Header updated on 24th April 2008

Market has been looking for an announcement re a licensing deal for Cetilistat, the obesity drug; instead it has been hit with the withdrawal of Renzapride, colonitis drug, following an unauspicious performance at Phase III. Folloiwng has been edited to reflect the situation

Alizyme is a speciality biopharmaceutical company that has been developing product categories for inflammatory gastrointestinal disorders, obesity and supportive cancer care . It is currently trading at a five year low of around 27p with a market cap. of around 60m. Prudential owned a near 20% stake (reduced in sale today?) There was good institutional taku-up of a placing in March rasing 10m at 50p; no wonder there has been "angry" selling. The directors hold 3.34million shares or about 1.7% of the equity (of which Tim McCarthy, CEO has 1.1million); thus, after some 10 years of development effort, they must be comletely focused on the success of the company and multiplying the value of their holdings (but with real doubts about their marketing competence). Alizyme had previously raised capital sums in the past three years at around 70p and 100p so it was somewhat surprising to see the share fall through its 70p support level. Clearly one reason is the current disaffection with the biopharm. market. Another has to be disappointment for the failure of the CEO, Tim McCarthy, to deliver on his expectation that 2007 would be a transformative year. The key question is whether 2008 will be that year and when is it likely to happen? The following points are relevant:

1. Alizyme did sign one deal in late-2007: with Prometheus Labs (U.S.) for the Colal-Pred, at a potential market of $250m, the smallest potential of their four products. Prometheus pay $2.5m up-front with a total of $15m payable upon future development milestones. They are responsible for all US development costs and will pay Alizyme undisclosed royalty rates which will increase with net sales. The deal was followed by a Japanese licensing agreement (which also gave Alizymen access to additional potential drug candidates).

2. This perhaps sets a precedent for subsequent deals for their other products. Cetistat (obesity) has an estimated potential of $1 billion p.a. sales and ATL-104 (mucositis) has a potential of $500m sales. The U.S. FDA has encouraged AZM to also launch a Phase III exercise for Cetistat for all diabetes sufferer because of positive II results for diabetes sufferers who also suffer from obesity.

3. Whilst the development programmes for the other drugs are on-going and appear to be satisfactorily funded from present resources, this is not the case for Cetilistat. The "Product and Company Update statement" (7th Jan 2008) says that 'the Phase III development programme is now ready to commence following the conclusion of a commercial deal'. So, perhaps for the first time, the development programme would be delayed if there was not a funding deal in either the U.S. or Europe. The reason for the sp shooting to nearly 200p in 2004 was the signing of a deal with Takada of Japan for some $50M development funding.

In response to a question at the Conference to report the Renzapride fiasco, McCarthy seemed pleased that there were six potential bidders for Cetilistat; however, that implies any announcement is some time away. When it comes, however, taking a line from the Takada and Prometheus deals it would seem likely that there would be of the order of $100m funding to support development. Of course, the major cash flow will be from licensing of actual sales. The analysts do their own discounted cash flow exercises; those seen tend to dwarf current valuations of the company.

There is not a strong argument for jumping in unless and until the sp establishes a baseline. Given the peaks in the sp, the time will probably come when there will be a very significant jump. An alternative scenario, is that management continue to rpove their level of incompetence and a buy-our results. Clearly the strength of the company is in their biochemists.

Eric

capa

Here is a repeat from an earlier post, quoting from the Times, the day after the interims when they had an analysts presentation:

"Richard Palmer, CE, said that talks aimed to finding a partner to help to bring AZM's fat-busting treatment to the market were continuing with several parties, but insisted that the company was unlikely to announce a deal before next year. He said that the main priorities for AZM was to find a partner committed to seeing its obesity treatment ... reach the pharmacy shelves."

