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Executive Summary

PharmaControl's near 100% runup during April paced a broad advance on the "F-D-C" Monthly Index of OTC stocks as all four components of the 47-issue index hit highs for the year. During the month's 22 trading sessions PharmaControl more than doubled, leaping 6-7/8 points to close the month at 13-1/4. Behind PharmaControl's market surge was a recent letter from FDA's OTC Drug Evaluation Director William Gilbertson to the company saying the agency would review PharmaControl's soluble aspirin, under the OTC drug review as well as Miles' Alka Seltzer, as separate ingredients from aspirin. FDA said its "conclusions on this ingredient will not appear in the forthcoming OTC internal analgesic tentative final monograph, but upon publication of that TFM, "the administrative record will be reopened to include the information" from PharmaControl. The agency also noted that Pharmacontrol can submit additional data if it chooses. The company is reportedly negotiating with other companies for a partner to market the drug. In addition, the startup firm is about to enter the orphan drug business. PharmaControl announced in mid-April that it had acquired from Gideon Richter the U.S. and Canadian marketing rights to zixoryn, a drug used to treat infant jaundice in eastern Europe. Granted orphan status by FDA, the drug will soon go into clinicals. PharmaControl has also been granted orphan status for colchicine in the treatment of multiple sclerosis, and the company is now preparing an IND. However, a very strong biotech group was again the prime mover behind the Pharmaceutical and Diversified Components of the "F-D-C" Monthly OTC Index in April. Genentech (up 15-1/2 to 79-1/2) continued its climb, helped by first quarter reports that sales of its one product, the recombinant human growth hormone Protropin, are annualizing at roughly $30 mil. The company also announced its NDA submission for Activase (tissue plasminogen activator). Cetus (up 7-1/8 to 36-1/8) also indicated it was near the NDA filing stage for Proleukin (interleukin-2). While Cetus stock has cracked the $30 a share mark several times during the last year, April was the issue's first monthly closing above $30. California Biotech (up 6 to 24-1/2) has also shown strong activity in recent weeks. Of the 47 Index issues, 26 advanced, 18 lost ground and three remained unchanged as all four components established yearly highs for the third consecutive month. In addition, the total number of Index stocks was reduced by one with Mylan's move to a New York Stock Exchange listing. The Composite's 2.4% April gain to 323.42 was in direct contrast to the S&P 400 average, which retreated less than a percentage point to 262.64 for the month, and the Dow Jones average, which slipped almost 2% to 1783.98. For the first time this year, declining whslr. stocks outnumbered advances four to two, with Moore Medical (down 2-1/4 to 20) and Owens Minor (down 2-1/4 to 18) the leading point losers. However, Alco Health Services (up 1-7/8 to 24-3/4) made a strong move on the company's announced acquisition of its third regional drug whslr. in 10 months, L.S. Dubois & Son. chart omitted.

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