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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: April 20, 1998
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: (781) 861-8444
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Item 5. Other Events
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On April 20, 1998, Interneuron Pharmaceuticals, Inc. (the "Company")
reported that a preliminary analysis of a recently completed 100-patient
clinical trial with CerAxon(TM) failed to meet its primary and the principal
secondary endpoint and that as a result, the Company notified the Food and Drug
Administration of its decision to withdraw its New Drug Application for
CerAxon(TM) pending the results of additional clinical testing.
Reference is made to the Company's press release dated April 20, 1998
filed as Exhibit 99.1 hereto and incorporated by reference herein.
Item 7 Financial Statements, Pro Forma Financial Information and Exhibits
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(c) Exhibits
99.1 Press Release dated April 20, 1998
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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: April 21, 1998
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE
CONTACT, AT (781) 402-3410:
GLENN L. COOPER, M.D. WILLIAM B. BONI
PRESIDENT AND CEO VP, CORP. COMMUNICATIONS
STROKE TRIAL SHOWS NO EFFECT ON INFARCT SIZE AMONG
PATIENTS TREATED WITH CERAXON
INTERNEURON DECIDES TO PROCEED WITH ADDITIONAL CLINICAL STUDIES OF CERAXON
BUT TO WITHDRAW APPLICATION FOR DRUG
LEXINGTON, MA, April 20, 1998 - Interneuron Pharmaceuticals, Inc. (NASDAQ:
IPIC) today announced that a preliminary analysis of a 100-patient trial with
CerAxon(TM) (citicoline sodium) failed to meet its primary and the principal
secondary endpoint. With respect to the primary endpoint, no difference was
detected in the reduction of infarct size among patients with ischemic stroke
who received 500 milligrams per day of CerAxon as compared with patients who
received placebo. With respect to the principal secondary endpoint, the trial
did not show an improvement in neurological function among drug-treated patients
as compared with patients who received placebo. As a result, the Company has
notified the FDA today of its decision to withdraw its New Drug Application
(NDA) for CerAxon pending the results of additional clinical testing.
This trial differed from earlier CerAxon clinical trials conducted by
Interneuron in that its primary endpoint, or outcome analysis, was the
measurement of infarct size by diffusion weighted magnetic resonance imaging. In
the Company's first Phase 3 trial, the groups of patients who received 500
milligrams and 2000 milligrams daily of CerAxon achieved statistically
significant improved neurological function, as compared with patients who
received placebo. In the Company's second Phase 3 trial, which utilized the 500
milligrams daily dose, patients with moderate to severe stroke who received
CerAxon showed similar improvement, as compared with patients who received
placebo.
This most recent study was based on certain assumptions relating to reductions
in infarct size among CerAxon and placebo patient groups. A placebo response
rate unexpectedly higher than that previously reported in the literature may
have accounted for the inability
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to detect a difference in infarct size reduction and neurological function among
drug-treated patients, as compared with patients who received placebo.
"The Company remains highly committed to the clinical development of CerAxon and
is withdrawing the NDA in order to obtain additional clinical data," said Glenn
L. Cooper, president and chief executive officer of Interneuron. "The new
findings announced today, although in a small patient population, weaken the
existing data package for CerAxon. We are closely evaluating protocol revisions,
including increased dosage amounts, that would apply to an approximately
700-patient study expected to commence shortly. We believe we will have the
results from this trial by the end of 1999, resulting in a significant delay in
the potential launch of this product.
"The FDA's recent designation of CerAxon as a Fast Track drug means that that
FDA has determined that CerAxon is intended to treat a serious or
life-threatening condition that currently has an unmet medical need," added Dr.
Cooper. "We are continuing to work with the FDA on the design of future studies
with CerAxon," said Dr. Cooper.
As a result of the delay in its clinical development of CerAxon, Interneuron has
also terminated the employment of its approximately 25-person sales force. Costs
related to severance are not expected to be material.
The Company is proceeding on schedule with its other lead product development
programs. Results from a Phase 2/3 clinical trial with pagoclone for
panic/anxiety are expected in late summer 1998. In addition, the Company is
conducting an ongoing Phase 3 clinical trial with BEXTRA(TM) (bucindolol) for
congestive heart failure. Interneuron plans to continue its business strategy of
development of its pipeline and continued in-licensing of new products. The
Company may explore financing opportunities to further this strategy.
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. 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 and Redux-related litigation, uncertainties
relating to regulatory approvals and clinical trials; product liability; the
need for additional funds; the early stage of products under development; risks
relating to product launches and managing growth; government regulation, patent
risks, dependence on third parties and competition.
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