HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ:
IPXL), announced today that the U.S. Food and Drug Administration (FDA)
issued a complete response letter regarding the New Drug Application
(NDA) for RYTARY™ (IPX066), an extended-release capsule formulation of
carbidopa-levodopa, a potential treatment for the symptomatic treatment
of Parkinson’s disease currently under review in the United States.
The complete response letter indicates that the FDA requires a
satisfactory re-inspection of the company’s Hayward facility as a result
of the warning letter issued in May 2011 before the company’s NDA may be
approved due to the facility’s involvement in the development of RYTARY,
and supportive manufacturing and distribution activities. During the
assessment of the NDA, the company withdrew the Hayward site as an
alternative site of commercial production at launch.
“We will work with the FDA on the appropriate next steps for the RYTARY
application,” said Larry Hsu, Ph.D., president and CEO, Impax
Laboratories, Inc. “We remain committed to resolving the warning letter
and bringing this new treatment option to patients who are suffering
from Parkinson’s disease.”
A complete response letter is issued by the FDA’s Center for Drug
Evaluation and Research when the review cycle for a drug is complete and
the application is not yet ready for approval.
About RYTARY TM (IPX066)
RYTARY is an investigational extended-release capsule
formulation of carbidopa-levodopa for the treatment of idiopathic
Parkinson’s disease. It is not approved or licensed anywhere in the
world. Results from the phase III studies of IPX066, APEX-PD (early PD),
ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously
been announced.
RYTARY has been licensed to GlaxoSmithKline (GSK) for
countries outside the U.S. and Taiwan for development and marketing.
About the Impax GSK collaboration
Impax Pharmaceuticals and GSK announced an agreement for the development
and commercialization of IPX066 in December 2010. Under the terms of the
agreement, GSK received an exclusive license to register and
commercialize IPX066 throughout the world except in the U.S. and Taiwan.
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 the Company’s revenues and operating income,
the Company’s ability to successfully develop and commercialize
pharmaceutical products, 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, increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies, consumer acceptance and
demand for new pharmaceutical products, the difficulty of predicting
Food and Drug Administration filings and approvals, 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, 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
the Company’s intellectual property, exposure to product liability
claims, changes in tax regulations, the Company’s ability to manage the
Company’s 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, any manufacturing difficulties or delays, 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 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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Source: Impax Laboratories, Inc.