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TILADE APPROVED BY FDA; FISONS ANNOUNCES CO-PROMOTION AGREEMENT WITH RHONE-POULENC RORER

 ROCHESTER, N.Y., Dec. 31 /PRNewswire/ -- The Food and Drug Administration (FDA) approved today the marketing of Tilade(R) (nedocromil sodium), a new class of anti-inflammatory drug, for the preventive management of asthma. Developed by Fisons Pharmaceuticals, Tilade is a non-steroid, inhaled, anti-inflammatory agent for asthma. Daily dosing provides patient benefits by reducing both symptoms and bronchial hyperreactivity in asthmatic patients.
 "In Tilade, we have a new inhaled anti-inflammatory asthma medication, notable especially for its safety profile. This gives clinicians an important new weapon for our mild to moderate asthma patients," says Dr. Stephen Wasserman, professor of medicine, chairman of the department of medicine and of the division of allergy and immunology, University of California at San Diego.
 Fisons has also announced an agreement in principle with Rhone- Poulenc Rorer through which the companies will exclusively co-promote Tilade and Azmacort(R) (triamcinolone acetonide), the leading metered dose inhaled steroid in the United States. "The co-promotion between Fisons and RPR creates an impressive respiratory sales force, totaling 800 representatives. It enables both companies to reach virtually every physician in the United States that treats asthma. Both the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health and the International Consensus Report on Asthma have urged first-line anti-inflammatory treatment in response to growing evidence about the key role of inflammation in causing asthma," says Heimo Reulecke, president of Fisons Pharmaceuticals.
 "Tilade and Azmacort each have a unique and important pharmacologic action, and the two drugs play a complementary role in contributing to the successful treatment of asthma," adds Glenn Mattes, vice president and division manager of Rorer Pharmaceuticals.
 According to the International Consensus Report on Diagnosis and Management of Asthma, June 1992, "Recent studies have revealed that inflammation is a critical feature in the pathogenesis of asthma, and, therefore, asthma therapy is predicated on medications to reverse and prevent this abnormality. Successfully treating airway inflammation can slow or stop the progression of this condition."
 Tilade has proven safe and effective as a bronchial anti- inflammatory agent in treating mild to moderate asthma in patients, age 12 and older, and contributes significantly to the better management of asthma for this major patient group.
 "Because inflammation is central to the pathogenesis of asthma, anti-inflammatory agents should be utilized as first-line therapy," says Albert L. Sheffer, M.D., Harvard Medical School, chairman of the International Consensus Report on Asthma.
 According to Reulecke, Tilade provides the first new generation chemical entity in asthma therapy in nearly a decade. Tilade will be available as a metered-dose inhaler. Manufacture of Tilade begins immediately; shipments should start in the second quarter, with availability to patients shortly thereafter. The company expects an enthusiastic reception from physicians to generate significant numbers of patient prescriptions.
 Fisons plc is a U.K.-based international company headquartered in Ipswich, Suffolk. Reporting sales of more than $2 billion in 1991, the company employs 14,500 people worldwide and operates in more than 100 countries.
 Rhone-Poulenc Rorer is a global pharmaceutical company dedicated to the discovery, development, marketing and manufacturing of human pharmaceuticals. The company reported sales of $3.8 billion in 1991 and has invested over $500 million in research and development in 1992.
 -0- 12/31/92
 /CONTACT: Ellen Kovak or Eileen Masciale of Kovak-Thomas Public Relations, 212-246-0540, for Fisons Pharmaceuticals/


CO: Fisons Pharmaceuticals; Rhone-Poulenc Rorer ST: New York IN: MTC SU: PDT

PS -- NY001 -- 0816 12/31/92 08:03 EST
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Publication:PR Newswire
Date:Dec 31, 1992
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