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): August 1, 2002
(August 1, 2002)
ENDO PHARMACEUTICALS HOLDINGS INC.
(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 Events.
On August 1, 2002, 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 August 1, 2002
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: Chairman & Chief Executive Officer
Dated: August 1, 2002
INDEX TO EXHIBITS
Exhibit No. Description
99.1 Press release issued by Endo Pharmaceuticals Holdings Inc.
on August 1, 2002
Exhibit 99.1
[ENDO LOGO]
For Immediate Release CONTACTS:
Bill Newbould
Endo Pharmaceuticals
(610) 558-9800
Jeremy Fielding/Jon Morgan
Kekst & Company
(212) 521-4800
ENDO PHARMACEUTICALS ANNOUNCES TENTATIVE FDA APPROVAL OF
ITS OXYCODONE EXTENDED-RELEASE PRODUCT
CHADDS FORD, Pa., August 1, 2002 - Endo Pharmaceuticals Holdings Inc.
(Nasdaq: ENDP; ENDPW), a market leader in pain management, announced today
that the U.S. Food and Drug Administration (FDA) has granted tentative
approval of Endo's abbreviated new drug application (ANDA) for Oxycodone
Extended-Release Tablets, 10 mg, 20 mg, 40 mg and 80 mg.
Endo's Oxycodone Extended-Release Tablets are AB-rated bioequivalent
versions of the 10mg, 20mg, 40mg and 80mg 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. These strengths had
combined 2001 U.S. branded sales of approximately $1.5 billion.
In accordance with the Waxman-Hatch Act, Endo made the required paragraph
IV certification when it filed and amended an ANDA with the FDA for this
product. Endo believes that once final FDA approval is granted, it will
have 180 days of marketing exclusivity with respect to the 10 mg, 20 mg and
40 mg strengths of this product since it believes that it was the first
company to file an ANDA containing a paragraph IV certification for these
strengths.
Since October 2000, Purdue Frederick has filed three lawsuits against Endo
in response to its ANDA submission and related amendments alleging that
Endo's Oxycodone Extended-Release product infringes three of its patents
which cover the 10 mg, 20 mg, 40 mg and 80 mg strengths of OxyContin(R).
These patent challenges are currently pending in the U.S. District Court
for the Southern District of New York.
Commenting on the tentative FDA approval, Carol A. Ammon, chairman and
chief executive officer, said, "We are pleased with the FDA's decision,
which reflects our ability to bring products successfully through the
regulatory process." She noted that tentative approval such as this
indicates that the FDA has made a determination that a generic product
meets the substantive requirements for approval, subject to the expiration
of all statutorily imposed non-approval periods. A final approval must be
granted before Endo is permitted to market Oxycodone Extended-Release
Tablets.
About Endo
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 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.
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.
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. Forward-looking statements are not
historical facts and include information regarding the Company's possible
or assumed results of operations. Also, statements or expressions that are
preceded by, followed by, or that include, the words "believes,"
"anticipates," "plans," "expects," "intends," "estimates" or similar
expressions 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.
The reader should not rely on any forward-looking statement. The Company
undertakes no obligations 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 the Endo and could cause those results to differ
materially from those expressed in the forward-looking statements contained
herein. 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 Registration Statement on Form
S-4 filed with the Securities and Exchange Commission on June 9, 2000, as
amended, and in Endo's Registration Statement on Form S-3 dated October 17,
2001. Readers should evaluate any statement in light of these important
factors.
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