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Endo Pharmaceuticals (ENDP) Announces Receipt of Paragraph IV Certification Received by Teikoku Pharma from Mylan Technologies Inc. Advising Filing of ANDA



1/31/2011 10:44:26 AM

CHADDS FORD, Pa., Jan. 31, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced today that its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc., have received a Paragraph IV Certification Notice from Mylan Technologies Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LIDODERM® (lidocaine topical patch 5%).

The company is currently reviewing the details of this notice from Mylan. Endo intends to vigorously defend LIDODERM's intellectual property rights and will pursue all available legal and regulatory pathways in defense of LIDODERM.

The Paragraph IV certification notice refers to U.S. Patent Nos. 5,741,510 and 5,827,529, which cover the formulation of LIDODERM, a topical patch to relieve the pain of postherpetic neuralgia launched in 1999. These patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book and expire in March 2014 and October 2015, respectively.

Citizen Petition

With respect to Endo's regulatory approach, the company submitted a Citizen Petition in 2006 in reaction to a proposal by FDA's Office of Generic Drugs that would diverge from applicable regulations and standards of practice regarding bioequivalence. The company is requesting that the agency reconsider its departure from its longstanding general rule of requiring clinical endpoint bioequivalence studies for locally acting topical generic drug products, including those that reference LIDODERM. To ensure the safe and effective equivalence of any generic version to LIDODERM, which acts locally in the skin, Endo believes that FDA must return to its established standard of clinical endpoint bioequivalence studies.

About Endo

Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit www.endo.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, Endo's financial position, results of operations, market position, product development and business strategy, as well as estimates of Endo's future total revenues, future expenses, future net income and future earnings per share. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may" "intend," "guidance" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors could affect the business combination of the companies, future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in this press release. These factors include, but are not limited to: Endo's ability to successfully develop, commercialize and market new products; timing and results of pre-clinical or clinical trials on new products; Endo's ability to obtain regulatory approval of any of its pipeline products; competition for the business of Endo's branded and generic products, and in connection with its acquisition of rights to intellectual property assets; market acceptance of our future products; government regulation of the pharmaceutical industry; Endo's dependence on a small number of products; Endo's dependence on outside manufacturers for the manufacture of a majority of its products; Endo's dependence on third parties to supply raw materials and to provide services for certain core aspects of its business; new regulatory action or lawsuits relating to Endo's use of narcotics in many of its core products; Endo's exposure to product liability claims, market withdrawals and product recalls and the possibility that Endo may not be able to adequately insure itself; the successful efforts of manufacturers of branded pharmaceuticals to use litigation and legislative and regulatory efforts to limit the use of generics and certain other products; Endo's ability to successfully implement its acquisition and in-licensing strategy; regulatory or other limits on the availability of controlled substances that constitute the active ingredients of some of its products and products in development; the availability of third-party reimbursement for our products; the outcome of any pending or future litigation or claims by third parties or the government, and the performance of indemnitors with respect to claims for which we have been indemnified; our dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion of its total revenues; a determination by a regulatory agency that Endo is engaging or has engaged in inappropriate sales or marketing activities, including promoting the "off-label" use of its products, the risk that demand for and acceptance of our products or services may be reduced; the risk of changes in governmental regulations; the impact of economic conditions; the impact of competition and pricing and other risks and uncertainties, including those detailed from time to time in Endo's periodic reports filed with the Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion under the caption "RISK FACTORS" in our periodic and current reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

SOURCE Endo Pharmaceuticals


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