CeNeS, Cambridge, UK, & ERGOMED, Frankfurt, Germany - 13 July 2006: CeNeS Pharmaceuticals (AIM:CEN), the Cambridge-based biopharmaceutical company, announced today that it is commencing two Phase II studies with its novel NMDA antagonist CNS 5161 in diabetic neuropathic pain and opioid refractory cancer pain respectively. The studies are planned to report results in 2007. 

At the same time, CeNeS and Ergomed also announced that they have entered into a Revenue Sharing and Co-development Agreement (“the Agreement”) whereby the parties intend to collaborate on a comprehensive development programme for CNS 5161. Seven Phase II trials are planned as part of the programme, including the two Phase II trials announced today. A detailed Product Plan has been prepared by CeNeS and Ergomed which sets out how the parties will collaborate to assemble Phase II data packages. 

Under the Agreement, CeNeS and Ergomed will work together to assemble a comprehensive Phase II data package with the goal of demonstrating that CNS 5161 can provide sustained pain relief to improve treatment in certain pain conditions.  Both parties will invest their respective expert internal resources and contribute funding into the programme to cover the external clinical trial costs. Under the terms of the Agreement, Ergomed is entitled to a share of commercial revenues generated from CNS 5161 in a ratio of Ergomed’s investment compared to the total development costs. Ergomed’s share of any revenues generated can be increased in the future if Ergomed, in agreement with CeNeS, takes responsibility for a further percentage of the investment required in the planned Phase II programme. 

In the first stage of the Phase II programme, announced today, there will be two studies focused on diabetic neuropathic pain and opioid refractory cancer pain respectively. 

The first study will be a double-blind, 3-way cross-over, acute study to compare the efficacy and safety of two doses of CNS 5161 HCl (250μg and 500μg) and placebo in 75 diabetic neuropathy patients with chronic, intractable neuropathic pain. This study follows the successful Phase IIa proof of concept study that reported in June 2005. 

The second study will be a Phase I/II dose-escalation study in 24 patients to establish the optimal schedule for infusion of CNS 5161 in the management of cancer pain. 

Once these studies are complete, the second stage of the Phase II programme is planned to include studies in other forms of neuropathic pain and post-operative pain. 

ERGOMED, an experienced clinical development company specialising in neurology and oncology clinical trial design and management, worked successfully with CeNeS on the most recent Phase IIa clinical trial of CNS 5161. The subsequent review of those results and analysis of expert clinical and commercial opinions has enabled CeNeS to establish the basis for the further clinical development of this compound which has significant potential in pain relief. 

Neil Clark, Chief Executive of CeNeS commented: “We are very pleased to be commencing the next set of Phase II trials for CNS 5161. There is a clear need for new treatments for neuropathic pain and the market is forecast to grow to at least $5 billion by 2010. We are also encouraged by the potential of CNS 5161 in the treatment of other pain types including opioid refractory cancer pain which is currently poorly treated. Ergomed and CeNeS have worked well together for several years and this agreement represents an exciting and efficient mechanism for continuing the development of our novel compound, CNS 5161. The combined expertise of CeNeS and ERGOMED significantly increases the chances of Phase II trials being completed successfully. The close relationship with a specialised clinical trials service provider such as Ergomed fits well with CeNeS’ outsourcing business model and removes one of the biggest issues facing smaller biotech companies in managing their clinical trials programmes”.  

Dr. Miroslav Reljanovic, Chief Executive of ERGOMED said, "We are delighted to invest in the development of CNS 5161, which has shown promising potential in Phase IIa trials to date and to continue the successful collaboration with CeNeS. The CNS 5161 clinical development plan which we have jointly prepared is flexible and comprehensive, based on our broad experience and expertise with the indications. This co development agreement is the first co-development deal we have signed and marks the launch of our dual business model".  

--ENDS-- 

For more information please contact: 

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

Neil Clark CEO 

Northbank Communications    Tel: +44 (0)20 3008 7556

Rowan Minnion – r.minnion@northbankcommunications.com 

Douglas Pretsell – d.pretsell@northbankcommunications.com 

Ergomed Clinical Research Ltd. Tel. +385 (0)1 4628500

Miroslav Reljanovic

About CeNeS

CeNeS (AIM:CEN) 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 www.cenes.com

About ERGOMED

ERGOMED is a specialised international clinical development company offering contract clinical research and co-development partnerships to biotechnology and pharmaceutical companies worldwide in the fields of neurology, oncology and immunology. Ergomed’s approach to clinical research ensures effective patient recruitment, reducing the time and costs of clinical trials and complementing the drug discovery capabilities of its customers and partners. The Company has a dual business model offering standard clinical trial management contracts and also co-development partnerships to share the risks and rewards of clinical development. Ergomed is headquartered in Frankfurt, Germany, and has offices in Croatia, Serbia, Poland, the UK and the USA. For further information visit www.ergomed-cro.com

About neuropathic pain

A range of primary diseases or conditions such as diabetes and shingles, or surgical procedures such as limb amputation can result in nerve damage which leads to a sustained chronic pain. This neuropathic pain is difficult to treat as traditional analgesics do not provide adequate relief for many patients. One of the most common forms of neuropathic pain is associated with diabetes, a poorly treated chronic condition that affects over 4 million patients in the US and Europe.   

Drug treatments for neuropathic pain represent a significant area of unmet medical need and a growing market opportunity and the total neuropathic pain market is forecast to grow to at least $5 billion by 2010. Glutamate (particularly NMDA) receptors have been implicated in the induction and maintenance of neuropathic pain and NMDA antagonists may represent a class of drugs for effective relief of neuropathic pain. 

About cancer pain

Pain is commonly associated with cancer.  It has been estimated that nearly 3 million patients in the seven major markets will require treatment for cancer pain annually, and that approximately 75% of late stage cancer patients suffer from moderate to severe pain (Datamonitor).  Cancer related neuropathic pain may have a number of causes, either directly related to a tumour, or indirectly related to surgery, chemotherapy and/or radiotherapy.  Drugs used for the management of cancer pain and cancer related neuropathic pain include opioids combined with NSAIDS, adjuvant analgesics, tricyclic antidepressants and anticonvulsants.  Opioids are commonly used for managing moderate to severe cancer pain, but it has been estimated that around 20% of patients will experience opioid-refractory pain.   

About CNS 5161

CNS 5161 is a blocker of the NMDA ion channel and has completed Phase IIa proof of concept clinical trials as a novel compound for the treatment of neuropathic pain. 

Two Phase I studies using CNS 5161 administered intravenously have been completed in male volunteers. The first study demonstrated the safety and tolerability of selected doses of CNS 5161 and the second that, at a dose of CNS 5161 that was well tolerated, analgesic effects were evident in an experimental model of pain. 

Two Phase IIa studies have been completed giving single dose intravenous infusions of CNS 5161 to patients with long standing intractable neuropathic pain. A total of 48 patients have received CNS 5161; 10 patients in an initial study and 38 patients in a study completed in 2005. CeNeS announced results for the second of these Phase IIa trials of CNS5161 in 2005. Both studies reported analgesic effects of CNS 5161 at doses that were well tolerated by the patients.