Bio-Technology General's BioLon Receives FDA Approval.ISELIN, NJ--(BUSINESS WIRE)--July 20, 1998--Bio-Technology General Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BTGC BTGC Bio-Technology General (stock symbol) BTGC Bukit Tinggi Golf Club (Malaysia) ) today announced that it has received approval from the U.S. Food and Drug Administration for the marketing of BioLon(TM), the Company's product for ophthalmic surgical procedures, in the United States. The product will be marketed by Akorn, Inc. (NASDAQ:AKRN), a leading U.S. manufacturer and marketer of eye care products. Akorn plans to launch the product this year. Commenting on the news, Sim Fass, Chairman, President and Chief Executive Officer of BTG BTG BIT (Built-In Test) Target Generator BTG Bridging the Gap BTG British Technology Group BtG Betreuungsgesetz (Germany) BTG Biomass Technology Group BV BTG Begbies Traynor Group , stated: "We are very pleased that BioLon(TM) has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. marketing approval. We look forward to its introduction in the United States which will bring the number of countries where BioLon(TM) is available to twenty-five. Akorn's position in the domestic market for ophthalmics should help maximize the sales of BioLon in the United States." BioLon(TM), a 1% solution of sodium hyaluronate hyaluronate /hy·al·uro·nate/ (hi?ah-ldbobr´ro-nat) a salt, anion, or ester of hyaluronic acid. The sodium salt and a derivative of it are used as analgesics in the treatment of osteoarthritis of the knee. , has been classified as a medical device and as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular) procedures, intraocular lens implantation and anterior segment surgery. It is a high molecular weight viscoelastic Adj. 1. viscoelastic - having viscous as well as elastic properties natural philosophy, physics - the science of matter and energy and their interactions; "his favorite subject was physics" lubricant that facilitates surgical manipulation of the ocular tissues. The U.S. market for sodium hyaluronate products in these ophthalmic surgical procedures is approximately $100 million. In the United States, BTG markets Oxandrin(R) (oxandrolone, USP USP - unique sales point ) for the treatment of involuntary weight loss and Delatestryl(R) (testosterone enanthate injection USP), an injectable testosterone product for the treatment of hypogonadism Hypogonadism Definition Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate. . In addition, Mircette(TM), a novel oral contraceptive, incorporating BTG's patented dosing regimen licensed to an affiliate of Organon, Inc., received FDA marketing approval in April 1998, and will be launched by Organon this year. BTG will receive royalties on Organon's sales of the product. BioLon(TM) will be the Company's third product to enter the U.S. market. The Company's Bio-Tropin(TM) (recombinant human growth hormone human growth hormone (HGH): see growth hormone. ) for the treatment of growth hormone deficiency growth hormone deficiency Hypopituitarism Endocrinology A condition which affects 1:4000 children; ♂:♀, 3-4:1 Etiology 70% of GHD is idiopathic and attributed to a prenatal insult, possibly due to hypothalamic dysfunction, given that GHD children in children, is marketed internationally in over 20 countries. Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human healthcare. The Company's product sales and revenues for the six months ended June 30, 1998 were $32.7 million and $36.1 million, respectively. The Company reported earnings per share (diluted) of $0.16 for the first six months of 1998. Statements in this news release concerning the Company'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.
CONTACT: Investor Relations
WOLFE AXELROD ASSOCIATES
Don Weinberger
732-632-8800
or
BIO-TECHNOLOGY GENERAL CORP.
Leah Berkovits
212-370-4500
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