Alizyme Plc .......3 x PHASE III ( Gnadenlos Unterbewertet) - 500 Beiträge pro Seite

[BrauchGeld]

Alizyme wurde auch in den letzten Monaten brutalst nach unten gedrückt ,der Grund hierfür ist die länger als geplante Dauer bei der suche nach einem geeigneten Vermarktungspartner für Cetilistat.
Ich hab wie schon erwähnt auch hier die Schwäche genutzt um nachzukaufen gestern erst hab ich nochmal 5000st gekauft (verbilligt auf ~0,60 €) .
Die Suche nach einem Vermartkungspartner für Cetilistat und andere Produkte neigt sich dem Ende zu ,signifikante News sind in den nächsten Wochen zu erwarten .


Alizyme PLC

Marktkap : 84 million GBP = 106 million €
Cash: 16 million GBP = 20,2 million € << reicht für 2 jahre
Kurs: 39,75 p

Pipeline
http://www.alizyme.com/alizyme/products/overview/

Präsentation März 2008 :
http://www.alizyme.com/alizyme/uploads/reports/Prelims2008FI…

Cetilistat (obesity + diabetes) Partner und start Phase III in 08

Renzapride (irritable bowel syndrome)1st Phase III resultat in April 08

Colal-Pred (ulcerative colitis) Phase III resultat u. zulassungsantrag in Europa 08

ATL-104 (mucositis) start Phase IIb in 08


Cetilistat und Renzapride haben Blockbuster potential das bedeutet jeweils 1 Milliarde Dollar und mehr an umsatz.

Colal-Pred hat nach angaben (250 Millon Dollar) und ATL-104 (500 Million $ ) umsatz potential .



News überblick für 2008 :

Cetilistat << Vermarktungspartner und start Phase III in 08

Renzapride << Vermarktungspartner und 1st Phase III resultat in April und start 2nd Phase III in 2008

Colal-Pred << Vermarktungspartner und Phase III rsultat in Juli und MAA zulassungsantrag für EU in 08

ATL-104 << start Phase IIb in 08

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.759.233 von BrauchGeld am 29.03.08 22:26:08

danke für die Kurzanalyse .

setze Alizyme auf die Watch list

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.759.405 von Fruehrentner am 30.03.08 00:09:33

@ Fruehrentner

Nicht der Rede wert ,mein Ziel ist es nur noch sehr aussichtsreiche Biotechs vorzustellen bei denen die Chancen auf Profit überwiegen .

Allein der Deal für Cetilistat dürfte mehr wert sein als die aktuelle Marktkapitalisierung .

kurstreibende News in kürze :

Renzapride (irritable bowel syndrome)1st Phase III resultat in April 08 << soll anfang April stattfinden

Colal-Pred (ulcerative colitis) final Phase III resultat in Juli 08

Deal und start Phase III für Cetilistat 2Q-3Q 08


Analyst report von 28.März 08:

BROKERWATCH Alizyme upgraded to 'Buy' from 'Hold' at Investec

LONDON (Thomson Financial) - Investec Securities has upgraded Alizyme to 'Buy' from 'Hold',saying it believes the wait for a major partnering deal is 'almost over'.

The broker said it hopes that the company's obesity drug Cetilistat will deliver a licensing deal in the short term, and adds that the company's Irritable Bowel Syndrome drug Renzapride may also be outlicensed in the next 12 months.

It adds that further value may come from the imminent results from late stage trials on Renzapride, due to report in April, and the ulcerative colitis treatment COLAL-PRED, which it expects to be positive.

In a note to clients, the broker says it expects the company will not be coming back to the market for more cash for at least two years, pointing out that Alizyme has promised no more major R&D for at least two years without it being funded by a development partner.

[Perlucidus]

Antwort auf Beitrag Nr.: 33.759.791 von BrauchGeld am 30.03.08 10:45:09

Ich habe auf pubmed.com mir angeschaut, was es zu Cetilistat publiziert wurde. Immerhin haben es sie Ergebnisse zu Int J obest gebracht. Ist gut, aber nicht weltbewegend.
Ich werde mir in den nächsten Tagen das Paper genau durchlesen. Wer solche Pharma-Unterstützte-Studien kennt, weiß, dass die Egebnisse im Review selektiv dargestellt werden.
Die Frage ist, in wiewiet Cetilistat wirklich weniger Gastrointestinale NW hat als Xenical und ob die Wirksamkeit vergleichbar ist. Im Review wird die Wirksamkeit nur im Verlgeich mit Placebo angegeben. Bin gespannt, ob in Fulltext mehr drin steht. Was mich wirklich positiv überrascht, ist dass Cetilistat angeblich nur 1,8 bis 2,2% gastrointestinale NW hat. Bei Xenical sind es über 20%. Wenn das wirklich so wäre, dann ist es wirklich exzellent. Aber das gilt es noch zu verifizieren.

Was ich auch noch nicht weiß und eruieren muß, ist die Frage wie groß der Umsatz von Roche mit Xenical ist, damit man eine ungefähre Vorstellung davon hat, welcher Umsatz möglich ist.
Die anderen Produkte habe ich mir alle noch nicht angeschaut.
Wenn Intersse besteht, dann setze ich nach Recheche die Ergebinisse hier gerne rein.
P

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.760.067 von Perlucidus am 30.03.08 12:25:31

Wenn Intersse besteht, dann setze ich nach Recheche die Ergebinisse hier gerne rein.

Ja bitte, wäre nett!

[Salem-]

Wenn se in P3 keinen Vermarktungspartner gefunden haben, dann wird dat nüschts mehr. Dann scheinen die Projekte schlicht Rohrkrepierer zu sein- also das MP lausig und Konkurrenz an allen Ecken. Vermarktungspartner, also oftmals die Großen der großen Konzerne, kommen oft schon vor P1, oder spätestens anfang P2.

siehe:

Adolor/Pfizer- Deal anfang Phase 2- 300 Mio$

oder noch gewaltiger

Santaris´ Antisense Pipeline- anfang Phase 1 zusammen mit GlaxoSmithKline über sage und schreibe 900 Mio$.

