SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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): March 28,
2000 (March 28, 2000)
Regeneron Pharmaceuticals, Inc.
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(Exact name of registrant as specified in its charter)
New York 333-31764 133444607
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.
incorporation)
777 Old Saw Mill River Rd, Tarrytown NY, 10591-6707
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(Address of principal executive offices) (Zip Code)
9143477000
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(Registrant's telephone number, including area code)
Regeneron Pharmaceuticals, Inc.
Current Report on Form 8-K
Item 5. Other Events
On March 28, 2000, the registrant issued a press release announcing
that it has initiated a Phase II dose ranging trial to study the safety and
efficacy of AXOKINE second generation ciliary neurotrophic factor in obese
patients.
Item 7. Financial Statements and Exhibits.
a. Financial Statements
Not required
b. Pro forma Financial Information
Not required
c. Exhibits
Exhibit No. Description
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99.01 Press Release of Regeneron
Pharmaceuticals, Inc. dated
March 28, 2000.
SIGNATURE
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's duly authorized signatory.
Dated: March 29, 2000
REGENERON PHARMACEUTICALS, INC.
By: /s/ Murray A. Goldberg
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Name: Murray A. Goldberg
Title: Vice President, Finance &
Administration, Chief Financial
Officer, Treasurer and
Assistant Secretary
EXHIBIT INDEX
Exhibit No. Description
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99.01 Press Release of Regeneron Pharmaceutical,
Inc. dated March 28, 2000.
EXHIBIT 99.01
REGENERON INITIATE PHASE II
OBESITY CLINICAL TRIAL
Tarrytown, New York (March 28, 2000) - Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) announced that it has initiated a Phase II dose-ranging
trial to study the safety and efficacy of AXOKINE(R) second generation
ciliary neurotrophic factor in obese patients. AXOKINE is being developed
for the treatment of obesity and complications of obesity such as Type II
diabetes. The double-blind, placebo-controlled multicenter clinical trial
will be conducted in approximately 175 severely obese patients who will be
treated for 90 days at doses up to 2 micrograms per kilogram per day
administered subcutaneously.
The Phase II study follows a two-week Phase I study completed in late
1999, in which mildly to moderately obese subjects treated with AXOKINE
lost weight and had reduced food intake compared to those on placebo.
In the Phase I study, some patients who received higher doses of AXOKINE
and who had previously contracted herpes simplex virus (HSV) experienced
"cold sores" related to reactivation of their HSV infection. The Phase II
study will be conducted at doses that were associated with weight loss,
generally well tolerated, and not associated with herpes cold sores in the
Phase I study; there will be no restrictions as to a subject's prior
history of herpes cold sores. The Phase II study is designed to confirm the
weight loss observed in the Phase I study in a trial of longer duration and
to determine the lowest effective well- tolerated dose.
Regeneron is a biopharmaceutical company that discovers, develops,
and intends to commercialize therapeutic drugs for the treatment of serious
medical conditions. Regeneron's platform technologies include Targeted
Genomics(TM), Functionomics(TM), and Designer Protein Therapeutics(TM).
Regeneron has drugs in clinical and preclinical development for the
potential treatment of obesity, rheumatoid arthritis, cancer, allergies,
asthma, amyotrophic lateral sclerosis, constipating conditions, ischemia,
and other diseases and disorders.
This news release discusses historical information and includes
forward-looking statements about Regeneron and about its products,
programs, finances, and business, all of which involve a number of risks
and uncertainties, such as risks associated with preclinical and clinical
development of drugs and biologics, determinations by regulatory and
administrative governmental authorities, competitive factors, technological
developments, the availability and cost of capital, the costs of
developing, producing, and selling products, the potential for any
collaboration agreement to be canceled or to terminate without any product
success, and other material risks. A more complete description of these
risks can be found in Regeneron's filings with the United States Securities
and Exchange Commission, including its Form 10-K for the year ending
December 31, 1999. Regeneron does not undertake any obligation to update
publicly any forward-looking statement, whether as a result of new
information, future events, or otherwise.
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Contact: Murray A. Goldberg, Vice President Finance and
Administration and CFO Regeneron Pharmaceuticals, Inc.
(914) 345-7492
Fax copies of new releases can be obtained from Regeneron's News-on-Demand
Service by dialing (800) 311-0841.
