Impax Laboratories Provides Update on Status of Warning Letter Resolution for its Hayward Facility
February 09 2012 - 7:00AM
Business Wire
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.
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