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Executive Summary

CIBA-GEIGY ONCE-DAILY ANTIHISTAMINE/DECONGESTANT OTC COMBO represents "a major issue" to the OTC cold products market, according to a recent review of that field by POV Reports. Noting the recent trademark registration of the name Efidac 24 by Ciba-Geigy for an antihistamine/decongestant cold relief product, POV Reports predicts an imminent market introduction for the product. The OROS sustained release system for the product was developed by Alza, which has recently reported that the "moment of [FDA] approval is near" for four products, including the cough/cold combo ("The Pink Sheet" Oct. 29, p. 16). "Efidac 24 could have a huge impact on the OTC cold market," POV says. "The possibility of all day and all night relief with a single dose is an exciting concept." The Efidac 24 name was filed with the Patent and Trademark Office on Sept. 28, 1989 and registered on Sept. 25, 1990. "Information surrounding this project" POV observes, "is being treated by both Ciba and Alza with a high level of security and secrecy." "Duration of performance," POV believes, will be "an extremely important attribute for any product competing in the cold relief marketplace." POV suggests that Ciba-Geigy's pending 24-hour dosage may succeed where some previous longer-acting products have failed. The once-a-day dosage may be easier to differentiate from existing products than J&J's abortive attempt to create a longer-acting dosage with Delsym. "The Delsym formula was only marginally differentiated in its 12-hour claim versus the 8-hour claims that were commonly available in the market," POV notes. The Delsym formulation was based on a Fisons/Pennwalt sustained-release technology. The active ingredients in the Ciba-Geigy product are likely to be brompheniramine maleate 16 mg/pseudoephedrine 240 mg, according to POV. The use of the sedating antihistamine, POV says, "could have major drawbacks in a 24-hour product." The combination of long action with sedation "could restrict the usage to the most severe stay-in-bed type colds." The consulting firm further speculates that "the use of a sedating antihistamine . . . could result in the FDA requiring stringent warnings." The cost of supporting an OTC market entry in the cold field and the potential for other forms of long-acting products also complicate the future for Efidac, POV says. The total market ad/sales ratio is growing in the OTC cough/cold field, the consulting firm reports: "from 23% in 1987, to 24.4% in 1988, to 24.8% in 1989." To break into the market with a new type of product takes an even higher level of expenditures. For example, Sandoz has had to spend at a level more than twice as high as the industry average to build a niche for its powder/hot liquid TheraFlu. The ad/sales ratio for that product was 66% in the first year, POV estimates. With that spending, POV said that TheraFlu carved out a significant slice of the OTC cold products market in 1989, generating sales of approximately $ 18 mil., or 2% of the overall $ 825 mil. market. The Sandoz product began the 1990 cold season with a 3% share of the market, POV says. Competitive long-acting products to compete with Ciba-Geigy are believed to be under development by Elan, POV notes. On a list of development projects in the report, POV cites an Elan chlorpheniramine project using the company's PharmaZome technology and a Verex brompheniramine and pseudoephedrine product. Both products are believed by POV to be in the early stages of development. The POV report is entitled "Cough and Cold Products: Business Opportunities and Threats." The report can be ordered through F-D-C Reports, 5550 Friendship Blvd., Chevy Chase, Maryland, 20815; 301-657-9830. Inquiries can be addressed to Bill Robinson.

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