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.760.540 von Salem- am 30.03.08 14:55:21

Wenn se in P3 keinen Vermarktungspartner gefunden haben, dann wird dat nüschts mehr. Dann scheinen die Projekte schlicht Rohrkrepierer zu sein

Sorry aber das stimmt nicht ,Alizyme hat für Cetilistat bereits mit Takeda Pharma den besten Partner für den japanischen Markt .

Auch für Colal-Pred gibts schon Partner für USA(Prometheus) und für Japan (TSD Japan).

Bitte Salem informier dich vorher bevor du was schreibst .

COMPLETED:

Takeda license agreement for cetilistat in Japan (Aug 2003)

Prometheus license agreement for COLAL-PRED®in North America (Nov 2007)

Co-development agreement with TSD Japan for COLAL-PRED®in Japan (Dec 2007)

ONGOING:

Negotiating further license agreements for COLAL-PRED®in Europe and in a number of additional territories

Strong interest in licensing cetilistat -extensive diligence carried out

Discussions ongoing across the remainder of the portfolio

[BrauchGeld]

Hier eine schöne ausfürhliche Analyse von 30.Dez 2007

http://seekingalpha.com/article/58598-alizyme-accelerates-pi…

In the interest of global and currency diversification, I offer Cambridge, UK-based Alizyme (ALZYF.PK) [London: AZM] as my top pick for 2008 among foreign-listed emerging biotech companies. (E*TRADE now offers a low cost, online global trading platform which allows U.S investors to purchase stocks on select foreign exchanges in their local currencies providing dual diversification opportunities.)

Alizyme is a specialty biopharmaceutical company that is developing product candidates for inflammatory gastrointestinal disorders, obesity, and supportive cancer care. The Company currently trades near its all-time lows at 57.50 pence (the British pound sterling is divided into 100 pence) with a market cap of about $115 million pounds (or $230 million US dollars – just multiply by two for the conversion). Insiders also appear bullish on Alizyme's prospects, with a total of 235,000 shares bought from August 2006 to February 2007 at much higher share prices of between 84 – 93 pence. Also, no insider selling has occurred since March 2006 and Prudential (PRU) owns a 15% stake in Alizyme through various wholly-owned subsidiaries, based on a regulatory filing from two weeks ago. The Company has four drug candidates in its late-stage clinical development pipeline, including cetilistat for obesity (Phase 2 ongoing and Phase 3 ready to begin), renzapride for irritable bowel syndrome (Phase 3), Colal-Pred for ulcerative colitis (Phase 3), and ATL-104 (Phase 2a completed) for mucositis (a common side effect of many cancer treatments causing ulcerations in the mouth and throughout the gastrointestinal tract).

Last month, Alizyme signed an exclusive, back-end loaded licensing deal for Colal-Pred in North America with privately held Prometheus Labs of San Diego for $2.5 million in upfront cash and $15 million payable upon future development milestones. Colal-Pred is a unique formulation of the widely used steroid prednisolone, designed for once-daily oral administration and colon-targeted delivery in order to avoid the systemic side effects associated with steroids while maintaining effectiveness in the treatment of ulcerative colitis. Prometheus will be responsible for all development costs in North America and will pay Alizyme undisclosed royalty rates which increase with higher annual net sales. An estimated 700,000 people in the U.S alone and 2 million people worldwide in major territories suffer from ulcerative colitis. Top line results from an ongoing Phase 3 trial in Europe are expected in 2Q08 to support a MAA filing in 2H08 for European approval with expected launch one year later in 2H09. Prometheus is expected to begin a Phase 2 trial in the U.S during 1H08 with an anticipated NDA filing in 2011.

Cetilistat is a peripherally acting lipase inhibitor for the treatment of obesity and obesity with diabetes, which has similar effects to orlistat by blocking the absorption of dietary fat – marketed in the U.S by Roche [Germany: RO] as Xenical (prescription strength) and by Glaxo (GSK) as Alli (over-the-counter). Previously reported Phase 2 results revealed that Alizyme's cetilistat was much better tolerated (i.e. less gastrointestinal side effects) than orlistat while both drugs demonstrated similar effectiveness in the form of weight loss. The Company's partner in Japan for cetilistat is Takeda Pharma (Tokyo: 4502) and Alizyme has received approval from the FDA to begin its first pivotal Phase 3 trial under a special protocol assessment. Renzapride is the Company's drug candidate for irritable bowel syndrome, which is in Phase 3 trials in the US and pre-Phase 3 status in Europe. Results are expected in 1H08 for a pivotal Phase 3 trial in the US for constipation-predominant irritable bowel syndrome and the FDA is reviewing plans for a second pivotal Phase 3 trial. Before being withdrawn from the market due to cardiovascular concerns, related drug Zelnorm achieved sales of over $500 million for 2006. Alizyme has conducted successful Phase 2 proof-of-concept trials for ATL-104 in the treatment of mucositis and is currently working with the FDA and EMEA on the appropriate clinical development program.

Alizyme's robust, late-stage clinical development program includes two drugs with blockbuster, billion dollar sales potential in cetilistat and renzapride. Colal-Pred and ATL-104 target smaller markets with peak sales potential of $250 million and $500 million, respectively. First half 2007 results included a net loss of 12.3 million pounds with cash/equivalents of just over $19 million pounds. The Company has adequate liquidity to fund operations and clinical development until 2H08. Alizyme has committed additional resources to secure licensing deals for all four products in its pipeline with the appointment of consulting firms NovaQuest and Ferghana Partners. The Company has relied on equity financing to fund operations since its listing on the London Stock Exchange in 2000 and is expected to shift its focus to licensing deals such as the strategic partnership and co-development deal signed in early December with bio-venture firm TSD Japan for the exclusive rights to co-develop Colal-Pred in Japan and the identification of new drug candidates in Japan for in-licensing or acquisition by Alizyme for ex-Japan development.

[Perlucidus]

Antwort auf Beitrag Nr.: 33.761.037 von BrauchGeld am 30.03.08 17:35:13

Eines vorab, damit keine Missverständnisse entstehen:
1.Ich empfehle hier keinen Wert.
2. Ich bin selbst nicht investiert und überprüfe für mich, ob ich investieren möchte.
3. Es gibt keine Garantie, dass ich alles 100pro richtig wieder gebe.

