Shares mag. recommending this stock this week. Is this going to be our killer this christmas!!!! any comments anyone?????

Yes, it's a strange feeling - such fantastic news and yet so little sp activity. They say the market's never wrong but surely in this case.....?!

Lets hope so Queen,if this is anything to go by i am tempted to sell my small stake in IQE,should that sp fall on expected good news.

Here is this mornings email from cenes in full-


CeNeS Pharmaceuticals plc

Successful Phase III results announced on Lead Product M6G
Phase III trial in Europe demonstrates M6Gs benefit compared to morphine in the treatment of post-operative pain


Cambridge, UK, 20th February 2007 - CeNeS Pharmaceuticals plc (AIM: CEN), the Cambridge based biopharmaceutical company, today announces preliminary results of the pivotal Phase III trial (M6G022) of M6G (morphine-6-glucuronide) in over 500 patients with post-operative pain. This study is the largest carried out to date with M6G and has delivered very strong results with M6G showing benefits over morphine in the management of post operative patients. M6G022 demonstrates the unique product profile of M6G with equal analgesia to morphine but with reduced nausea and vomiting.

Phase III trial results

1. M6G matches morphine for analgesic effect

Importantly for a novel pain product, the trial results unequivocally show that M6G is as good as morphine in terms of analgesia achieved in patients up to 48 hours post-operatively. Successful achievement of this first primary endpoint supports data from previous clinical trials of M6G and is an essential component in the product profile of M6G.

2. M6G shows significant reduction in post-operative nausea and vomiting compared to morphine

The trial results confirm the excellent potential of M6G as an analgesic with a clinically significant improved side effect profile compared to morphine. The study results show that patients receiving M6G experienced a 28% reduction in the severity of post-operative nausea and vomiting (PONV) in the key 6 24 hours after treatment (statistically significant, p=0.018).

In addition, the incidence of dry retching/vomiting in the M6G arm compared to the morphine arm in the 24 hour period after treatment was reduced by 32% (statistically significant, p= 0.044). The incidence and severity of post-operative nausea in the M6G arm was 27% less than that observed in the morphine arm in the period 6 24 hours after treatment. This was the second primary endpoint and approached statistical significance (p=0.052).

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 vomiting are the most common. PONV is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life.

M6Gs lower propensity to cause nausea and vomiting in the post-operative period strongly supports CeNeS belief in the potential of M6G as a novel product for the treatment of post-operative pain with clear advantages over morphine.


The global market was valued at $1 billion in 2000 and growing at a rate of 6-7%.

3. Safety profile/adverse events

The trial confirmed that M6Gs safety profile is similar to morphine. Aside from nausea and vomiting, the adverse events reported were at levels similar to those experienced by patients receiving morphine in a post-operative setting.

Dr Alexander Binning M.B. Ch.B. FRCA, Consultant Anaesthetist at Western Infirmary, Glasgow and Principal Investigator on M6G022, commented: These data demonstrate that M6G is equivalent to morphine in its analgesic properties. It also shows a clear improvement in managing post-operative nausea and vomiting and has significantly advanced the development of M6G as a potential new drug.

Neil Clark, Chief Executive of CeNeS, commented: These results strongly confirm our belief in the excellent potential of M6G as a novel product for post operative pain. The quality and breadth of the data contained in this large study support M6Gs anticipated product profile. With the completion of this large European study CeNeS is confident that it has a substantial data package that differentiates M6G from morphine which will be attractive to a larger pharma partner to licence. CeNeS intends to file an IND (Investigational New Drug application) for M6G with the FDA in the next few weeks. The data from this trial will also be submitted for publication in a scientific journal in due course.


The successful completion of this large, pan-European study demonstrates the excellence of our clinical development team and the quality of the clinical trial protocol. Following this success we now look forward to working with partners to register M6G as a product in major markets.


M6G022 Study Design
The study involved 24 centres in six European countries and recruited 517 patients. The study was designed primarily to provide key information on a comparison of effective intravenous pain management regimens of M6G or morphine treatment for a minimum of 24 hours (and up to 48 hours) following major abdominal surgery. Morphine is generally accepted as the gold standard drug for use in these circumstances. Initial pain management was achieved by administration of a loading dose and titration of either M6G or morphine to achieve acceptably low levels of pain for the patient to go onto the ward. In the ward, pain management treatment was achieved by patient controlled analgesia (PCA), whereby the patient was allowed to self administer a dose of M6G or morphine as required to control their pain. The study was randomised and double blind so that neither patient nor carer was aware of which treatment was being administered. The main purpose of the study was to demonstrate statistically that:

- treatment with either M6G or morphine, particularly during PCA, results in similar levels of pain management; and

- effective analgesic treatment during PCA results in lower levels of nausea and vomiting in patients receiving M6G compared to those receiving morphine.

In addition, other important side effect, efficacy and safety features were determined throughout the study.


M6G Commercial Strategy
CeNeS has commissioned a number of qualitative market research studies on M6G, which have been carried out by independent market research agencies with extensive experience of the pain market. The outcomes of these studies, involving interviews with clinicians and payers in major markets, support CeNeS view that potential global peak sales of M6G in post-operative pain could reach $400 million. This is underpinned by a clear need for an improvement on existing drugs for moderate to severe pain which do not offer the attractive M6G profile of morphine-like pain relief with reduced side effects.

