CHADDS FORD, Pa., Jan. 9 /PRNewswire/ -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. , announced today that it has signed a license agreement with ZARS Pharma that will give Endo the exclusive North American rights to Synera(TM) (lidocaine 70 mg and tetracaine 70 mg) topical patch. Under the terms of the agreement, Endo will pay ZARS an upfront fee of $11 million, with additional payments of up to approximately $27 million upon achievement of certain commercial milestones. Endo will also pay ZARS undisclosed royalties on net sales of Synera(TM). ZARS is a privately held company based in Salt Lake City, Utah, focused on the development and commercialization of patented technologies that deliver drugs into and across the skin.
Synera(TM) is a topical local anesthetic patch for use on intact skin to provide local dermal analgesia in children and adults. Approved by the U.S. Food and Drug Administration on June 23, 2005, Synera(TM) is expected to become commercially available in the second half of 2006. The safety and efficacy of Synera(TM) have been demonstrated in a series of clinical trials that included more than 660 pediatric (aged three to 17 years) and adult patients undergoing superficial dermatological procedures.
“We are pleased to add an innovative treatment such as Synera(TM) to our growing product portfolio,” said Peter A. Lankau, Endo’s president and chief executive officer. “We believe that Synera(TM) is a good strategic fit for Endo, consistent with our objective of expanding our commercial presence in the institutional setting.” He noted that Endo will promote Synera(TM) through its existing 70-person hospital sales force, which currently promotes DepoDur(R) (morphine sulfate extended-release liposome injection), a novel single dose extended-release injectable formulation of morphine.
According to published data, children under the age of 15 are hospitalized for an estimated 11.5 million days annually. These children are routinely subjected to multiple venous access procedures such as, IV starts, IV changes and blood draws.
Lankau added that Synera(TM) will also be studied for use with additional procedures, such as pediatric immunization, potentially giving healthcare providers another option to reduce the injection-site pain associated with childhood immunizations.
Synera(TM) has a thin layer of local anesthetic formulation integrated with an oxygen-activated heating element (Controlled Heat-Assisted Drug Delivery, or CHADD(TM)). The heating element enhances the delivery of lidocaine and tetracaine anesthetics into the skin. When removed from the storage pouch, the patch begins to heat, warming the skin after application. Synera(TM) has a familiar, adhesive bandage-like appearance and is applied 20 to 30 minutes prior to venipuncture, intravenous cannulation or superficial dermatologic procedure.
Important Information about Synera(TM)
Synera(TM) is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions. Synera(TM) is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, hypersensitivity to paraaminobenzoic acid (PABA), or sensitivity to any other component of the product. Synera(TM) should not be used for a longer duration than recommended. The simultaneous or sequential application of multiple Synera(TM) patches is not recommended. Contact with the eyes should be avoided with Synera(TM).
During or immediately after treatment with Synera(TM), the skin at the site of treatment may develop erythema, blanching, edema, or abnormal sensation. In clinical studies, the most common local reactions were erythema (71%), blanching (12%) and edema (12%). These reactions were generally mild, resolving spontaneously after treatment.
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About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. , Endo Pharmaceuticals is a fully integrated specialty pharmaceutical company with market leadership in pain management products. The company researches, develops, produces and markets a broad product offering of 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 April 30, 2004, as amended and in Endo’s Registration Statement on Form S-3 filed with the SEC on September 2, 2005, as amended . Readers should evaluate any statement in light of these important factors.
CONTACT:
Bill Newbould
(610) 558-9800
Endo Pharmaceuticals Inc.
CONTACT: Bill Newbould of Endo Pharmaceuticals Holdings Inc.,+1-610-558-9800
Web site: http://www.endo.com/
