Cambridge, UK, 25th May 2006 - CeNeS Pharmaceuticals plc (AIM: CEN) the Cambridge based biopharmaceutical company today announced that an important review of its lead product morphine-6-glucuronide (M6G) has been published in the international journal ‘Anesthesia and Analgesia’. The review, entitled ‘Morphine-6-Glucuronide: Morphine’s Successor for Postoperative Pain Relief?’ was written by the leading researcher, Professor Albert Dahan, and his team at the University of Leiden in the Netherlands. It indicates that currently available data demonstrate M6G’s efficacy as well as its improved safety profile when compared to morphine.

The authors provide a comprehensive analysis of the available data on the site of action, disposition and elimination, analgesic properties and side effect profile of M6G in comparison to morphine. They conclude:

“In clinical studies, M6G is well tolerated and produces adequate and long lasting postoperative analgesia. At analgesic doses, M6G causes similar reduction of the ventilatory response to C0₂ as an equianalgesic dose of morphine but significantly less depression of the hypoxic ventilatory response (i.e. less respiratory depression). Preliminary data indicate that M6G is associated less than morphine with nausea and vomiting, causing 50% and 75% less nausea in postoperative and experimental settings respectively.”

Neil Clark, CEO of CeNeS commented: “We are delighted to see this positive review on M6G being published in a respected, peer-reviewed, scientific journal. The authors bring together the published data on M6G, demonstrating its attractive efficacy and improved side-effect profile. They also note that more studies are necessary before we may conclude definitively that M6G is superior to morphine for postoperative analgesia. Our current phase III trial is designed to do exactly  that and is comparing the performance of M6G against morphine in a large patient population to establish statistically that M6G has equivalent analgesia to morphine but reduced potential to cause nausea and vomiting.  

If this trial is successful CeNeS will have taken a major step forward in the development of M6G as a product replacement for morphine in the significant post-operative pain market. 

--ENDS-- 

For more information please contact:  

CeNeS Pharmaceuticals plc                                                    Tel: +44 (0)1223 266466

Neil Clark, CEO  

Northbank Communications                                                    Tel: +44 (0)20 7886 8150

Douglas Pretsell – d.prestell@northbankcommunications.com

Justine Lamond – j.lamond@northbankcommunications.com 

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: www.cenes.com  

About M6G

Morphine formulations are currently the gold standard treatment for the relief of moderate to severe post-operative pain. A limitation of morphine treatment is often the unpleasant side effects experienced, of which nausea is the most common. The active potent metabolite of morphine, morphine-6-glucuronide (M6G), may offer therapeutic advantages over morphine in having an equivalent analgesic effect, but with a reduced tendency to cause nausea, vomiting and respiratory depression. Phase II clinical trials have shown that M6G given intravenously produces equivalent analgesia to morphine to combat post-operative pain. Studies have also shown that M6G reduced the incidence of nausea and vomiting when compared directly with morphine. Other studies published recently in the scientific literature demonstrate that M6G also reduces respiratory depression compared to morphine. M6G completed a single dose, dose-ranging Phase III trial in mid-2004. The trial recruited 167 patients in hospitals in three European countries, suffering from post-operative pain following knee surgery carried out under spinal anaesthesia. The study compared the analgesic efficacy of a range of doses of M6G given intravenously, compared with placebo, A single dose of M6G was effective over 12h and through 24h, and positive trends in secondary outcome measures such as reduced nausea and vomiting were observed. A pivotal Phase III trial has now commenced directly comparing patients receiving M6G or morphine over a 24 hour period, with the aim of demonstrating that patients on M6G achieve equivalent analgesia to those on morphine, but with less nausea and vomiting.