My point is that Alizyme management never say anthing that doesn't happen - in sharp contrast with quite a few others (ASOS don't need to say anything as it just happens!). If Palmer (given that he was properly reported) says "unlikely to announce a deal before next year" then he means that they will announce a deal next year and probably early. You could, however, be right that they will wait for the diabetic trial to complete in order to get the best deal. However, whilst I think it would give them an important discriminator and must be worth the extra wait, AZM must be very confident of the ouitcome to do it and there must be competition to get hold of this drug. You get the clear message that AZM are choosing the best aprtner who will be fully committed to give this appropriate priority and marketing muscle. Good to have other insights!

The price is back somewhat, suggesting that the price rise is on broker recommendations rather than an imminent announcement. Alternatively, it is in response to my CFD as a punishment meted out for over optimism (ASC easing back too!)

Eric

Eric

Yes I forgot that the article specifically referred to ATL-962, I thought incorrectly that it was all encompassing, always assuming as you say that the report was accurate.

I do feel that media is fixated with the obesity drug and AZM sometimes are reported as a one trick pony, when in fact Renzapride is also a potential blockbuster.

If and when regulatory approval for Phase III trials for COLAL-PRED and Renzapride are granted which could be by the end of the year bearing in mind Nomuras comments after the interims, I would expect to hear about partners for these two not long after.

capa

EW...Just thought I would update you on MBP trial results

Press Release
Successful trial results for world-first obesity drug
Monday 13 December 2004, Melbourne Australia: An Australian-owned obesity drug, developed by Melbourne-based
biotechnology company Metabolic Pharmaceuticals Limited, is set to enter final human trials next year after successfully
completing a Phase 2b human trial which proved that the drug induces weight loss and is very well tolerated with no evidence
of the side effects commonly experienced with existing obesity drugs.
The drug, which stimulates the metabolism of body fat, is the first of its kind in the world. All other obesity drugs artificially
reduce appetite or food absorption.
The drug codenamed AOD9604 was taken orally once daily by 300 obese patients at five trial sites over a 12-week
period. Six doses were used 0 mg (placebo), 1mg, 5 mg, 10 mg, 20 mg and 30 mg.
The group receiving the 1mg dose lost the most weight, averaging a weight loss over the 12 weeks of 2.8 kilograms, more
than triple the weight lost by those on placebo, who lost an average of 0.8 kilograms. The rate of weight loss was maintained
throughout the treatment period, an encouraging trend for expectations of longer-term dosing.
The weight lost by the 1mg group was slightly more than that achieved by the worlds largest selling prescription obesity
medication in similar trials over the same period, without its troublesome side effects. The trial results also demonstrated a
small but consistent improvement in cholesterol profiles, and a reduction in the number of patients with impaired glucose
tolerance.
Obesity is the Western Worlds most common health problem, and has reached epidemic proportions according to the World
Health Organisation. More than 20% of the adult population in developed countries are obese more than 300 million adults
worldwide. In addition, more than 50% of adults in developed countries are overweight. Obesity is associated with other
health-related problems such as heart disease, cancer and diabetes.
AOD9604 is based on a small part of the human growth hormone molecule. This hormone, which occurs naturally in the body
and which stimulates fat metabolism, is suppressed in obese people.
We are delighted with these results, stated Metabolic Pharmaceuticals CEO, Chris Belyea. The evidence from the trial is
that over 12 weeks AOD9604 induces competitive weight loss with accompanying health benefits at a low dose and has
superior tolerability. Our next major focus is a partnership with a major pharmaceutical company to assist in financing late
stage longer term human clinical trials for worldwide marketing approval as a prescription treatment.
Prof. Gary Wittert, Adelaide-based Principal Investigator on the study, said: As the worlds first drug with a metabolic
mechanism of action AOD9604 could occupy a unique position among the options available to doctors for the management
of obesity. It is pleasing that the invention and its development from the laboratory bench has been an allAustralian effort.
Prof. Louis J Aronne MD, President of the North American Association for the Study of Obesity and a member of Metabolics
Clinical Advisory Panel, said: "This is an exciting new approach to a problem which has defied easy solutions. We will need
many different treatments if we are going to manage obesity successfully, in much the same way we have many treatments
available for diabetes and hypertension".
For more information:
Chris Belyea or David Kenley
Metabolic Pharmaceuticals Limited
Ph: 03 9860 5700
Richard Allen Simon Watkin
Oxygen Financial Public Relations Market Connect Investor & Media Relations
Ph: 0403 493 049 Ph: 0413 153 272

capa

Very helpful post. Clearly an AZM competitor but they say that competition stimulates market. I note the comment that "we will need many different treatments...". All pretty quiet on the AZM front after the excitment on no news a month or so ago. I think it is one for the new year, but I will strengthen my position on weakness (and as funds are available!).