4. die von mir genauer angeschaute Studie wurde schon mehrfach zittiert (Online publikation 09/06, Printe Version 03/07). Also keine neue Studie.
Ich will hier nur die Ergebnisse etwas detaillerter vorstellen:


Cetilistat wurde in 3 verschiedenen Dosierungen im Vgl mit einem Scheinmedikament über 12 Wochen verabreicht. Alle 3 gruppen hatten einen statistisch signifikant höheren Gewichtsverlust im Vgl. mit Placebo. Alle drei Gruppen hatten einen signifikanten Abfall des LDL und des Cholesterins (sehr gut). Keine der Gruppen zeigte einen signifikanten Abfall des HbA1C (Makrer für Zuckerkrankheit) (das ist nicht so gut).
Die höchste Dosierungsgruppe hatte auch den höchsten Gewichtsverlust und Abnahme des LDL (klingt logisch).
Man kann in etwa sagen, dass 1/3 aller Patienten in der Cel-Gruppe mindestens 5% Gewichtabnhame verzeichneten (placebo 15%)
In den Studien mit Xenical hatte die Placebogruppe etwa 7% und die Therapiegruppe 15%.
Damit läßt sich MEINER MEINUNG NACH nicht sagen, dass Celistat wirksamer sei, da die Placebogruppen gänzlich voneinander abweichen.

Alle drei Dosierungsgruppen hatten vergleichbare Nebenwirkungsraten (klingt meiner Meinung nach zu gut, um es zu glauben). Entscheidend ist, dass die gastrointestinalen Nebenwirkungen (Stuhlinkontinenz, öliger Schleimabgang und unwilkürlicher Stuhlabgang beim Flatus) deutlich niedriger in der Studie angegeben werden, als bei Xenical.
Andere Gastrointestinale Nebenwirkungen wie Bauchschmerzen etc. sind vergleichbar.

Da in jedem Arm etwa 90 Patienten eingeschleust wurden, sind sie Ergebnisse statistisch gut verwertbar. Ich persönlich finde die Ergebnisse gut und vielversprechend. Ein selbstläufiger ist es aber noch nicht.
Was der direkte Vergleich mit Xenical in der PIII bringt, ist natürlich offen. Ich finde es aber sehr spannend.

Als nächstes werde ich mir mal das Präparat zu irritable bowel syndrome anschauen. Kann mir beim besten Willen nicht vorstellen, dass da eine Tablette hilft. Lasse mich aber gerne eines besseren belehrten
p
ps: wenn Euch das nicht interessiert, dann sagt bitte bescheid, damit ich den Thread nicht vollspamme, Danke
pps:@Brauchgeld: Danke für Dein Link. Sehr interessant. Klingt alles ziemlich gut, abgesehen vom Abschnitt:
he Company has adequate liquidity to fund operations and clinical development until 2H08.
Das klingt eher sehr bedenklich.

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.761.872 von Perlucidus am 30.03.08 20:52:30

Company has adequate liquidity to fund operations and clinical development until 2H08.

Dieses Problem hat sich bereits vor 3 wochen erledigt geld reicht wie oben erwähnt für 2 weitere Jahre .

06-03-08
Alizyme to raise 10 mln stg in 20 mln shr placing, should last 2 years UPDATE

LONDON (Thomson Financial) - Drug development company Alizyme has announced that it has raised 10 mln stg in a placing, which should provide enough cash for two years while the company works on securing a licensing deal, said chief executive Tim McCarthy.

McCarthy told Thomson Financial news in an interview that the company was now on the "front foot" and any deals, some of which are expected this year, would represent upside.

"The message we're sending out today is that if anybody was concerned we were going to do a fundraising, well it's done now, it's off the table, we've got enough money to see us through for two years and anything's upside now in terms of deals that we sign, so that should settle the whole situation down," he said.

The company was "on the front foot", he said, because it has clinical data coming up for IBS treatment Renzapride and Colal-Pred for ulcerative colitis, and updates on commercial deals, some of which were expected this year.

"There's a big emphasis at the moment on Alizyme doing partnering deals, a couple of which we entered into at the end of last year and we've got a number more lined up for this year to conclude," he said.

"I'm very confident of the discussions that I'm having at the moment across the portfolio, including Cetilistat, our high-profile obesity drug, more geographical deals for Colal-Pred which we signed a couple of deals on at the end of last year, and the other products as well, so from where I stand it all looks pretty good," he said.

He explained that the company could survive for two years because it would cut back spending to an absolute minimum.

The company announced this morning in its full-year earnings statement that its cash levels at Dec 31 were 5.8 mln stg compared with 27.7 mln stg a year ago.

The new 2 pence shares represent about 10 pct of the issued share capital prior to the placing, and were placed at a price of 50 pence per share.

The placing price of the shares represents a premium of 3.6 pct to the closing middle market price on the London Stock Exchange yesterday, the company says.

It also issued a research update to say that the US FDA had agreed the remaining two protocols for late-stage tests of its obesity drug Cetilistat, and recommended that it lodge a new Investigational New Drug Application for the drug as a treatment for diabetes.

The additional indication, according to McCarthy, is a very positive development for the drug because diabetes drugs are more commonly reimbursed by healthcare payers.

The market reacted well to the news and, at 10.39 am shares were up 0.25 pence, or 0.52 pct at 48.5 pence, but off a high of 51.25.

Robin Davison, an analyst at Edison Investment Research, welcomed the placing by Alizyme, and added that the diabetes news strengthened Alizyme's hand.

"It's a sensible move to get themselves in a stronger position to attempt to negotiate a licensing deal," he said.

"And their hand is strengthened also by clarifying what has to be done with Cetilistat with the FDA in terms of this Special Protocol Assessment," he said.

[BrauchGeld]

http://uk.finance.yahoo.com/q?s=azm&m=L&d=

[BrauchGeld]

Kauf vs Verkauf:

http://telegraph.digitallook.com/telegraph/security.cgi?csi=…

[BrauchGeld]

Alizyme schließt auf Tageshoch bei 44p = 0,55€
Soviel ich mitgekriegt habe sollen die Renzapride Phase3 Ergebnisse diese Woche veröffentlicht werden .

