BusinessWire, Monday, September 15, 1997 at 08:07
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
KEYWORD: MASSACHUSETTS
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL BIOTECHNOLOGY
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