Conference Call and Webcast Scheduled for 5:00 p.m. ET
HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced
that the U.S. Food and Drug Administration (FDA) completed its
re-inspection of the Company’s Hayward manufacturing facility in
connection with the previously disclosed Form 483 issued in March 2012.
In addition to the re-inspection, the FDA conducted a Pre-Approval
Inspection (PAI) for RYTARYTM, as analytical method
validation and a portion of the stability data were generated in
Hayward, and a general Good Manufacturing Practices (GMP) inspection. At
the conclusion of this inspection, the FDA issued a new Form 483 with
twelve (12) observations, three (3) of which are designated as repeat
observations from inspections that occurred prior to the Warning Letter.
“We have committed significant resources in our efforts to meet FDA
requirements and are clearly disappointed by this news,” said Larry Hsu,
Ph.D., president and CEO, Impax Laboratories, Inc. “The analytical
method assessment observations arose from our internal work and review
as a part of the ongoing quality improvement program designed to assess
and enhance our Quality Control Laboratory Analytical Methods and to
ensure they meet or exceed internal and industry standards. Resolving
the FDA concerns remains a top priority and we intend to complete this
work as quickly as possible.”
The Company is working diligently to address the observations raised by
the FDA and will respond to these new observations within the fifteen
(15) business day period from the receipt of the Form 483.
Currently, the Company has not been informed by the FDA of the impact
this latest Form 483 will have on the resolution or timing of resolving
the warning letter or whether any further regulatory action may be taken
as to its manufacturing operations. Until remedial action is complete
and the FDA has confirmed compliance with current GMP, approval of
pending and new applications listing the Hayward facility as a
manufacturing location of finished dosage forms may be withheld.
The Company has provided a redacted version of the Form 483 as an
exhibit in a Current Report on Form 8-K filed with the SEC concurrently
with the issuance of this press release.
Conference Call Information
The Company will host a conference call today at 5:00 p.m. EDT. The call
can also be accessed via a live Webcast through the Investor Relations
section of the Company’s Web site, www.impaxlabs.com.
The number to call from within the United States is (877) 356-3814 and
(706) 758-0033 internationally. The conference ID is 18793480. A replay
of the conference call will be available shortly after the call for a
period of seven days. To access the replay, dial (855) 859-2056 (in the
U.S.) and (404) 537-3406 (international callers).
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.
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, 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
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.