Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Robert Siegfried/Jeremy Fielding
Kekst and Company
212-521-4800
ENDO PHARMACEUTICALS CHALLENGES THE PURDUE FREDERICK
COMPANY'S OXYCONTIN(R)(OXYCODONE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS, 40 MG) PATENTS
Chadds Ford, PA, October 25, 2000 - Endo Pharmaceuticals Holdings
Inc. (NASDAQ: ENDP and ENDPW), a fully integrated, specialty pharmaceutical
company with market leadership in pain management, announced today that, on
October 20, 2000, The Purdue Frederick Company (and related companies)
filed suit against Endo in the U.S. District Court for the Southern
District of New York alleging that Endo's bioequivalent version of Purdue
Frederick's OxyContin(R), 40 mg strength, infringes three of its patents.
The United States Food and Drug Administration (FDA) accepted Endo's
Abbreviated New Drug Application (ANDA) submission, including the required
Paragraph IV certification, for a bioequivalent version of Purdue
Frederick's OxyContin(R), 40 mg strength, earlier this year. OxyContin(R)
is indicated for the management of moderate-to-severe pain. Although Endo
believes the patents asserted by Purdue Frederick are invalid and/or not
infringed, no assurance can be given as to the outcome of the patent
challenge process.
Carol A. Ammon, Endo's President and Chief Executive Officer, said,
"Endo is very pleased to have filed this important ANDA. This ANDA
underscores Endo's continued commitment to expanding its portfolio of pain
management products. Endo believes that it is the first to have filed this
ANDA and is prepared to vigorously defend its position in this lawsuit."
Endo, through its wholly owned subsidiaries Endo Pharmaceuticals Inc.
and Endo Inc., is a fully integrated specialty pharmaceutical company with
market leadership in pain management. The company is engaged in the
research, development, sales and marketing of both branded and generic
pharmaceutical products primarily for the treatment of pain. Endo has a
portfolio of thirteen branded products that includes established brands
such as Percocet(R) and Percodan(R), opioid analgesics that treat
moderate-to-severe pain.
To the extent any statements made in this release contain information
that is not historical, these statements are essentially forward-looking
and are subject to risks and uncertainties. As a result of such risks and
uncertainties, which include, but are not limited to, 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 and other risks discussed from
time to time in Endo's filings with the Securities and Exchange Commission,
actual results may differ materially from those expressed or implied by
such forward-looking statements.
# # #
