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

Agree, it would be a shame to miss out on deal.
got to admit, i thought about selling @ 1.20 and hoping to to get back in, but did'nt have the balls on this occation.
Well done canary.

Here we go again.

AZM's current share price at 92p is seriously undervalued.

AZM's IBS drug Renzapride looks to currently be worth around 100p alone; even before considering the value of Cetilistat, COLAL-PRED, ATL-104, and the cash in the bank (approx 25m).

Optimist,

Last years profit = -18.97M forecast 2007 =-19.55 M.

Ah well, perhaps I am wrong.

There are those who regularly trade in and out of this stock and make money. My holding began years ago at 26p. it is now 67p. as I have added over time. Anything below 80p is a buy signal for me but my gut feeling is that the price will not fall to that level again. My target is anything above 200p at the end of this year, when I want to turn the paper into cash. I'm hoping the waiting game will pay off! The downside, for me, would be bad news regarding Cetilistat or a take over below my target. However, I regard both of these scenarios as unlikely.

amana - I would have thought the low share price actually makes the company more vulnerable to a takeover.

EWRobson, can I suggest you amend valuations in the last paragraph of the thread header to something more recent:

Valuations & Analyst Recommendations:

2/4/2007
Evolution reiterates "buy" Alizyme, with a 173p target.

http://uk.biz.yahoo.com/02042007/336/broker-recommendations-monday-2nd-april-2007-12-15-pm.html

The above 173p figure was before the announcement on 4/4/2007 of a SPA for Cetilistat and a new patent for Renzapride to 2024, both of which add further to the value.

For a summary of Analyst Recommendations, follow the link below and press the blue GO button:

http://today.reuters.co.uk/stocks/Recommendations.aspx?symbol=AZM.L

Been keeping an eye on Alizyme for a while and puchased an initial holding today at 89.66p. sp been subdued while waiting for further developments

Copied from ADVFN's site:

QAZWSX123 - 6 Jun'07 - 09:23 - 6910 of 6922 edit

According to the British Medical Journal (Drug & Therapeutics Bulletin) on 30th May 2007, British experts are expressing doubts about the benefits of Sanofi's Acomplia (Rimonabant/Zimulti). In contrast, they express continuing positive opinion about Roche's Xenical (which they say will continue to be the drug for obesity) and as we know, AZM's Cetilistat is similar to but has advantages over Xenical.

This all bodes well for AZM's Cetilistat, which looks like it could become the prescription obesity drug of choice with NICE (and thus others) for obese patients, replacing Xenical; and Acomplia may not even get a look in.

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ADDED HEALTH CLAIMS FOR DIET DRUG ACOMPLIA / ZIMULTI QUESTIONED BY EXPERTS
30th May 2007

Claims that diet drug rimonabant (Acomplia / Zimulti) offers benefits beyond those associated with weight loss may not be justified, according to a new report by independent British medical experts.

The diet drug has been sold as Acomplia in the U.K. since June 2006 for treatment of obese and some overweight adults, and developer Sanofi Aventis has claimed some of the improvement in cardiometabolic risk factors observed in clinical trials cannot solely be attributed to weight loss.

Cardiometabolic risk factors -- including low HDL (good) cholesterol, high LDL (bad) cholesterol, elevated fat levels in the blood, high blood pressure and insulin resistance -- in combination increase a person's chance of developing heart disease and/or type 2 diabetes.

Acomplia "has a beneficial effect on blood glucose and lipid levels -- a more beneficial effect than would be expected from weight loss alone," Sanofi claims on its website.

But experts writing in the Drug and Therapeutics Bulletin (DTB), published by the British Medical Journal (BMJ) on May 30th, said there was no proof in the clinical trials that Acomplia had any beneficial effects outside those expected by weight loss.

"It might be related to increased activity based on the lifestyle advice given to participants at the start of the trials," according to their report. "Furthermore, it is not known whether rimonabant's effects on individual risk factors translate into a reduced long-term likelihood of cardiovascular events."

The experts said the trials also showed rimonabant to have no effect on LDL cholesterol and little or no effect on high blood pressure.

While the drug is available in the U.K., the country's National Institute for Health and Clinical Excellence (Nice) is still weighing whether and under what conditions the drug should be paid for by the National Health Service.

"Rimonabant has not been directly compared with other, less expensive, drug treatments for obesity. Also, as with these other treatments, it is not known whether rimonabant reduces the likelihood of obesity-related diseases, such as cardiovascular problems," the researchers concluded.

They said Xenical (orlistat) "is the drug for obesity for which there is the most evidence for efficacy and safety to date, and we have previously concluded that it is a reasonable option for obese patients where diet and exercise and/or behavioural measures alone have failed.

"On current evidence, we do not believe that rimonabant represents a significant advance for patients with obesity," they said.

http://www.acompliareport.com/News/news-053007.htm

Copied from ADVFN's site:

QAZWSX123 - 6 Jun'07 - 10:21 - 6918 of 6922 edit

A report from the Scottish Medicines Consortium (January 2007) Page 6, gives an important price comparison for obesity drugs, as follows:

1) Sanofi's Acomplia (Rimonabant) costs 720 pa.
2) Abbot's Sibutramine (Meridia) costs 592-647 pa (depending on the dose).
3) Roche's Xenical (Orlistat) costs 515 pa.

i.e. Sanofi's Acomplia (Rimonobant) is 39.8% more expensive than Xenical (and Xenical is also cheaper than Sibutramine) !!!

Obviously AZM's Cetilistat should (as a lipase inhibitor like Xenical) be closer in price to Xenical, than to Acomplia (Rimonobant) or Sibutramine.

In view of Acomplia's disadvantages of safety (depression, etc), high costs, and questionable benefits, it is reasonable to expect that Roche's Xenical and subsequently AZM's Cetilistat, will remain the obesity drugs of first choice with state healthcare providers imo.

http://www.scottishmedicines.org.uk/smc/files/rimonabant%20_Acomplia_%20%20_341-07_.pdf

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).