Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Robert Siegfried/Jeremy Fielding
Kekst and Company
212-521-4800
ENDO PHARMACEUTICALS MEETS WITH FDA ON MORPHIDEX(R)
Chadds Ford, PA, September 26, 2000 - Endo Pharmaceuticals
Holdings Inc. (NASDAQ: ENDP and ENDPW), a fully integrated, specialty
pharmaceutical company with market leadership in pain management, announced
today that it met with the United States Food and Drug Administration (FDA)
on September 25th to discuss the New Drug Application (NDA) for
MorphiDex(R), an NMDA enhanced opioid analgesic. Discussion at the meeting
focused on clarifying what information the FDA needs from Endo in order to
approve MorphiDex(R).
Endo requested this meeting with the FDA to outline the new
ownership of the company, as well as to reach agreement on the additional
information that the company needs to submit to obtain timely approval of
MorphiDex(R). At the meeting, the FDA requested a second pivotal chronic
multiple dosing study to support the intended indication in addition to the
pivotal study previously submitted. This second study will be initiated
promptly and will run in parallel to studies that were already underway at
the time of the merger. "Yesterday, Endo and the FDA discussed the path to
obtaining approval of the first of our NMDA enhanced opioid analgesics,
MorphiDex(R). ThE discussion reinforced Endo's belief in the safety and
efficacy of MorphiDex(R)," said David A. Lee, MD, Ph.D., Endo's Senior Vice
President, Research & Development.
Endo intends to file a supplement to the NDA as promptly as
practicable and hopes to be in a position to file such supplement to the
NDA prior to the beginning of 2002. The company expects the FDA to respond
within six months after its acceptance of the supplement. Endo currently
has outstanding warrants that are exercisable into shares of Endo common
stock. The amount of shares that can be acquired upon exercise of these
warrants will be materially affected by the timing of any FDA approval of
MorphiDex(R).
No assurance can be given as to the outcome of the clinical
studies or whether or if MorphiDex(R) will be approved by the FDA and
whether or if additional studies will be required.
"We are now approaching a new era of pain treatment, and I know
that the pain-management community is anxiously awaiting the approval of
MorphiDex(R), as well as Endo's other NMDA enhanced opioid analgesics,"
said Bradley S. Galer, MD, Endo's Vice President, Scientific Affairs.
In August, Dr. Galer joined Endo from the Department of Pain
Medicine and Palliative Care at Beth Israel Medical Center, New York where
he was Director of Clinical Studies and Co-Director, Nerve Pain Disorders
Clinic. Dr. Galer is a founding member of, and was chairman for, the Pain
Medicine Section of the American Academy of Neurology over the past two
years. He has published over 100 articles and book chapters regarding pain
management and pain pharmacotherapy. He is a co-chair of the annual
International Neuropathic Pain Conference. In addition, Dr. Galer holds
academic memberships in a dozen medical societies, including the
International Association for the Study of Pain, The American Academy of
Pain Management and the American Academy of Neurology. He was named in the
1998 Best Doctors in America for Pain Management/Neurology.
Endo, through its wholly owned subsidiaries Endo Pharmaceuticals
Inc. and Endo Inc., is a fully integrated specialty pharmaceutical company
with market leadership in pain management. The company is engaged in the
research, development, sales and marketing of both branded and generic
pharmaceutical products primarily for the treatment of pain. Endo has a
portfolio of thirteen branded products that includes established brands
such as Percocet(R) and Percodan(R), opioid analgesics that treat
moderate-to-severe pain.
An NDA for MorphiDex(R) was submitted by Algos Pharmaceutical
Corporation in August 1998. A "not approvable" letter for MorphiDex(R) was
received by Algos on August 2, 1999. On July 17, 2000, Endo merged with
Algos, thereby acquiring MorphiDex(R), a patented combination oF morphine
and the NMDA-receptor antagonist dextromethorphan.
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, 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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