Healthcare Industry News: shingles
News Release - October 17, 2006
Endo Pharmaceuticals Comments on Lidoderm(R)CHADDS FORD, Pa., Oct. 17 (HSMN NewsFeed) -- Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP ) announced today that its wholly owned subsidiary, Endo Pharmaceuticals Inc., has learned that the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research ("OGD") has issued, in response to an inquiry, bioequivalence recommendations regarding Endo's patent-protected product, LidodermŽ (lidocaine topical patch 5%).
The company has learned that OGD has recommended a bioequivalence study characterizing the pharmacokinetic profile of lidocaine as well as a skin irritation/sensitization study of any lidocaine-containing patch formulation. This deviates from Endo's understanding of the applicable regulations and of OGD's past practices, which, for a topically acting product, have generally required demonstration of bioequivalence through a comparative clinical efficacy study. It should be noted that Lidoderm is a topically acting product that works locally at the site of application rather than through systemic absorption of the active ingredient. Accordingly, Endo believes that clinical studies consistent with those required for other topical products are more appropriate in proving bioequivalence to Lidoderm. Endo has already expressed this view to OGD, and these discussions are ongoing.
Importantly, Lidoderm is covered by five Orange Book-listed patents, the last of which is set to expire in 2015. These patents form the basis of what the company believes is a strong intellectual property estate around Lidoderm and cover not only the product's method of use in neuropathic pain, including post-herpetic neuralgia pain, but also its formulation. Endo intends to vigorously assert these patents against any challenge to Lidoderm.
Note to Investors
Endo will conduct a conference call with financial analysts to discuss this news release today at 5:00 p.m. ET. Investors and other interested parties may access the conference call by dialing (800) 299-0148 (domestic) or (617) 801-9711 (international), passcode 55254338. Please dial in 10 minutes prior to the scheduled start time. A replay of the call will be available from October 17, 2006 at 7:00 p.m. ET by dialing (888) 286-8010 (domestic) or (617) 801-6888 (international), passcode 93932186, and will run until 12:00 a.m. ET on October 24, 2006.
A simultaneous webcast of the call for interested investors and others may be accessed by visiting http://www.endo.com. In addition, a replay of the webcast will be available until 12:00 a.m. ET on October 24, 2006. The replay can be accessed by clicking on "Events" in the Investor Relations section of the website.
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.
LidodermŽ is a registered trademark of Hind Healthcare Inc.
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.
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.
Source: Endo Pharmaceuticals
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