Billed as a major advance against colds, a new anti-viral nasal spray developed by Schering-Plough nevertheless faces an uphill climb to become as commonplace as chicken soup or prescription cough remedies due to its narrow efficacy and expected high cost, analysts say.
Although scientists last week published data showing the drug--called alpha-2-interferon--to be effective against the most common group of viruses that cause colds, analysts estimate that the nasal spray may cost between $25 and $50 per application when and if it is approved by the U.S. Food and Drug Administration for prescription sale. What's more, they say, the spray is only effective in healthy people who run the risk of getting a cold, not those already infected.
Such drawbacks could dim the hopes of Schering President Robert Luciano, who once boasted that, "if just 10% of all cold suffers can use interferon, we've got a heck of a product." Madison, N.J.-based Schering has an exclusive worldwide license for the manufacture and sale of alpha-2-interferon, which was developed in 1980 by Biogen Inc. of Cambridge, Mass.
Hoffmann-La Roche, a Swiss-American company, has also been testing interferon to treat colds, according to industry analysts.
Vast Potential Market
The potential market for a cold treatment is vast. The sale of prescription and non-prescription preparations to fight colds represents an estimated $2-billion annual market.
A spokesman for Schering-Plough, a major pharmaceutical company, said the firm has committed a sizable portion of its $175-million research budget to exploiting that market by attempting to develop interferon-based medicines. The nasal spray, however, would be the company's first major offering stemming from such biotechnology.
It is not known when the FDA might approve the nasal spray, although industry analysts estimate that it could occur as early as next year.
In recent years, sales of both prescription and over-the-counter remedies have been stagnant, despite inflation and population growth.
David G. Crossen, a pharmaceutical analyst for the Sanford C. Bernstein & Co. investment house in New York, speculates that increased use of vitamins may be "cannibalizing" sales of cold medicines and that the nation's health and fitness trend, which has spawned legions of joggers and nutrition-conscious Americans, has fueled concern about excessive medication.
Consumers' purchases of aspirin products slipped $5 million to $162 million in 1984, for example, while purchases of nasal sprays fell $11 million to $171 million in 1984, according to the trade magazine Product Marketing.
Spray Proves Effective
Clinical trials involving more than 150 families showed that Schering's alpha-2-interferon spray was effective about 80% of the time against the common group of viruses and about 40% of the time against all colds, according to researchers at the University of Virginia Medical Center and the University of Adelaide in Australia.
But those percentages aren't high enough in the eyes of many experts.
"The pricing will be at least $50 plus doctors' fees," Crossen said, "and all of that to have a 40% chance of not getting a cold." Crossen also said the other applications of Schering's interferon product--to treat several relatively rare types of cancers--appear unlikely to produce large demand either.
Adds Norbert Rapoza, senior scientist in the drugs department of the American Medical Assn. in Chicago: "I don't think the public is willing to spend money on something like that unless we're talking a matter of pennies. I mean, this is not something that will protect you from AIDS--we're talking about the common cold. I don't think physicians will prescribe (the nasal spray) because they know the efficacy is not that high."
Company officials say the drug may gain use as a precautionary measure in high-risk situations, such as when frail or elderly patients enter the hospital or when one member of the family catches a cold and the others want to avoid it.
But for consumers, long used to seeing a doctor after they are ill, Schering's nasal spray may require considerable foresight. Patients must use the drug daily, and it must be taken at the onset of a cold--thus making it all but impossible for patents to predict when they should visit a physician for an interferon prescription.