Viel Glück

[StaatsKnecht]

Hier gibt es nichts zu bemängeln diese Aktie ist eine Perle.

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.772.549 von StaatsKnecht am 31.03.08 23:24:27

Und wieder sind mehr Käufer als Verkäufer unterwegs ,mein Kursziel liegt kurzfristig (3-6 monate) zwischen 100p -120p (1,26€ -1,51 €).

Viel Glück allen investierten .

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.769.284 von BrauchGeld am 31.03.08 18:44:39

Hattest du explizit bei ALIZYME nachgefragt, wann die Renzaprid Ergebnisse aus Phase III veröffentlicht werden?

Wurde dir Anfang April/diese Woche explizit bestätigt?

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.774.878 von Fruehrentner am 01.04.08 10:35:41

Nein das hat jemand anders getan und bisher hatte er immer behalten .


http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…

KTB, Thu 15:13

I have been informed that the results are expected the first week in April, so anytime next week.

I am hoping that sucessfull results for Renzapride will start a recovery for Alizyme. I personally think that this will be the most significant piece of news for the company yet, and hopfully will confirm the competitive profile of the drug now that Zelnorm has been pulled.

Jimie

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.775.117 von BrauchGeld am 01.04.08 10:55:20

Danke.

Charttechn. Raum für 'ne satte Kurserholung bei positiven Daten wäre in jedem Fall reichlich vorhanden, denke ich:

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.761.872 von Perlucidus am 30.03.08 20:52:30

off-topic:

MERCK meldet Phase-III Studiendaten ihres Obesity- Medikamentkandidaten:

Merck's taranabant found effective in Phase III obesity trial

1st April 2008
By Staff Writer

Merck & Co. has reported positive fifty-two week results of a two-year Phase III study of taranabant, which showed that patients experienced statistically significant weight loss when taking the drug in combination with diet and exercise.

In this study, patients taking taranabant 2mg experienced more than double the amount of weight loss at 52 weeks compared to patients treated with placebo. Patients on taranabant 2mg demonstrated a mean weight loss reduction from baseline of 6.6kg or 14.5lbs compared to 2.6kg or 5.7lbs for patients on placebo, which was statistically significant (p<0.001 vs. placebo), at 52 weeks.

Maximum weight loss in this study was achieved by week 36 and was maintained throughout the next 16 weeks of the study in patients taking taranabant 2mg. Patients in all treatment groups were placed on a diet and exercise regimen in addition to therapy or placebo.

John Amatruda, vice president of clinical research, metabolic disorders at Merck Research Laboratories, said: "Based on the benefit-risk considerations and the lack of a substantial improvement in the efficacy of taranabant at the 4mg and 6mg doses seen in our clinical program compared to the 2mg dose, we have decided to continue to evaluate taranabant in doses up to and including 2mg in our Phase III studies. We have a robust Phase III clinical program in place, and we look forward to presenting further results later this year."

http://www.pharmaceutical-business-review.com/article_news.a…


Kann die Daten mal jemand mit den Alizymedaten vergleichen? Wer performt besser?

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.787.822 von Fruehrentner am 02.04.08 13:15:06

Taranabant hat keine Chance gegen Alizyme´s Cetilistat wegen den starken Nebenwirkungen .


Merck obesity drug falls short in trial: analyst
http://biz.yahoo.com/rb/080310/merck_taranabant.html


By Ed Susman

CHICAGO -- April 1, 2008 -- Patients taking an experimental weight loss drug lost an average of 6.6 kg (14.5 pounds) over the course of 1 year, researchers reported here at the 57th Annual Meeting of the American College of Cardiology (ACC 2008).

"There is a critical unmet need for new weight loss options for the millions of people living with obesity," said Louis Aronne, MD, Clinical Professor of Medicine, Weill-Cornell Medical College, and Director, Comprehensive Weight Control Program, New York Presbyterian Hospital, New York, New York.

"The results of this study suggest that taranabant, an investigational therapy, has the potential to be a valuable treatment option -- if approved -- for patients suffering from obesity and its many complications," Dr. Aronne said.

Dr. Aronne, one of several investigators in the phase 3 trial, said the critical difference between taranabant and placebo is that 27.9% of overweight and obese patients on the 2-mg dose of taranabant lost more than 10% of their body weight in the year-long study compared with 8.4% of placebo patients (P < .001).

"Even losing just 5% of your body weight is important to your health," Dr. Aronne said in a presentation on March 31. "It will help you reduce your risk factors of cardiovascular disease."

In the 2,502-patient study, Dr. Aronne and colleagues assigned 417 patients to placebo and 414 patients to the 2-mg daily dose of taranabant, with the remainder receiving higher doses of taranabant.

Merck Research Laboratories, the company that makes the drug, has decided to more forward with the 2-mg dose and will not proceed with the 4- or 6-mg dose. The higher doses showed marginally better efficacy, but there was a greater incidence of adverse effects.

In the trial, patients reported their maximum weight loss after about 36 weeks and maintained that loss through week 52.

The most commonly reported adverse events were transient gastrointestinal side effects (41.8%); of subjects on taranabant who reported these adverse events, 1.7% discontinued the treatment.

More patients in the trial discontinued treatment due to patient-reported psychiatric complaints -- mainly irritability. Of the 28.3% of patients who reported these effects, 8.2% dropped out of the trial, compared with 4.1% of patients who were on placebo. There were no suicides or suicide attempts. Three patients on the 6-mg dose of taranabant reported suicide ideation.

About 56.5% of patients on 2 mg of taranabant were able to achieve at least a 5% weight loss, compared with 27.2% of patients on placebo (P < .001), Dr. Aronne said.

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.788.292 von BrauchGeld am 02.04.08 13:57:38

danke

[BrauchGeld]

In den letzten Tagen waren eindeutig mehr käufer tätig .

Auch heute gehts gut los

09:14 43.00p 62 £27 Buy AT
08:57 42.66p 2,304 £983 Buy O
08:48 43.00p 674 £290 Buy AT
08:48 43.00p 2,500 £1,075 Buy AT
08:11 42.75p 1,000 £428 Buy

[BrauchGeld]

Es gab gestern zwar keine Nachrichten,aber lange wird es nicht mehr dauern .

