Preliminary results for the year ended 31 December 2006
Product profile of lead drug candidate confirmed in large Phase III study International partnering process to commerialise M6G underway
CAMBRIDGE, England, March 28, 2007 - CeNeS Pharmaceuticals plc ("CeNeS" or "the Company"), the CNS focused developing specialty pharmaceutical company, today announces its preliminary results for the year ended 31 December 2006.
M6G - post-operative pain
* Successful major Phase III study results announced
* showing clear benefits over morphine in management of post-operative pain * demonstrates the unique product profile
* IND submitted to FDA in March 2007 * Strengthened M6G intellectual property position * Actively pursuing M6G partnering deals
CNS 5161 - cancer pain and neuropathic pain
* Signed Revenue Sharing and Co-Development agreement with ERGOMED * PhaseI/II cancer pain study to start recruitment in mid 2007 * Second Phase II study in neuropathic pain to start later in 2007 * Phase II clinical supply manufacturing completed early 2007 * Acquisition of transdermal patch formulation IP enabling development of high value transdermal formulation for neuropathic pain
CNS 7056 - short acting sedation/anaesthesia
* Japanese, Hong Kong and European patents granted for short acting sedative * Encouraging pre-clinical studies
* reveal rapid onset and offset of sedative action and rapid metabolism * support the potential to expand the indications into anaesthesia
* Further studies in anaesthesia initiated with a large pharmaceutical company * The first CNS 7056 academic paper has been accepted for publication in "Anesthesiology" a leading journal
COMT inhibitors - Parkinson's disease
* Pre-clinical development candidate for Parkinson's disease progressing well * Several potential lead candidates have already been identified
* M6G partnering process has commenced. Phase III clinical data clarifies the value of the opportunity * Licensing discussions ongoing in relation to earlier portfolio programmes * Agreement signed with Rodman & Renshaw - appointed to assist in partnering of M6G
* Scientific Advisory Board (SAB) strengthened * Further progress in portfolio of carried interests
* Fund raising of ?.5 million net of expenses through placing new shares * Increased net loss after tax of ?.7 million (2005: ?.7million restated) due to planned increase in clinical development activities on M6G Phase III trial * Cash at year end of ?.3 million (2005: ?.5 million)
Alan Goodman, Chairman of CeNeS, said:
"CeNeS has taken a major step forward in the development of M6G and is now well placed to successfully commercialise its lead asset. The partnering process has begun and the Company is well positioned to deliver significant value to shareholders in the near-term."
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: www.cenes.com.
About M6G Morphine formulations are 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 and vomi ting are the most common. Post operative nausea and vomiting ('PONV') is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life.
The active potent metabolite of morphine, morphine-6-glucuronide (M6G), offers therapeutic advantages over morphine in having an equivalent analgesic effect, but with a reduced tendency to cause nausea, vomiting and respiratory depression. Phase II and III 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 in the scientific literature demonstrate that M6G also induces less respiratory depression compared to morphine.
The press release can be downloaded from the following link:
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