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 of 1934
Date of Report: September 15, 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 02173
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(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
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On September 15, 1997, Interneuron Pharmaceuticals, Inc. (the "Company")
and Wyeth-Ayerst Laboratories announced a voluntary and immediate withdrawal of
ReduxTM.
Reference is made to the Company's related press release attached hereto
as Exhibit 99.1 and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL STATEMENTS AND EXHIBITS
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(c) Exhibits:
99.1 Press Release dated September 15, 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, M.D.
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Glenn L. Cooper, M.D.
President and Chief Executive Officer
Dated: September 15, 1997
FOR IMMEDIATE RELEASE
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Contact:
William B. Boni
VP, Corp. Communications
(617) 402-3410
REDUX(TM) TO BE VOLUNTARILY WITHDRAWN
Pondimin Also To Be Withdrawn
Actions Are Based On New Information
Company Says It Is Taking The Most Prudent Course Of Action
For Patients And Doctors
LEXINGTON, MA, September 15, 1997 - Interneuron Pharmaceuticals, Inc. (NASDAQ:
IPIC) and Wyeth-Ayerst Laboratories today announced a voluntary and immediate
withdrawal of the weight loss medication Redux (dexfenfluramine hydrochloride
capsules) C-IV. Simultaneously, Wyeth-Ayerst announced withdrawal of the weight
loss medication Pondimin (fenfluramine hydrochloride) tablets C-IV.
The companies are taking this action based on new, preliminary information
regarding heart valve abnormalities in patients using these medications, most
often in combination with phentermine, another weight loss medication. Although
this information is not derived from a thorough clinical study and is difficult
to evaluate, the Company is taking what it believes is the most prudent course
of action. The Company is committed to safeguarding the health and well-being of
patients and ensuring that health care providers have the latest medical
information.
Patients who have used either Redux or Pondimin should contact their physicians.
Wyeth-Ayerst will be placing a full-page notice in leading national and regional
newspapers announcing this decision and providing a toll-free telephone number
(1-800-892-2718) for patients requiring further information.
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In addition, Wyeth-Ayerst has sent notification of this action to approximately
450,000 physicians and pharmacists nationwide and will also offer an opportunity
to return unused product. Owing to the unanswered questions prompted by the
emerging findings, Wyeth-Ayerst today also announced that it is forming an
expert panel of leading physicians and researchers to thoroughly evaluate the
data and recommend additional actions to address this situation. Interneuron
will work closely with this panel, as well as with the U.S. Food and Drug
Administration (FDA), to better understand this new information.
Based on postmarketing reports from the Mayo Clinic of 24 cases of heart valve
disease in patients treated with the combination of phentermine and
fenfluramine, Wyeth-Ayerst advised health care providers in a July 24, 1997
letter of the addition of boxed warnings concerning heart valve disease to the
labeling for Pondimin and Redux. Wyeth-Ayerst has also announced a joint effort
with the Mayo Clinic to initiate a comprehensive study to examine the possible
association of unusual valvular disorders with these products. The Mayo Clinic
cases were subsequently reported in an article appearing in the August 28, 1997
issue of The New England Journal of Medicine.
This article was accompanied by a letter to the editor from the FDA reporting
additional cases of heart valve disease in 28 patients taking the combination of
phentermine and fenfluramine, two patients taking fenfluramine alone, four
patients taking dexfenfluramine alone and two patients taking dexfenfluramine
and phentermine.
Additional adverse event reports of abnormal heart valve findings in patients
using dexfenfluramine or fenfluramine alone or in combination with other weight
loss agents continue to be received by the companies and the FDA. These reports
have included symptoms such as shortness of breath, chest pain, fainting,
swelling of the ankles or a new heart murmur.
Most recently, on Friday afternoon, September 12, 1997, the FDA provided the
companies with new summary information concerning abnormal echocardiogram
findings in patients with no symptoms of heart valve disease. These patients had
been treated with fenfluramine or dexfenfluramine for up to 24 months, most
often in combination with phentermine. Redux was launched in June 1996. Abnormal
echocardiogram findings were reported in 92 of 291 subjects evaluated. Two
hundred and seventy-one of the 291 patients had taken fenfluramine in
combination with phentermine, and 20 of the 291 patients had taken
dexfenfluramine or a combination of dexfenfluramine and phentermine. Of these
20, six had abnormal echocardiograms, and two of the six took Redux alone.
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The abnormal echocardiogram findings included 80 reports of aortic regurgitation
(mild or greater), four of which occurred in patients taking Redux alone or in
combination with phentermine, and 23 reports of mitral regurgitation (moderate
or greater), two of which occurred in patients taking Redux alone or in
combination with phentermine.
These observations reflect a preliminary analysis of pooled information rather
than results of a formal clinical investigation, and are difficult to evaluate
because of the absence of matched controls and pretreatment baseline data for
these patients. Nevertheless, Interneuron believes it is prudent, in light of
this information, to withdraw Redux from the market at this time.
In connection with the withdrawal of Redux, the Company anticipates taking
charges to operations in its fourth quarter and fiscal year ending September 30,
1997, for expenses related to the discontinuation of the operations related to
Redux. Based on preliminary estimates, the Company anticipates these changes
will be in the range of $8 million to $12 million. A significant portion of
Interneuron's revenues has been derived from Redux sales. The Company
anticipates that it will not incur certain previously planned expenses related
to the development of a once-a-day formulation and other activities relating to
Redux.
Interneuron has been named, together with other pharmaceutical companies, as a
defendant in a number of legal actions involving the use of Redux and other
weight loss drugs. The withdrawal of Redux and related events may materially
adversely affect the Company and its financial condition.
Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged
in the development and commercialization of a portfolio of products and product
candidates primarily for neurological and behavioral disorders. Redux(TM) was
licensed to Interneuron in the U.S. by Les Laboratoires Servier, a French
pharmaceutical company, and sublicensed by Interneuron to Wyeth-Ayerst
Laboratories, a division of American Home Products Corporation. Interneuron is
also developing products and technologies, generally outside the central nervous
system field, through four subsidiaries: Intercardia, Inc. focused on
cardiovascular disease, Progenitor, Inc. focused on developmental genomics,
Transcell Technologies, Inc. focused on carbohydrate-based drug discovery, and
InterNutria, Inc. focused on dietary supplement products.
Except for the descriptions of historical facts contained herein, this press
release contains forward looking statements that involve risks and uncertainties
as detailed from time to time in the Company's filings under the Securities Act
of 1933 and the Securities Exchange Act of 1934, including in particular, risks
relating to the withdrawal of Redux, such as safety and regulatory, product
liability, litigation, contractual obligations, uncertainties relating to
clinical trials and other risks.
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