Was mich positiv stimmt ist das ,die Instis anfang März bei der Kapitalerhöhung bereit waren zu einem weit höheren kurs Aktien zu kaufen und Geld zu verschenken haben die sicherlich nicht .





Director Shareholdings

Notifier.....Holding.....Value* (1 GBP = 1,26€)
Tim P McCarthy.....1,105,000.....£442,000
William Edge.....678,066.....£271,226
Brian Richards.....552,301.....£220,920
John E Gordon.....441,312.....£176,525
Richard Palmer.....363,493.....£145,397
David Campbell.....78,228.....£31,291
Roger Hickling.....71,954.....£28,782
Richard Forrest.....47,000.....£18,800

Major Shareholders

Notifier**.....Holding.....Value*
Prudential Plc.....44,197,627.....£17,679,051
M&G Investment Funds 3.....33,128,590.....£13,251,436
Royal Bank of Scotland Group plc.....8,000,000.....£3,200,000
Legal & General Group Plc.....7,823,400.....£3,129,360

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.817.744 von BrauchGeld am 05.04.08 18:11:08

Also auch auf dieser langfristigen Zeitebene betrachtet ist der Kurs ausgebombt bzw. die Firma wohl (krass) unterbewertet angesichts der laufenden Projekte/Studien und sollte einen Boden gefunden haben. Eine gute Nachricht, und das Teil sollte nach oben schiessen ...

[StaatsKnecht]

Ich hab mir die britischen Biotechs etwas genauer angeschaut, also es gibt einige Perlen drüben auf der Insel aber Alizyme gehört absolut zu den Top 5 .

Britische Biotechs
http://www.iii.co.uk/investment/detail?code=cotn:NMX4570.L&d…


Alizyme hat mit seinen Produkten noch nie einen Fehlschlag erlitten ,ich hoffe es bleibt so .

Company Milestones

1995 - Business formation

1996 - IPO on Alternative Investment Market (London)

1999 - First products commence clinical trials (renzapride and COLAL-PRED®)

2000 - Listing on the Official List of the London Stock Exchange

2003 - Successful results of Phase IIb clinical trial of cetilistat for obesity

- License and development agreement with Takeda for cetilistat in Japan

- Successful results of Phase IIb clinical trial of renzapride for c-IBS

- Successful results of Phase IIb clinical trial of renzapride for m-IBS

2004 - Takeda exercise rights to cetilistat for Japan

2005 - Successful results of Phase IIb clinical trial of cetilistat for obese diabetics

- Agreement with FDA through Special Protocol Assessment for Phase III clinical trial in the US of renzapride for c-IBS

- Approval from the MHRA to conduct Phase III registration clinical trial in EU of COLAL-PRED® for ulcerative colitis

2006 - Takeda commence Phase II clinical trial of cetilistat in Japan

- Patient recruitment into US Phase III clinical trial of renzapride

- Patient recruitment into EU Phase III clinical trial of COLAL-PRED® for ulcerative colitis

- Successful results of Phase IIa ‘proof of concept’ clinical trial of ATL-104 for mucositis

[BrauchGeld]

Das warten geht weiter ...

19 x Buy vs 7 x Sell

Time...Price....Volume...Value..Buy/Sell..Type

16:35 40.25p 8,595 £3,460 Buy UT
16:29 40.00p 1,756 £702 Buy AT
16:24 39.78p 3,500 £1,392 Sell O
16:24 40.00p 10,000 £4,000 Buy AT
14:19 39.75p 6,605 £2,626 Sell AT
14:04 40.00p 5,515 £2,206 Buy AT
14:04 40.00p 4,485 £1,794 Buy AT
14:04 40.00p 10,000 £4,000 Buy AT
14:04 40.00p 5,385 £2,154 Buy AT
14:04 40.00p 10,000 £4,000 Buy AT
14:04 40.00p 10,000 £4,000 Buy AT
14:03 40.00p 9,226 £3,690 Sell AT
14:02 40.00p 10,130 £4,052 Buy AT
14:02 40.00p 6,250 £2,500 Buy AT
14:02 40.00p 6,250 £2,500 Buy AT
14:02 40.00p 22,372 £8,949 Buy AT
14:02 40.00p 1,075 £430 Buy AT
12:54 39.22p 20,000 £7,844 Sell O
12:48 39.50p 9,494 £3,750 Sell AT
12:32 39.75p 20,041 £7,966 Buy AT
10:14 39.69p 5,000 £1,984 Buy O
09:16 39.25p 41 £16 Sell AT
08:36 39.50p 1,319 £521 Buy AT
08:15 39.25p 1,000 £392 Sell AT
08:01 40.00p 1,553 £621 Buy AT
08:00 40.00p 17 £7 Buy UT

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.775.117 von BrauchGeld am 01.04.08 10:55:20

Alizyme's Kandidat Renzaprid ist chemisch dem zurückgezogenen Cisaprid (Prepsulsid®) ähnlich. Beides sind m.W. nach kombinierte 5-HT3-Antagonisten und 5-HT4-Agonisten.

Cisaprid wurde aufgrund seiner kardialen Auswirkungen
(QT-Intervall) vom Markt weltweit zurückgezogen.

Ist schon von Alizyme bzw. den Studien klar bestätigt worden, dass Renzaprid keine negativben kardialen Auswirkungen zeigt?

Wie schneidet Renzaprid bisher zu den Konkurrenten Itaprid, Prucaloprid und Tegaserod ab?

Hintergrund:
http://www.aerzteblatt.de/v4/archiv/artikel.asp?id=41235

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.846.148 von Fruehrentner am 09.04.08 15:02:07

Ist schon von Alizyme bzw. den Studien klar bestätigt worden, dass Renzaprid keine negativben kardialen Auswirkungen zeigt?


http://www.ibs-c.net/2007/08/ibs-c-drug-renz.html

IBS-C drug Renzapride should complete Phase III trials in early 2008
A new Irritable Bowel Syndrome drug called Renzapride is expected to complete Phase III trials in early 2008, according to specialty biopharmaceutical development company, Alizyme, based in Cambridge, UK. Alizyme focuses on developing products for the treatment and management of gastrointestinal disorders. Renzapride is a 5-HT4 receptor full agonist, like Zelnorm, designed to help IBS-C sufferers as well as a 5-HT3 receptor antagonist which should help those with occasional IBS-D.

