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): June 24, 2002 (June 24, 2002)
ENDO PHARMACEUTICALS HOLDINGS INC.
(Exact name of registrant as specified in its charter)
DELAWARE 39040 13-4022871
(State or other (Commission File Number) (I.R.S. Employer
jurisdiction of Identification No.)
incorporation)
100 Painters Drive
Chadds Ford, Pennsylvania 19317
(Address of principal executive offices) (Zip Code)
(610) 558-9800
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Item 5. Other Events.
On June 24, 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 June 24, 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
Name: Carol A. Ammon
Title: President &
Chief Executive Officer
Dated: June 24, 2002
INDEX TO EXHIBITS
Exhibit No. Description
99.1 Press release issued by Endo Pharmaceuticals Holdings Inc.
on June 24, 2002
Exhibit 99.1
Contact: Robert Siegfried/Jeremy Fielding
Kekst and Company
212-521-4800
Endo Pharmaceuticals Announces Results from MorphiDex(R)
Phase III Clinical Trial
CHADDS FORD, PA, June 24, 2002 -- Endo Pharmaceuticals Holdings Inc.
(Nasdaq: ENDP; ENDPW), today announced results from the first of its three
Phase III clinical trials for its development product, MorphiDex(R).
The primary endpoint of the study was to demonstrate that the average
daily dose of morphine given in combination with the N-methyl-D-aspartate
(NMDA)-receptor antagonist, dextromethorphan is less than the average daily
dose of morphine when given as morphine alone in order to maintain the same
degree of pain control over a three-month period. No statistically significant
difference in average daily morphine dose was observed in the morphine
sulfate:dextromethorphan (MS:DM) group compared to the morphine sulfate group.
A secondary endpoint of the study was to determine if the combination
of morphine and dextromethorphan minimizes the rate of escalation of daily
morphine dose compared with morphine alone over the study period in order to
maintain satisfactory pain control. No statistically significant difference in
the percentage change from baseline in daily morphine dose averaged by week
from the commencement of the double-blind study period to the completion of
the double-blind study period was observed.
Carol A. Ammon, Chairman and Chief Executive Officer of Endo
Pharmaceuticals, said, "Although we are disappointed by these study results,
we will continue to analyze the data from this study and await the results of
our other two ongoing Phase III clinical studies. As you may be aware, this
study is the first of Endo's three Phase III clinical trials that we undertook
for MorphiDex(R). Enrollment for the second of these trials has recently been
completed, and we expect enrollment for the third of these trials to be
completed in the next couple of weeks. We expect to be able to announce the
results of the second and third of these clinical trials in the fourth quarter
of this year. Until we are able to analyze the data from these studies, we
will not be in a position to resubmit an amendment to the existing
MorphiDex(R) new drug application with the FDA."
This clinical trial compared MorphiDex(R) (morphine and the
N-methyl-D-aspartate (NMDA)-receptor antagonist, dextromethorphan) to
immediate-release morphine sulfate among chronic pain patients. This pivotal,
randomized, double-blind trial enrolled 193 chronic pain patients from 20
centers in the United States of America. The protocol called for patients
enrolled in the study to be dosed for a three-month period in a double-blind
fashion. Prior to this three-month double-blind period, patients were
stabilized at a predefined level of pain control with their current opioid
medication during a seven to 21-day run-in period in order to establish the
morphine-equivalent daily dose needed to maintain satisfactory pain control.
Following this open-label run-in period, patients were randomized to one of
two double-blind treatment groups - receiving either MS:DM 15:15mg or
immediate-release morphine sulfate 15 mg capsules, both of which are identical
in appearance. These patients started this three-month double-blind period
with 50% of their morphine-equivalent daily dose that had been established
during the run-in period. During the three-month double-blind period, patients
were permitted to self-titrate their dose of medication in order to achieve
the predefined level of pain control. The study population consisted of 193
patients (101 men and 92 women). The mean age of the patients was 49 years,
ranging between 22 and 75 years.
Ms. Carol A. Ammon and Dr. David A.H. Lee will be hosting a
conference call for the investment community on June 24, 2002 from 9:30 A.M.
(EST) to 10:00 A.M. (EST). Those who wish to participate in this conference
call should telephone (800) 946-0712 or (719) 457-2641 approximately 15
minutes before the 9:30 A.M. starting time. There will be a replay of the call
from 12:30 P.M. (EST) on June 24, 2002 until 6:00 P.M. (EST) on July 1, 2002.
Callers wishing to access the replay should dial (888) 203-1112 or (719)
457-0820, Passcode: 435441. The conference call will also be webcast at
www.vcall.com.
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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. This and past press releases of Endo
Pharmaceuticals Holdings Inc. are available at Endo's Web site 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.
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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