HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced
that its Board of Directors has established a Compliance Committee
composed of three independent directors to provide oversight for all
activities of the Company related to the U.S. Food and Drug
Administration (FDA) warning letter for the Hayward site including
obtaining approval of the Company’s New Drug Application for an
investigational drug, RYTARYTM, for the treatment of
idiopathic Parkinson’s disease. The Committee will also provide
oversight for the Company’s Quality Improvement Program (QIP) with
respect to change management, training, documentation, investigation,
validation and risk assessments in response to the FDA 483s. The
Compliance Committee will be comprised of Dr. Leslie Z. Benet (Chair of
the Compliance Committee), Dr. Allen Chao and Mr. Peter R. Terreri.
Dr. Les Benet has been a member of the UCSF faculty since 1969 and
served as Chairman of the Department of Biopharmaceutical Sciences from
1978 to 1998. He has been an elected member of the Institute of Medicine
of the US National Academy of Sciences for more than 25 years and brings
to the Compliance Committee a deep knowledge and understanding of drug
development and quality control aspects of the pharmaceutical industry,
as well as policies and practices of the US FDA. Dr. Benet formerly
served as Chair of the FDA Expert Panel on Individual Bioequivalence and
the FDA Center for Biologics Peer Review Committee, and as a member of
the FDA Science Board and the Generic Drugs Advisory Committee.
Dr. Allen Chao was a co-founder of Watson Pharmaceuticals, Inc. (now
Actavis, Inc.), serving as Chief Executive Officer from 1985 to 2007 and
Chairman of the Board of Directors from 1996 to 2008. He brings to the
Compliance Committee a profound understanding of strategic planning and
operational management in Impax’ sphere of activities and will provide
invaluable practical guidance, oversight and perspective with respect to
operations, strategy and corporate governance.
Peter R. Terreri is President, Chief Executive Officer and director of
CGM, Inc., a manufacturing company that he has owned and operated since
2000. He previously served as Senior Vice President and Chief Financial
Officer of Teva Pharmaceuticals USA from 1985 through 2000. Mr.
Terreri’s more than 20 years of experience in the pharmaceutical
industry provides the Compliance Committee with comprehensive
understanding of operations, strategy and risk management issues.
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. 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 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 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.
Source: Impax Laboratories, Inc.