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| |  Development and Marketing Agreement for Migraine Treatment LEXINGTON, Mass.—Dec. 19, 1996 -- Algos Pharmaceutical Corporation (NASDAQ: ALGO) and Interneuron Pharmaceuticals Inc. (NASDAQ: IPIC) today announced that they have entered into an agreement for the development and commercialization of an innovative combination pharmacological product for the treatment of acute migraine headache. This combination of lidocaine and the N-methyl-D-aspartate antagonist, dextromethorphan, may offer the potential for rapid and prolonged relief of acute migraine headaches through intranasal administration. The agreement establishes a multi-stage development collaboration between Algos and Interneuron and licenses to Interneuron rights, co-exclusive with Algos, to manufacture and market the combined agent, known as LidodexNS. This collaboration will include certain pre-clinical studies, clinical trials and regulatory review activities overseen by a joint steering committee. The companies will also share in the marketing and profits of LidodexNS. "We are pleased to cooperate with Interneuron in the development and marketing of an innovative treatment for migrane using Algos' patented lidocaine/NMDA antagonist combination," said John Lyle, president and chief executive officer of Algos. "This joint effort accelerates the development of an agent which potentially provides improved and rapid relief for millions who suffer from migraine headaches." "The qualities inherent in the LidodexNS combination are consistent with Interneuron's objectives in expanding its product pipeline, including the pursuit of products with significant clinical or pre-clinical data which target large, unsatisfied markets and have clearly definied pathways through the clinic to market," said Glenn L. Cooper, M.D., president and chief executive officer of Interneuron. "We expect the well-understood mechanisms and broad market experience of each compound within this combination to expedite and to reduce the costs involved in the clinical development of LidodexNS." Results of an 81-patient trial (Journal of American Medical Association, Vol. 276, No. 4, July 24/31, 1996) showed that intranasal lidocaine relieved headache pain in 55 percent of patients with migraine, with relief usually occuring within five minutes but with relapse occurring commonly and early after treatment. Pre-clinical studies with dextromethorphan suggest that the LidodexNS combination may improve the potency and duration of action of lidocaine. The market for migraine headache is estimated to include 11 million sufferers in the U.S., according to the National Health Survey of 1994. A significant unmet need among these individuals is acute relief and treatment of the severe initial "break-through" pain associated with migraine. Algos Pharmaceutical Corporation is a leader in developing a new generation of proprietary pain management products. Algos develops its proprietary pain management products by combining existing analgesic or anesthetic drugs with NMDA antagonist drugs that have been approved for human use in other applications. Independent research and Algos' pre-clinical studies and clinical trials have shown that Algos' products may significanly improve pain relief over currently available analgesics, including narcotic drugs and non-narcotic analgesics such as acetominophen (e.g. Tylenol) and ibuprofen (e.g. Advil). Algos is developing local anethetic products that have the potential to provide greater anesthetic effect with longer and more controlled duration. Algos' analgesic and anesthetic products will target markets with combined U.S. sales estimated at $6.4 billion. Ten of Algos' products have reached Phase 2 or Phase 3 clinical trials. Interneuron Pharmaceuticals Inc. is a diverse biopharmaceutical company engaged in the development and commercialization of a portfolio of products and product candidates primarily for neurological and behavioral disorders. The company's lead products include: Redux for obesity, currently marketed by American Home Products and co-promoted by the company; citicoline for stroke, in Phase 3 clinical trials; and bucindolol for congestive heart failure, in Phase 3 clinical trials through Intercardia Inc., a majority-owned subsidiary. Interneuron's four subsidiaries include: Intercardia Inc. focused on cardiovascular disease, Progenitor Inc. focused on gene discovery through developmental biology, Transcell Technologies Inc. focused on carbohydrate-based drug discovery and drug transport, and InterNutria Inc. focused on dietary supplement products. Except for the descriptions of historical facts contained herein, this release contains forward-looking statements that involve risks and uncertainties as detailed from time to time in Algos' and Interneuron's SEC filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" that could cause either company's actual results to differ significantly from those discussed in the forward-looking statements including the uncertainties related to the successful development of LidodexNS, such as pre-clinical development, clinical trials, government regulation, manufacturing and dependence on third parties for clinical marketing.
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