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: September 28, 1995
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
C:\BTPM_NY_\46\0035682.01
10/2/95
-1-
<PAGE>
Item 5. OTHER EVENTS
The Company reported results of the Endocrinologic and Metabolic
Advisory Committee meeting of the Food and Drug Administration ("FDA") held on
September 28, 1995 and a Joint Meeting of the Endocrinologic and Metabolic
Advisory Committee and the Drug Abuse Advisory Committee of the FDA held on
September 29, 1995 in press releases attached hereto as Exhibit 20(b) hereto,
which are incorporated by reference herein, relating to dexfenfluramine, a
prescription drug under development by the Company to treat obesity.
Item 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(c) EXHIBITS
Exhibit 20(b) Press Releases of the Registrant dated September 28, 1995 and
September 29, 1995.
C:\BTPM_NY_\46\0035682.01
10/2/95
-2-
<PAGE>
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, M.D.
-------------------------------------
Glenn L. Cooper, M.D.
President and Chief Executive Officer
Dated: October 2, 1995
C:\BTPM_NY_\46\0035682.01
10/2/95
-3-
EXHIBIT INDEX
Exhibit 20(b) Press Releases of the Registrant dated September 28, 1995
and September 29, 1995.
<PAGE>
EXHIBIT 20(B)
FOR IMMEDIATE RELEASE
Contact at (617) 861-8444
Glenn L. Cooper, M.D. William B. Boni
President and CEO V.P. Corp. Communications
Thomas F. Farb
Sr. VP, CFO
FDA ADVISORY COMMITTEE VOTE ON DEXFENFLURAMINE
REMAINS OPEN
LEXINGTON, MA September 28, 1995 - Interneuron Pharmaceuticals (NASDAQ:
IPIC) today announced that the Endocrinologic and Metabolic Advisory Committee
of the U.S. Food and Drug Administration (FDA) adjourned its meeting today
without reaching a final decision on whether or not to recommend the approval of
dexfenfluramine (Redux TM), under development by Interneuron as a prescription
treatment for obesity.
After mixed votes by the Committee on safety and efficacy, a final poll
on the question of whether to recommend approval resulted in a vote by the
remaining committee members of 3 to 2 in favor of recommending such approval,
provided additional studies were performed.
FDA stated that final polling of the three committee members who were
no longer present will be conducted as promptly as practicable.
Interneuron Pharmaceuticals is engaged in the development and
commercialization of innovative products for neurological and behavioral
disorders. Through three subsidiaries, Intercardia, Inc., Progenitor, Inc., and
Transcell Technologies, Inc., Interneuron is developing products and
technologies related to cardiovascular disease, gene therapy, stem cell biology,
carbohydrate-based drug discovery and drug transport.
C:\BTPM_NY_\46\0035684.01
10/2/95
<PAGE>
FOR IMMEDIATE RELEASE
Contact at (617) 861-8444
Glenn L. Cooper, M.D. William B. Boni
President and CEO V.P. Corp. Communications
Thomas F. Farb
Sr. VP, CFO
FDA ADVISORY COMMITTEE VOTES TO REMOVE
FENFLURAMINE AND DEXFENFLURAMINE
FROM LIST OF CONTROLLED SUBSTANCES
LEXINGTON, MA, September 29, 1995 - Interneuron Pharmaceuticals, Inc.
(NASDAQ: IPIC) today announced that a joint committee of the Endocrinologic and
Metabolic Advisory Committee and the Drug Abuse Advisory Committee of the U.S.
Food and Drug Administration (FDA) has voted to remove fenfluramine and its
isomers, including dexfenfluramine, from Schedule IV of the Controlled
Substances Act.
The joint committee vote followed a September 28 meeting of the
Endocrinologic and Metabolic Advisory Committee to consider the approval of
dexfenfluramine under development by Interneuron as a prescription anti-obesity
treatment for obesity, provided additional studies are performed. As previously
announced, a decision was not reached at the September 28 meeting because of the
lack of a quorum, although the vote was 3 to 2 in favor of approval. It is
expected that the vote will be completed as promptly as practicable.
Fenfluramine is currently marketed by Wyeth-Ayerst, a division of
American Home Products Corp. (NYSE:AHP) and dexfenfluramine is expected to be
marketed by Wyeth-Ayerst, with Interneuron retaining certain manufacturing and
co-promotion rights.
If dexfenfluramine is approved, milestone and royalty payments to
Interneuron from sales of dexfenfluramine will vary depending upon whether or
not the drug is scheduled.
C:\BTPM_NY_\46\0035684.01
10/2/95
<PAGE>
Glenn L. Cooper, M.D., president and chief executive officer of
Interneuron, noted that a petition for the de-scheduling of fenfluramine and its
isomers was submitted in 1991. "The decision made by the joint committee was
based upon their review of an extensive body of scientific and clinical evidence
which indicates that fenfluramine and dexfenfluramine do not have abuse
potential," he added.
Controls imposed upon all Schedule IV substances relate to
record-keeping procedures for dispensing pharmacists and procedural mandates for
prescribing physicians.
Interneuron Pharmaceuticals is engaged in the development and
commercialization of innovative products for neurological and behavioral
disorders. Through three subsidiaries, Intercardia, Inc., Progenitor, Inc., and
Transcell Technologies, Inc., Interneuron is developing products and
technologies related to cardiovascular disease, gene therapy, stem cell biology,
carbohydrate-based drug discovery and drug transport.
C:\BTPM_NY_\46\0035684.01
10/2/95
