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

All good info Ludlow thanks, it realy is just down to Xenical and Cetilistat, and as we know so far in trials Cetilistat is superior.

Another post copied from ADVFN, this time about Alizyme's Renzapride:

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QAZWSX123 - 10 Jun'07 - 16:20 - 6997 of 6999 edit

Birdie4 (Post 6995) let's not overlook AZM's Renzapride for c-IBS (35% of IBS sufferers) and m-IBS (40% of IBS sufferers) which could be huge.

Sales of Novartis's Zelnorm in just c-IBS (it did not address m-IBS) reached a substantial $561m pa in the US (it was not on sale in Europe) and were rising steadily (predicted to exceed $1 billion pa) before being suspended. AZM's Renapride addresses both c-IBS and m-IBS, appears to be more efficaceous and safer than Zelnorm (Renzapride and Zelnorm are not members of the same chemical class and Renzapride has undergone an additional safety trial) and could get approval in the US and EU. Hence, sales of AZM's Renzapride for c-IBS and m-IBS in the US (SPA granted and currently in PIII for c-IBS) and EU could potentially surpass $2.5 billion pa. AZM's Renzapride is potentially a mega blockbuster!

P.S.
Renzapride sales royalties to AZM @ 15% of $2.5 billion pa = $375m pa (190m pa) = approx 95p Earnings Per Share (currently 200m shares) and if then trade on even a modest PE of 12 = a future share price based on just Renzapride when at peak sales = 11.40. (Need to discount this back, to give a Discounted Present Value; but it does illustrate the potential for future explosive growth).

From the ADVFN site:

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QAZWSX123 - 11 Jun'07 - 20:39 - 7006 of 7006 edit

Just checked the Acomplia Report site again. More ugly safety data has been released for Sanofi's Rimonobant/Acomplia and it looks like its all going pear-shaped. Two further suicide attempts by patients taking Acomplia (Rimonobant) have been reported, plus 74 possible and/or definite cases of suicidality outnumbering placebo 3 to 1, 11 likely or possible cases of "seizures", 4 confirmed cases of multiple sclerosis, 15 reports of thoughts of or planning for suicide, 4 reports of delusional symptoms, 6 reports of psychotic behavior (including a man who attempted to strangle his daughter) and 5 reports of aggression (including a man who beat his wife).

I cannot see Acomplia getting US prescription approval now, or ever getting OTC approval in the US.

I would not be surprised to see the European regulators now withdrawing Acomplia

Excellent indirect implications for the competitive positioning and value of AZM's Cetilistat imo.

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FDA DELAY ON DIET PILL ACOMPLIA (RIMONABANT) TIED TO SUICIDE, SEIZURES
11th June 2007

http://www.acompliareport.com/News/news-061107.htm

The long delay in FDA action on diet drug rimonabant (Acomplia / Zimulti) is the result of concern over "increased frequencies of psychiatric adverse effects" including suicide and seizures, the agency's staff disclosed on June 11th.

The confirmation of long-rumored FDA worries over the neuropsychiatric side-effects of this novel diet drug -- which works by blocking the CB1 receptors in the brain -- came in a briefing paper prepared for the June 13th airing of issues surrounding rimonabant by an FDA panel of outside medical experts.

The staff report suggests that rimonabant's developer, Sanofi-Aventis, is in for a rough day Wednesday, and that without a favorable recommendation by the advisory panel, the FDA may well decide in July to defer approval of sale of rimonabant in the United States until it has more data -- perhaps until 2010.

"Among the most significant adverse events throughout the Phase 3 (clinical trial) program were those in the primary System Organ Class (SOC) Psychiatric Disorders, specifically depressive events, anxiety, psychomotor agitation, and sleep disorders," the FDA staff said.

While the FDA reported only two completed suicides during the trials by participants on Acomplia, the "possible and/or definite cases of suicidality" during the trials identified by a Columbia University team that advises the FDA totalled 74 with those on rimonabant outnumbering those on a placebo by almost three to one.

The staff also pointed out that an unusually high percentage of participants withdrew early from the clinical trials, the staff reported, "with more rimonabant subjects doing so due to depression, anxiety, mood alteration with depressive symptoms, and the need for antidepressant medication.

"Given the lack of systematic follow-up of these subjects and rimonabants long half-life (the time it continues acting after a person stops taking it), the results of the above analyses should be viewed as incomplete at best and at worse as an underestimate of rimonabants risk for suicidality," the staff said.

