AMED Amedeo Res

RNS No 0794b
CHIROSCIENCE GROUP PLC
13th January 1999
                                 
                                  
   POSITIVE RECOMMENDATIONS FROM FDA ADVISORY COMMITTEE MEETING ON
                             CHIROCAINE
                                  
Chiroscience  Group  plc  announces  that,  at  the  meeting  of  the
Anesthetics and Life Support Drugs Advisory Committee of  the  United
States  Food  and  Drugs  Administration ("FDA"  )  held  today,  the
Committee voted unanimously in favour of recommending to the FDA that
Chirocaine   would not need to carry a 'black-boxed' warning  on  the
label. Also, during the meeting, the FDA indicated that Chirocaine is
approvable.
 
Chirocaine  is  the  long  acting  local  anaesthetic  developed   by
Chiroscience  for use in a wide range of surgical procedures  and  in
pain  management, both in adults and in children. Chirocaine received
approval by the Medical Products Agency in Sweden in December 1998.
 
The  two  questions posed by the FDA to the Advisory Committee  asked
whether  Chiroscience had adequately evaluated Chirocaine's potential
for  reduced  cardiac toxicity in humans at the  labelled  doses  and
whether the product should carry a 'black-boxed' warning relating  to
the use of the product in obstetrics at high doses of more than 0.75%
by volume.
 
Chiroscience  made presentations to the Committee members  addressing
these issues and answered questions posed by them.  This was followed
by  a  presentation by the FDA of the pre-clinical and clinical  data
made available by Chiroscience.
 
The  consensus of the Committee was that Chiroscience had  adequately
evaluated   Chirocaine  in  accordance  with  established  standards,
particularly  in  assessing the potential for cardiac  toxicity,  and
that  the  safety  profile  of  Chirocaine  had  been  satisfactorily
demonstrated.  The pre-clinical data submitted by Chiroscience showed
an  advantageous cardiac and central nervous system toxicity  profile
for   Chirocaine  over   bupivacaine.   Furthermore,   the   clinical
pharmacology  data also demonstrated differences in cardiac  toxicity
between these two drugs.
 
Therefore, the Committee recommended to the FDA that Chirocaine  need
not  carry  a 'black-boxed' warning once approved. The exact  wording
and  data  for  use in the indications and combinations requested  by
Chiroscience  to  be  included in the product  label,  together  with
appropriate warnings, will be determined in discussion with the  FDA.
The  Committee recommended that the Company commit to certain studies
which  could  be carried out post-approval to enable the  utility  of
Chirocaine to be maximised.
 
It  should  be  noted  that the decisions of the  Committee  are  not
binding on the FDA.
 
Dr   John  Padfield,  Chief  Executive  of  Chiroscience  Group  plc,
commented:
 
"This is an excellent outcome and is a tribute to the many people  in
Chiroscience  and in the scientific and clinical community  worldwide
who  have  developed Chirocaine.  The next steps are for the  FDA  to
consider  the  recommendations of the Committee  and  decide  on  the
detailed wording and data which can be included in the product label.
We remain hopeful that the label will allow us to demonstrate a clear
advantage over the market-leader.
 
Meanwhile we continue to review the commercialisation of the  product
in the light of the proposed merger of our marketing partner, Zeneca,
with  Astra.  Today's review by the Advisory Committee  supports  our
contention that Chirocaine is an important addition to the  range  of
drugs used in anaesthesia and pain."
 
 
 
 
Conference call:
There will be a conference call at 9.30 a.m. today for analysts, that
will  be  hosted  by Dr John Padfield and Christine Soden.   Analysts
interested in attending should contact Financial Dynamics.
 
For further information contact:
Dr John Padfield, Chief Executive    Giles Sanderson
Christine Soden, Finance Director    Victoria Springett
Chiroscience Group plc               Financial Dynamics
Tel: +44 (0)171 831 3113 (on the     Tel: +44 (0)171 831 3113
day)
Tel:     +44     (0)1223     420430
(thereafter)
http://www.chiroscience.com
                                     
 
Notes For Editors:
 
'Black-Boxed' warning
A  'black-boxed' warning is required by the FDA where  a  major  side
effect  problem  has  been identified with a pharmaceutical  product.
This  is  a  method of drawing specific problems to the attention  of
physicians   and   is  designed  to  help  them  prescribe   products
appropriately.
 
Chirocaine
Chirocaine  is  the trade name for levobupivacaine,  the  long-acting
local  anaesthetic developed by Chiroscience for use in a wide  range
of  surgical procedures, as well as in pain relief during  childbirth
and  in  pain  management  following  surgery.   On  31  March  1998,
Chiroscience  entered  into an agreement  to  license  Chirocaine  to
Zeneca  Limited on an exclusive and worldwide basis, excluding Japan.
Under  the  licensing  agreement,  Chiroscience  is  responsible  for
gaining approval of Chirocaine in EU countries and in the U.S.  On  7
September 1998, Chiroscience entered into an agreement with  Maruishi
Pharmaceutical  Co  Ltd for the development and marketing  rights  to
Chirocaine for Japan.
 
Chiroscience  is  seeking  approval  for  the  widespread  usage   of
Chirocaine  in local, regional, epidural and 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 with appropriate dosage requirements for use in children.
 
Chirocaine  is  a  new drug derived from the established  anaesthetic
bupivacaine.  Pre-clinical studies have shown that Chirocaine  is  as
potent  as  bupivacaine, but has a superior  safety  profile  in  its
action  on  the heart and central nervous system.  Its  efficacy  and
safety profiles have been confirmed in over 25 clinical trials  which
have  been completed in the UK, USA, Australia, New Zealand,  Denmark
and The Netherlands.
 
In  trials completed to date over 1,400 patients have been exposed to
Chirocaine.
 
Chirocaine was developed in response to the growing demand for  local
anaesthetic  procedures.  The number of surgical  procedures  carried
out  using  long acting local anaesthetics is predicted  to  increase
from  45  million worldwide in 1997 (with an estimated value of  $250
million)  to  around  80  million in 10  years  ($750  million  -  $1
billion).   This increase is being driven by a growth in surgery  and
pain  management  (acute  and chronic).   When  compared  to  general
anaesthesia, local anaesthesia has the potential for improved patient
outcome   as  it  is  faster,  providing  a  less  painful  recovery,
minimising  hospital costs by reducing hospital stays and  decreasing
the risk of post-operative infection.
 
 
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  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.
 
Chiroscience Group plc is listed on the London Stock Exchange and  is
based in Cambridge and Stevenage, UK, and Seattle, Washington, USA.
 


MSCSFASWDUUUFEF

Grafico Azioni Amedeo Res (LSE:AMED)
Storico
Da Giu 2024 a Lug 2024

Grafico Azioni Amedeo Res (LSE:AMED)
Storico
Da Lug 2023 a Lug 2024