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8-K - FORM 8-K - Impax Laboratories, LLC | c18455e8vk.htm |
Exhibit 99.1
Company Contact:
Impax Laboratories, Inc.
Mark Donohue
Sr. Director, Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com
Impax Laboratories, Inc.
Mark Donohue
Sr. Director, Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com
Impax Laboratories Provides an Update on Recent FDA Site Inspection
Conference call and Webcast scheduled for 9:00 a.m. ET
HAYWARD, Calif., June 6, 2011 Impax Laboratories, Inc. (NASDAQ: IPXL) today
announced that late Friday, June 3, it received a warning letter from the U.S.
Food and Drug Administration (FDA) dated May 31, 2011 related to an on-site
inspection of its Hayward, Calif. manufacturing facility conducted between
December 13, 2010 and January 21, 2011.
In the warning letter, the FDA cited deviations from current Good Manufacturing
Practice (cGMP) for Finished Pharmaceuticals. The deviations cited related to
sampling and testing of in process materials and drug products, production record
review and our process for investigating the failure of certain manufacturing
batches (or portions of batches) to meet specifications. As a result of the FDAs
initial inspection results, the Company conducted a voluntary recall in March of
2011 of five lots of Fenofibrate capsules 200 mg at the wholesale level and took
additional remedial actions as noted below.
The Company notes that the observations cited in the letter relate to the Hayward
manufacturing facility only, and do not relate to any of the Companys other
facilities. It also notes that until remedial action is complete and the FDA has
confirmed compliance with cGMP, approval of pending and new applications listing
the Hayward facility as a manufacturing location of finished dosage forms may be
withheld. The warning letter did not place restrictions on the Companys ability
to manufacture and ship product. While during the past three months, the
production level at the Hayward facility was reduced to implement several key
changes in the Companys quality system, the Company is now producing product at a
normal pace and does not currently plan to reduce its product manufacturing or
hold shipments of finished product.
Following the initial inspection, the Company took a number of steps to thoroughly
review its manufacturing systems and standards, including the use of leading
consulting firms to assist in that review. This work is ongoing and the Company is
committed to improving its manufacturing practices. The Company will continue to
work to fully address the FDAs concerns and to resolve these issues. The Company
will respond to the FDAs warning letter within the mandated 15 business day
response period.
Impax remains committed to providing the highest quality products to our
customers and working with the FDA to diligently resolve any issues, said Larry
Hsu, Ph.D., president and CEO, Impax Laboratories. We intend to promptly respond
to the FDAs letter, and have already begun to implement changes and establish
procedures that address the observations cited during the inspection. We will work
diligently to remedy any outstanding issues in a timely manner.
Dr. Hsu concluded, We dont anticipate that this manufacturing setback will delay
our ongoing research and development activities. We expect to continue to develop
our generic pipeline of 82 products and two brand products.
Unless and until the Companys remedial action is completed to the FDAs
satisfaction, it is possible that the Company may be subject to additional
regulatory action by the FDA as a result of the issues raised in the warning
letter. The warning letter will be posted on the FDAs website at www.fda.gov and,
once posted, will be available for viewing.
Conference Call Information
The Company will host a conference call and Webcast today at 9:00 a.m. ET. The number to call from within the United States is (877) 273-1376 and (702) 800-7095 internationally. The call can also be accessed via a live Webcast through the Investor Relations section of the Companys Web site, www.impaxlabs.com. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (800) 642-1687 (in the U.S.) and (706) 645-9291 (international callers). The access conference code is 73701231.
The Company will host a conference call and Webcast today at 9:00 a.m. ET. The number to call from within the United States is (877) 273-1376 and (702) 800-7095 internationally. The call can also be accessed via a live Webcast through the Investor Relations section of the Companys Web site, www.impaxlabs.com. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (800) 642-1687 (in the U.S.) and (706) 645-9291 (international callers). The access conference code is 73701231.
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 its 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 Companys Web site at: www.impaxlabs.com.
SOURCE: Impax Laboratories, Inc.
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 Companys 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 Companys
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, the regulatory environment, the ability to
protect the Companys intellectual property, exposure to product liability claims
and other risks described in the Companys 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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