The FDA said that subsequent to Sanofi's submission of a safety update on Acomplia trials that are still continuing in March 2007, it has received 2 additional reports of suicide attempts - one by a 60-year-old female and the other by a 56-year-old male taking rimonabant in the CRESCENDO trial.

The staff said the FDA also has been maintaining a log of all adverse event reports reported by patients taking Acomplia in countries where it has been approved for sale.

The agency said that in addition to 15 reports of thoughts of or planning for suicide, it had received " 4 reports of delusional symptoms, 6 reports of psychotic behavior (including a man who attempted to strangle his daughter), and 5 reports of aggression (including a man who beat his wife.)"

The FDA said data from countries where Acomplia is being marketed also "reveal that reports of nervous system disorders are frequent (15% of adverse events reported) and are driven predominantly by dizziness."

The staff also reported that experts had identified 11 likely or possible cases of "seizures" among participants in the clinical trials, as well as four confirmed cases of multiple sclerosis among trial participants taking rimonabant.

During the trials, the staff reported that dizziness and vertigo occurred with greater frequency in the rimonabant 20 mg group...motor impairment occurred with greater frequency (driven predominantly by tremor and balance disorder)... .and cognitive disorders occurred with greater frequency ... driven predominantly by mental impairment, somnolence, and disturbance in thinking/perception.

"These neurological adverse events may well have contributed to the disproportionate number of subjects who sustained injuries (contusions, concussions, falls, road traffic accidents, whiplash, and injuries) during the RIO trials in the rimonabant 20 mg group," the staff added.

I never have been a fan of Acomplia, far too complex.
I think AZM will have a deal(s) in the bag July/August time, whats your stance Ludlow?

I agree but also suggest Alizyme could conclude a deal for Cetilistat at any time after tomorrow (when the FDA's Advisory Committee meets to consider Acomplia). There is also a high chance of a take-over.

Two more from the ADVFN site:

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QAZWSX123 - 12 Jun'07 - 13:48 - 7019 of 7026 edit

Another item just published on the Acomplia Report website. 30% of US fatties on diet drugs are also taking anti-depressants, which should exclude them from taking Sanofi's Rimonabant (Acomplia); and they might be at even greater risk than the existing data suggests, if they were to take Acomplia because they were excluded from the original trials.

All good for the competitive position of AZM's Cetilistat, which has no adverse effects of the type associated with Rimonabant (Acomplia) (e.g. depression) and is safe to take with other drugs.

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FDA: 30% OF US PATIENTS ON DIET DRUGS ALSO TAKE ANTIDEPRESSANTS
Zimulti-Acomplia Report Website
12th June 2007

While Sanofi-Aventis says patients on antidepressants should not take diet-drug rimonabant (Acomplia / Zimulti), the FDA says data it obtained for 2004-2006 showed that 30 percent of the 580,000 patients prescribed diet pills each year received a concurrent prescription for an antidepressant drug.

The fact that many people who purchase prescription diet drugs appear to also be candidates for antidepressants is a key problem the FDA is grappling with as it decides whether to approve rimonabant, which it has concluded is effective as a weight loss drug but with worrisome psychiatric side-effects.

Sanofi-Aventis, in a briefing paper prepared for the June 13th meeting of an FDA advisory panel that will air these issues, concedes that in its clinical trials "depressive events" and suicidal thoughts were more frequent for the patients on rimonabant.

Sanofi also says it excluded from its Phase III clinical trials patients with a history of severe depression or with severe psychiatric illness, and said antidepressant treatment was not permitted.

But that may only add to concerns, since it would appear to indicate the higher incidence of psychiatric disorders seen in patients taking Acomplia in the clinical trials was occurring among patients without a history of depression. So what happens when patients on antidepressants start taking rimonabant?

Sanofi's answer to that question is "there is limited data in patients taking antidepressant medication in combination with rimonabant; therefore, the use of rimonabant is not recommended in these patients."

That's all well and good, but what is the likelihood that depressed obese patients will not succeed in obtaining rimonabant -- which would be known as Zimulti in the United States -- if it is approved for sale?

Sanofi has an answer for that, too, proposing a Risk Minimization Action
Plan (Risk MAP) to "reduce the possibility of rimonabant use inconsistent with the labeling in patients with diseases, conditions, or concomitant therapy that raise identified or potential safety concerns."

The French pharmaceutical company claims that in Europe, where Acomplia has been on sale for almost a year, fewer than 5 percent of the more than 100,000 patients who have been prescribed rimonabant have been given it in a manner not " consistent with product labeling."

