SOURCE: Endo Pharmaceuticals

December 19, 2006 07:30 ET

Endo Pharmaceuticals Submits Citizen Petition to FDA Regarding Lidoderm®

CHADDS FORD, PA -- (MARKET WIRE) -- December 19, 2006 -- Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP) announced today the submission of a Citizen Petition with the U.S. Food and Drug Administration requesting that the FDA apply existing bioequivalence regulations to any Abbreviated New Drug Application (ANDA) seeking regulatory approval of a generic drug product that references Endo's Lidoderm® (lidocaine topical patch 5%).

As disclosed on October 17, 2006, Endo became aware that, in response to an independent inquiry, the FDA's Office of Generic Drugs (OGD) had proposed that a study of blood levels of lidocaine should be used as the key measure in proving bioequivalence of a generic version of Lidoderm®. This petition contends that this proposed standard deviates from applicable regulations and OGD's past practices, both of which contemplate demonstration of bioequivalence for a topically acting product like Lidoderm® through a comparative clinical efficacy study.

Lidoderm®, as a topical patch and not a systemic patch, acts at the site of application. As such, blood levels of the active ingredient, lidocaine, cannot be used as the key measure in proving bioequivalence. To appropriately assess the efficacy and safety of any generic version of Lidoderm®, Endo believes that it is critical that the FDA require any ANDA satisfy the regulations by following these additional criteria to those that FDA has proposed:

--  An applicant attempting to demonstrate bioequivalence of its generic
    product to Lidoderm® must conduct comparative clinical studies
    demonstrating identical safety and efficacy between the generic version and
    Lidoderm®.
--  An applicant relying on Lidoderm® as its Reference Listed Drug must
    show that its product produces the same local analgesic effect as Lidoderm®
    without producing a complete sensory block, in order to assure that the
    generic product has the same labeling, efficacy and safety profile as
    Lidoderm®.
    

Peter A. Lankau, President and Chief Executive Officer, said, "There are five Orange Book-listed patents for Lidoderm®, the last of which expires in 2015. We firmly believe that this patent estate protects our intellectual property in Lidoderm®. We have filed a Citizen Petition to address a separate concern: that any generic that would potentially come to market would ensure that a patient receiving a generic version of Lidoderm® would feel confident that its safety and efficacy would be the same as Lidoderm®. Only by conducting comparative clinical studies can it be appropriately demonstrated that a generic version and Lidoderm® are truly bioequivalent."

The Citizen Petition is available on line at the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-irhome

About Lidoderm®

Lidoderm® (lidocaine patch 5%) is a topical analgesic patch approved by the U.S. Food and Drug Administration (FDA) in 1999 to treat the pain associated with post-herpetic neuralgia (PHN), a chronic condition resulting from nerve damage caused by shingles. Lidoderm® produces an analgesic effect by the penetration of lidocaine. Lidoderm® should only be applied to intact skin. Lidoderm® is contraindicated in patients with a history of sensitivity to local anesthetics (amide type) or any product component. The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Lidoderm® patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of Lidoderm® out of the reach of children and pets.

Excessive dosing of Lidoderm® could result in increased absorption of lidocaine and high blood concentrations leading to serious adverse effects. Lidoderm® should be used with caution in patients with severe hepatic disease, pregnant or nursing mothers, or those receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) because of the potential for serious adverse effects. Avoid contact of Lidoderm® with the eye. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. During or immediately after Lidoderm® treatment, application-site reactions may occur. The most commonly reported post-marketing adverse events are: application-site erythema, burning sensation, dizziness, erythema, headache, nausea, pain exacerbated, pruritus (itching), rash, and rash erythematous.

The FDA-approved dosing for Lidoderm® is up to three patches applied for up to 12 hours within a 24-hour period. Lidoderm® has not been approved by the FDA for any indications other than for the relief of pain associated with PHN, and its safety and efficacy in other indications have not been established.

Lidoderm® is a registered trademark of Hind Healthcare Inc.

About Endo

Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. Through its Endo Pharmaceuticals Inc. subsidiary, the company researches, develops, produces and markets a broad product offering of both branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at http://www.endo.com.

Forward-Looking Statements

This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management's beliefs and assumptions, current expectations, estimates and projections. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and statements are forward-looking statements. Endo's estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Endo's current perspective on existing trends and information. Many of the factors that will determine the Company's future results are beyond the ability of the Company to control or predict. These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these forward-looking statements individually, could affect the future results of Endo and could cause those results to differ materially from those expressed in the forward-looking statements contained in this press release. Important factors that may affect future results include, but are not limited to: market acceptance of the Company's products and the impact of competitive products and pricing; dependence on sole source suppliers; the success of the Company's product development activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability to timely and cost effectively integrate acquisitions; uncertainty associated with pre-clinical studies and clinical trials and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks with respect to technology and product development; the effect of competing products and prices; uncertainties regarding intellectual property protection; uncertainties as to the outcome of litigation; changes in operating results; impact of competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future litigation; availability of future financing and reimbursement policies of government and private health insurers and others; and other risks and uncertainties detailed in Endo's filings with the Securities and Exchange Commission, including its Registration Statement on Form S-3 filed with the SEC on March 21, 2006. Readers should evaluate any statement in light of these important factors.

Contact Information

  • CONTACT:
    Bill Newbould
    (610) 558-9800