New Drug Application
06 8월 2003 - 1:06AM
UK Regulatory
RNS Number:3567O
Theratase PLC
05 August 2003
For Immediate Release: 5 August 2003
THERATASE PLC
Customer To Proceed With Second Vitrase New Drug Application To The FDA
Theratase plc, one of the world's leading manufacturers and suppliers of
specialist enzymes to the diagnostic and pharmaceutical industries, is pleased
to announce that its customer ISTA Pharmaceuticals Inc. ("ISTA") announced today
that it has filed with the Food and Drug Administration (FDA) its second New
Drug Application (NDA) for Vitrase(R).
ISTA's NDA seeks approval from the FDA for use of Vitrase(R), as a spreading
agent to facilitate the dispersion and absorption of other drugs. It also seeks
approval to provide directions for reconstitution of Vitrase(R) for potential
treatment applications in the back of the eye.
ISTA states in its announcement that the Vitrase(R) formulation and
configuration filed today is the same as that filed in its first NDA for Vitrase
(R) for the treatment of vitreous haemorrhage.
Theratase plc, through its subsidiary Biozyme Laboratories Limited, supplies the
unique API, which is used in ISTA's proprietary formulation for Vitrase.
Commenting on the second New Drug Application, Dr John Chesham, CEO of Theratase
said,
"This is excellent news for both ISTA Pharmaceuticals and Theratase as it shows
the potential properties of the Vitrase drug in ophthalmic treatment that we
believe existed."
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For further information, please contact:
Theratase
Colin Anderson, Finance Director Tel: +44 (0) 20 7863 8819
Buchanan Communications Tel: +44 (0) 20 7466 5000
James Strong
Notes to Editors:
Theratase: a specialist in the development, manufacture and marketing of
enzymes and biochemicals to the diagnostic and pharmaceutical industries.
Floated in 1993, its core business, Biozyme Laboratories Ltd., was set up in
1971 and has over 30 years' experience in the field of enzyme production.
This information is provided by RNS
The company news service from the London Stock Exchange
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