AMED Amedeo Res

RNS No 1009p
CHIROSCIENCE GROUP PLC
16th December 1998
 
                 FIRST REGULATORY APPROVAL FOR CHIROCAINE
                                     
            US FDA ADVISORY COMMITTEE MEETING IN JANUARY 1999,
                           EARLIER THAN EXPECTED
                                     
              PRODUCT COMMERCIALISATION STRATEGY UNDER REVIEW
 
Chiroscience  Group  plc, the emerging pharmaceutical  company,  announces
that  it  has achieved significant progress in gaining regulatory approval
for Chirocaine, the long-acting local anaesthetic:
 
-   The  Medical  Products Agency in Sweden has approved the  grant  of  a
licence  for  Chirocaine  and  this  Swedish  approval,  under  EU  Mutual
Recognition procedure, would lead to licences in other European countries.
-  Chiroscience has been notified that the US Food and Drug Administration
will discuss the New Drug Application for Chirocaine at the meeting of the
Anesthetics and Life Support Drugs Advisory Committee on 12 January 1999.
 
The  approval by the Medical Products Agency in Sweden confirms Chirocaine
to  be  safe  and  effective for a broad range of uses in anaesthesia  and
pain, including for children and chronic pain sufferers.  Chirocaine  will
be  an important addition to the range of products used in anaesthesia and
pain  management,  since the Swedish approval allows  it  to  be  used  in
situations   that   are  unavailable  using  existing  long-acting   local
anaesthetics.
 
Following the announcement of the proposed merger between Zeneca Group PLC
and Astra AB, Zeneca is in discussion with Chiroscience to ensure that any
impact  of  the proposed merger on the commercialisation of Chirocaine  is
resolved as soon as possible.
 
Having  won  broad approval for Chirocaine, Chiroscience now is  reviewing
its   product   commercialisation  strategy  which  may  include   further
differentiating   the  labelling  of  Chirocaine  from  other   competitor
products, particularly with respect to cardiovascular safety. Chiroscience
will commence discussions with the Swedish authorities which could lead to
a  variation  to  the  licence being submitted  later  in  1999,  possibly
following  the  completion  of  some  additional  clinical  trials.    Any
additional  clinical  studies  that  may  be  undertaken,  to  demonstrate
enhanced benefits to patients through an increased safety margin,  can  be
accommodated within the Group's cash reserves, which stood at #59  million
as  at  the  Interim  Results of 24 September 1998.  The  results  of  the
commercialisation  strategy review, including any impact  of  any  product
launch, will be announced in due course.
 
Dr John Padfield, Chief Executive of Chiroscience Group plc, commented:
 
"We are delighted that the Swedish authorities have found Chirocaine to be
safe  and  effective for a broad range of uses, including new applications
for  long-acting local anaesthetics in children and for those  who  suffer
from  chronic  pain.  Given the importance of the US market  we  are  also
pleased that the FDA review will occur earlier than we had expected.
 
Our  decision to review the commercialisation strategy is necessary  given
the  changed  circumstances in the market.  Chiroscience has an  extensive
range  of  patents protecting Chirocaine, the earliest of which  does  not
expire  for  another  15  years.  Thus, while  we  are  disappointed  that
Chirocaine  may not be launched in Europe as quickly as we had hoped,  our
product is the superior one and the outcome of our review will be  in  the
long-term best interests of Chiroscience and its shareholders."
 
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
Christine Soden, Finance Director
Chiroscience Group plc
Tel: +44 (0)1223 420430
http://www.chiroscience.com
 
Giles Sanderson
Victoria Springett
Financial Dynamics
Tel: +44 (0)171 831 3113
 
Notes For Editors:
 
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, Canada, New Zealand, Denmark and The Netherlands.
 
In trials completed to date approximately 1,400 patients have been exposed
to Chirocaine.
 
 
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 


MSCVEFFFVLKEFKD

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