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RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data to be Presented at

  RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase
  III and Open-Label Extension Data to be Presented at the American Academy of
  Neurology Conference

Business Wire

HAYWARD, Calif. -- March 15, 2013

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL),
today announced that data from the RYTARY^TM Phase III and open-label
extension trials will be presented at the 65th Annual Meeting of the American
Academy of Neurology in San Diego, California, held from March 16 to March 23.
IPX066 is an investigational extended-release capsule formulation of
carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease.

The presentation of IPX066 posters is as follows:

Date: March 18, 2013 (all posters)
Time: 2:00-6:30, with authors in attendance from 5:30-6:30 PM PT (all posters)
Location: San Diego Convention Center

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules
in Patients with Motor Fluctuations in Advanced Parkinson’s Disease
Abstract / Poster Number: 3706/ P01.065

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules
in Patients with Early Parkinson’s Disease
Abstract / Poster Number: 3662/ P01.064

Presentation Title and Number:
Analysis of IPX066 Dosing Data in Advanced Parkinson's Disease (PD) Patients
Abstract / Poster Number: 49/ P01.063

About RYTARY^TM (IPX066)

RYTARY is an investigational extended-release capsule formulation of
carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease. It is
not approved or licensed anywhere in the world. Results from the phase III
studies of RYTARY, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD
(advanced PD) have previously been announced.

On January 21, 2013, Impax received a complete response letter which indicated
that the FDA could not approve the NDA at that time. The complete response
letter stated that satisfactory resolution and verification of the
deficiencies identified during the inspection of the manufacturing facility in
Hayward California would be required before the NDA for IPX066 may be
approved. On March 4, 2013, the Company announced the receipt of a Form 483
following an inspection by the FDA of the Hayward facility. The Form 483
contained several observations specific to IPX066 which the Company believes
must be satisfactorily resolved before the NDA for IPX066 may be approved.

RYTARY has been licensed to GlaxoSmithKline (GSK) for countries outside the
U.S. and Taiwan for registration and commercialization.

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 Impax Pharmaceuticals

Impax Pharmaceuticals is the branded products division of Impax Laboratories,
Inc. Impax Pharmaceuticals is focused on targeting significant unmet needs,
with a primary focus on developing treatments for neurological disorders. For
more information, please visit its Web site at www.impaxpharma.com.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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
develops marketing partnerships to fully leverage its technology platform and
pursues partnership opportunities that offer alternative dosage form
technologies, such as injectables, nasal sprays, inhalers, patches, creams and
ointments. 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:
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, fluctuations in revenues and operating income, the
Company’s ability to promptly correct the issues raised in the warning letter
and Form 483 observations received from the FDA, the Company’s ability to
successfully develop and commercialize pharmaceutical products in a timely
manner, reductions or loss of business with any significant customer, the
impact of consolidation of the Company’s customer base, the impact of
competition, the Company’s ability to sustain profitability and positive cash
flows, any delays or unanticipated expenses in connection with the operation
of the Company’s Taiwan facility, the effect of foreign economic, political,
legal and other risks on the Company’s operations abroad, the uncertainty of
patent litigation, the increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies, consumer acceptance and demand
for new pharmaceutical products, the impact of market perceptions of the
Company and the safety and quality of the Company’s products, the difficulty
of predicting FDA filings and approvals, the Company’s ability to achieve
returns on its investments in research and development activities, the
Company’s inexperience in conducting clinical trials and submitting new drug
applications, the Company’s ability to successfully conduct clinical trials,
the Company’s reliance on third parties to conduct clinical trials and
testing, impact of illegal distribution and sale by third parties of
counterfeits or stolen products, the availability of raw materials and impact
of interruptions in the Company’s supply chain, the use of controlled
substances in the Company’s products, disruptions or failures in the Company’s
information technology systems and network infrastructure, the Company’s
reliance on alliance and collaboration agreements, the Company’s dependence on
certain employees, the Company’s ability to comply with legal and regulatory
requirements governing the healthcare industry, the regulatory environment,
the Company’s ability to protect its intellectual property, exposure to
product liability claims, changes in tax regulations, the Company’s ability to
manage growth, including through potential acquisitions, the restrictions
imposed by the Company’s credit facility, uncertainties involved in the
preparation of the Company’s financial statements, the Company’s ability to
maintain an effective system of internal control over financial reporting, the
effect of terrorist attacks on the Company’s business, the location of the
Company’s manufacturing and research and development facilities near
earthquake fault lines andother 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 the Company
undertakes no obligation to update publicly or revise any forward-looking
statement, regardless of whether new information becomes available, future
developments occur or otherwise.

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Contact:

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