Phase III clinical trials in the US started in December 2005 seeking 1700 female recruits ages 18-65. In this study patients with IBS-C will receive one of two dosing regimens of renzapride or placebo for 12 weeks. The study is no longer recruiting new patients.

With the voluntary suspension of Zelnorm sales in the US, Alizyme says that "Renzapride has the opportunity to be the market leader as it has been shown in Phase II studies to have the potential to be more effective than Zelnorm." According to Phase II data, Renzapride has a 25% improvement on relief of overall IBS symptoms over placebo, suggesting superior efficacy to Zelnorm. Alizyme is expecting to meet the product requirements for EU approval.

However, in the post-Vioxx world, the FDA will pay close attention to Renzapride's safety record. According to Alizyme's website, a "Thorough Cardiovascular Safety" trial of Renzapride showed "no propensity to cause disturbances in heart rhythm." The safety trial involved 44 males and females who were evaluated for the effects of a single oral therapeutic dose (4 mg) and supratherapeutic dose (20 mg). A release of the results found that "Neither the 4 mg, nor the 20 mg dose, of renzapride affected the heart rhythm, using a number of approved data analysis methods."

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.853.751 von BrauchGeld am 10.04.08 09:36:45

Und wie schneidet Renzaprid bisher zu den Konkurrenten Itaprid, Prucaloprid und Tegaserod ab?

Was ich jetzt nicht weiss, ist, ob einer der drei o.a. Kandidaten schon auf dem Markt ist und sich bewährt, oder ob es sich ebenfalls noch um Entwicklungskandidaten handelt.

Für einen Nachzügler (wie möglicherweise Renzaprid) ist es dann immer schwer sich gegen einen Platzhirschen auf dem Markt als Newcomer zu behaupten, wenn nicht klare Vorteile da sind.

Als Patient würde ich zumindest nicht einfach ein Medikament wechseln, was gut bei mir wirkt und keine/geringe Nebenw. bei mir zeigt.

[BrauchGeld]

Antwort auf Beitrag Nr.: 33.853.972 von Fruehrentner am 10.04.08 09:53:24

Für einen Nachzügler (wie möglicherweise Renzaprid) ist es dann immer schwer sich gegen einen Platzhirschen auf dem Markt als Newcomer zu behaupten, wenn nicht klare Vorteile da sind.

"Platzhirsch" war bis mitte letzten Jahres Zelnorm(Tegaserod) das wegen seiner Nebenwirkungen wieder vom Markt genommen wurde.
Wenn Renzapride in der Phase III Studie genauso gute Daten liefert wie in Phase IIb dann hat Renzapride beste Chancen Marktführer zu werden.
Im Moment heißt es erstmal die Daten abwarten .


Renzapride

It is estimated that up to 22% of the population experience IBS at some time. Renzapride has been shown to be an effective and well tolerated treatment for constipation-predominant IBS. It also has the potential to be the first line treatment for mixed-symptom IBS.

Renzapride

Alizyme’s gastrointestinal product, renzapride, is being developed for the treatment of constipation-predominant IBS (“IBS-C”) and for mixed-symptom IBS (“IBS-M”). It aims to be a more effective treatment for IBS-C than is currently available and also to become the first line treatment for IBS-M. Renzapride was initially discovered at Beecham Research Laboratories and was licensed from SmithKline Beecham in 1998 by Alizyme for use in the treatment of IBS. As a result of the merger between GlaxoWellcome and SmithKline Beecham to form GlaxoSmithKline, Alizyme acquired all rights to renzapride in 2000.

Current clinical focus

IBS-C and IBS-M.

Potential additional applications

Chronic constipation, dyspepsia, GORD/GERD and gastroparesis.

Disease

IBS is a functional gastrointestinal disorder characterised by recurrent symptoms of abdominal pain and discomfort associated with disturbed bowel function, which may also be accompanied by a feeling of bloating. Patients may have IBS-C, IBS-M or diarrhoea-predominant IBS (“IBS-D”).

Commercial opportunity

There are currently few effective drug treatments for IBS of any type. IBS is one of the most frequent disorders seen by physicians with estimates of up to 22% of the general population experiencing it at some time, of whom around 35% have IBS-C and around 40% have IBS-M, both of which renzapride aims to address. The remainder of around 25% have IBS-D.

Until recently, the major marketed product in the US was Novartis’ Zelnorm®, for the treatment of IBS-C in women. However, Zelnorm® is not approved in the EU and has currently been suspended from sale in the US following concerns regarding the incidence of cardiovascular ischemic events in its clinical trials. Launched in 2002 and approved in a number of countries outside the EU, prior to its suspension, Zelnorm® had seen its sales continue to increase strongly, reaching annual sales of $561 million in 2006, and had been projected to reach peak sales in excess of US$1 billion per annum.

Competitive advantage

Renzapride is both a 5-HT4 receptor full agonist (which acts as a pro-kinetic, enhancing motility) and a 5-HT3 receptor antagonist (which can reduce pain and diarrhoea). This dual mode of action is unique and gives renzapride the potential to normalise bowel function rather than move from one extreme of constipation or diarrhoea to the other. It may, therefore, provide benefit in both IBS-C and IBS-M, covering up to 75% of the IBS patient population.

Renzapride has the opportunity to be the market leader as it has been shown in Phase II studies to have the potential to be more effective than Zelnorm®. In addition, Zelnorm® is not approved for use in the EU, therefore this represents a significant commercial opportunity for renzapride as a major IBS product in the EU.

Clinical experience

Renzapride has been shown to be safe and well tolerated in both IBS-C and IBS-M patients. It has completed an extensive Phase I and Phase II clinical development programme, including an IBS-C trial involving 510 patients and an IBS-M trial involving 168 patients in Europe and an IBS-C trial involving 48 patients at Mayo Clinic in the US.

Phase II clinical data from renzapride, showing up to 25% improvement on relief of overall IBS symptoms over placebo, suggest superior efficacy to Zelnorm®, the product currently suspended from marketing in the US for the treatment of IBS-C. These results, if confirmed in Phase III studies, are also expected to meet the EU requirement for product approval, there currently being no approved product for IBS-C in the EU.

