FDA Issues Complete Response Letter for RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug

  FDA Issues Complete Response Letter for RYTARY™ (Carbidopa and Levodopa)
  Extended-Release Capsules (IPX066) New Drug Application

Business Wire

HAYWARD, Calif. -- January 21, 2013

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL),
announced today that the U.S. Food and Drug Administration (FDA) issued a
complete response letter regarding the New Drug Application (NDA) for RYTARY™
(IPX066), an extended-release capsule formulation of carbidopa-levodopa, a
potential treatment for the symptomatic treatment of Parkinson’s disease
currently under review in the United States.

The complete response letter indicates that the FDA requires a satisfactory
re-inspection of the company’s Hayward facility as a result of the warning
letter issued in May 2011 before the company’s NDA may be approved due to the
facility’s involvement in the development of RYTARY, and supportive
manufacturing and distribution activities. During the assessment of the NDA,
the company withdrew the Hayward site as an alternative site of commercial
production at launch.

“We will work with the FDA on the appropriate next steps for the RYTARY
application,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories,
Inc. “We remain committed to resolving the warning letter and bringing this
new treatment option to patients who are suffering from Parkinson’s disease.”

A complete response letter is issued by the FDA’s Center for Drug Evaluation
and Research when the review cycle for a drug is complete and the application
is not yet ready for approval.

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 IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD
(advanced PD) have previously been announced.

RYTARY ^ has been licensed to GlaxoSmithKline (GSK) for countries outside the
U.S. and Taiwan for development and marketing.

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 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 the Company’s revenues and
operating income, the Company’s ability to successfully develop and
commercialize pharmaceutical products, 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, increased government scrutiny on
the Company’s agreements with brand pharmaceutical companies, consumer
acceptance and demand for new pharmaceutical products, the difficulty of
predicting Food and Drug Administration filings and approvals, 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, 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 the Company’s intellectual property, exposure to product liability
claims, changes in tax regulations, the Company’s ability to manage the
Company’s 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, any
manufacturing difficulties or delays, 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 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.

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Contact:

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