HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and
Drug Administration (FDA) has extended the Prescription Drug User Fee
Act (PDUFA) date for its review of the RytaryTM (IPX066) New
Drug Application (NDA) from October 21, 2012, to January 21, 2013.
The FDA notified Impax that its September 28, 2012 submission of
requested information on an excipient in the RytaryTM
formulation to the FDA has been designated as a major amendment. Since
the receipt date of this additional information is within three months
of the PDUFA date, the FDA has exercised its option to extend the PDUFA
date to review the information. No new clinical trials or studies have
been requested by the FDA.
About RytaryTM (IPX066)
RytaryTM 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 pivotal phase III studies of IPX066, APEX-PD
(early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have
previously been announced.
RytaryTM 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. (NASDAQ: IPXL) 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, 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.