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ISELIN, NJ--(BUSINESS WIRE)--July 20, 1998--Bio-Technology
General Corp. (NASDAQ:BTGC) 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, stated: "We are very pleased that BioLon(TM)
has received FDA 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, 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 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)
for the treatment of involuntary weight loss and Delatestryl(R)
(testosterone enanthate injection USP), an injectable testosterone
product for the treatment of hypogonadism. 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) for the treatment of growth hormone deficiency 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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