Bio-Technology General files BioLon with FDA.NEW YORK--(BUSINESS WIRE)--June 27, 1996--At its annual meeting of stockholders today, Bio-Technology General Corp. (Nasdaq:BTGC BTGC Bio-Technology General (stock symbol)
BTGC Bukit Tinggi Golf Club (Malaysia) ) announced that the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. , after initial review, has filed for full review a Premarket Approval Application (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.
PMA Progressive muscular atrophy ) for BTG's ophthalmic product, BioLon(TM), which has been classified as a medical device.
BioLon(TM) is a 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" 1 percent 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. for use in ophthalmic surgical procedures such as cataract removal. The U.S. market size for sodium hyaluronate in such procedures is approaching $100 million.
Sim Fass, 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 at the New York meeting that the Company looks forward to adding BioLon(TM) to its U.S. product line. BioLon(TM), which is already marketed in 17 countries worldwide, is manufactured, filled in syringes and packaged at BTG's Israeli facility. Dr. Fass added that over the next several months the Company plans further submissions to the FDA for approval to market additional products.
Also at the meeting, Dr. Fass reviewed the enormous progress the Company has made over the past year, noting the U.S. launch last December of Oxandrin(R) for the treatment of weight loss, as well as the fact that 1995 was BTG's first profitable year. Moreover, BTG was one of only five U.S. publicly traded therapeutic biotech companies that recorded a profit in 1995. The Company's net income for 1995 was $4.8 million, or $0.11 per share, on revenues of $28.0 million, of which $21.4 million was generated from product sales. In contrast, first quarter 1996 results showed net income, on an operating basis, of $2.3 million, or $0.05 per share. A one-time charge brought this to net income of $0.9 million, or $0.02 per share. The Company expects to report its second quarter earnings in late July.
The Company further announced that its recombinant human growth hormone human growth hormone (HGH): see growth hormone. is now approved for marketing in Australia 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. Scitech Medical Products, BTG's licensee for the Far East, will market the product in Australia under the trade name SciTropin(TM).
Bio-Tropin(TM) is being marketed in 19 countries worldwide and BioLon(TM) in 17 countries. In the U.S., BTG currently markets Oxandrin(R) and Delatestryl(R).
Bio-Technology General Corp. develops, manufactures and markets genetically engineered and other products for human health care.
CONTACT: Strategic Growth International
Don Weinberger (investors), 516/829-7111
Bio-Technology General Corp., Iselin
Leah Berkovits, 908/632-8800