SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): November 16, 2000
(November 15, 2000)
ENDO PHARMACEUTICALS HOLDINGS INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 39040 13-4022871
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(State or other (Commission File Number) (I.R.S. Employer
jurisdiction of Identification No.)
incorporation)
100 Painters Drive
Chadds Ford, Pennsylvania 19317
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(Address of principal executive offices) (Zip Code)
(610) 558-9800
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(Registrant's telephone number, including area code)
N/A
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(Former name or former address, if changed since last report)
Item 5. Other Matters.
On November 16, 2001, the Registrant issued a press release, a
copy of which is filed herewith as Exhibit 99.1 and is incorporated herein
by reference.
Item 7. Financial Statements and Exhibits.
(a) Financial Statements of Business Acquired.
Not applicable.
(b) Pro Forma Financial Information.
Not applicable.
(c) Exhibits.
Exhibit Number Description
99.1 Press release issued by Endo Pharmaceuticals Holdings Inc.
on November 16, 2001
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
ENDO PHARMACEUTICALS HOLDINGS INC.
(Registrant)
By: /s/ CAROL A. AMMON
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Name: Carol A. Ammon
Title: President & Chief Executive
Officer
Dated: November 16, 2001
INDEX TO EXHIBITS
Exhibit No. Description
99.1 Press release issued by Endo Pharmaceuticals Holdings Inc.
on November 16, 2001
Exhibit 99.1
Contact: Robert Siegfried/Jeremy Fielding
Kekst and Company
212-521-4800
ENDO PHARMACEUTICALS CHALLENGES SMITHKLINE BEECHAM'S
PAXIL(R) (PAROXETINE HYDROCHLORIDE, 40 mg) PATENTS
Chadds Ford, PA, November 16, 2001 - Endo Pharmaceuticals Holdings
Inc. (NASDAQ: ENDP and ENDPW), a fully integrated, specialty pharmaceutical
company with market leadership in pain management, announced today that, on
November 15, 2001, SmithKline Beecham Corporation (and related companies)
filed suit against it subsidiary, Endo Pharmaceuticals Inc., in the U.S.
District Court for the Eastern District of Pennsylvania alleging that
Endo's bioequivalent version of SmithKline's Paxil(R), 40 mg strength,
infringes five 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 SmithKline's Paxil(R), 40 mg strength, earlier
this year. Paxil(R) is indicated for the treatment of depression, obsessive
compulsive disorder and panic disorder, and is one of the most widely
prescribed prescription drugs in the United States. Although Endo believes
the patents asserted by SmithKline Beecham are invalid and/or not
infringed, no assurance can be given as to the outcome of the patent
challenge process.
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 for the relief of
moderate-to-moderately 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.
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