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 23, 2002 (August 21, 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 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 21, 2002
Item 9. Regulation FD Disclosure.
On August 21, 2002, the Registrant issued a press release, a copy of
which is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
This press release related to presentations made by researchers at the
International Association for the Study of Pain's (IASP) 10th World Congress on
Pain.
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
Name: Carol A. Ammon
Title: Chairman & Chief Executive Officer
Dated: August 23, 2002
INDEX TO EXHIBITS
Exhibit No. Description
99.1 Press release issued by Endo Pharmaceuticals Holdings Inc.
on August 21, 2002
Exhibit 99.1
[ENDO LOGO]
For Immediate Release CONTACTS:
Bill Newbould
Endo Pharmaceuticals
(610) 558-9800
Jennifer Goldberg
Cooney/Waters Group
(212) 886-2200
DATA FROM STUDIES investigating
extended-RELEASE OXYMORPHONE PRESENTED TODAY
AT 10TH WORLD CONGRESS ON PAIN
SAN DIEGO, August 21, 2002 --- Researchers at the International Association for
the Study of Pain's (IASP) 10th World Congress on Pain today presented clinical
data from two studies on Endo Pharmaceuticals' investigational drug EN3202, an
extended-release (ER) oral form of the opioid oxymorphone.
The first, a Phase III multicenter, randomized, double-blind, parallel group
study, compared the safety and efficacy of EN3202, oxycodone ER (Oxycontin(R)),
and placebo in patients with moderate-to-severe pain due to osteoarthritis of
the hip and/or knee.
Following a two-to-seven day washout period during which all analgesic use was
discontinued (except aspirin for cardiovascular prophylaxis), patients
experiencing pain in the index joint of at least 40 mm on a visual analog scale
(VAS) due to OA of the knee and/or hip were randomized to the following
treatment groups: (1) 119 patients received oxymorphone ER, 20 mg, every 12
hours from weeks 1 - 4; (2) 121 patients received oxymorphone ER, 20mg, every 12
hours from weeks 1 - 2, and then increased to 40 mg every 12 hours for weeks 3
and 4; (3) 125 patients received oxycodone ER (Oxycontin(R)) 10 mg every 12
hours from weeks 1 - 2, and then increased to 20 mg every 12 hours for weeks 3
and 4; and (4) 124 patients received placebo every 12 hours from weeks 1 - 4.
The primary endpoint was change in arthritis pain intensity (VAS) from baseline
to Week 3 versus placebo. The mean change from baseline in VAS at week 3 in both
oxymorphone ER treatment groups was significantly superior compared with the
placebo group. The oxycodone ER treatment group did not differ significantly
from placebo in this study at Week 3 at the given dose.
The most common adverse events were those typically associated with opioid use
(constipation, nausea, somnolence, dizziness, and vomiting), and most were
mild-to-moderate in severity. There were no clinically meaningful effects on
laboratory test, vital sign, physical examination, or EKG results associated
with active treatment.
Data were also presented from a randomized, placebo-controlled, multicenter
trial comparing the analgesic efficacy of EN3202 with placebo in a standard
model for assessment of analgesic efficacy, postoperative pain associated with
unilateral knee arthroplasty.
The study incorporated two measures of analgesic efficacy. The primary outcome
measure was a 12-hour standard analgesic evaluation following a single dose of
the study drug. A second outcome measure was a patient-controlled analgesia
(PCA) opioid dose-sparing evaluation during a 24-hour assessment period
associated with two doses of the study drug. A patient who continued to have
pain after doses of either EN3202 or placebo could receive "rescue doses" of
oxymorphone (0.2 mg) as needed using an intravenous PCA device.
Data from the study demonstrate that oxymorphone ER 20 mg both relieved pain
better than placebo in the 12 hours following a single dose, and was more
effective than placebo in the 24-hour PCA opioid dose-sparing analgesic
evaluation following two doses.
The overall incidence of adverse events in the oxymorphone ER 20 mg group was
similar to that for the placebo treatment group. As expected, some patients
experienced opioid-related side effects. There were no clinically significant
changes in vital signs, laboratory tests, or physical examination findings.
Endo developed oxymorphone ER using Penwest Pharmaceuticals' proprietary
time-release technology, TIMERx(R). The two companies provided funding for the
studies.
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings (Nasdaq: ENDP;
ENDPW), Endo Pharmaceuticals Inc. 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 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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