ZingoTreatment for Local Anesthesia
Update: Zingo Now FDA Approved - August 16, 2007
Endo Comments on Notices Received From Anesiva Regarding Zingo
Endo Comments on Notices Received From Anesiva Regarding Zingo
CHADDS FORD, PA, Apr 10, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), announced today that it received notice from Anesiva, Incorporated, advising of the filing of a New Drug Application (NDA) under 21 U.S.C. Section 355(b)(2)(A)(iv) (also referred to as Section 505 (b)(2)(A)(iv) of the Federal Food, Drug and Cosmetic Act) for its Zingo Dermal PowderJect Lidocaine HCl topical powder and referring to the patents that cover the method of use and formulation of Endo's lidocaine-containing topical patch products, Lidoderm and Synera.
Section 505(b)(2) does not allow for automatic generic substitution of these prescription products for any other products.
If approved, Endo believes that Zingo will not be a generic to, nor will it compete with, Lidoderm because of Zingo's indication and formulation. Anesiva's notice stated that Zingo's proposed indication is for preventing or reducing pain associated with blood draws and intravenous placements. Unlike Lidoderm, Zingo is not a topical patch. However, Endo believes that, although Zingo would not be a substitutable generic to Synera and uses a different delivery mechanism, Zingo may compete with Synera because their indications may be similar. Endo will continue to evaluate these notices.
According to Anesiva's notice letter, Zingo's injection device drives lidocaine powder into the skin surface using accelerated inert gas particles. An NDA for Zingo was filed in late 2006 and accepted for filing in January 2007.
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 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 10-K filed with the SEC on March 1, 2007. Readers should evaluate any statement in light of these important factors.
SOURCE: Endo Pharmaceuticals
Posted: April 2007
- Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults - January 9, 2009
- Anesiva Receives FDA Approval for Zingo, a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children - August 17, 2007
- Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children - February 7, 2007
- Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children - November 27, 2006