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): October 28, 2002 (October 28, 2002)
ENDO PHARMACEUTICALS HOLDINGS INC.
(Exact name of registrant as specified in its charter)
| DELAWARE | 39040 | 13-4022871 | |
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | |
| 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 October 28, 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 No. |
Description
|
| 99.1 |
Press release issued by Endo Pharmaceuticals Holdings Inc. on October 28, 2002
|
| 99.2 |
Slide Presentation of Endo Pharmaceuticals Holdings Inc.
dated October 29, 2002
|
Item 9. Regulation FD Disclosure.
On October 29, 2002, the Registrant intends to make a slide presentation at the Salomon Smith Barney 2002 Global Health Care Conference in New York, New York, a copy of which presentation is filed herewith as Exhibit 99.2 and is incorporated herein by reference.
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. |
|
|
By: /s/ Carol A. Ammon |
Dated: October 28, 2002
INDEX TO EXHIBITS
| Exhibit No. |
Description
|
| 99.1 |
Press release issued by Endo Pharmaceuticals Holdings
Inc. on October 28, 2002
|
| 99.2 |
Slide Presentation of Endo Pharmaceuticals Holdings Inc.
dated October 29, 2002
|
Exhibit 99.1
For Immediate Release CONTACT:
Bill Newbould
Endo Pharmaceuticals
(610) 558-9800
ENDO PHARMACEUTICALS ANNOUNCES RESULTS FROM MORPHIDEX(R)PHASE III CLINICAl
TRIAL
Chadds Ford, Pa., October 28, 2002 - Endo Pharmaceuticals Holdings Inc.
(Nasdaq: ENDP; ENDPW) today announced results from the second of its three
Phase III clinical trials for its development product MorphiDex(R).
The primary endpoint of the study was to demonstrate that MorphiDex(R),
administered at a fixed dose throughout the study, provided superior analgesia
(pain relief) compared to morphine alone at equivalent morphine doses. No
statistically significant difference in analgesia was observed in the
MorphiDex(R) group compared to the morphine sulfate alone group. The study
also did not meet its secondary endpoint, a reduction in analgesic tolerance
for patients administered MorphiDex(R).
"We are disappointed that this study, similar to our previously announced
Phase III trial, did not have a positive outcome," said Carol A. Ammon,
chairman and chief executive officer. "While we expect the results of the
remaining Phase III trial to be available shortly, the company believes that
the data that has been generated to date would suggest that we will not have
enough evidence to support the filing of an amendment to the MorphiDex(R)
NDA," said Ammon.
Trial Summary
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. Chronic pain
patients totaling 327 were randomized into this double-blind trial from
approximately 30 centers in the United States. In the initial unblinded
portion of the study, patients had their level of pain stabilized on
MorphiDex(R). If patients were able to attain satisfactory pain control on a
stable dose of MorphiDex(R) during this run-in period, they were then
randomized in a double-blind fashion to either the same dose of morphine
sulfate, either alone or in combination with dextromethorphan (MorphiDex(R)).
During the double-blind treatment period, patients were instructed to maintain
the same daily dose of study medication throughout the three-month study
period and not to take any additional pain medication. If a patient could not
maintain the same dose for any reason, they were discontinued from the study.
The trial was designed to demonstrate analgesic superiority of MorphiDex(R)
over morphine alone for patients with moderate-to-severe chronic pain as
measured by the change in the level of pain reported by patients. In addition,
the study examined whether MorphiDex(R) would reduce the rate of opioid
analgesic tolerance.
Conference Call Information
Ms. Ammon and Dr. David A.H. Lee, senior vice president, research and
development, will be hosting a conference call for the investment community on
October 28, 2002 from 9:00 a.m. (ET) to 9:30 a.m. (ET). Those who wish to
participate in this conference call should telephone (800) 305-2862
(US/Canada) or (706) 634-1979 (International) approximately 15 minutes before
the 9:00 A.M. starting time. There will be a replay of the call from 12:30
P.M. (ET) on October 28, 2002 until 12:00 A.M. (ET) on November 4, 2002.
Callers wishing to access the replay should dial (800) 642-1687 (US/Canada) or
(706) 645-9291 (International), Passcode: 6386077. The conference call will
also be webcast at www.vcall.com.
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings (Nasdaq: ENDP;
ENDPW), 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.
* * *
Exhibit 99.2
