EXHIBIT 99.1
------------
FOR IMMEDIATE RELEASE
- ---------------------
CONTACT, AT (781) 861-8444:
MICHAEL W. ROGERS WILLIAM B. BONI
EXEC. VP AND CHIEF FINANCIAL OFFICER VP, CORP. COMMUNICATIONS
INTERNEURON PROVIDES PAGOCLONE UPDATE FOLLOWING PFIZER REPORT
OF POSITIVE RESULTS IN GENERALIZED ANXIETY DISORDER
COMPANY ALSO REPORTS ON PROGRESS OF OTHER CLINICAL-STAGE PRODUCTS
LEXINGTON, MA, December 18, 2001 - Following a presentation today by Pfizer Inc.
at a meeting with investment financial analysts in New York, Interneuron
Pharmaceuticals, Inc. (NASDAQ: IPIC) reported that patients treated with
pagoclone experienced a statistically significant improvement in symptoms of
generalized anxiety disorder (GAD), compared to patients treated with placebo.
In addition, pagoclone was well tolerated, with no difference from placebo in
sedation and no evidence of withdrawal effects.
The six-week clinical trial conducted by Pfizer among 200 patients involved a
flexible dose regimen ranging from 0.3 milligrams of pagoclone per day to 1.2
milligrams per day. Entry criteria for patients included Hamilton Anxiety Scale
(HAM-A) scores of 18 or higher. Pagoclone patients had a mean 2.3 point lower
HAM-A score than placebo patients at week three (p=.033), a mean 3.3 point lower
score at week four (p=.006) and a mean 3.2 point lower score at week six
(p=.012). At week six, the mean reduction in HAM-A score among pagoclone
patients was 11.7 versus 8.5 for placebo.
With respect to side effects, there were no statistically significant
differences between pagoclone-treated and placebo-treated patients in
sleepiness, as measured by the Stanford Sleepiness Scale, and in withdrawal
symptoms, as measured by the Rickel's Withdrawal Symptom Checklist. In
addition, there were no serious clinical or laboratory adverse events among
patients treated with pagoclone.
As part of its comprehensive clinical development program for pagoclone, Pfizer
is conducting a number of clinical trials, including a Phase III trial in panic
disorder, multiple Phase II trials in GAD and multiple clinical pharmacology
studies. Pfizer is currently analyzing data from a Phase III trial in panic
disorder.
- MORE -
Page 1 of 3
- 2 -
"We are extremely pleased with the results of Pfizer's study," said Glenn L.
Cooper, M.D., chairman, president and chief executive officer of Interneuron.
"Pagoclone continues to meet its target product profile as a potentially novel,
potent, non-sedating anti-anxiety agent which has not shown withdrawal effects.
As the compound progresses in late-stage development, Pfizer, in our view, is
the ideal development and commercialization partner."
Pagoclone is a member of the cyclopyrrolone class of compounds and is a novel
GABA (gamma amino butyric acid) receptor agonist in development for the
treatment of anxiety disorders. To date, preclinical and clinical testing have
shown pagoclone to have promise in the treatment of anxiety disorders. Based on
the mechanism of action of pagoclone as a potent agonist of the GABA receptor,
the compound has the potential for a rapid onset of anxioloytic effect. Also,
preclinical and clinical data suggest the potential to avoid the side effects
commonly seen with other drugs currently used to treat anxiety disorders.
Interneuron licensed pagoclone from Rhone-Poulenc Rorer, S.A., now Aventis,
S.A., and subsequently conducted several clinical trials prior to licensing
worldwide rights to this product to Warner-Lambert Company, now Pfizer, which is
responsible for conducting all further clinical development, regulatory review
and commercialization of pagoclone.
Additional Interneuron Products:
Additional products currently under development in Interneuron's late-stage
product portfolio include: trospium, in Phase III clinical testing for
overactive bladder; PRO 2000, in Phase II for the prevention of the sexual
transmission of HIV; dersalazine, in Phase I for inflammatory bowel disease; and
IP 501, in Phase III for liver disease.
The enrollment of patients in the Company's Phase III trial with trospium for
overactive bladder is continuing on schedule following its initiation in
September 2001. This trial will include over 500 patients and will compare the
reduction in both micturitions and incontinence episodes among trospium-treated
patients versus placebo-treated patients during a 12-week double-blind treatment
period. Completion of this trial is anticipated in the fall of 2002. If this
trial is successful, the Company plans to file a New Drug Application (NDA) for
trospium by the end of 2002.
Trospium is a muscarinic receptor antagonist that relaxes smooth muscle, or
detrusor, tissue in the bladder, thus decreasing bladder contractions. Trospium
does not appear to cross the blood-brain barrier, thereby avoiding central
nervous system side effects. In addition, because trospium
- MORE -
Page 2 of 3
- 3 -
is not extensively metabolized by the liver and is excreted primarily unchanged
in the urine, the Company believes treatment with trospium may avoid many
potential drug interactions seen in existing agents that are metabolized
extensively in the body. Trospium is currently marketed in Europe, where it is
one of the leading treatments for overactive bladder.
The Company has received preliminary indications of the results of an 800-
patient clinical trial sponsored by the Veterans Administration with IP 501
among patients with alcoholic cirrhosis showing that neither the placebo nor
drug-treated groups had significant progression to cirrhosis, thus the primary
endpoint of the trial, prevention of the development of cirrhosis, could not be
achieved. The Company will not perform further work with IP 501 in alcoholic
cirrhosis. IP 501 continues to be studied in a Phase III, NIH-sponsored trial
in Hepatitis C-induced cirrhosis.
Two clinical trials with PRO 2000, the Company's topical microbicide for the
prevention of HIV transmission, are expected to begin in 2002. These include a
European Commission-funded Phase II safety trial in at-risk African women and an
NIH-sponsored Phase II/III pivotal trial in Africa and India to determine the
efficacy and safety of this product candidate in blocking male-to-female HIV
transmission. These trials will build upon pre-clinical and clinical findings
that include Phase I/II results presented earlier this year showing that PRO
2000 was safe and well tolerated in HIV-negative and HIV-positive women.
Following the acquisition of worldwide rights to dersalazine for inflammatory
bowel disease (IBD) in September 2001, Interneuron is planning to initiate a
Phase I multi-dose clinical study in Europe in the first half of 2002 and a
Phase II trial in ulcerative colitis by the end of that year. Dersalazine is a
new chemical entity combining a novel potent anti-inflammatory agent that
inhibits key cytokines, including TNF-alpha, with the standard first-line
therapy for IBD, 5-ASA (5-aminosalicylic acid). The chemical cleavage of
dersalazine by bacteria in the colon releases these two active components for
the topical treatment of inflammation in the colon. The systemic absorption of
the compound and its active components has been shown to be very low.
Interneuron Pharmaceuticals is engaged in the development and commercialization
of a portfolio of products and product candidates for panic/anxiety disorders,
overactive bladder, inflammatory bowel disease, liver disease, prevention of HIV
infection, stroke and other disorders.
Except for the descriptions of historical facts contained herein, this press
release contains forward-looking statements that involve risks and uncertainties
that could cause the Company's actual results and financial condition to differ
materially from those anticipated by the forward looking statements. These
risks and uncertainties are set forth in the Company's filings under the
Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk
Factors" and elsewhere, and include, but are not limited to: the early stage of
products under development; uncertainties relating to clinical trials and
regulatory approvals; dependence on third parties for manufacturing and
marketing; need for additional funds and corporate partners; history of
operating losses and expectation of future losses; product liability; risks
relating to the Redux-related litigation; government regulation, patent risks
and competition.
###
Page 3 of 3