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 Parkinsonâ€™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 Companyâ€™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 Companyâ€™s industry, business, financial position and results of operations, fluctuations in the Companyâ€™s revenues and operating income, the Companyâ€™s ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of consolidation of the Companyâ€™s customer base, the impact of competition, the Companyâ€™s ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Companyâ€™s Taiwan facility, the effect of foreign economic, political, legal and other risks on the Companyâ€™s operations abroad, the uncertainty of patent litigation, increased government scrutiny on the Companyâ€™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 Companyâ€™s inexperience in conducting clinical trials and submitting new drug applications, the Companyâ€™s ability to successfully conduct clinical trials, the Companyâ€™s reliance on third parties to conduct clinical trials and testing, the availability of raw materials and impact of interruptions in the Companyâ€™s supply chain, the use of controlled substances in the Companyâ€™s products, disruptions or failures in the Companyâ€™s information technology systems and network infrastructure, the Companyâ€™s reliance on alliance and collaboration agreements, the Companyâ€™s dependence on certain employees, the Companyâ€™s ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Companyâ€™s ability to protect the Companyâ€™s intellectual property, exposure to product liability claims, changes in tax regulations, the Companyâ€™s ability to manage the Companyâ€™s growth, including through potential acquisitions, the restrictions imposed by the Companyâ€™s credit facility, uncertainties involved in the preparation of the Companyâ€™s financial statements, the Companyâ€™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 Companyâ€™s business, the location of the Companyâ€™s manufacturing and research and development facilities near earthquake fault lines and other risks described in the Companyâ€™s periodic reports filed with the Securities and Exchange Commission.Â 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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Last updated on: 12/10/2012