BIO-TECHNOLOGY GENERAL ANNOUNCES LICENSE OF OXSODROL(TM), HUMAN SOD, TO JCR PHARMACEUTICALS CO., LTD. OF JAPAN.

ISELIN, N.J.--(BUSINESS WIRE)--January 10, 1995--Bio-Technology General Corp. (NASDAQ:BTGC) today announced that JCR Pharmaceuticals Co., Ltd. has obtained exclusive licensing rights in Japan to OXSODROL(TM), a genetically engineered human superoxide dismutase (SOD) enzyme, for treatment of bronchopulmonary dysplasia (BPD). The license agreement is between JCR and Bio-Cardia Corporation, a company which has licensed certain products from BTG and for which BTG is performing research and development services. BTG has the right, under a December 1993 agreement, to reacquire the products licensed to Bio-Cardia.

Under the agreement between Bio-Cardia and JCR, BTG will manufacture and supply the enzyme on behalf of Bio-Cardia and JCR will develop and commercialize the product in Japan. JCR will pay milestone fees totaling $2 million and will purchase all its SOD product needs from Bio-Cardia.

"We are very pleased to have this new opportunity to work with JCR on the development of a potentially very important product to treat a condition for which there is as yet no effective therapy. We have a high regard for the the capabilities and commitment of JCR with whom we have had an excellent ongoing relationship for several years now. They have done an outstanding job in Japan with Growject, BTG's human growth hormone," stated Sim Fass, President and CEO of BTG and Bio-Cardia, "and we look forward to comparable success with OXSODROL(TM)."

SOD is an enzyme that degrades oxygen free radicals and has been shown to be protective against tissue damage in a variety of preclinical situations. BPD is a chronic lung disorder that a substantial percentage of premature neonates develop following treatment with oxygen and mechanical ventilation. The etiology of BPD is not completely understood. One of the most likely mechanisms causing BPD is the oxidative insult associated with high concentrations of oxygen to which premature infants are exposed. Oxygen free radicals produced in the lung by high concentrations of oxygen initiate lung injury at the cellular level. Premature neonates have low levels of naturally occurring antioxidant enzymes such as superoxide dismutase which catalyze the conversion of toxic oxygen free radicals to less toxic hydrogen peroxide and water. It is hoped that administration of human SOD would counteract the negative effects of high oxygen levels and prevent the development of BPD in these premature infants.

This clinical concept is supported by the results of studies of BTG's human SOD in newborn piglets. In these studies, acute lung injury in piglets mechanically hyperventilated for 48 hours in an environment of 100% oxygen was significantly ameliorated by prophylactic administration of BTG's human SOD.

Bio-Technology General Corp. develops, manufactures and markets genetically engineered and other products for human healthcare.

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