Even if the experts on the FDA advisory panel believe the 5 percent figure, they will need to decide as part of their "risk-benefit" analysis whether finding out what happens when more than 25,000 U.S. patients take rimonabant together with antidepressants is a risk the United States wants to take.


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QAZWSX123 - 12 Jun'07 - 21:51 - 7026 of 7026 edit

bigboyo (Post 7024) I have copied below some extracts from the FT article today, regarding Alli, which is the over-the-counter (OTC) version of Roche's Xenical.

Particularly important are the predicted peak global sales for Alli (excluding prescription sales) of 250m to 500m pa (i.e. $500m to $1000m pa) with an estimated 5m-6m users in the US alone.

This confirms what I have previously said (Post 6875) about the huge potential for Alizyme's Cetilistat (which is better tolerated than Xenical and safer than Acomplia) in the OTC market.

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GSK to Launch Obesity Drug in US Pharmacies
Financial Times
By Andrew Jack
12th June 2007

GlaxoSmithKline, the UK-based pharmaceutical group, will launch on Wednesday the first weight-control drug to be "switched" from prescription to over-the-counter sales in the US.

Alli...will go on sale in pharmacies and other outlets in the US priced at about $55 a month...

Widely varying forecasts by analysts have suggested that Alli could achieve peak global sales of 250m - 500m, with an estimated 5m - 6m users in the US alone.

GSK has significantly cut the price from Xenical's prescription level of $270 a month reflecting the competitive market of rival non-prescription drugs and dietary supplements sold for weight loss...

GSK stressed that Alli was distinct because it had no "systemic" effect in the body, absorbing fat in food in the gut without passing into the body's other organs, where side-effects often occur.

That meant the drug was very safe, a factor driving regulators' agreement to allow the medicine to switch.

More from the ADVFN site:

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QAZWSX123 - 13 Jun'07 - 14:02 - 7036 of 7038 edit

Information just emerged from the first hour of the EMDAC meeting on Sanofi's Rimonabant (Zimulti/Acomplia). Looks like there could have been under reporting of suicidality in Sanofi's original figures. Could call into question the characteristicness of data from some of the trial centres and the safety of the drug.

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FDA PANEL FOCUS OF SUICIDALITY AT HEARING ON DIET DRUG RIMONABANT
13th June 2007

The make-or-break FDA advisory panel meeting on rimonabant (Acomplia / Zimulti) got underway on June 13th with a presentation on how independent experts attempted to sort-out and evaluate incidents of "suicidality" that occurred among participants in the clinical trials of the diet drug.

Dr. Eric Coleman, FDA deputy director, said at the outset of the day-long hearing that the relationship between rimonabant, depression and suicide has been "a big concern for us."

Dr. Kelly Posner of the New York State Psychiatric Institute told the panel that a major challenge in assessing the number of incidents of suicidality that occurred during the trial was the wide variation that occurred from medical center to center in how patient incidents were reported.

At the FDA's request, independent researchers went back through data collected by the drug's developer, Sanofi-Aventis, in an effort to further identify events that might have been missed, and also to weed out incidents that had been reported but which might not have been significant.

"We found more suicidal events over all, but fewer events were labeled suicide attempts," Dr. Posner told the panel.

The day-long meeting, which will air concerns raised about "rimonabant and increased rates of psychiatric adverse events, including depression and suicidality, and neurological adverse events, including seizures," will see members of the committee vote on a variety of recommendations to the FDA.

As an indication of the level of Sanofi's concern over findings by the FDA staff on the issue of suicidality and the possible link of rimonabant to seizures, the company brought eight outside experts in psychiatry and neurology wilth it to the hearing.

The recommendations of members of the FDA's Endocrinologic and Metabologic Advisory Committee are expected to weigh heavily on the decision of the FDA, expected in late July, whether to approve marketing of Zimulti in the United States.

The news everyone has been waiting for and it looks good for Alizyme!

From the ADVFN site.

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QAZWSX123 - 13 Jun'07 - 21:37 - 7043 of 7043 edit

The FDA's Advisory Committee have, in the last few minutes, voted 14 - 0 against the approval of Sanofi's diet pill Rimonabant (Acomplia/Zimulti).

This should help the potential competitive position of Alizyme's much safer diet drug Cetilistat, and Alizyme to now conclude a deal for Cetilistat before commencing PIII later this year imo.

