PRESS RELEASES

Biomedica
Foscama

FURTHER EVIDENCE OF POWERFUL ACTIVITY OF THE NEW BIOMEDICA FOSCAMA'S ANTIOXIDANT, RAXOFELAST, IN RESTORING IMPAIRED ENDOTHELIAL FUNCTION AND WOUND HEALING IN DIABETES

Business Editors/ Health & Medical Writers

FERENTINO, Italy, April 4th, 2001 - BIOMEDICA FOSCAMA Industria Chimico-Farmaceutica S.p.A. announced today pubblication in the March 2001 issue (Vol. 50, No. 3, Pages 667-674) of the high-ranked journal Diabetes, edited by the American Diabetes Association, of an important study carried out with raxofelast, a vitamin E-like antioxidant drug in development by Biomedica Foscama.

The study, carried out by Prof. Francesco Squadrito’s team at University of Messina, Italy, provides evidence that systemic administration of raxofelast stimulates wound healing in genetically diabetic mice and normalizes the defect in vascular endothelial growth factor (VEGF) regulation associated with diabetes-induced skin-repair disorders. The paper reinforces the paradigm that oxidative stress and an increased lipid peroxidation could have a causal role in determining a defect of wound repair processes in diabetes, which in turn is closely related to endothelial dysfunction. Therefore, appropriate treatments with suitable antioxidant and radical scavenging drugs such as raxofelast may prove useful in healing or halting the progression of foot ulcers, which are known to cause much discomfort in many diabetic patients.

A previous Phase II clinical trial conducted at the Centre for Cardiovascular Biology and Medicine, King’s College, London, UK, found that oral treatment with raxofelast for one week produced a pronounced reduction in oxidative stress and significantly improved endothelial function in Type II diabetic patients (Diabetologia 2000, 43, 974-977).

“These and other relevant findings have shown that raxofelast has a strong potential as a prophylactic or therapeutic agent for the treatment of vascular diabetic complications, where considerable unmet medical need still exists despite the recent advent of new therapies” said Dr. Franco Gritti, President and CEO of Biomedica Foscama. “We plan to confirm and extend these results in our Phase II and III clinical development programme. At the same time, a collaboration with a large multinational company aimed to reduce the time-to-market for this highly valuable and unique drug would be welcomed.”

Diabetes is one of the single most serious health problems facing the healthcare systems of developed countries today, and its prevalence is expected to dramatically grow in the next future, with estimates of about 300 million people that will be affected in 2020. These patients are at risk for developing severe, chronic complications including retinopathy, neuropathy, nephropathy, foot ulcers and cardiovascular disease.

 Biomedica Foscama is an Italian pharmaceutical company established in 1947, with a staff of 190 people, including 90 reps visiting hospitals and care units, GPs and  specialists. In 2000 domestic and international (China and other countries) turnover will amount to 21,7 million of euro. 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) and CV drugs (metoprolol ) co-marketed in Italy with multinational companies (Pharmacia&Upjohn, Sanofi-Synthelabo, Pfizer, Astra-Zeneca). 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).