as compared to IR CD-LD in multiple clinical measures in subjects with advanced PD. IPX066 treatment resulted in a 37% improvement from baseline for IPX066 vs. a 17% improvement from baseline for IR CD-LD (p<0.0001). "Off time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson's symptoms. Additional clinical and patient-reported outcome measures in the study consistently demonstrate the improved IPX066 efficacy profile when compared to IR CD-LD. IPX066 was generally well tolerated, and during the double-blind portion of the trial had an adverse event (AE) rate of 43% compared to 40% for IR CD-LD. The most common AEs reported for IPX066 included: insomnia, nausea, fall, dizziness, and dyskinesia (no event was associated with a greater than 3.5% overall incidence).

About the APEX-PD Study

The APEX-PD study is a randomized, double-blind, placebo controlled, parallel group, fixed-dose study comparing three doses of IPX066 to placebo in patients with early 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. 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.

The APEX-PD results demonstrated the safety and efficacy of IPX066 in patients with early PD. The study met its primary efficacy endpoint of change from baseline in the sum of United Parkinson's Disease Rating Scale (UPDRS) Parts II and III score at end of study. The study also met several secondary endpoints including, Clinician Global Impression of change and Patient Global Impression of change. There were no unexpected drug-related serious adverse events observed in IPX066 treated subjects. The most commonly reported adverse events in the IPX066 treatment arms included nausea, headache, and dizziness which are consistent with carbidopa-levodopa products.

About IPX066

IPX066 is an investigational CD-LD product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD motor symptoms, such as the reduction in "off time" throughout the day, which has been observed in preliminary studies of IPX066.

About Our Collaboration with GlaxoSmithKline (GSK) Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066, outside the United States and Taiwan, in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan. Impax will complete the current Phase III program for IPX066, which includes the ADVANCE-PD study.

About Parkinson's Disease

Parkinson's Disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

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, but are not limited to, the effect of current economic conditions on the Company's industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on 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, the ability to protect the Company's intellectual property, 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.
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com

Impax Pharmaceuticals Provides an Update on Pipeline Candidate IPX159

Tue, 10 May 2011 08:00:00 -0400

HAYWARD, Calif., May 10, 2011 (BUSINESS WIRE) -- Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced the successful filing of an Investigational New Drug Application (IND) for IPX159 in Restless Legs Syndrome (RLS) and initiated a Phase I study.

The Company will test multiple formulations of IPX159 in this Phase I study in healthy volunteer subjects. The Company plans to start a Phase IIb study in RLS patients in the fourth quarter of 2011 after selection of a preferred formulation.

"We are pleased to announce progress in our neurology pipeline, with the start of the Phase I study of IPX159 and we look forward to continued development of this compound in RLS," said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

About IPX159

IPX159 is an oral controlled-release formulation of a small molecule with a unique mechanism of action in RLS. IPX159 is a new molecular entity in the US. The compound has an established pharmacologic and safety profile for non-RLS use outside the US and Impax has completed a proof of concept study in RLS.

About Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a condition characterized by an irresistible urge to move ones' limbs, most commonly the legs, to stop uncomfortable sensations and is associated with sleeping abnormalities, somnolence, pain and discomfort. There are about 25 million RLS sufferers in the US and an estimated current market size of $800 million.

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, but are not limited to, the effect of current economic conditions on the Company's industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements, the regulatory environment, the ability to protect the Company's intellectual property, 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.
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
215-558-4526
www.impaxlabs.com

Data on IPX066 APEX-PD Phase III Study for the Treatment of Early Parkinson’s Disease to be Presented at the American Academy of Neurology Conference

Fri, 01 Apr 2011 08:00:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ:IPXL - News), today announced that IPX066 APEX-PD Phase III clinical study data will be presented in a Late Breaker Session at the 63rd annual meeting of the American Academy of Neurology Conference in Honolulu, Hawaii, held from April 9 to April 16. IPX066 is an investigational extended release carbidopa-levodopa (CD-LD) product intended to treat the motor symptoms of Parkinson’s disease.

