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Executive Summary

Sandoz has a leading, low side-effect product in the Japanese asthma category which is nearing market approval in the U.S., according to a recent report on the respiratory disease market by SRI, the market research/consulting firm. Zaditen (ketotifen) has "the image," SRI reports, of being "a product somewhat in a class by itself." The consulting firm notes that the product "is increasingly popular in Japan, and, although it may not be scientifically unimpressive, it has been commercially impressive." SRI points out that "ketotifen is generally classified as an antiallergic or nonbronchodilating antiasthma drug, not as an antihistamine. It appears to be promoted more for 'pure' respiratory problems than for allergic conditions like hay fever." According to 1985 Japanese sales figures cited by SRI, Zaditen with $60 mil. in annual sales was third in that country's bronchodilator/antiasthmatic category -- behind cromolyn ($100 mil.) and tranilast ($90 mil.). The SRI study of the respiratory care field is entitled, "Dynamics and Opportunities in Respiratory Disease Management." The report costs $15,000 from SRI in Menlo Park, California. Procaterol, an oral beta-2 stimulant being developed in the U.S. by Warner-Lambert as Pro-Air, was not far behind ketotifen in the Japanese market with sales of $50 mil for Otsuka. No Other Ketotifen-like Drugs In U.S. Market Before Early 1990's, SRI Says Ketotifen has been in the NDA-pending stage at FDA for four years, since November 1982. It could be one of the next new entries into the anti-asthma drug category in the U.S. According to a list of research projects compiled by SRI, ketotifen and procaterol are two of seven respiratory care compounds pending regulatory approval in the U.S. Schering, through Key, has an NDA pending for sobrelol, a mucolytic licensed from Camillo Corvi; J&J is waiting for approval of Janssen's non-sedating antihistamine, Hismanal (astemizole); and J&J has another NDA at FDA for an orally-active anti-allergic product, oxatomide. SRI notes that oxatomide was licensed for development to Key but that agreement was discontinued. Cloprednol, a Syntex oral corticosteroid, was pending an NDA but reportedly is no longer being developed. Another drug reported by SRI as nearing the U.S. market, Pfizer's nasal inhalant beta-2 stimulant Exirel (pirbuterol), reached the "approvable stage" at FDA in late October. SRI projects a target in the U.S. and major European markets of between $100 mil. and $150 mil. annually for the ketotifen-type products in the year 1995. SRI ranks ketotifen class research as one of the four important short-term respiratory disease product opportunities. The consulting firm estimates the full world market for bronchodilators and antiasthmatics at $2.1 bil. by 1995. The 1985 market was $810 mil. The total OTC and Rx drug market for respiratory products in 1985 was $3.1 bil., according to SRI. The success of ketotifen in Japan, SRI says, "has sparked R&D interest in this area and several products are under investigation -- especially by the Japanese who prefer relatively mild, oral prophylactic approaches for treating asthma to more potent, inhaled beta-2 stimulants." Despite the research activity, however, SRI believes no other products of the ketotifen type will reach the U.S. market prior to "the early 1990's." Sandoz is "working on at least one ketotifen analog (etolotifen)," SRI reports. That product is believed to be in an early stage of development -- preclinical pharmacology. SRI says that "little clinical information" exists in English on the major competitive agent to ketotifen, Kissei's Rizaben (tranilast). "Experts in Japan," SRI reports, "stated that this drug [Rizaben] has good efficacy and relatively few side effects in both adults and children." From interviews in West Germany and France, SRI reports that "ketotifen is quite popular with non-academic, nonhospital-based physicians in those countries, and that its popularity can be attributed to Sandoz' promotional efforts." SRI learned, the consulting firm says, that many of the non-academic and nonhospital-based physicians in the two European countries "like the drug because it is 'safe' and 'mild', but that patients are sometimes unenthusiastic because it makes them tired." SRI cites a report on ketotifen which places the onset of action for the drug at about one to three weeks; "it appears to work in about 70% of the patients treated." Fisons has "at least two cromolyn sodium analogs [minocromil and nedocromil] under development" as prophylactic antiallergy drugs, SRI reports. Nedocromil was recently launched in the U.K. as Tilade. SRI says it is in Phase III trials in the U.S. Nedocromil is being promoted as "being useful because it permits the physician to reduce the amount of coadministered steroids when treating asthma," the consulting firm notes. SRI estimates a patient population for that type of product at about 15-20% of the asthma population. However, the consultants also note that one interviewee for the report called the Fisons' drug "the only new [respiratory] product of any real note to have been marketed in the past couple of years." Sandoz is one of five major pharmaceutical companies, according to SRI, to participate in all four classes of the respiratory drug business: antihistamines, bronchodilators, nonbronchodilating agents, and cough/cold remedies. In terms of 1985 sales, Sandoz is ninth among respiratory care drug companies. SRI estimates Sandoz' U.S. market position in 1985 as between 5-15% of two markets: antihistamines and cough/cold and less than 5% of the bronchodilator/antiasthmatic market. The other companies with broad participation in the class are Bristol Myers, J&J, Schering-Plough and Warner-Lambert. Overall, SRI characterizes the respiratory markets as fragmented, with domination by "the medium-sized pharmaceutical companies." Worldwide, Schering-Plough, Glaxo and Boehringer-Ingelheim rank one-two-three in SRI's analysis. "It is notable," SRI says, "that only a few companies -- Boehringer-Ingelheim and Glaxo -- are prominent in more than one national market. The presence of strong national firms in respiratory medicine in local markets argues in favor of joint venture and licensing arrangements for the commercial exploitation of new respiratory drugs discovered by small firms with modest international resources." The market fragmentation means, in SRI's view, that "many of the second and third tier pharmaceutical companies with stakes in respiratory care have an apparent headstart in developing new compounds." The consulting firm adds, however, that the attention of the current market leaders "seems directed toward making improvements in symptomatic treatment rather than toward basic research into disease processes and respiratory physiology." Chart omitted.

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