Eric

From a technical approach - the Golden cross is just about to be met!! Could see a continued run upto 160's by mid JAn05, and probably stabalise till the next lot of newsflow in the 160 - 170 bracket. Any news will then see a rise of 20% at least - back to the rightful side of 2.00

seagullsslimjim

Interesting analysis. The charts do look positive but could you explain the golden cross please. Presumably crossing trend lines but which ones? From a fundamentals viewpoint, I see demand increasing with new year speculation of licensing agreements - for obesity drug in particular. Your figures appear very reasonable but I would put the jump as larger on a positive announcement re obesity deal.

Eric

The golden cross consists of the 200 stock market average crossing above the 50day SMA. Certainly conservative re licensing - the next 3 months could well indeed catapult this share 50% - but seeing is believing . Although I have faith in the company we must not become over focussed on thinking these are the only drugs in the world looking for type approval.

Jim

Jim

Thanks for that - certainly crossing over with a vengeance and I can see that its positive for MA50 to be in the lead. The chart makes an interesting pattern: sort of an inverted head and shoulders; it looks ready for a push to challenge previous peaks. Indicators look very good: Momentum, RSI and MACD. I see AZM as something special in their drug selection and management; a really dedicated management team putting the best part of their lives into their (our) company. By the way, posting from Whistler (marvellous skiing today) so not nearly New Year yet but hope this is the first post of your New Year. Happy New Year AZM investors.

Eric

Just a post to keep AZM in the mind's eye. My money is on a licensing deal for the obesity drug before that long: 50% Q1, 30% Q2, 10% Q3, 10% Q4 or later. Results last year were 1st April so probably then if not earlier. Time to build up a position but don't leave it too long! Price likely to go to 250p at least.

Eric

Prelims and annual Report 1/4/2005 Agm 3/6/2005. It is a hell of a long time to be crossing one legs. %-)

Positive write up in Shares mag this week.

Fred1New

I think the main thing is not to be sitting crossing your legs; you need to have an occasional visit to the loo anyway. Better posture is to sit with your hands under your bottom so thay don't sneak out and hit the sell button! I'm sitting with five shares which have some form of reporting over the next month so there is plenty of excitment there. So AZM can just sit there gradually increasing in value with some buys and fewer sales. Then the announcement! Away for the stars! No particular reason why it should be with results although, if not before then, we should get an update. In a way, I hope its not in the next month because after that it will be easier to salt away a decent position in AZM. My aim is to build up to 'overweight' by the results.

Eric

114p ?

Hello, doctor! Not so mad, I think. I sold out on the RNS and had chalked in 115p as the level to buy back in. I was obviously part of a collective opinion that said that AZM are playing it long, again. OK! They've been at it for some 9 years so what's an extra year or two between friends. Frustrating though, particularly for those investors with trading instincts. Important to be in when the news breaks - that's the difficult thing!

Eric

Eric , hi , glad to hear you are out. Just posted hoping to get some sort of response because I am now looking for an entry but downside momentum too great at the mo , chart says 120 or 114 but we will have to see if we get there. Don't follow fundamentals much , rely on you for that! but somewhere in the back of my brain is the fact that Unilever have taken a slimming product from somebody else and I was wondering if that was affecting sentiment.

Doctor. The obesity problem is so huge (!) that I expect there is room for various solutions as we discussed before. Slim or reduce the appetite or remove the fat: some will try one, some will try them all, some will glorify and waddle in their fatness and provide excellent work for the medical profession! Billions of $ all round, particularly for the slim Jim professionals!

