Redux To Be Voluntarily Withdrawn; Pondimin Also To Be
Withdrawn
Business Wire - September 15, 1997 08:00
LEXINGTON, Mass.--(BW HealthWire)--Sept. 15, 1997--
Actions Are Based on New Information; Company Says
It Is Taking the Most Prudent Course of
Action for Patients and Doctors
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.
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.
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 charges 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 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.
CONTACT: Interneuron Pharmaceuticals, Inc.
William B. Boni, 617/402-3410 |