CeNeS believes that the positive results announced today from M6G022 will enable the Company to secure valuable licensing agreements for Europe and North America with partners able to offer strong specialist marketing, sales and distribution capabilities within the hospital sector. CeNeS intends to explore all opportunities to capture value from any such licensing agreement including the possibility of retaining promotion or co-promotion rights within certain territories.

CeNeS is in discussion with a number of potential partners and is confident that the positive results from M6G022, together with the extensive package of clinical, non-clinical and manufacturing data provides an attractive package for out-licensing.

--ENDS--


There will be a teleconference briefing for analysts and investors today at 9.00am. For details please contact Mo Noonan on +44 (0) 207 831 3113 or mo.noonan@fd.

Suspect that the market is going on the principal of "Show us the Money". Two major steps still need to be overcome to hit the jackpot
1) FDA approval - by no means guaranteed.
2) Licensing deal.
All today has done is to greatly increase the chances of success. If you have belief
this could give you an excellent chance to top-up

Am guessing on institutional seller, but also results are not as good as expected.

Could anyone help on my below assumption by filling in the figures

1. Total Morphine Sales
2. % of people sick when taking morphine

1*2= potential market as would expect CEN drug to be back up if costs more than morphine --- i.e. used as substitute to morphine when patient sick

Anyone know?

Just as well the trials were positive. As if not, the share would have been south of 5p by the look of it

Leaving me in pain and feeling somewhat sick !!! :-O

No gain without pain!

Joined you today on the news, lets hope it has the same run as my ASM who also have a drug in phase three looking for a deal. As you say when the news gets more widely known this is going up.

Driver, could be a really good future for CEN, I've been holding for a couple of years, very small amount but topped up today. I have to take morphine on a regular basis, whilst I have got used to it there are still some side affects and I think that CEN may well have produced an excellent alternative. This could be a real winner.

Kim
I agree the M/Cap is far to small for cen with a drug thats an alternative to morphine I would imagine there are millions of people world wide that suffer side effects and would love to try some thing different if they had the choice.

Yes Driver, the prospects are huge if approval is given, there is still some way to go but it certainly looks good at the moment.

Interesting to speculate that in addition to patients receiving CEN's M6G experiencing a 28% reduction in the severity of post-operative nausea and vomiting, and a 32% reduction in dry retching/vomiting, compared to morphine; the proportion of patients taking M6G who also just "feel better" with M6G in comparison to morphine, would probably be even higher, so the benefits of M6G may be even greater than indicated in the successful headline figures!

There appears to be a large seller causing some of the market makers to hold down the share price, otherwise it looks OK. Hopefully the sells will soon clear and the price will be rerated upwards, particularly now the European Phase PIII M6G results have been positive.

I hope so Ludlow Castle as the SP performance since the announcement has been truly disappointing.

queen1, consider the following:

1) M6G just passed pivotal PIII European trial. Should be on the market in 2008.
2) IND to go directly into USA PIII M6G expected to be filed in next few weeks.
3) Deal for M6G anticipated or take-over of CEN possible.
4) CNS 5161 already in PII and a potential blockbuster.
5) CNS 7056 and COMT inhibitor to enter PI's during 2007. Potential blockbusters.
6) Objective Capital valued CEN at 27p, even before the good M6G PIII results.

A disappointing fall today on relatively small volumes. Still very early days for M6G so I think there is a way to go yet before we see any sp movement.

johnny, the small sellers this week have just been shaken out by the fall in the share price caused by the recent big seller.

Furthermore, M6G has just passed European PIII and is not therefore in "early days" as you say.

4 market makers now blue. The share price could bounce high and fast once the big seller ends imo.

Ludlow, I meant 'early days' in as much as there is yet to be any cash generated. I have been accumulating for twelve months & would hate to see cen swallowed by a t/over just as the products are coming to fruition.

The potential market is huge.

Good luck

The Times (Online)
21st February 2007
Robin Pagnamenta

Synthetic Morphine Trials Give Booster to CeNeS

Shares in CeNeS Pharmaceuticals rose sharply yesterday after the Cambridge biopharmaceutical company announced encouraging final-stage trial results for its synthetic morphine drug, M6G.

Preliminary results of a European trial of 500 patients using the drug for postoperative pain showed it worked as effectively as morphine but with less severe side-effects.

The opiate morphine is one of the most commonly prescribed drugs for relief from postoperative and cancer pain as well as pain associated with trauma but it frequently causes vomiting, respiratory problems and constipation as well as being highly addictive.

The study showed that patients receiving the synthetic version of the drug experienced a 28 per cent reduction in the severity of postoperative nausea and vomiting in the six to 24 hours after treatment.

The global market for a less harmful synthetic version of morphine could be worth as much as $500 million (255 million).

Its a decent late-stage trial result, said Navid Malik, pharmaceuticals analyst at Collins Stewart.
Neil Clark, CeNeS chief executive, said: With the completion of this large European study CeNeS is confident that it has a substantial data package that differentiates M6G from morphine, which will be attractive to a larger pharma partner to licence. The company, which is planning to seek approval from US regulators for the drug in the next few weeks, is currently seeking a licensing partner to market the drug in Europe.

CeNeS was founded in 1997 and is listed on the Alternative Investment Market.The shares rose nearly 3 per cent to 8.625p.

As well as its synthetic morphine drug, the company is developing additional pharmaceuticals for Parkinsons disease and schizophrenia.

Ludlow Castle, my comment was on the market reaction rather than CEN Thanks for the pointers though.