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| | | ![]() FIBLAST to be Developed for Neurological and Cardiovascular Disorders MOUNTAIN VIEW, Calif. and RADNOR, Pa., Oct. 23, 1996 -- Scios Inc. (Nasdaq: SCIO) and Wyeth-Ayerst, the pharmaceutical division of American Home Products Corporation (NYSE: AHP) today announced the signing of a collaboration agreement for the joint development and commercialization of Scios' FIBLAST(R) trafermin (basic fibroblast growth factor), for the treatment of neurological and cardiovascular disorders. FIBLAST is currently in Phase I/II clinical trials for stroke and coronary artery disease (CAD) and in preclinical studies for peripheral vascular disease (PVD). Under the terms of the agreement, Wyeth-Ayerst and Scios will collaborate in the development and commercialization of FIBLAST in North America, where the companies will share development costs and profits. Scios has granted Wyeth-Ayerst exclusive marketing rights outside of North America and certain Pacific Rim countries and will receive royalties on sales outside of North America and payments for bulk drug supply worldwide. Wyeth-Ayerst will make a $12 million upfront payment in cash and will also pay Scios up to $32 million in milestone payments upon achievement of all key development events. In addition, Wyeth-Ayerst will provide a $12 million line of credit that Scios may draw upon from time to time to fund expansion of its manufacturing facility for FIBLAST. The total of all payments including the line of credit could reach $56 million, excluding shared development costs, royalties, supply payments and profit sharing. "American Home Products is focusing its research efforts in those areas where there are unmet medical needs. FIBLAST is an excellent example of this high-innovation research," said Fred Hassan, Executive Vice President, American Home Products Corporation. "We are excited to work with Scios to develop FIBLAST as a new therapy for stroke and cardiovascular diseases," added Robert I. Levy, M.D., President, Wyeth-Ayerst Research. "We are enthusiastic about expanding our relationship with Wyeth-Ayerst given its strength and experience in developing and marketing pharmaceutical products worldwide," said Richard L. Casey, Scios Chairman and Chief Executive Officer. "This collaboration provides the opportunity to accelerate the development of FIBLAST and maximize its value to Scios shareholders." Earlier this year, the companies signed a co-promotion agreement for Wyeth-Ayerst's antidepressant, EFFEXOR(R), and American Home Products currently owns 1,579,000 shares or 4.4% of Scios common stock. Basic fibroblast growth factor (bFGF), a protein produced naturally in the body, is a potent stimulator of blood vessel formation and other tissue repair processes. Scios scientists were the first to clone and produce recombinant human bFGF. Scios holds patents in the United States and Europe covering the manufacture, use and sale of recombinant human bFGF. In extensive preclinical studies, bFGF has been shown to protect neurons from damaging effects associated with stroke, including oxygen and glucose deprivation, and glutamate release. bFGF has demonstrated a reduction of neuronal death in both permanent occlusion and reperfusion animal models of stroke. Earlier this year, Scios began a Phase I/II study of FIBLAST for the treatment of stroke, a condition that affects approximately 500,000 patients in the United States each year. Scios has demonstrated in preclinical studies, FIBLAST's potential to increase blood flow to peripheral blood vessels and reduce the complications of PVD through angiogenesis, or the growth of new blood vessels. PVD affects approximately 2,000,000 patients in the United States. In a clinical study in collaboration with researchers at the National Institutes of Health, Scios is exploring the potential of FIBLAST to increase blood flow to the heart in patients with advanced CAD. In 1988, Scios entered into an agreement with Kaken Pharmaceutical Co., Ltd., for the development and marketing of FIBLAST for all indications in Japan, Korea, Taiwan, Hong Kong and the People's Republic of China. Recently, Kaken filed a New Drug Application for FIBLAST in Japan for the treatment of recalcitrant dermal ulcers. Scios is a biopharmaceutical company engaged in the discovery, development, manufacture and commercialization of novel human therapeutics. The Company's research and development efforts are primarily focused on acute cardiovascular and renal disorders. Scios has three major clinical development programs. AURICULIN(R) anaritide is in a Phase III clinical study for the treatment of oliguric acute renal failure. NATRECOR(R) BNP is in Phase II clinical studies for the treatment of acute congestive heart failure. FIBLAST(R) trafermin is currently in Phase I/II clinical trials for stroke and CAD and in preclinical studies for PVD. Scios' commercial operations division currently markets six psychiatric products. Wyeth-Ayerst Laboratories is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines and generic pharmaceuticals. American Home Products is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, crop protection products, animal health care and medical devices. Except for historical information contained herein, this news release contains forward-looking statements that involve risks and uncertainties, including timely regulatory review and approval of FIBLAST and its acceptance as a treatment, the timely development of FIBLAST for stroke, PVD and CAD, and the scope of Scios' and third-party patents, as well as the other risks detailed from time to time in the SEC reports filed by American Home Products and Scios, including their reports on Form 10-K for the year ended December 31, 1995.
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