Unimed Licenses Two Testosterone Products

Unimed Pharmaceuticals has licensed from Besins Iscovesco of France two new products for the treatment of testosterone deficiency in men. The products are once-a-day gel formulations of testosterone and dihydrotestosterone (the active metabolite of testosterone). The gels are designed to be quickly absorbed into the blood after application on the arms and stomach. Current routes of administration include deep intramuscular injection or transdermal patches.

Unimed will develop the two products in the USA for the 400,000 or so men, aged between 18 and 59, who are diagnosed with testosterone deficiency. The company also plans to investigate the use of the product in men over 60 who suffer from low testosterone levels. A number of government-funded studies are underway in the USA to see if testosterone replacement therapy can help alleviate some of the negative effects of aging.

In exchange for the exclusive marketing rights for all therapeutic indications in the USA, Canada and Mexico, Unimed has granted Besins 145,000 common shares and 72,550 warrants to buy Unimed stock at $8 per share. Besins will manufacture the product for Unimed, and will receive royalties on sales. The deal also involves a payment of $500,000 for R&D funding, and a further similar payment will also be made in January 1996. Phase II clinical trials are expected to start next year, according to Unimed.