Chiroscience Group - Re Licensing Agreement
07 Settembre 1998 - 9:32AM
UK Regulatory
RNS No 5273a
CHIROSCIENCE GROUP PLC
7th September 1998
CHIROSCIENCE AND MARUISHI TO DEVELOP CHIROCAINE
IN JAPAN
Chiroscience Group plc announces that it has entered into an
agreement with Maruishi Pharmaceutical Co Ltd for the development
and marketing rights to its long acting local anaesthetic,
Chirocaine, for Japan.
Under the licensing agreement Maruishi will conduct the development
and registration of a series of products and formulations containing
levobupivacaine exclusively for the Japanese market. Clinical
trials in Japan are expected to commence in 1999. Maruishi will
gain exclusive rights to market products under the Chirocaine
trademark in Japan. Maruishi will have the right to manufacture
levobupivacaine in Japan, although Chiroscience will initially
manufacture and supply levobupivacaine to them.
Maruishi will make access payments amounting to #3.25m, as well as
undisclosed milestone payments and will fully fund the development
of Chirocaine in Japan. Maruishi will invest in new drug delivery
techniques for levobupivacine. Chiroscience will gain royalties on
all sales of Chirocaine, other financial terms and royalty rates are
not being disclosed.
As announced on 31 March 1998, Chirocaine has been licensed to
Zeneca for marketing by them in all territories other than Japan.
Chirocaine is a long acting local anaesthetic developed by
Chiroscience for use in a wide range of surgical procedures, as well
in pain relief during childbirth or following surgery. Chirocaine
(levobupivacaine) has been selected to maintain the desirable
potency of the currently favoured anaesthetic (bupivacaine) but with
a much improved safety profile in terms of reduced side effects on
the heart and the brain. Chirocaine was submitted in December 1997
for registration to the Swedish regulatory authorities and Sweden
will act as rapporteur in the European Union mutual registration
process. Submission to the FDA in the USA took place in April 1998.
Dr John Padfield, Chief Executive of Chiroscience, said:
"We have built up a strong relationship with Maruishi who are
specialists in anaesthesia in Japan, where they are the market
leaders. They will make an excellent marketing partner for
Chirocaine and have a good track record in developing and maximising
the sales potential of innovative anaesthetic products."
Mr Nobuyuki Inoue, President of Maruishi Pharmaceutical, said:
"We are very pleased with this deal and have high expectations for
Chirocaine products in the Japanese market. We believe that the
superior properties of Chirocaine will allow us to develop a range
of products, and will facilitate the increased use of safe and
effective regional anaesthesia in Japanese hospitals. We look
forward to working closely with Chiroscience on this exciting
project."
For further information contact:
Dr John Padfield, Chief Executive
Christine Soden, Finance Director
Rebecca Iveson, Media and Investor Relations
Tel:+44 (0) 1223 420430
http://www.chiroscience.com
Giles Sanderson, Financial Dynamics
Tel:+44 (0) 171 8313113
NOTES TO EDITORS
Chiroscience Group plc
Chiroscience Group plc 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 cancer,
inflammation, pain, osteoporosis 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 of genomic technologies and
services, which it provides to Chiroscience R&D and partner
companies' drug discovery programmes.
ChiroTech provides chiral technology services to pharmaceutical and
related industries, including Chiroscience R&D. It has created an
integrated chiral technology and manufacturing business with
Mitchell Cotts Chemicals Ltd, whose parent company, Ascot plc, has a
30% shareholding in ChiroTech.
Chiroscience Group plc is listed on the London Stock Exchange and is
based in Cambridge and Stevenage, UK, and Seattle, Washington, USA.
Chirocaine
Chirocaine is the trade name for levobupivacaine, a new drug derived
from the established anaesthetic 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. The good efficacy and safety profiles have
been confirmed in over 25 phase III clinical trials which have been
completed in the UK, USA, Australia, Canada, New Zealand Denmark and
The Netherlands. In trials completed to date approximately 1,000
patients have been exposed to levobupivacaine.
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), driven by
a growth in surgery and pain management (acute and chronic).
The trials programme for Chirocaine has been designed to enable its
use in pain management, both post-operatively and for intractable
pain. An extensive patent protection programme includes 24
applications, covering process, use and formulation, a number of
which have already proceeded to grant. This will allow patent
protection to 2014 and beyond.
Maruishi
Maruishi Pharmacceutical Co. Ltd is the leading anaesthetic company
in Japan with total sales of 25,052 million Yen in 1997. They
developed the general anaesthetic Sevofrane (sevoflurane) which was
launched in 1990 in Japan and was licensed to Abbott for markets
outside Asia and Japan. Sevofrane is the leading selling
anaesthetic in Japan, with a 71% share of the Japanese market for
inhaled anaesthetic and it is now the leading selling inhaled
general anaesthetic worldwide. Maruishi is based in new corporate
offices in Osaka and invested 1,430 million Yen in R&D in 1997.
END
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