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 1934
Date of Report: July 25, 1997
INTERNEURON PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in charter)
DELAWARE
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(State of other jurisdiction of incorporation)
0-18728 043047911
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(Commission File Number) (IRS Employer Identification No.)
One Ledgemont Center, 99 Hayden Avenue, Lexington, Massachusetts
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(Address of principal executive offices)
02173
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(Zip Code)
Registrant's telephone no. including area code: (617) 861-8444
ITEM 5. OTHER EVENTS
On July 25, 1997, Wyeth-Ayerst Laboratories ("Wyeth") announced that it
is working with the U.S. Food and Drug Administration ("FDA") relating to
revised labeling for Pondimin(R) (fenfluramine hydrochloride) tablets C-IV and
Redux(TM) (dexfenfluramine hydrochloride capsules) C-IV. Redux is licensed to
Wyeth by Interneuron Pharmaceuticals, Inc. Interneuron has submitted to the FDA
proposed revised labeling for Redux.
Reference is made to the press release of Wyeth-Ayerst Laboratories
dated July 25, 1997 filed as Exhibit 99.1 hereto and incorporated by reference
herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(c) Exhibits
99.1 Press Release of Wyeth-Ayerst Laboratories dated July 25, 1997
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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.
INTERNEURON PHARMACEUTICALS INC.
By: /s/ Glenn L. Cooper
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Glenn L. Cooper, M.D.
President and Chief Executive Officer
Dated: July 28, 1997
EXHIBIT 99.1
Wyeth Ayerst
Contact: Wyeth-Ayerst Laboratories
Audrey Ashby
(610) 971-5823
Doug Petkus
(610) 971-4980
Robinson, Lerer & Montgomery
Sheilagh Mylott
(212) 484-7697
WYETH-AYERST TO ADD INFORMATION TO LABELING OF ANTIOBESITY THERAPIES
PHILADELPHIA, PA July 25, 1997 -- Wyeth-Ayerst Laboratories has written
to health care providers to inform them that the company is working with the
U.S. Food and Drug Administration (FDA) to develop appropriate warning language
which will reflect heightened concerns about potential serious side effects
which have been reported with concomitant use of fenfluramine and phentermine
("fen/phen"). When the language is finalized with the FDA, it will be
incorporated as a boxed warning in the physician and patient labeling of the
company's antiobesity products.
The revised labeling for PONDIMIN(R) (fenfluramine hydrochloride)
tablets C-IV will include a boxed warning about a possible serious heart valve
disorder which has been reported with concomitant use of fenfluramine and
phentermine ("fen/phen").
Phentermine manufacturers were also asked by the FDA to develop
appropriate warning language to revise the labeling of their products.
Revised labeling including a boxed warning for REDUX(TM)
(dexfenfluramine hydrochloride capsules) C-IV, which is marketed in the U.S. by
Wyeth-Ayerst, has also been submitted to the FDA because it is a related
chemical compound to fenfluramine.
A boxed warning is the method used in product labeling to prominently
display information on special problems of a critical nature. In this case,
doctors and patients will be made aware of a possible association between the
concomitant use of fenfluramine (Pondimin) and phentermine (e.g., Ionamin(R),
Fastin(R) and Adipex-P(R)) and a serious and unusual valvular heart disease. The
symptoms of this valvular heart disease may include dyspnea (unexplained
shortness of breath), reduced exercise tolerance and/or lower extremity edema
(swelling). Patients who develop these symptoms or a new heart murmur during
therapy should be given a complete cardiac evaluation.
--more--
2
Evidence of a causal relationship between the treatment of obesity with
fenfluramine and phentermine combination therapy and valvular heart disease is
inconclusive. Wyeth- Ayerst is initiating scientific studies to supplement
currently available data. In January 1997, Wyeth-Ayerst sent a letter to
physicians cautioning that the concomitant use of phentermine and Pondimin has
not been adequately studied and is not an approved use of Pondimin.
The warning will also contain information from the current labeling on
the small risk of developing primary pulmonary hypertension (PPH), an
often-fatal disorder which has been associated with the use of prescription
weight loss medications. PPH has symptoms which are similar to those of cardiac
valvular disease. Wyeth-Ayerst will send another letter to physicians with a
copy of the revised labeling when it is finalized with the FDA.
According to the World Health Organization, obesity is considered the
"biggest, global, chronic health problem in adults. If action is not taken to
stem the pandemic, millions will develop related diseases such as diabetes and
heart disease." Antiobesity medications can be important therapies in
combination with diet and exercise for treating obesity, a serious medical
condition. Wyeth-Ayerst is committed to provide physicians and patients with as
much information as possible so they can make an appropriate individualized
benefit/risk decision.
Wyeth-Ayerst Laboratories is a major research-oriented pharmaceutical
company with leading products in the areas of women's health care,
cardiovascular, and metabolic disease therapies, central nervous system drugs,
anti-inflammatory agents, vaccines, and generic pharmaceuticals. American Home
Products Corporation (NYSE: AHP) is one of the world's largest research-based
pharmaceutical and health care products companies. It is a leader in the
discovery, development, manufacturing and marketing of prescription drugs and
over-the-counter medications. It is also a global leader in vaccines,
biotechnology, agricultural products, animal health care, and medical devices.
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