BIOMEDICA FOSCAMA'S LEADING DRUG ESAFOSFINA® ACKNOWLEDGED AS A SAFE AND EFFECTIVE PHOSPHORUS SOURCE IN TOTAL PARENTERAL NUTRITION
 
 

Business Editors/ Health & Medical Writers

FERENTINO, Italy, January 10, 2000 - Biomedica Foscama Industria Chimico-Farmaceutica S.p.A. announced today publication in the November-December 1999 issue (Vol. 23, No. 6, Page 326-332) of the Journal of Parenteral and Enteral Nutrition, edited by the American Society for Parenteral and Enteral Nutrition, of a study which demonstrated the much higher Calcium/Phosphorus compatibility of Esafosfina's active drug d-fructose-1,6-diphosphate (FDP) with respect to inorganic phosphate.

Providing the recommended high intakes of both calcium (Ca) and phosphorus (P) during total parenteral nutrition (TPN) has been matter of concern because of the risk associated with calcium phosphate precipitation. The US Food and Drug Administration (FDA) issued in 1994 a Safety Alert on that problem (several injuries, including two deaths, have been reported as a result of calcium phosphate precipitation from parenteral nutrient solutions), incouraging the development of appropriate remedies from the industry.

"The results of this study, which has successfully been conducted in the Biomedica Foscama's R&D laboratories, clearly indicate that the use of Esafosfina as the P source in parenteral nutrition solutions is highly effective in avoiding the life-threatening calcium phosphate precipitation and represents therefore a safe choice that allows the simultaneous administration of high amounts of Ca and P even in restricted fluid volumes and in the presence of low amino acid concentrations" said Dr. Franco Gritti, CEO of Biomedica Foscama. "Thanks to these exciting data and to the increasing international reputation of Esafosfina, we are confident that our company will be able in the next years to further expand the penetration of this unique and valuable drug into the international markets."

It is known that FDP is a high-energy glycolytic intermediate that bypasses the critical, ATP-requiring step catalyzed by phosphofructokinase. Many studies have indicated that administration of exogenous FDP enhanced energy production and ATP generation in a number of severe pathologic conditions involving hypophosphatemia and phosphate depletion, such as acute respiratory failure, chronic alcoholism and prolonged malnutrition. Thus, unlike other sources of P, Esafosfina provides additional benefit in several debilitating conditions requiring TPN support.

Biomedica Foscama is an Italian pharmaceutical company established in 1947, with a staff of 230 people, including 90 reps visiting hospitals and care units, GPs and  specialists. In 1999 domestic and international (China and other countries) turnover will amount to 22 million USD. Biomedica Foscama is committed in research, manufacturing and marketing of prescription drugs in CNS, CV, GI/Metabolism areas. The main currently marketed products are Esafosfina® (i.v. applied d-fructose-1,6-diphosphate for the treatment of hypophosphatemia and phosphate depletion), Tad® (injectable reduced glutathione as detoxicant), Irrodan® (buflomedil HCl by oral route for peripheral vascular diseases), Ursolac® (oral ursodeoxycholic acid for the dissolution of gallbladder stones), plus a number of licensed high-value CNS drugs (alprazolam, zolpidem, sertraline) co-marketed in Italy with multinational companies (Pharmacia&Upjohn, Sanofi-Synthelabo, Pfizer).

The Company facilities are equipped to manufacture sterile injectables as lyophilized powders and ready-to-use solutions, with the availability of a remarkably large freeze drying production line.

The Biomedica Foscama Research Center has originated a number of NCEs under development including raxofelast (a vitamin E-like antioxidant, under clinical investigation for the treatment of vascular complications of diabetes mellitus) and midaxifylline (an highly selective and orally bioavailable xanthine A1-adenosine antagonist in preclinical trials).