On November 18, 2010, the Company reported positive top-line results of the APEX-PD trial. The results demonstrated the safety and efficacy of IPX066 in patients with early PD. The study met its primary efficacy endpoint of change from baseline in the sum of United Parkinson’s Disease Rating Scale (UPDRS) Parts II and III score at end of study. The study also met several secondary endpoints including, Clinician Global Impression of change and Patient Global Impression of change. There were no unexpected drug-related serious adverse events observed in IPX066 treated subjects.

The Late-Breaker oral presentation of IPX066 APEX-PD results is as follows:

Date and Time:
April 13, 2011 at 5:00 PM (local time)

Presentation Title and Number:
Double-Blind, Placebo-Controlled Fixed-Dose Trial of IPX066, a Novel Carbidopa-Levodopa (CD-LD) Extended-Release Formulation, in Early Parkinson’s Disease (APEX-PD Trial); LBS.001

Presenter:
Rajesh Pahwa, MD, Professor of Neurology, University of Kansas Medical Center

About the APEX-PD Study

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 IPX066

IPX066 is an investigational CD-LD product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD motor symptoms, such as the reduction in “off time” throughout the day, which has been observed in preliminary studies of IPX066.

About Our Collaboration with GlaxoSmithKline (GSK) Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066, outside the United States and Taiwan, in December 2010. Under the terms of the agreement, GSK received an exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will complete the current Phase III program for IPX066, which includes the ADVANCE-PD study.

About Parkinson’s Disease

Parkinson’s Disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

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, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on 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, the ability to protect the Company’s intellectual property, 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.

Contact:

Impax Pharmaceuticals
Company Contact:
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com

IPX066 Demonstrates Efficacy and Safety in ADVANCE-PD Phase III Study in Treatment of Advanced Parkinson's Disease

Mon, 14 Mar 2011 08:00:00 -0400

IPX066 met the primary end point, significantly reducing percentage of "off time" over IR CD-LD
Conference call and Webcast presentation scheduled for Tuesday, March 15 at 9:00 a.m. ET

HAYWARD, Calif., Mar 14, 2011 (BUSINESS WIRE) -- Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced statistically significant, positive, top-line results of the ADVANCE-Parkinson's Disease (PD) Phase III clinical study of the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients experiencing motor fluctuations. IPX066 is an investigational extended release (ER) CD-LD product. The ADVANCE-PD results demonstrated that IPX066 produced significantly improved control of motor symptoms as compared to IR CD-LD in multiple clinical measures in subjects with advanced PD.

The primary endpoint of this comparison study of IPX066 to IR CD-LD was the percentage of "off time" during waking hours. IPX066 demonstrated a 37% improvement from baseline for IPX066 vs. a 17% improvement from baseline for IR CD-LD (p<0.0001). "Off time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson's symptoms.

The study enrolled 471 subjects on a stable regimen of IR CD-LD who were first entered into a dose-adjustment phase of their IR CD-LD, followed by a conversion to IPX066 after which they were then randomized to either IPX066 or IR CD-LD. Subjects converted to IPX066 experienced a reduction from baseline of more than 2 hours in total "off time" during waking hours, and this effect was maintained in the group then randomized to IPX066 during the blinded study portion. While the group treated with IR CD-LD achieved similar improvement during conversion to IPX066, "off time" worsened by 1.0 hours during double blind treatment with IR CD-LD (p<0.0001). In addition, during double-blind treatment, subjects experienced similar results in "on time" without troublesome dyskinesia with an increase of 1.9 hours for IPX066 compared to an increase of 0.8 hours for IR CD-LD as measured from study entry (p<0.001).

Additional clinical and patient-reported outcome measures in the study consistently demonstrate the improved IPX066 efficacy profile when compared to IR CD-LD. This includes the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician Global Impression of Change (CGI) and Patient Global Impression of Change (PGI), which also demonstrated significant improvements in treatment with IPX066 compared to IR CD-LD (p<0.0001 for all comparisons). In quality-of-life (QOL) measures, IPX066 demonstrated significant improvement over IR CD-LD as measured by PDQ-39 (p<0.035) and modified Rankin Test (p<0.006).