Alizyme have successfully completed a ‘Thorough Cardiovascular Safety’ trial in healthy volunteers, which showed that renzapride has no propensity to cause disturbances in heart rhythm at the therapeutic dose (4mg) and at a dose five times this level (20mg).

Development status

Renzapride now has a safety database of more than 1,000 subjects and has completed Phase II clinical development. Patient recruitment into the first of two required Phase III pivotal efficacy studies, agreed with FDA under the Special Protocol Assessment (“SPA”) procedure, has now completed.

Next steps

Headline results from the first Phase III pivotal efficacy study are expected in April 2008. The second Phase III pivotal efficacy study has now also been agreed under the SPA procedure and is expected to commence in 2008.

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.875.574 von BrauchGeld am 13.04.08 18:47:55

hallo BrauchGeld,

d.h., im Moment ist für diese Indikation IBD kein wirklich brauchbares Medikament auf dem Markt?

[BrauchGeld]

d.h., im Moment ist für diese Indikation IBD kein wirklich brauchbares Medikament auf dem Markt

Richtig . Renzapride hat bisher das beste Profil also daumen drücken für uns Aktionären und natürlich für die von der Krankheit betroffenen .

Nur noch 10 Tage ...............

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.898.103 von BrauchGeld am 16.04.08 14:16:49

Nur noch 10 Tage ...............

Steht das Datum genau fest, oder ist es der spätestmögliche Termin, also eine Bekanntgabe auch davor noch möglich?

Wann ist Tag X?

[BrauchGeld]

oder ist es der spätestmögliche Termin

Exakt !

Analysten von Investec gehen von positiven Daten für Renzapride und Colal-Pred aus .Das würde mein Herz und mein Depot höher schlagen



BROKERWATCH Alizyme upgraded to 'Buy' from 'Hold' at Investec

LONDON (Thomson Financial) - Investec Securities has upgraded Alizyme to 'Buy' from 'Hold', with a price target of 59p, saying it believes the wait for a major partnering deal is 'almost over'.

The broker said it hopes that the company's obesity drug Cetilistat will deliver a licensing deal in the short term, and adds that the company's Irritable Bowel Syndrome drug Renzapride may also be outlicensed in the next 12 months.

It adds that further value may come from the imminent results from late stage trials on Renzapride, due to report in April, and the ulcerative colitis treatment COLAL-PRED, which it expects to be positive.

In a note to clients, the broker says it expects the company will not be coming back to the market for more cash for at least two years, pointing out that Alizyme has promised no more major R&D for at least two years without it being funded by a development partner.

[Fruehrentner]

hier gibts intensivere Diskussonen zur Aktie:

http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…

[Fruehrentner]

es gibt news, is aber nix weltbewegendes:

http://www.alizyme.com/alizyme/uploads/reports/NoticeofAGM20…

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.759.233 von BrauchGeld am 29.03.08 22:26:08

Renzapride << Vermarktungspartner und 1st Phase III resultat in April

Kommt da noch was jetzt im April oder wird's doch erst was im Mai mit den news zu Renzaprid?

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.775.117 von BrauchGeld am 01.04.08 10:55:20

KTB, Thu 15:13
I have been informed that the results are expected the first week in April, so anytime next week.
I am hoping that sucessfull results for Renzapride will start a recovery for Alizyme. I personally think that this will be the most significant piece of news for the company yet, and hopfully will confirm the competitive profile of the drug now that Zelnorm has been pulled.
Jimie

War wohl nix mit Anfang April. Warum verzögern sich die news zu Renzaprid?

[BrauchGeld]

Volumen ist heute etwas kräftiger und bisher fast alles käufe(blau) .

Vielleicht ein Vorzeichen für gute Ergebnisse hoffen wir mal das beste .
http://finance.yahoo.com/q?s=azm.l

[BrauchGeld]

Renza ist nun Geschichte tja so ist das halt mit Biotech ,aber das Hauptprodukt ist Cetilistat und da sind noch Colal-Pred und ATL-104.


ALIZYME PLC

RESULTS FROM RENZAPRIDE PHASE III CLINICAL TRIAL

Cambridge, UK, 23 April 2008, Alizyme plc ("Alizyme" or "the Company") (LSE: AZM) announces clinical trial results from Study 038, its Phase III study of renzapride in constipation-predominant irritable bowel syndrome ("IBS-C").

* Statistical significance achieved on the primary endpoint (duration of

relief of overall IBS symptoms) * Treatment groups showed limited clinical improvement over placebo group
* Limited effects seen on the three key secondary endpoints (relief of


pain, bowel problems and bloating)
* No safety or tolerability issues
* Results do not justify further development of renzapride by Alizyme


The Phase III study compared renzapride 4mg once a day, renzapride 2mg twice daily and placebo, dosed for 12 weeks, in women with IBS-C. 1,821 patients were randomised, of whom 1,798 were eligible for inclusion in the 'intention-to-treat' ("ITT") population.

Both renzapride patient groups showed a statistically superior response compared to placebo on the primary endpoint (the number of months for which a patient was a responder). The proportion of patients who reported at least some improvement in their overall symptoms were about 60% in the two renzapride patient groups compared to about 55% in the placebo patient group each week, with an average increase over the placebo group of 5-6%.

Limited effects were seen on the three key secondary endpoints; those being relief of abdominal pain, relief of bowel problems and relief of bloating.

Data from the Phase II programme provided strong evidence of the pro-kinetic effect of renzapride through increased frequency of bowel movements and improved stool consistency. The Phase II programme also showed evidence of adequate relief of abdominal pain. These outcomes contrast with the data seen in this Phase III study.

As in the Phase II programme, there were no safety or tolerability issues observed in the Phase III study.

The Company believes this Phase III study was well designed to detect any durable benefits of renzapride versus placebo in a large patient population with IBS-C. Based on the adequacy of the study itself, together with today's clinical results, the Company considers that the efficacy shown is not sufficient to justify further development of renzapride by Alizyme. As a result, the Company is discontinuing clinical development of renzapride, including Study 052, the on-going open label extension study to evaluate the long-term safety and tolerability of renzapride.

