Too all: great news today. Stock is up in heavy volume.
Monday October 28 10:32 AM EDT
BTG announces FDA review of applications for approval to market
Oxandrin for delayed puberty and Turner's syndrome
ISELIN, N.J.--(BUSINESS WIRE)--Oct. 28, 1996-- Bio-Technology General Corp today announced that the United
States Food and Drug Administration has accepted for full review and has initiated the review process for BTG's applications
for approval to market Oxandrin(R) for both the treatment of constitutional delay of growth and puberty (CDGP) in boys and
Turner's syndrome, a genetic disorder in girls.
CDGP and Turner's syndrome are pediatric growth disorders associated with short stature. Oxandrin, an orally active
testosterone analog, is beneficial in the treatment of these children. Approximately 80,000 boys and 50,000 girls in the U.S.
are affected with these conditions. Oxandrin stimulates growth and the onset of puberty in boys with CDGP. Turner's
syndrome is the result of a damaged or missing X chromosome in girls. Oxandrin is effective in accelerating growth in this
condition. Oxandrin has been designated an Orphan Drug by the FDA for both CDGP and Turner's syndrome. These Orphan
designations, granted to drugs for rare diseases or conditions with a prevalence of less than 200,000 cases in the U.S., will
provide BTG with seven years of market exclusivity for both CDGP and Turner's syndrome, post-approval.
BTG currently markets Oxandrin in the United States for the promotion of weight gain following weight loss due to severe
trauma, chronic infection or extensive surgery and for the treatment of weight loss due to unknown pathophysiology. Recent
treatment with Oxandrin has been shown to result in dramatic gains in weight and body cell mass in patients suffering from
weight loss due to a variety of conditions, including AIDS, burns and chronic obstructive pulmonary disease.
In addition to the two Oxandrin filings now under review for marketing approval by the FDA, BTG's application for
Premarket Approval for its ophthalmic product, BioLon(TM), which was submitted to the FDA in May 1996, is also currently
under review. Further, the Company is seeking FDA approval for a sublingual formulation of testosterone, Androtest-SL(R).
In other news this month, BTG announced earnings of $0.07 for the third quarter of 1996 as compared with $0.01 in the third
quarter of 1995.
Bio-Technology General Corp. develops, manufactures and markets genetically engineered and other products for human
health care.
CONTACT: Investor Relations
Don Weinberger
Strategic Growth International
516-829-7111
or
Leah Berkovits
Bio-Technology General Corp.
908-632-8800 |