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DIET DRUG ACOMPLIA / ZIMULTI DEALT BLOW AS FDA PANEL SAYS KEEP IT OFF U.S. MARKET
AcompliaReport.com
13th June 2007 (9.30 pm UK time, 4.30 pm US Eastern time)

Diet pill rimonabant (Acomplia / Zimulti) was dealt a major setback on June 13th when an FDA advisory panel of outside experts unanimously recommended that the regulatory agency not approve the novel weight-loss drug for sale in the United States.

The panel voted 14-to-0 that based on data provided to date, it was impossible to conclude that rimonabant has a "favorable risk-benefit profile," and recommended that Zimulti -- as it was to be known in the U.S. -- not be approved to aid weight loss by obese and overweight individuals.

"My level of concern regarding riminobant and psychiatric events is very high," said Dr. Sid Gilman of the University of Michigan. Added Dr. Paul D. Woolf of Crozer-Chester Medical Center: "I am concerned about what we don't know and the dangers we can fall into."

"We had better learn some more before we lunge into massive use," said Dr. Jules Hirsch of Rockefeller University. "I wouldn't in any way suggest that it be approved at the present time for use.

While the FDA is not obligated to follow the recommendations of its advisory panels, it generally does. With a recommendation this overwhelming, the agency almost certainly will decide next month to defer action on Acomplia and await more data -- perhaps keeping it off the U.S. market until a large 50-month trial now underway is completed in 2010.

The drug has been on sale in Europe as Acomplia for almost a year, and is also now available in Argentina, Brazil, Mexico and a handful of other countries.

Members of the FDA's Endocrinologic and Metabolic Drug advisory panel recommended against adding the U.S. to the list of countries where rimonabant is available after unanimously concluding that available safety data is not adequate.

The action came at the end of a day-long hearing during which Sanofi Aventis emphasized clinical trial results showing Acomplia helped many patients to achieve significant weight loss while also producing improvement in a variety of other cardiometabolic risk factors.

While FDA participants generally conceded the weight-loss benefits of rimonabant, they focused their presentations on safety concerns over a novel drug which works by blocking the CB1 receptors in the brain.

"The risks include an approximate doubling in the risk of psychiatric adverse events, an approximate doubling in the risk of sucidiality, an increase in a constellation of neurological events of unkown significance, an increase in nausea and vomiting, and as yet to be identified risks," said the FDA's Dr. Amy Egan. "And there will be further risks."

Sanofi earlier had challenged the FDA's analysis of the data, and insisted that no "causal relationship" has been established between rimonabant and "suicidality."

But the French pharmaceutical company also pledged to immediately begin asking all patients in ongoing clinical trials whether they are having any suicidal thoughts.

"Sanofi-Aventis will be implementing the questionairre discussed today. We will be using it in the clinical trials going forward," Dr. Paul Chew, a Sanofi vice president told the panel. "If you want to get the answer, you have to ask the question."

SP,bit better now hopefully up from here on.

AZM is now over 1.00 to sell neil777 :0).

Going well Bluelady, and fairly heavy volume.

From ADVFN today:

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QAZWSX123 - 20 Jun'07 - 18:03 - 7398 of 7401 edit

2nd Annual Piper Jaffray Conference
London
Wednesday 20th June 2007

SUMMARY OF PRESENTATION COMMENTS BY ALIZYME'S CEO TIM Mc CARTHY

1) No ambition to set-up sales or marketing teams.

2) Cetilistat and Renzapride are both potential blockbusters.

3) Cetilistat: Takeda expected to report PII Cetilistat results from Japan in H1 2008. Will be 6 month dosing data.

4) Expects to conclude a deal for Cetilistat during the next few months, before starting PIII later this year. (From which I imply a deal in July or August so this is also a good time for a take-over).

5) Sanofis Zimulti/Acomplia is dead in the water.

6) Cetilistat will be the last man standing. The nearest competitor is Arena(?) but it has side effects.

7) Renzapride: PIII c-IBS expected to finish recruitment in 2007 and report in H1 2008.

8) COLAL-PRED: Expects to finish PIII recruitment in 2007, report H1 2008, submit Marketing Authorisation Application in H2 2008, and market launch in 2009.

9) ATL-104: Discussing with FDA and EMEA how best to progress. Competitor Kepivance struggling because of intravenous delivery and safety concerns, but ATL-104 is an easier to deliver mouthwash and not circulated in blood stream.

10) Cash: Enough cash to last into H2 2008.

