Impax Laboratories Provides Update on Status of Warning Letter Resolution for its Hayward Facility
Outlines Progress in Executing Growth Strategy and on Implementing Quality Improvement Initiatives
HAYWARD, Calif.--(BUSINESS WIRE)--Feb 9, 2012 - Impax Laboratories, Inc. (NASDAQ: IPXL) today provided an update on the status of its resolution of the previously disclosed warning letter issued by the U.S. Food and Drug Administration (FDA) covering its Hayward manufacturing facility. Late last year, Impax received an acknowledgement letter from the FDA stating that it had received a complete response from Impax to the warning letter. However, a satisfactory re-inspection is required to close out the warning letter and the re-inspection by the FDA has not occurred to date. Therefore, the Company's previously stated goal for completing the closing out of the warning letter before the end of February 2012 may not occur. Until such re-inspection is completed and the warning letter is closed out, approval of the Company's pending drug applications listing the Hayward manufacturing facility as a manufacturing location may be withheld by the FDA.
“We worked as quickly and diligently as possible to ensure we addressed all FDA concerns, and look forward to a timely resolution,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories. “At the same time, we have been successfully executing our growth strategy, including pursuing external growth opportunities, further advancing our generic and brand R&D pipeline, and servicing our customers. Our focus on achieving these objectives is evident in several recent positive events, including obtaining a long-term licensing agreement for Zomig®, advancing our pipeline with the filing of a New Drug Application for IPX066 and submitting 11 Abbreviated New Drug Applications in 2011.”
As part of its Global Quality Improvement Program, the Company said it has revised its Standard Operating Procedures, made key staffing changes, revalidated manufacturing processes, conducted additional training, and purchased and validated new equipment.
Hsu added, “Improving the operation of all of our production facilities and company-wide quality systems has strengthened our Company, and continuous improvement will remain a top priority. We appreciate the communication and guidance provided by the FDA throughout this process and look forward to their re-inspection of our Hayward facility.”
Yesterday Impax received notice from the FDA that it has forfeited exclusivity on its generic version of Doryx 150mg.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. 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 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 has developed marketing partnerships to fully leverage its technology platform. 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, including the statements under the heading “2011 Financial Outlook,” 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, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the pharmaceuticals and healthcare industries, the regulatory environment, the ability to protect the Company's intellectual property, exposure to product liability claims 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.
Contact: Impax Laboratories,
Mark Donohue, 215-558-4526
Sr. Director, Investor Relations and Corporate Communications
Posted: February 2012