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FDA approves IND on Lead Product M6G

CAMBRIDGE, England, 26th April 2007 - CeNeS Pharmaceuticals plc (LSE: CEN), the Cambridge based biopharmaceutical company, today announces that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the clinical development of morphine-6-glucuronide (M6G), its novel drug for the treatment of post-operative pain. Earlier this year, CeNeS announced results of a Phase III study of M6G in Europe in over 500 patients with post-operative pain. The study demonstrated that M6G provided equivalent pain relief to morphine but induced significantly less post-operative nausea and vomiting (PONV). The opening trial under this IND will be a Phase I pharmacokinetic study in volunteers. This study is required by the FDA as is an additional pre-clinical toxicology analysis before progressing to Phase III trials. CeNeS is currently completing the protocol design of the first US Phase III trial. The filing of the IND enhances the package of data already available to potential US partners for review. Neil Clark, Chief Executive of CeNeS, said:

"The FDA's approval of our IND application for M6G is a major landmark in CeNeS' clinical development programme. North America is an attractive market for our drug candidate and M6G is clearly positioned to be a genuine alternative to standard morphine therapy."

For more information please contact: CeNeS Pharmaceuticals plc Neil Clark, CEO Tel: +44 (0)1223 266 466

JM Finn Geoff Nash Tel: +44(0) 207 628 9688

Financial Dynamics Ben Brewerton/Emma Thompson Tel: + 44 (0) 207 831 3113

About CeNeS Pharmaceuticals CeNeS is a biopharmaceutical company specialising in the development and commercialisation of drugs for pain control, sedation and other CNS disorders such as Parkinson's disease. The company is based in Cambridge, England. For further information visit the CeNeS web site: '"/>




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