"Impax Pharmaceuticals is excited to report these positive results for the ADVANCE-PD trial demonstrating the clinical benefits of IPX066 over IR CD-LD, which is the gold standard in treating advanced PD," stated Dr. Suneel Gupta, Impax Pharmaceuticals' Chief Scientific Officer. "Consistent with our Phase II findings, these data show IPX066 provides a robust level of efficacy across a range of PD clinical and QOL measures, which represents a potentially significant improvement over existing treatment options. With the successful completion of this ADVANCE-PD trial and the APEX-PD trial in patients with early PD, we have completed the two required Phase III trials for a New Drug Application (NDA) as agreed with the Food and Drug Administration. We are working diligently to file an NDA in the fourth quarter of 2011."

IPX066 was generally well tolerated, and during the double-blind portion of the trial had an adverse event (AE) rate of 43% compared to 40% for IR CD-LD. The most common AEs reported for IPX066 included: insomnia, nausea, fall, dizziness, and dyskinesia (no event was associated with a greater than 3.5% overall incidence). The rate of related serious AEs was comparable, with one subject in each treatment arm reporting serious treatment-related AEs in the double-blind treatment phase.

According to Robert A. Hauser, MD, Professor of Neurology, Molecular Pharmacology, and Physiology and Director of the Parkinson's Disease & Movement Disorders Center at the University of South Florida and an ADVANCE-PD study investigator, "There is a major unmet need in patients with advanced PD for a therapy that can consistently extend and improve motor symptom control through the day and enhance quality of life." Dr. Hauser added, "In the ADVANCE-PD study, daily "off time" was reduced without worsening of dyskinesia, and both patients and clinicians reported overall improvement. The magnitude of benefit observed with IPX066 was clinically significant and results indicate that PD patients should be able to enjoy improved control of their motor symptoms and a better quality of life."

Impax Pharmaceuticals plans to present complete results of the ADVANCE-PD study at an upcoming scientific meeting.

Conference Call Information

The Company will host a conference call and Webcast with a slide presentation on Tuesday, March 15 at 9:00 a.m. ET to discuss the results. The number to call from within the United States is (888) 461-2024 and (719) 325-2417 internationally. The call can also be accessed via a live Webcast through the Investor Relations section of the Company's Web site, www.impaxlabs.com. In addition, a copy of the slide presentation is available in the Investor Relations section. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (888) 203-1112 (in the U.S.) and (719) 457-0820 (international callers). The access conference code is 8896538.

About Our Collaboration with GlaxoSmithKline (GSK)

Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066, outside the United States and Taiwan, in December 2010. Under the terms of the agreement, GSK received an exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will complete the current Phase III program for IPX066, which includes the ADVANCE-PD study.

About the ADVANCE-PD Study and IPX066 Development Program

The ADVANCE-PD study is the second of two pivotal trials designed to support an NDA for IPX066 in PD. The study is a randomized, double-blind, active-control, parallel-group Phase III study of the safety and efficacy of IPX066 versus IR CD-LD in advanced PD patients with motor fluctuations. The trial enrolled 471 subjects in North America and Europe of which 393 subjects were randomized to participate in the 13-week comparison of IPX066 versus IR CD-LD. Prior to randomization, subjects on a stable IR CD-LD dose regimen entered a 3-week dose-adjustment or dose optimization period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066. Subjects were instructed to take IPX066 three times a day.

The ADVANCE-PD trial results complement the earlier announced positive APEX-PD Phase III study in early PD. APEX-PD was a randomized, double-blind, placebo-controlled, parallel group, fixed-dose study comparing 3 doses of IPX066 to placebo in 381 patients with early PD.

The Company is also conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, which is currently enrolling subjects.

An Open Label Extension study for subjects from the ADVANCE-PD and APEX-PD studies is also ongoing.

About IPX066

IPX066 is an investigational CD-LD product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD symptoms, such as the reduction in "off time" throughout the day, which has been observed in preliminary studies of IPX066.

About Parkinson's Disease

Parkinson's Disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

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, but are not limited to, the effect of current economic conditions on the Company's industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, 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, the ability to successfully conduct clinical trials, reliance on 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, the ability to protect the Company's intellectual property, 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.

