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Bio-Technology General and Serono Laboratories Announce Co-Promotional Agreement for Serono's Line of Pediatric Growth Products

Business Wire, May 19, 1998

ISELIN, N.J.--(BUSINESS WIRE)--May 19, 1998--Bio-Technology General Corp. (NASDAQ:BTGC) and Serono Laboratories, Inc., U.S. member of The Ares-Serono Group, today announced a co-promotional agreement, under which BTG will co-market Serono's line of pediatric growth products in the United States. Serono has developed and markets the most comprehensive line of products to treat pediatric growth hormone deficiency, including growth hormone and growth hormone releasing hormone. Co-promotional activities will begin on June 1, 1998.

Under this agreement, BTG will market Serono's recombinant human growth hormone, Saizen(R) (somatropin (r-DNA origin) for injection) for the treatment of children with growth failure due to inadequate levels of growth hormone; Geref(R) (sermorelin acetate for injection), the first approved growth hormone releasing hormone for the treatment of idiopathic growth hormone deficiency in children; and Geref(R) Diagnostic (sermorelin acetate for injection), a complementary product for the diagnosis of growth disorders.

"This new relationship with Serono complements our commercial activities related to endocrine and metabolic disorders and we believe that this agreement will positively impact our 1998 revenues," stated Sim Fass, chairman, president and chief executive officer of BTG. "Our marketing team has considerable expertise in this therapeutic area which will allow us to successfully enhance the distribution of these important products."

"In addition to Saizen, we have just launched Geref and Geref Diagnostic, which provides physicians with a new option for treating children with growth hormone deficiency," said Hisham Samra, M.D., president, Serono Laboratories, Inc. "Serono now offers a comprehensive line of treatments for pediatric growth disorders and this agreement, by tripling the sales force effort, will accelerate market penetration and adoption of all three products."

Saizen is produced through recombinant technology and is manufactured using mammalian cells; BTG's human growth hormone, Bio-Tropin(TM), is manufactured in bacterial cells and is marketed outside the U.S. for the treatment of pediatric growth hormone deficiency. Geref, a growth hormone releasing hormone, triggers the release of the body's available reserves of growth hormone. Geref Diagnostic is a tool for detecting the cause of a child's slow growth and can be used either prior to Geref treatment or as a stand-alone diagnostic agent.

Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human healthcare. BTG's commercial products are: Oxandrin(R) (oxandrolone tablets) for the treatment of involuntary weight loss, Bio-Tropin(TM) (recombinant human growth hormone) for the treatment of growth hormone deficiency in children, BioLon(TM) (sodium hyaluronate) for use in ophthalmic surgical procedures, and Delatestryl(R) (testosterone enanthate injection USP) for hypogonadal men. The Company's worldwide 1997 product sales and revenues were $53.7 million and $65.3 million, respectively. The Company believes that the agreement with Serono will strengthen both the Company's revenues and the Company's focus in the area of endocrine and metabolic therapeutic agents.

Serono Laboratories, Inc., is the United States member of The Ares-Serono Group of companies. The Ares-Serono Group is a leading Swiss developer and marketer of pharmaceutical products with executive headquarters in Geneva, Switzerland. Ares-Serono operates subsidiaries and manufacturing facilities in more than 25 countries. World leader in the treatment of infertility, Ares-Serono is also active in the fields of growth, metabolism and immunology/oncology. With seven recombinant products under development, Ares-Serono is one of today's biotechnology leaders. Three of these products are already marketed for various indications. Products of The Ares-Serono Group are sold under the trademark Serono in over 90 countries. Shares of Ares-Serono S.A., the parent company of Ares-Serono, are traded on the Swiss stock exchanges. -0-

Statements in this news release concerning BTG's business outlook or future economic performance, anticipated profitability, revenues, expenses or other financial items; and statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements" as that term is defined under the Federal Securities Laws. Forward-looking statements are subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to, changes and delays in product development plans and schedules, customer acceptance of new products, changes in pricing or other actions by competitors, patents owned by the Company and its competitors, and general economic conditions, as well as other risks detailed in the Company's filings with the Securities and Exchange Commission.

 

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