AMED Amedeo Res

RNS No 2567x
CHIROSCIENCE GROUP PLC
4th December 1997
 
                CHIROSCIENCE FILES MARKETING AUTHORISATION
                        APPLICATION FOR CHIROCAINE
 
Chiroscience  Group plc today announced that it has submitted  a  European
Marketing     Authorisation    Application    (MAA)     for     Chirocaine
(levobupivacaine)*, the long acting local anaesthetic.  The MAA  has  been
filed  under  the  decentralised or mutual  recognition  procedure,  using
Sweden as the reference member state.
 
In  submitting  the MAA, Chiroscience seeks approval for  broad  usage  of
Chirocaine  in  local, regional or spinal anaesthesia,  for  surgical  and
obstetric  procedures, and as an epidural infusion for  post-surgical  and
intractable  pain.  In addition, approval is sought for use  alone  or  in
combination with morphine, fentanyl or clonidine, and for use in  children
with appropriate dosage adjustments.
 
"The  submission  of  Chiroscience's first MAA marks  a  very  significant
occasion for the Company and for the anaesthetic community.  In just  four
years,  Chiroscience has progressed Chirocaine from concept to  regulatory
filing,  thanks  to  the  tremendous  efforts  of  the  many  Chiroscience
employees and external personnel involved in the programme," said Dr  John
Padfield,  chief executive of Chiroscience.  "We anticipate receiving  the
first  approval to market Chirocaine in the middle of next  year,  and  we
remain  on course to submit the New Drug Application in the USA  in  April
1998," he added.
 
For further information contact:

Andrew  Burrows, Media Relations              Giles Sanderson
Dr Brian Gennery, Director of Development     Financial Dynamics
Tel: +44(0)1223 420430                        Tel: +44 (0)171 831 3113
http://www.chiroscience.com    
 
Notes:
 
*Chirocaine   is   a   registered  trademark  in  the  UK;   international
registration is pending
 
Chiroscience Group plc
 
Chiroscience is an emerging pharmaceutical company operating in the UK and
USA,  which  uses its diverse technology platform to discover and  develop
novel  medicines  for improved healthcare.  The Group  has  two  principal
activities, operating as Darwin Discovery and ChiroTech.  Chiroscience  is
listed on the London Stock Exchange.
                                                                          
Darwin  Discovery embraces activities in Cambridge, Seattle and Stevenage,
including gene-based research and molecular biology, through chiral-based,
combinatorial, medicinal and process chemistries, to clinical development.
It  is  engaged  in  the  discovery and development  of  innovative  small
molecule  drugs  and  related  diagnostics with  a  therapeutic  focus  on
autoimmune disease, cancer, inflammation, pain and osteoporosis.
 
ChiroTech  provides  chiral technology services to  customers  within  the
pharmaceutical and related industries and in support of Darwin Discovery's
research and development programmes.
 
Chirocaine
 
Chirocaine is the trade name for levobupivacaine, a new drug derived  from
the  established  drug bupivacaine. Pre-clinical studies have  shown  that
Chirocaine  is as potent as bupivacaine, but has a significantly  superior
safety  profile  in  its action on the heart and central  nervous  system.
These  pre-clinical  results are being confirmed  in  over  20  Phase  III
clinical trials which are under way in the UK, USA, Australia, Canada, New
Zealand,  Denmark and The Netherlands.  In trials completed to  date  more
than 800 patients have been exposed to levobupivacaine.
 
The  number  of  surgical procedures carried out using long  acting  local
anaesthetics is predicted to increase from over 45m in 1997 to around 110m
in  10 years, driven by a growth in surgery and pain management (acute and
chronic).   It  is  estimated that up to 40% of patients currently  suffer
unnecessary acute and chronic pain, owing to a reluctance to use  opiates.
The trials programme for Chirocaine has been designed to enable its use in
pain management, both post-operatively and for intractable pain, including
cancer pain.
 
MAA: decentralised procedure
 
Under  the  decentralised or mutual recognition procedure,  pharmaceutical
companies  can  submit their application for a marketing  licence  to  one
Member  State of the European Union.  This, the first or reference  Member
State, has 210 days to decide whether or not to grant an authorisation  to
market  the  product in that Member State.  If approval  is  granted,  the
applicant  may then seek to have other Member States accept the  marketing
approval  of  the  first Member State.  They must decide  within  90  days
whether to recognise the approval.
 
Chiroscience  opted to file under the mutual recognition procedure  as  it
allows  the use of different trade names within Europe, providing  greater
flexibility in terms of commercialising Chirocaine.  Under the centralised
filing  procedure,  applications  are reviewed  by  two  rapporteurs  from
different  Member  States,  selected  by  the  Committee  for  Proprietary
Medicinal Products (CPMP).  However, this system provides for use of  only
one trade name.
 

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