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: April 29, 1996
INTERNEURON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in charter)
DELAWARE
(State of other jurisdiction of incorporation)
0-18728 043047911
(Commission File Number) (IRS Employer Identification No.)
ONE LEDGEMONT CENTER, 99 HAYDEN AVENUE, LEXINGTON, MASSACHUSETTS 02173
(Address of principal executive offices) (Zip Code)
Registrant's telephone no. including area code: (617) 861-8444
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Item 5. OTHER EVENTS
On April 29, 1996, the Registrant announced the receipt of FDA clearance for
marketing of Redux (dexfenfluramine) as a prescription drug for the treatment of
obesity. The approved indication is the management of obesity, including weight
loss and maintenance in patients on a reduced calorie diet who have an initial
body mass index of 30 kg/m2 or greater or 27 kg/m2 or greater in the
presence of certain risk factors. The related news release is attached hereto as
Exhibit 20 and the text of the release is incorporated by reference herein.
Item 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(c) Exhibits
Exhibit 20 - News Release dated April 29, 1996
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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
-------------------------------------
Glenn L. Cooper, M.D.
President and Chief Executive Officer
Dated: April 30, 1996
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EXHIBIT 20
FOR IMMEDIATE RELEASE
Contact, at (617) 861-8444:
Glenn L. Cooper, M.D. William B. Boni
President and Chief Executive Officer VP, Corp. Communications
FDA CLEARS REDUXTM (DEXFENFLURAMINE)
FOR MARKETING TO TREAT OBESITY
Lexington, Mass., April 29, 1996 -- Interneuron Pharmaceuticals, Inc. (NASDAQ:
IPIC) today announced that the U.S. Food and Drug Administration (FDA) has
cleared ReduxTM (dexfenfluramine hydrochloride capsules) c-iv for marketing as
prescription therapy for the management of obesity, including weight loss and
maintenance of weight loss in patients on a reduced calorie diet. Redux will be
marketed in the U.S. by Wyeth-Ayerst Laboratories, a division of American Home
Products (NYSE:AHP), and co-promoted by Interneuron.
Based upon its clinical pharmacology, Redux is believed to increase the activity
of serotonin, a neurotransmitter that has been shown to influence appetite, and
thereby to reduce calorie consumption and excess body weight in obese patients.
People taking Redux are believed to experience satiety, or to feel full, faster
than usual when eating.
Redux is recommended for persons with an initial body mass index (BMI) of 30
kg/m2 or greater and for persons with a BMI between 27 kg/m2 and 30 kg/m2 if
there is presence of other risk factors, such as hypertension, diabetes and
elevated cholesterol. A BMI of 27 corresponds with a level of excess weight
approximately 20% above healthy body weight, and a BMI of 30 corresponds with a
level of excess weight approximately 30% above healthy body weight, as derived
from the weight-for-height tables issued by the National Research Council in
1989. BMI figures are determined by dividing weight, in kilograms, by height, in
meters, squared.
Redux will be available in 15 milligram capsules, to be taken twice daily under
a physician's prescription. Studies of one year duration have shown that Redux
produces a significant reduction in weight during the first four to six months
and that this weight reduction was maintained during continuation of therapy, up
to 12 months. The safety and effectiveness of Redux beyond one year have not
been determined.
"FDA clearance of Redux for marketing signals the near-term availability in the
United States of the first prescription drug to be used for both weight loss and
maintenance of weight loss,"said Glenn L. Cooper, M.D., president and chief
executive officer of Interneuron.
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"Obesity is a significant health problem affecting millions of Americans," said
Dr. Cooper. "We believe that Redux will help physicians and patients address a
major public health concern that is one of the leading preventable causes of
disease and death in the U.S. Well documented studies demonstrate the
association between obesity and other serious diseases, including cardiovascular
disease, hypertension and diabetes."
Common side effects associated with dexfenfluramine use are generally mild and
disappear within a few weeks. They include drowsiness, diarrhea and dry mouth.
In one epidemiological study, the use of all types of prescription weight loss
drugs has been associated with an increase in the risk of developing primary
pulmonary hypertension (PPH), a serious cardiovascular condition. The risk of
developing PPH associated with the long-term use of these drugs is estimated to
be approximately 18 cases per one million users per year. Also in this study, an
association has been identified between the condition of obesity itself and PPH.
In the general population, the yearly occurrence of PPH is approximately one to
two cases per one million people.
In studies of animals receiving dexfenfluramine at doses that resulted in brain
concentrations approximately ten times those observed in humans, neurochemical
changes have been observed. The relevance of these animal findings to humans is
not known.
Redux should not be used in pregnant women, in patients hypersensitive to
dexfenfluramine or fenfluramine, in patients diagnosed with pulmonary
hypertension, or in patients taking other serotoninergic agents or monoamine
oxidase inhibitors (MAOIs).
The Company has also agreed with the FDA to conduct a Phase 4, or post
marketing, study of Redux.
Obesity is a chronic disease, resulting from an imbalance between energy intake
and energy expenditure that can be caused by genetic, environmental or
behavioral influences. One of the most prevalent diseases in the U.S., obesity
has been estimated by former surgeon general C. Everett Koop, M.D., to cause
300,000 excess deaths per year, making it the second leading cause of
preventable deaths in the country. Academic researchers have estimated that the
total economic cost of obesity in the U.S. was approximately $68 billion in
1990. These estimates, which include direct and indirect costs, reflect expenses
incurred in connection with obesity-related non-insulin dependent diabetes
mellitus, cardiovascular disease, gall bladder disease, cancer and
musculoskeletal disorders.
Dexfenfluramine was discovered by Servier of France and is currently marketed by
Servier in 65 countries. Interneuron licensed exclusive U.S. rights to
dexfenfluramine from Servier in 1990, conducted clinical trials in the U.S. and
filed a New Drug Application for the drug in May 1993. The use of
dexfenfluramine to treat obesity is the result of work done by Servier and by
Dr. Richard J. Wurtman, scientific founder of Interneuron and professor of
neuroscience at the Massachusetts Institute of Technology (MIT), and Dr. Judith
Wurtman of MIT.
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Interneuron Pharmaceuticals is engaged in the development and commercialization
of innovative products for neurological and behavioral disorders. Through four
subsidiaries, Intercardia, Inc., Progenitor, Inc., Transcell Technologies, Inc.
and InterNutria, Inc., Interneuron is developing products and technologies
related to cardiovascular disease, gene therapy, stem cell biology,
carbohydrate-based drug discovery, drug transport and nutritional and food
related products.
Except for the descriptions of historical facts contained herein, this news
release contains forward-looking statements that involve risks and uncertainties
as detailed from time to time in Interneuron's SEC filings under the Securities
Act of 1933 and the Securities Exchange Act of 1934, including, among other
things, uncertainties as to the commercial success of Redux, dependence on
corporate partners, including American Home Products, for marketing and
manufacturing, and competitive, patent, regulatory, product liability and third
party reimbursement issues.
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