CHADDS FORD, Pa., March 24 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals Holdings Inc. , a market leader in pain management, announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of Endo’s abbreviated new drug application (ANDA) for oxycodone extended-release tablets, 10mg, 20mg and 40mg. Endo’s oxycodone extended-release tablets are AB-rated bioequivalent versions of the 10mg, 20mg and 40mg strengths of OxyContin(R), a product of The Purdue Frederick Company that is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. OxyContin(R) had combined 2003 U.S. branded sales of approximately $1.9 billion. The 10mg, 20mg and 40mg strengths represent approximately 63% of the US branded sales of OxyContin(R).
On January 5, 2004, the U.S. District Court for the Southern District of New York issued an Opinion and Order dismissing the claims that Endo’s oxycodone extended-release tablets, 10mg, 20mg, 40mg, and 80mg, infringe Purdue’s U.S. Patent Nos. 5,549,912, 5,508,042 and 5,656,295, declaring the patents invalid, and enjoining Purdue from enforcing the patents. On January 12, 2004, Purdue filed a Notice of Appeal in the United States District Court for the Southern District of New York, petitioning the United States Court of Appeals for the Federal Circuit to overturn the District Court’s January 5, 2004 ruling. Purdue requested that the District Court stay its injunction against enforcement of the patents until its appeal was resolved, but such request was denied by the District Court on February 13, 2004. Purdue had also petitioned the Federal Circuit to stay the District Court’s injunction during the pendency of its appeal and to expedite the appeal. The Federal Circuit denied both requests on March 19, 2004, noting that “we are not persuaded that Purdue has shown a strong likelihood that it will succeed in establishing that the district court’s findings concerning materiality and intent are clearly erroneous.”
The FDA also confirmed that Endo will have 180 days of marketing exclusivity with respect to the 10mg, 20mg and 40mg strengths of this product, since the company was the first applicant to file an ANDA containing a Paragraph IV certification for these oxycodone extended-release strengths.
The FDA also reaffirmed the tentative approval to market the 80mg strength, which will be granted final approval upon the expiration of another company’s exclusivity on this strength. Finally, the FDA has informed Endo that it has found Endo’s Risk Management Plan adequate to support Endo’s marketing of its oxycodone extended-release tablets.
Carol A. Ammon, Endo’s chairman and chief executive officer, stated, “We are extremely pleased by the FDA’s approval of our oxycodone extended-release product, which represents a substantial market opportunity for Endo and reinforces our leadership position in pain management. We will be making a decision with respect to the launch of our oxycodone extended-release product in due course.”
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 July 1, 2003. Readers should evaluate any statement in light of these important factors.
CONTACT: Bill Newbould Endo Pharmaceuticals (610) 558-9800
Endo Pharmaceuticals Holdings Inc.
CONTACT: Bill Newbould of Endo Pharmaceuticals, +1-610-558-9800
Web site: http://www.endo.com/