11) Deals: Change in management now concentrating on commercialisation.

12) Novaquest/Quintiles plus Scala (? difficult to hear the name) helping to broker deals, which are progressing well.

13) Multiple discussions on all 4 products.

14) Looking to complete more than one deal by the end of this year. (Which I take to imply Cetilistat in the next few months Point 4 above - , plus something else).

15) Not straightforward licensing deals will retain value to make more of an industry here in the UK.

16) Two drugs with billion dollar plus opportunities.

17) Transforming deals.

18) He (Tim) is accumulating a large carbon footprint from flights associated with deal talks. (From which I imply potential partners include non-UK pharmas).

19) Goal to create a self-sustaining company and be one of the first biotechs to start paying a dividend.

Everything coming together it seems.
Now focal point deals.

Another one from ADVFN:

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QAZWSX123 - 26 Jun'07 - 17:35 - 7500 of 7500 edit

Just published on the AcompliaReport this afternoon: the European regulators may publish new safety recommendations for Sanofi's Acomplia as early as this month (i.e. this week).

All potentially helps the competitive position of Alizyme's Cetilistat and conclusion of a deal imo.

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NEW EUROPEAN RECOMMENDATIONS ON DIET DRUG ACOMPIA MAY BE PUBLISHED JUNE 29th

A European regulatory review of diet drug Acomplia (rimonabant) may result in publication of new safety recommendations as early as June 29th, accordilng to a spokesperson for the European Medicines Agency (EMEA).

The EMEA said it anticipates that comments of Acomplia will be included in the monthly report of its drug safety committee which is due out on Friday.

The European review of Acomplia was triggered by the overwhelming vote of the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee earlier this month recommending against sale of the diet drug in the United States based on currently available safety date.

Acomplia is now widely available in Europe, where the diet drug was approved by the EMEA more than a year ago, and has been purchased by more than 100,000 Europeans.

However, the U.S. advisory panel's vote was based on newer data than that available to the EMEA a year ago -- including data from post-marketing reports on usage in Europe.

While Acomplia remains on sale in European Union countries for the moment on the same basis as it has been for the past year, the EMEA may reinforce warnings about side effects associated with the drug, including depression and suicidality.

Approval of rimonabant for sale in the United States, where it was to be marketed as Zimulti, now is not expected until additional data from the large CRESCENDO trial becomes available in another two or three years.

http://www.acompliareport.com/News/news-062607.htm

Seems to me that a habitual trading range has developed which will probably continue until we hear of further deal news. Taken the opportunity to add a few more.

I have a spare axe and chopping block. When or will AZM deliver. Fore casted loss this year 20+ million. Stage 3 development of a drug in a difficult area.


Good luck, but I wouldn't put the family silver in it and I am a high risk taker.

Point taken Fred1new about the family silver. This is not normally my type of stock but, in this case, I think the Risk/Reward is in favour of the bulls at current levels. I was reading somewhere that Glaxo had purchased rights to market Xenical under the name of Alli. This will be the first anti-obesity drug sold over the counter. It may well be that the Board of Alizyme will use this type of deal to help it assess any deal to put Cetilistat into phase 111. Moreover, Renzapride is currently in phase 111 and could also prove successful. If a favourable deal on Cetilistat occurs the sp will perhaps move nearer to 120p+. There lays the nature of risk.

From ADVFN:

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QAZWSX123 - 27 Jun'07 - 11:48 - 7517 of 7546 edit

gnomet2 (Post 7516) thank you.

That makes it absolutely clear, the $100m paid by GSK to Roche in 2004 for the US over-the-counter rights to Xenical, was in addition to milestone payments and royalties.

Thus Alizyme could get at least $100m upfront, plus milestone payments and royalties, just for the US OTC rights to their Cetilistat and probably much more; and that is before considering the prescription rights and other territories!

Details as follows:

"Roche to out-license US non-prescription rights to orlistat to GlaxoSmithKline for an upfront payment of 120 million Swiss Francs plus milestone payments and royalties...

Roches pharmaceuticals division has granted GlaxoSmithKline Consumer Healthcare an exclusive license for the US non-prescription rights to the anti-obesity drug orlistat, marketed by Roche as a prescription medicine under the brand name Xenical. The agreement provides for an up-front payment of 100 million US dollars (around 120 million Swiss francs) and additional payments on the achievement of agreed milestones and royalties. Roche and GSK have already begun work to develop an OTC orlistat formulation in the US. Roche has also concluded an agreement to supply GSK with the active ingredient for the new formulation. Roche retains all rights to market Xenical as a prescription drug in the US and all rights (prescription and non-prescription) outside the US. In 2003 Roches worldwide sales of Xenical totaled 618 million Swiss francs (including 146 million Swiss francs in sales in the US).

