Chiroscience Group - Approvable Letter from FDA
01 Marzo 1999 - 12:07PM
UK Regulatory
RNS No 3285c
CHIROSCIENCE GROUP PLC
1st March 1999
CHIROCAINE DESIGNATED APPROVABLE BY FDA
Chiroscience Group plc announces today that it has received an Approvable
Letter from the United States Food and Drug Administration (FDA) for
Chirocaine, its long-acting local anaesthetic. The Approvable Letter
represents the last step in the regulatory process before FDA approval of
the New Drug Application. The Company is in advanced discussions with the
FDA regarding final printed labeling.
Dr John Padfield, Chief Executive of Chiroscience Group plc, commented:
"This important decision is consistent with Chiroscience's belief that,
following the final FDA review of the product labeling and approval of its
New Drug Application, Chirocaine will be regarded as an important addition
to the range of drugs used in anaesthesia and pain."
This document is intended to provide information on Chiroscience to
interested members of the public and not to provide product information to
health professionals.
For further information contact:
Dr John Padfield, Chief Executive Giles Sanderson
Chiroscience Group plc Victoria Springett
Tel: +44 (0)1223 420430 Financial Dynamics
http://www.chiroscience.com Tel: +44 (0)171 831 3113
Chiroscience Group plc
Chiroscience is an emerging pharmaceutical company which uses its diverse
technology platform to discover, develop and bring to market novel medicines
for improved healthcare. It has three businesses: Chiroscience R&D,
Rapigene and ChiroTech.
Chiroscience R&D's focus is on innovative small molecule drugs and related
diagnostics in the therapeutic areas of inflammatory disease, pain,
osteoporosis, cancer and autoimmune diseases. Its technology platform
allows the conception and development of receptor-based and enzyme-
inhibiting small molecule drugs with high selectivity of action. Rapigene
is involved in the creation and provision of genomic technologies and
services to partner companies and to Chiroscience's drug discovery
programmes. Its DNA analysis systems comprise of DNA hybridization, DNA
arrays and mass spectrometry tags. ChiroTech provides chiral technology
services to pharmaceutical and related industries, including Chiroscience
R&D.
Chiroscience Group plc is listed on the London Stock Exchange and is based
in Cambridge and Stevenage, UK, and Seattle, Washington, USA.
Chiroscience financial highlights for the six months to 31 August 1998
(unaudited):
+ Revenues increased to #11.4m (H1 1997: #9.2m); net loss for the period
#11.4m (H1 1997: #14.4m)
+ ChiroTech contributed sales of #6.8m (H1 1997: #5.9m); Chiroscience's
drug discovery business contributed revenues of #4.5m (H1 1997: #3.3m).
+ Investment in research and development of #13.5m (1H 1997: #19.0m).
+ Current cash reserves of #59m as at 24 September 1998.
END
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