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Interneuron Licenses Novel Neuropeptide for the Treatment of Acute Stroke and Other Neurodegenerative Diseases.

LEXINGTON, Mass.--(BW HealthWire)--April 30, 1998--Interneuron Pharmaceuticals, Inc. (NASDAQ:IPIC) today announced that it has licensed from Tulane University the exclusive, worldwide rights to a U.S. patent and both U.S. and foreign patent applications owned by Tulane relating to a novel neuropeptide, known as PACAP (pituitary adenylate cyclase activating polypeptide). Preclinical data suggests the potential of PACAP as a treatment for stroke and other neurodegenerative diseases. Interneuron plans to pursue clinical development of PACAP as both an independent project and one which may offer complementary synergies with CerAxon(tm) (citicoline), in Phase 3 testing for stroke. The form of PACAP that Interneuron intends to study in stroke has been administered to volunteers in small European clinical pharmacology studies.

Under terms of the license, Interneuron paid Tulane an upfront licensing fee and will fund research over a two-year period. Interneuron will make additional payments based on the achievement of clinical and regulatory review milestones. Tulane will receive royalties on net sales of any product developed from this program.

While the licensing agreement covers two forms of PACAP and their analogs, Interneuron will focus on the development of the 38-amino acid form known as PACAP 38. PACAP 38 has been shown in animal studies to cross the blood-brain barrier by an active transport mechanism, to significantly reduce infarct size and to have a high degree of in vivo potency in the picomolar range.

"This agreement reinforces Interneuron's commitment to the development of stroke compounds, established through our development to date of CerAxon," said Glenn L. Cooper, M.D., president and chief executive officer of Interneuron. "PACAP also provides the opportunity for Interneuron to explore synergies with CerAxon in stroke treatment as well as applications in other neurodegenerative diseases. CerAxon is an orally administered compound under development for administration within 24 hours of stroke and continued for six weeks. PACAP 38 will be studied as an intravenous agent possibly administered as a single dose.

"Interneuron will support additional research on PACAP at Tulane to expand existing findings showing that PACAP prevents neuronal cell death in animals even when administered 24 hours following experimentally induced stroke," said Dr. Cooper.

Akira Arimura, M.D., Ph.D., professor of medicine at the Tulane University School of Medicine, discovered PACAP and explains its neuroprotective action: "Possible mechanisms of neuroprotection by PACAP may involve stimulation of production and release of several neurotrophic or neurosurvival factors by astrocytes which are essential for the survival of neurons. Human neurons manufacture PACAP 38 for their survival. Neurons knocked out by stroke may cease to produce PACAP 38. Thus we administer PACAP 38, just as insulin is injected when endogenous insulin is deficient in patients with diabetes."

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.

CONTACT: Interneuron Pharmaceuticals, Inc.

Glenn L. Cooper, M.D., President and CEO


William B. Boni, VP, Corp. Communications

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Publication:Business Wire
Date:Apr 30, 1998
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