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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 1934
Date of Report: August 17, 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
On August 17, 1998, Interneuron Pharmaceuticals, Inc. (the "Company")
reported results of a recently completed 277-patient Phase 2/3 clinical trial
with pagoclone.
Reference is made to the Company's press release dated August 17, 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 August 17, 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: August 18, 1998
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FOR IMMEDIATE RELEASE
Contact, at (781) 402-3410:
Glenn L. Cooper, M.D. William B. Boni
President and CEO VP, Corp. Communications
INTERNEURON'S PAGOCLONE SIGNIFICANTLY REDUCES
PANIC ATTACKS IN PHASE 2/3 CLINICAL TRIAL
Drug Achieves Primary Endpoint, Advances in Clinical Development
LEXINGTON, MA, August 17, 1998 -- Interneuron Pharmaceuticals, Inc. (NASDAQ:
IPIC) today announced results of a Phase 2/3 trial showing that treatment with
pagoclone, a novel GABA receptor modulator, statistically significantly reduced
the frequency of panic attacks among patients suffering from panic disorder. In
addition, pagoclone was well-tolerated by these patients, with no evidence of
sedation and no apparent withdrawal symptoms in this study, which included a
tapering-off period. Based on the results of this trial, Interneuron has
identified an optimal dose of pagoclone for Phase 3 clinical testing.
The double-blind, placebo-controlled, parallel group study involved 277 patients
at six clinical sites in the U.S. Patients were enrolled in the study following
confirmed diagnoses of panic disorder. The number of attacks experienced by each
patient during a two-week screening period prior to enrollment represented the
baseline for subsequent comparison of panic attack frequency.
Following the screening period, patients were randomized to receive one of three
doses of pagoclone orally (.15 milligrams/day, .30 milligrams/day or .60
milligrams/day) or placebo for eight weeks. The primary outcome measurement was
the change from baseline in the number of panic attacks seen at the eight week
time point.
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This primary analysis, conducted on a last observation carried forward (LOCF)
basis, showed that patients in the .15 milligrams/day group experienced a 42
percent reduction in the number of panic attacks relative to patients on placebo
(p=0.141), that patients in the .30 milligrams/day group experienced a 73
percent reduction relative to patients on placebo (p=0.021), and that patients
in the .60 milligrams/day group experienced a 52 percent reduction (p=0.098)
relative to patients on placebo.
Pagoclone was extremely well tolerated with a low incidence of side effects in
all dosage groups and no clinically significant differences from placebo.
Sedation, a major liability of benzodiazepine drugs, was evaluated by use of the
Stanford Sleepiness Scale. There were no differences observed between pagoclone
and placebo using this scale. In addition, there were no evident withdrawal
effects seen at the end of the study as determined by the Rickels Withdrawal
Scale. Of note, other common side effects seen with existing classes of
anti-anxiety drugs were not significantly different between pagoclone patients
and patients receiving placebo in this trial. These traditional side effects
include sedation, lack of mental acuity, withdrawal and rebound anxiety related
to the benzodiazepine class of drugs, and agitation, insomnia and sexual
dysfunction related to serotonin reuptake inhibitors.
Full results of this trial will be submitted for presentation at an upcoming
meeting of the American College of Neuro-Psychopharmacology (ACNP).
"We are pleased that this trial successfully achieved its objectives," said
Glenn L. Cooper, M.D., president and chief executive officer of Interneuron.
"The study demonstrated that pagoclone statistically significantly reduced panic
attacks, and it provides dose-response data identifying an optimal dose that
allows us to proceed with the remainder of Phase 3 clinical testing. It is
notable that the .30 milligrams/day dose was the minimally effective dose and
that the higher dose did not confer additional benefit. Furthermore, the study
demonstrated an excellent safety profile for pagoclone that differentiates this
novel agent from older benzodiazepines and newer serotonin reuptake inhibitors."
The results of this study support findings from the Company's previous Phase 2
double-blind placebo-controlled cross-over clinical trial, conducted in the U.K.
These findings showed that the .30 milligrams/day dose produced a statistically
significant reduction in the total number of panic attacks among 16 patients
over a
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two week treatment period and a reduction in the average number of panic attacks
per day compared to the pre-treatment period. No significant change in the total
number of panic attacks was observed during placebo treatment in this earlier
trial, and the drug was well tolerated with no evidence of sedation or
withdrawal effects.
Panic disorder is a severe anxiety condition characterized by panic attacks,
acute episodes of anxiety comprised of distressing symptoms, such as difficulty
breathing, sweating, heart palpitations, feeling dizzy or faint, and fear of
losing control. There are approximately 2.5 million patients in the U.S. with
panic disorder and over 20 million patients with anxiety disorders.
Anxiety disorders, including panic disorder, are believed to be associated with
excessive neuronal activity resulting from a decrease in the function of the
major inhibitory neurotransmitter called GABA (gamma amino butyric acid).
Pagoclone, a member of the cyclopyrrolone class of compounds that is believed to
modulate GABA neurotransmission, may normalize the action of GABA in the brain,
thereby reducing the excessive neuronal activity associated with anxiety and
panic attacks. A particular benefit of such a GABA modulator is a reduction in
the propensity for unwanted side effects, such as sedation and withdrawal.
Interneuron licensed worldwide rights to pagoclone from Rhone-Poulenc Rorer
(RPR) in 1994 in exchange for licensing, milestone and royalty payments to RPR.
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 three subsidiaries: Intercardia, Inc. focused on
cardiovascular disease and carbohydrate-based drug discovery; Progenitor, Inc.
focused on developmental genomics; 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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