Chiroscience and Maruishi to Develop Chirocaine in Japan.LONDON--(BUSINESS WIRE)--Sept. 8, 1998--Chiroscience Group plc today announced that it has entered into an agreement with Maruishi Pharmaceutical Co Ltd for the development and marketing rights to its long acting local anaesthetic an·aes·thet·ic adv. & n. Variant of anesthetic. anaesthetic or US anesthetic Noun a substance that causes anaesthesia Adjective causing anaesthesia , Chirocaine(R), 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 pounds, 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 levobupivacaine. Chiroscience will gain royalties on all sales of Chirocaine, other financial terms and royalty rates are not being disclosed. As announced on March 31, 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 Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. , as well as in pain relief during childbirth or following surgery. Chirocaine (levobupivacaine) has been selected to maintain the desirable potency of the currently favored anaesthetic (bupivacaine) but with a much improved safety profile in terms of reduced side effects Side effects Effects of a proposed project on other parts of the firm. 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 rap·por·teur n. One who is designated to give a report, as at a meeting. [Middle English raportour, judge, from Old French raporteur, from raporter, to bring back in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community mutual registration process. Submission to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 anesthesia 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 maximizing 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 anesthesia regional anesthesia n. Anesthesia characterized by the loss of sensation in a circumscribed region of the body, produced by the application of a regional anesthetic, usually by injection. in Japanese hospitals. We look forward to working closely with Chiroscience on this exciting project." 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 Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . 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 programs. ChiroTech provides chiral chi·ral adj. Of or relating to the structural characteristic of a molecule that makes it impossible to superimpose it on its mirror image. chi·ral 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 London Stock Exchange London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses. and is based in Cambridge and Stevenage, UK, and Seattle, Washington The reason for its protection is listed on the protection policy page. , USA. Chirocaine(R) 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 Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the which have been completed in the UK, USA, Australia, Canada, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. 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 anesthetics 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 program for Chirocaine has been designed to enable its use in pain management, both post-operatively and for intractable pain intractable pain Refractory pain Pain medicine Persistent pain which does not respond to at least 3 dosease of parenteral analgesics given over a 12-24 hr period; pain that does not respond to appropriate doses of opioid analgesics. . An extensive patent protection program 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 Pharmaceutical Co. Ltd is the leading anaesthetic company in Japan with total sales of 25,052 million Yen in 1997. They developed the general anaesthetic general anaesthetic Noun a substance that causes general anaesthesia See anaesthesia Noun 1. general anaesthetic - an anesthetic that anesthetizes the entire body and causes loss of consciousness 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. Additional information on Chiroscience can be accessed on the company's home page: http://www.chiroscience.com.
CONTACT: Chiroscience, London
Dr. John Padfield, Chief Executive
Rebecca Iveson, Media and Investor Relations
44-1223-420-430
or
Taylor Rafferty Associates, New York
James P. Prout
212-889-4350
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