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 27, 2001
(November 26, 2001)
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 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 26, 2001
Item 9. Regulation FD Disclosure.
On November 26, 2001, the Registrant issued a press release, a
copy of which is filed herewith as Exhibit 99.1 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.
(Registrant)
By: /s/ CAROL A. AMMON
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Name: Carol A. Ammon
Title: President & Chief Executive
Officer
Dated: November 27, 2001
INDEX TO EXHIBITS
Exhibit No. Description
99.1 Press release issued by Endo Pharmaceuticals Holdings Inc.
on November 26, 2001
Exhibit 99.1
FOR IMMEDIATE RELEASE
CONTACT:
Robert Siegfried/Jeremy Fielding
Kekst and Company
212-521-4800
Endo Receives FDA Approval for New Percocet(R) Strengths
Reduced Acetaminophen Should Ease Concern About Daily Acetaminophen Limits
Chadds Ford, Pa., November 26, 2001 -- Endo Pharmaceuticals
Holdings Inc. (Nasdaq: ENDP; ENDPW) today announced the Food and Drug
Administration's approval of the abbreviated new drug application to market
Percocet(R) 7.5/325 and 10/325 oxycodone/acetaminophen tablets that was
filed by Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo
Pharmaceuticals Holdings. Percocet(R), the leading brand of
oxycodone/acetaminophen on the market, is indicated for the treatment of
moderate to moderately severe pain. The new reformulated Percocet(R)
7.5/325 and 10/325 strengths offer proven pain relief with reduced
acetaminophen content as compared with previously available formulations of
the pain-relieving drug.
Carol A. Ammon, president and CEO of Endo Pharmaceuticals stated,
"The new reformulated Percocet(R) 7.5/325 and 10/325 underscore the
strengths of Endo in the marketplace. We believe that we have a a robust
pipeline that feeds into our growing marketing and sales organization, and
the gold standard in pain management with our Percocet(R) products.
"These new formulations were developed in response to physician
demand. These formulations combine the higher strengths of 7.5 and 10
milligrams of oxycodone that physicians have increasingly adopted, with up
to 50% less acetaminophen per day than previous formulations. This
reinforces Endo's commitment to providing a broad range of safe and
effective pain management products," Ms. Ammon said.
"With this new formulation, physicians can still take advantage of
the synergistic action of the two analgesics combined, but without worrying
about exceeding the daily limit of acetaminophen," said Nathaniel Katz, MD,
Assistant Professor of Anesthesia at Harvard Medical School. "This will
really be helpful to patients who may need higher doses of oxycodone to
relieve their pain."
The new reformulated strengths, which are expected to be available
in pharmacies within the next week to ten days, will potentially enable
patients to take their Percocet(R) on a simpler dosing schedule, allowing
them to take fewer tablets per day, and less frequently than the original
5mg tablet. And due to the lower acetaminophen levels, these new strengths
may allow physicians to prescribe Percocet(R) 7.5/325 and 10/325 for more
long- term use than previously acceptable.
"The new strengths continue to deliver the dual benefits of
oxycodone and acetaminophen, while lowering the risk of excessive
acetaminophen exposure," said Lori Reisner, Pharm.D. and Associate Clinical
Professor of Pharmacy at the University of California in San Francisco.
"The ever-increasing number of acetaminophen-containing products and other
over-the-counter pain relievers requires pharmacists to be diligent in
reminding physicians and patients about the appropriate level of usage."
The most frequently reported side effects of Percocet(R) include
lightheadedness, dizziness, sedation, nausea and vomiting. Oxycodone can
produce drug dependence and has the potential for being abused. Physicians
are reminded that the total daily dose of acetaminophen must be carefully
considered in the use of any combination product. For complete prescribing
information call 800/462-3636.
Endo Pharmaceuticals Holdings Inc.
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.
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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