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Biomedica Foscama

BIOMEDICA FOSCAMA SIGNS CO-OPERATION AND CONSULTANCY AGREEMENT WITH OXFORD NUTRITION

Business Editors/ Health & Medical Writers

FERENTINO, Italy, May 22, 2000 - BIOMEDICA FOSCAMA Industria Chimico-Farmaceutica S.p.A. announced today that it has signed a 'Co-operation and Consultancy Agreement' with OXFORD NUTRITION, Ltd., a science based British company specializing in formulation, design and supply of clinical nutrition and related intravenous therapies to hospitals in the UK.

According to the Agreement, the parties will collaborate in order to introduce Biomedica Foscama's leading products Esafosfina^® and Tad^® into the UK market. Oxford Nutrition will provide assistance in connection with the registration documentation required to obtain marketing approval for the above products by EU regulatory authorities through the mutual recognition procedure and with clinical and pharmaceutical studies on products imported from Italy. 

Commenting on the Agreement, Gil Hardy, Professor of Pharmaceutical Nutrition at the Oxford Brookes University and Chairman of Oxford Nutrition, stated "Esafosfina and TAD are leading examples of a new generation of nutraceuticals that have exciting potential in the field of clinical nutrition and other metabolically orientated therapies. TAD (glutathione) is one of the most important antioxidants in human cells.  It plays a key role in the regulation of protein synthesis and vitamin regeneration. It may also protect skeletal muscle, liver and endothelial tissues against free radical-induced oxidative stress following shock, sepsis, pancreatitis and surgical trauma. Parenteral nutrition mixtures prepared with Esafosfina (FDP) provide high intakes and good retention rates of calcium and phosphorus that may not be possible with inorganic sources of phosphorus. Moreover, FDP enhances energy production and ATP generation in a number of severe pathological conditions involving hypophosphatemia and phosphate depletion, such as respiratory failure, chronic alcoholism and prolonged malnutrition. We are looking forward to working with these novel products in the UK and welcome this opportunity for a close collaboration with the Biomedica Foscama Research Centre."

Dr. Franco Gritti, President and CEO of Biomedica Foscama, stated "This is an important step toward an increasing diffusion of the company core products in 'first-class' markets such as the UK, known for their very high scientific and regulatory standards. Thanks to the excellent reputation of the Oxford Nutrition team in the field of parenteral clinical nutrition, this collaboration will greatly aid Biomedica Foscama in its efforts focused to spread worldwide the awareness of the high therapeutic potential and absolute safety of Esafosfina and Tad.

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, 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).