IMPAX Laboratories, Inc. Board Steps in to Oversee Hayward Manufacturing Issues
Published: May 21, 2013
HAYWARD, Calif. -- 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.
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