Commenting on the transactions, Roche Chairman and CEO Franz B. Humer said: With the sale of RCH we are proceeding with our long term strategy of focusing on our two research-driven, high-margin businesses diagnostics and prescription pharmaceuticals. These businesses have significant growth potential and a steadily increasing potential for synergies. The sale of Roche Consumer Health to Bayer ensures that Roches non-prescription brands move to a company with traditionally strong expertise and solid market positions in the non-prescription field, offering healthy prospects to Roche Consumer Health and its employees worldwide. By licensing out the US non-prescription rights to orlistat to GSK, Roche has gained a top-tier partner in pursuing a successful OTC switch and significant upside potential for future royalty streams.

(Source: Roche, Media News, Basel - Switzerland, 19th July 2004)

http://www.roche.com/med-cor-2004-07-19

Thanks Ludlow Castle. Watch this space !

A few more from our helper on ADVFN. Sanofi have withdrawn their current application for Rimonabant/Acomplia/Zimulti in the US:

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QAZWSX123 - 29 Jun'07 - 20:01 - 7579 of 7586 edit

gambill (Post 7571) & Birdie (Post 7575) thanks both. It does indeed appear that Sanofi have today withdrawn their application for Zimulti (Acomplia/Rimonabant) in the US, subsequent to the FDA's Advisory Committee recently recommending against approval. It also appears that Sanofi will probably now have to wait until after the large 50 month CRESENDO trial is finished in 2010 (I have also seen 2011 mentioned) before considering a re-submission, if at all; and I suspect the results may just reconfirm the problems already identified and/or suspected with Acomplia, plus reveal further problems.

http://www.bloomberg.com/apps/news?pid=20601085&sid=a2n97cIyloTw&refer=europe

This means potential partners for Alizyme's Cetilistat do not now need to wait for an FDA decision on Zimulti (previously expected around 27th July) to conclude a deal.

Next month (July) should be very busy for Tim and the folks at Alizyme, as deal terms for Cetilistat are finalised. It could even trigger a take-over bid for Alizyme imo.

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QAZWSX123 - 29 Jun'07 - 20:31 - 7582 of 7586 edit

Here is a link to Sanofi's own press release today, anouncing both the withdrawal of the current New Drug Application for Rimonabant (Zimulti/Acomplia) in the US; and the conference call that was subsequently reported by Bloomberg Europe (referred to above) as follows:

http://www.sanofi-aventis.us/live/us/medias/07B70509-ED2F-4FCE-9533-EDB7187D57AB.pdf

Great indirect news for the competitive positioning and thus value, of Alizyme's Cetilistat imo.

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QAZWSX123 - 30 Jun'07 - 10:24 - 7586 of 7586 edit

SANOFI WITHDRAWS BID TO SELL DET DRUG ACOMPLIA (RIMONABANT) IN UNITED STATES
AcompliaReport.com
30th June 2007

The effort to get diet drug rimonabant (Acomplia / Zimulti) approved for sale in the United States temporarily ended on June 29th, when Sanofi-Aventis withdrew its application rather than await next month's near-certain rejection by the U.S. Food and Drug Administration.

The action followed the crushing vote two weeks ago of the FDA's expert advisory committee, which unanimously recommended that sale of rimonabant not be permitted in the United States pending further study of rimonabant's link to an increased risk of depression and suicidality.

Sanofi, in a statement, said it would "undertake the necessary discussions with the FDA to determine" what additional data is needed before resubmitting its application, which will likely not occur until 2010.

But, the company added, "Sanofi-Aventis is committed to making all efforts necessary to make rimonabant available to patients in the U.S. market."

Rimonabant, the first weight-loss drug which works by blocking CB-1 receptors in the brain, has been on sale in Europe for more than a year and currently is approved for sale in 42 countries.

European Union regulators said a week ago following the FDA advisory panel decision that they will review the medicine for psychiatric side effects, and said today they are "currently reviewing the available data on psychiatric events (in particular suicidal ideation and depression-related events).

"The review is expected to be finalised at the July meeting and its outcome will be communicated then," the European Medicines Agency added.

http://www.acompliareport.com/News/news-062907.htm