Impax Provides an Update on FDA Inspection of Hayward Facility

  Impax Provides an Update on FDA Inspection of Hayward Facility

            Conference Call and Webcast Scheduled for 5:00 p.m. ET

Business Wire

HAYWARD, Calif. -- March 4, 2013

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and
Drug Administration (FDA) completed its re-inspection of the Company’s Hayward
manufacturing facility in connection with the previously disclosed Form 483
issued in March 2012. In addition to the re-inspection, the FDA conducted a
Pre-Approval Inspection (PAI) for RYTARY^TM, as analytical method validation
and a portion of the stability data were generated in Hayward, and a general
Good Manufacturing Practices (GMP) inspection. At the conclusion of this
inspection, the FDA issued a new Form 483 with twelve (12) observations, three
(3) of which are designated as repeat observations from inspections that
occurred prior to the Warning Letter.

“We have committed significant resources in our efforts to meet FDA
requirements and are clearly disappointed by this news,” said Larry Hsu,
Ph.D., president and CEO, Impax Laboratories, Inc. “The analytical method
assessment observations arose from our internal work and review as a part of
the ongoing quality improvement program designed to assess and enhance our
Quality Control Laboratory Analytical Methods and to ensure they meet or
exceed internal and industry standards. Resolving the FDA concerns remains a
top priority and we intend to complete this work as quickly as possible.”

The Company is working diligently to address the observations raised by the
FDA and will respond to these new observations within the fifteen (15)
business day period from the receipt of the Form 483.

Currently, the Company has not been informed by the FDA of the impact this
latest Form 483 will have on the resolution or timing of resolving the warning
letter or whether any further regulatory action may be taken as to its
manufacturing operations. Until remedial action is complete and the FDA has
confirmed compliance with current GMP, approval of pending and new
applications listing the Hayward facility as a manufacturing location of
finished dosage forms may be withheld.

The Company has provided a redacted version of the Form 483 as an exhibit in a
Current Report on Form 8-K filed with the SEC concurrently with the issuance
of this press release.

Conference Call Information

The Company will host a conference call today at 5:00 p.m. EDT. The call can
also be accessed via a live Webcast through the Investor Relations section of
the Company’s Web site, www.impaxlabs.com. The number to call from within the
United States is (877) 356-3814 and (706) 758-0033 internationally. The
conference ID is 18793480. A replay of the conference call will be available
shortly after the call for a period of seven days. To access the replay, dial
(855) 859-2056 (in the U.S.) and (404) 537-3406 (international callers).

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
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.

Contact:

Impax Laboratories, Inc.
Mark Donohue, 215-558-4526
Sr. Director, Investor Relations and Corporate Communications
www.impaxlabs.com
 
Press spacebar to pause and continue. Press esc to stop.