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DELPHI PHARMACEUTICALS IS NEW AEROSOL DRUG DELIVERY R&D ARM

Executive Summary

DELPHI PHARMACEUTICALS IS NEW AEROSOL DRUG DELIVERY R&D ARM of Armstrong Labs, the 33-year-old contract filler of aerosolized drug formulations. Delphi, in Norwood, Massachusetts, was recently formed by Armstrong Labs' parent ATI Pharmaceuticals to research and develop new drugs in aerosol formulations and reformulate existing drugs using environmentally-safe, non-chlorofluorocarbon (CFC) propellants. The company plans to offer a complete range of services from identification of appropriate delivery systems to clinical testing and regulatory approval process testing. Delphi's near-term efforts will be directed to the creation of aerosol formulations of existing drugs as a means of providing efficacy, convenience and competitive advantages and finding new uses for aerosols, particularly in delivering drugs directly to the bloodstream. Longer term, the company will work on environmentally-sensitive aerosol propellants for metered dose inhalers. Asthma drugs, for example, now typically use propellants composed of Freon-11, 12 or -114. The research effort will be directed to finding non-chlorofluorocarbon (CFC) propellants that have adequate safety and toxicity data for FDA approval. A ban for medical uses of CFCs is a decade away; however, the availability of CFC propellants is already affected by the gradual phasing out of ozone-damaging CFCs under the terms of the 1988 Montreal Protocol, of which the U.S. is a signatory. In a study published in the March edition of Pharmaceutical Technology, Delphi researchers noted the costs of Freon-11, -12, and -114 are rising rapidly due to scarcity and heavy excise taxes on CFCs. * Armstrong Labs President Harvey Mintzer is president of Delphi and Peter Byron, PhD, of the Medical College of Virginia/Viriginia Commonwealth University, is chairman of the scientific advisory board. ATI Chairman "Shep" Shepherd, VP And Chief Financial Officer Augustine Lawlor and Senior Research Scientist Richard Evans, PhD, comprise the rest of Delphi's executive staff. Armstrong's pharmaceutical clients include Merck, Schering-Plough, Warner-Lambert, Kodak/Sterling, Rorer and American Home Products. The company currently fills more than 30 aerosol drug products for 25 major drug company clients. Parent ATI reported nearly $13 mil. in sales for the year ended Sept. 30, 1989 and earnings of $956,000.

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