Eric

AZM seems very quiet at the moment.

Just re-read this thread haven't seen below reported. Good news but seems a long time away.

With this news I would have expected price up not down. Although looking at the chart by candle light I don't know.
Will it be this years winner?


Alizyme is fighting the good fight against ills brought on by the good life. The development-stage biotechnology company licenses drug candidates and develops them. It targets conditions prevalent primarily in industrialized countries, including obesity, irritable bowel syndrome, inflammatory bowel disease, and type 2 diabetes often associated with obesity. Alizyme is focused on developing a family of lipase inhibitors, which prevent the body from absorbing fat. In addition to its pipeline of treatments for lifestyle-related conditions, the company is developing a drug for mucositis, cancer therapy-induced damage to the gastrointestinal tract.

""""""""""""""""""""""""""""""""""""""""""""
Alizyme opens Investigational New Drug application with FDA for obesity drug

LONDON (AFX) - Alizyme PLC said it has opened an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a clinical trial in the USA of ATL-962 in obese patients.
ATL-962 acts in a similar way to Xenical, the anti-obesity drug marketed by Roche Holding AG, which has current sales of approximately 500 mln usd.
Opening an IND for ATL-962 allows Alizyme to discuss the development of the product with FDA in preparation for Phase III studies and ultimately for registration in the US.
Results of the trial are expected to be available around the end of 2005. Patient recruitment is also ongoing in Europe for a Phase IIb clinical trial of ATL-962 in obese diabetics, Alizyme said.
This study in up to 600 patients, is expected to report results at the end of 2005.
ATL-962, an inhibitor of gastro-intestinal lipases, is designed to cause weight loss by blocking the digestion and thus the absorption of fat from the diet.
newsdesk@afxnews.com
"""""""""""""""""""""""""""""""""""""""""""""""

Fred

The news is good - for the long-term investor. If you are happy to tuck your investment away for a couple of years than it will multiply. As I posted earlier, my interpretation of this report was that they are playing it long. They've been going at this is for some 9 years. I expect, that the drug majors look upon them as a realtively small company and think they can strike a hard deal or swallow them up. No thankyou, say AZM management, we will take it right down the line ourselves until the major hurdles have been surmounted and the value is there for all to see. Who can blame them? But, if you are looking for quick investment returns like me, and many others on these threads, that's not quick enough. I keep watching the situation closely looking for any sign of licensing action but nothing yet on the horizon. Anyone think differently?

Eric

Good buying today with some sizeable trades; pretty well one way. Could be some rumours around the city. Decided that I couldn't bear to be out and have started a new position. Any inklings?

Eric

The answer to my own question is that there was an excellent article in the IC (sorry Shares but they do do one occasionally!) recommending AZM as a BUY. Accepts "AZM as out of favourt as investors lose patience waiting for the company to sign licensing deals with Pharma giants". Note the following quotes:

- "at current levels they are looking attractive again - especially as AZM have two drugs entering late-stage clinical trials this year. So the company could soon be a credible takeover target again".

- "Analysts anticipate that AZM should hopefully license both Renzapride and COLAL-PRED this year with a licensing deal for ATL-962 in 2006"

- "On the downside, AZM could have to raise further capital soon, unless it signs a lucrative licensing deal. Its cash is due to run out ine arly 2006."

- "At current levels, the shares look worth a gamble. Buy"

I see the fact that cash is due to run out as positive encouragement that they press ahead with licensing deal(s). The article predicts the market for irritable bowel-syndrome, Renzapride, as 3bn a year; for ulcerative colitis, COLAL-PRED, as 300 million; for anti-obesity drigs (ATL-962) as 1.4bn by 2012.

sp is starting to move ahead from its support level with demand growing and no sellers. Have taken out a CFD this morning for 15K shares, a one-sided bet but one that may require patience (of which I do not have a plentiful supply).

Eric