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PHARMACIA AZULFIDINE RHEUMATOID ARTHRITIS MODIFYING NDA MAY BE FILED IN MID-1985; SIDE EFFECTS PROFILE BETTER THAN GOLD, FIRM TELLS NYC ANALYSTS

Executive Summary

Pharmacia anticipates a supplemental NDA filing for a rheumatoid arthritis "disease modifying" claim for Azulfidine (sulfasalazine) in mid-1985, Erik Danielsson, president of the Swedish firm's Health Care group, told a meeting of New York City analysts on March 26. Pharmacia reported that clinical trials in the U.S. are just now beginning. In addition, Azulfidine has already received approval in West Germany for a "disease modifying" claim for rheumatoid arthritis on Feb. 21 of this year based on a 500-patient European trial. Danielsson added that the firm expects approval in the U.K. for the rheumatoid arthritis indication by the end of 1984. "I think it goes without saying that this is an excellent opportunity for Pharmacia," Danielsson declared. "We have more than 40 years experience with this drug. We can make the claim that it is a disease modifier like gold, but it has a substantially better side effect profile." SmithKline Beckman's Ridaura (auranofin) oral form of gold treatment has also been approved in West Germany for the same disease-modifying claim. An NDA for the SmithKline Beckman drug in the U.S. has been pending for over two years. Asked by an analyst to compare Azulfidine with Ridaura, Danielsson cited the Swedish firm's long experience with Azulfidine. "We think we have an advantage in side effects," he said. "It's a fierce marketplace, highly competitive," Danielsson remarked, "but the medical profile of Azulfidine is excellent." He added: "We're going to start now with Germany, and then come Finland and Sweden" for market introductions. He predicted that the U.S. filing for the rheumatoid claim would be among the last among major pharmaceutical markets. Pharmacia Looking At Healon Ingredient Hyaluronic Acid As Possible Osteoarthritis Treatment Ayerst also is looking at a drug for potential remission of rheumatoid arthritis. The firm recently reported that it is beginning a three-year multi-center trial in the U.S. with its nonsteroidal anti-inflammatory agent Ultradol (etodolac) to try to reverse bone damage in patients with rheumatoid arthritis ("The Pink Sheet" March 26, T&G-2) Azulfidine is currently indicated in the U.S. for treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis. Danielsson acknowledged that Pharmacia's success in expanding Azulfidine sales with a rheumatoid arthritis indication depends on distinguishing Azulfidine from generic forms." We can do that by improving the purity of Azulfidine," Danielsson said. "It was 90% five years ago, now it's 96-97%," he noted. "We can take it up to 98.5%, and later we will take it to 100% purity, for which we will have patent on it." In addition, Pharmacia reported that it is also developing an Azulfidine analogue for rheumatoid arthritis treatment. "We have a cousin of Azulfidine called Homosal, which is another leukogen activator, but much more potent than Azulfidine," Danielsson said. He noted that Homosal is undergoing Phase II testing. Also in the arthritis area, Pharmacia said it is currently studying hyaluronic acid in the treatment of osteoarthritis. Danielsson said that Pharmacia has worked for "ten years in this area" and that the firm is looking for a much bigger potential market for the drug in the arthritis area, than in ophthalmics. Hyaluronic acid is the active ingredient in Healon, which is used to prevent the eye from collapsing during viscosurgery. FDA has classified Healon as a device. Pharmacia reported that Healon sales tripled last year. In the gastroenterology area, Pharmacia is working to develop an Azulfidine product, 5-ASA, with even lower side effects, the firm indicated. "We have 27 trials going on right now [with 5-ASA] and this is, of course, the next generation of salazopyrin." He predicted that the first approval will likely come in 1985. Pharmacia's most recent annual report for 1982 noted that this product "has strong patent protection." Commenting on the firm's Spherex adjunctive cancer therapy, Danielsson reported that the compound has been classified in the U.S., unlike Europe, as a device. "The FDA has decided that Spherex should be regarded as a device in this country for vascular occlusion and we hope to submit a filing later this year," Danielsson noted. Spherex "is now coming to an interesting stage," he added. "We have just concluded our multi-center trial where we showed that we could decrease the systemic concentration (of other chemotherapeutic agents) by 40%, and we have some excellent survival studies coming out." The firm has described Spherex as an adjunct cancer therapy used to diminish the concentration of anticancer drugs in the organs that could be damaged by the toxic side effects. In describing the firm's research strategy, Danielsson noted: "We have said that our research strategy should not be a traditional screening chemical-oriented research program, but that we should work in naturally occuring substances." Also, he said, "we work with products that are based on a physical-mechanical approach."

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