Printer Friendly


For immediate release

CeNeS and ERGOMED announce Revenue Sharing and Co-Development Agreement for CNS
5161 and commencement of two Phase II studies in diabetic neuropathic pain and
cancer pain

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 (250[eth]-g and 500[eth]-g)
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".


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

Douglas Pretsell

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


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

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

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

COPYRIGHT 2006 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire UK Disclose
Date:Jul 13, 2006
Previous Article:FUN TECHNOLOGIES PLC - Announces New Senior Executive Appointments.
Next Article:CENES PHARMACEUTICALS PLC - Acquisition(s).

Terms of use | Copyright © 2018 Farlex, Inc. | Feedback | For webmasters