Photos/Multimedia Gallery Available: www.businesswire.com/cgi-bin/mmg.cgi?eid=6646211&lang=en

SOURCE: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
215-558-4526
www.impaxlabs.com

GlaxoSmithKline and Impax Pharmaceuticals Enter Global Agreement to Develop and Commercialize a late stage compound for Parkinson's Disease

Thu, 16 Dec 2010 08:00:00 -0500

LONDON & HAYWARD, Calif., Dec 16, 2010 (BUSINESS WIRE) -- GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced an agreement for the development and commercialization of IPX066, Impax's novel extended release carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational product under development for the treatment of Parkinson's Disease (PD), is currently in Phase III clinical trials.

Under the terms of the agreement, GSK will receive an exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will receive an $11.5 million upfront payment and is eligible to receive potential payments of up to $175 million upon the successful achievement of development and commercialization milestones. Impax will also receive tiered, double-digit royalty payments on GSK sales of IPX066. Impax will manufacture and supply IPX066 to GSK.

Impax will complete the current Phase III program for IPX066, which includes the recently completed APEX-PD trial in early PD. The results from the remaining Phase III study program are expected to be available in 2011. In the U.S., Impax expects to file a New Drug Application for Parkinson's Disease in late 2011 and will be responsible for commercialization. In other regions, excluding Taiwan, GSK will be responsible for further development and registration of IPX066 and commercialization of the product in those markets. A team structure with representatives from both companies is being established to enable effective coordination of planned global regulatory and commercialization activities.

"We are very pleased to announce this development and collaboration agreement with GSK, which is a significant milestone in the development of Impax Pharmaceuticals and an important achievement in the planned global commercialization for IPX066 for the treatment of Parkinson's Disease," stated Michael Nestor, President of Impax Pharmaceuticals. "GSK is an ideal partner for IPX066, combining global best-in-class development, regulatory and commercial experience in Parkinson's Disease, which will be an asset in the successful commercialization of IPX066."

"We are excited by the opportunity IPX066 represents to patients," commented, Atul Pande, senior vice president, Neurosciences Medicines Development Center, GSK. "There is a significant need for a therapy which can improve on clinical symptom management and control in Parkinson's Disease. We look forward to collaborating with Impax and hope to deliver an improved treatment option to the millions of people living with this devastating disease."

About IPX066

IPX066 is an investigational extended release carbidopa-levodopa product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of Parkinson's Disease symptoms, such as the reduction in "off time" throughout the day, which has been observed in preliminary studies of IPX066. "Off time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms.

The phase III clinical development program for the registration of IPX066 in the U.S. includes the recently completed APEX-PD trial in early PD, the ADVANCE-PD study in advanced PD subjects, an open label extension study for subjects from the ADVANCE-PD and APEX-PD studies. Additionally, for the European application, Impax is conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, which is currently enrolling subjects.

About Parkinson's Disease

Parkinson's Disease is a chronic neurodegenerative movement disorder affecting over three million people in the U.S., Europe and Japan.

About Impax Laboratories, Inc.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Impax Laboratories, Inc."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.

GSK's cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.

Photos/Multimedia Gallery Available: www.businesswire.com/cgi-bin/mmg.cgi?eid=6547953&lang=en

SOURCE: Impax Laboratories, Inc.

Impax Laboratories, Inc: Company Contact:
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
(215) 933-3526
www.impaxlabs.com
or
GlaxoSmithKline Enquiries:
UK Media enquiries:
David Mawdsley, (020) 8047 5502
Claire Brough, (020) 8047 5502
Stephen Rea, (020) 8047 5502
Alexandra Harrison, (020) 8047 5502
Jo Revill, (020) 8047 5502
or
US Media enquiries:
Nancy Pekarek, (919) 483 2839
Mary Anne Rhyne, (919) 483 2839
Kevin Colgan, (919) 483 2839
Jennifer Armstrong, (919) 483 2839
or
European Analyst/Investor enquiries:
Sally Ferguson, (020) 8047 5543
Gary Davies, (020) 8047 5503
Ziba Shamsi, (020) 8047 3289
or
US Analyst/ Investor enquiries:
Tom Curry, (215) 751 5419
Jen Hill Baxter, (215) 751 7002