Commenting on today's announcement, Tim McCarthy, Chief Executive Officer, of Alizyme said:

"We are disappointed with the outcome of this Phase III clinical study for renzapride. Data from our Phase II clinical programme provided a strong basis for progressing to the Phase III development of this compound for the management of IBS. Although in this Phase III study, renzapride has demonstrated some therapeutic benefit and was shown to be safe, the results do not provide sufficiently compelling data to justify further development by Alizyme.

Following today's announcement we will focus our resources on the other three products in our product portfolio and on the commercialisation of these late-stage assets."

[Fruehrentner]

Die Renzaprid-Daten sind da! Kurs bricht ein!!


Results from renzapride
Dated: Wednesday 23 April 2008

Please note that an Analyst meeting is being held at the offices of Buchanan Communications, 45 Moorfields, London, EC2Y 9AE at 11:00am. A web cast will be available, to connect to the web cast facility, please go to: mediaserve.buchanan.uk.com/webcasts/livegold/Irframes.htm approximately 10 minutes (10:50am) before the start of the briefing.

Cambridge, UK, 23 April 2008, Alizyme plc ("Alizyme" or "the Company") (LSE: AZM) announces clinical trial results from Study 038, its Phase III study of renzapride in constipation-predominant irritable bowel syndrome ("IBS-C").
Statistical significance achieved on the primary endpoint (duration of relief of overall IBS symptoms)

Treatment groups showed limited clinical improvement over placebo group

Limited effects seen on the three key secondary endpoints (relief of pain, bowel problems and bloating)
No safety or tolerability issues

Results do not justify further development of renzapride by Alizyme

The Phase III study compared renzapride 4mg once a day, renzapride 2mg twice daily and placebo, dosed for 12 weeks, in women with IBS-C. 1,821 patients were randomised, of whom 1,798 were eligible for inclusion in the 'intention-to-treat' ("ITT") population.

Both renzapride patient groups showed a statistically superior response compared to placebo on the primary endpoint (the number of months for which a patient was a responder). The proportion of patients who reported at least some improvement in their overall symptoms were about 60% in the two renzapride patient groups compared to about 55% in the placebo patient group each week, with an average increase over the placebo group of 5-6%.

Limited effects were seen on the three key secondary endpoints; those being relief of abdominal pain, relief of bowel problems and relief of bloating.

Data from the Phase II programme provided strong evidence of the pro-kinetic effect of renzapride through increased frequency of bowel movements and improved stool consistency. The Phase II programme also showed evidence of adequate relief of abdominal pain. These outcomes contrast with the data seen in this Phase III study.

As in the Phase II programme, there were no safety or tolerability issues observed in the Phase III study.

The Company believes this Phase III study was well designed to detect any durable benefits of renzapride versus placebo in a large patient population with IBS-C. Based on the adequacy of the study itself, together with today's clinical results, the Company considers that the efficacy shown is not sufficient to justify further development of renzapride by Alizyme. As a result, the Company is discontinuing clinical development of renzapride, including Study 052, the on-going open label extension study to evaluate the long-term safety and tolerability of renzapride.

Commenting on today's announcement, Tim McCarthy, Chief Executive Officer, of Alizyme said:

"We are disappointed with the outcome of this Phase III clinical study for renzapride. Data from our Phase II clinical programme provided a strong basis for progressing to the Phase III development of this compound for the management of IBS. Although in this Phase III study, renzapride has demonstrated some therapeutic benefit and was shown to be safe, the results do not provide sufficiently compelling data to justify further development by Alizyme.

Following today's announcement we will focus our resources on the other three products in our product portfolio and on the commercialisation of these late-stage assets."


For further information, please contact:

Alizyme plc
Tim McCarthy, Chief Executive Officer
David Campbell, Finance Director
Tel: + 44 (0) 1223 896000

UK/Europe Enquiries
Buchanan Communications
Lisa Baderoon
Rebecca Skye Dietrich
Tel: + 44 (0) 20 7466 5000

US Enquiries
Trout Group
Tim Ryan Tel: + 1 [phone]
Lee Stern Tel: + 1 [phone]

Further information on Alizyme can be found on the Company's website: www.alizyme.com


Editor's Note

Alizyme plc
Alizyme is a speciality biopharmaceutical development company, focused on the therapeutic areas of metabolic disorders, gastrointestinal disorders and cancer supportive care. It is developing cetilistat for the treatment and management of obesity and related diseases, such as type 2 diabetes, COLAL-PRED(R) for ulcerative colitis, and ATL-104 for mucositis, a side effect of cancer therapy.

IBS
IBS is a functional gastrointestinal disorder characterised by recurrent symptoms of abdominal pain and discomfort associated with disturbed bowel function, which may also be accompanied by a feeling of bloating. Patients may have constipation-predominant IBS ("IBS-C"), mixed-symptom IBS ("IBS-M") or diarrhoea-predominant IBS ("IBS-D").

renzapride
renzapride was being developed by Alizyme for the treatment of IBS-C and for IBS-M. It is both a 5-HT4 receptor full agonist (which acts as a pro-kinetic, enhancing motility) and a 5-HT3 receptor antagonist (which can reduce pain and diarrhoea).

renzapride has completed an extensive Phase I and Phase II clinical development programme, a 'Thorough Cardiovascular Safety' trial in healthy volunteers and a Phase III pivotal efficacy study in over 1,800 female IBS-C patients.

renzapride has been shown to be safe and well tolerated in both IBS-C and IBS-M patients in Phase I and Phase II studies. Phase II clinical data showed up to 25% improvement on relief of overall IBS symptoms over placebo. The 'Thorough Cardiovascular Safety' trial showed that renzapride has no propensity to cause disturbances in heart rhythm at the therapeutic dose (4mg) and at a dose five times this level (20mg).

http://www.alizyme.com/alizyme/media/press/show.jsp?ref=128


Das war's dann wohl. Bitte thread schliessen

[Fruehrentner]

Antwort auf Beitrag Nr.: 33.949.066 von BrauchGeld am 23.04.08 09:55:06

Renza ist nun Geschichte tja so ist das halt mit Biotech ,aber das Hauptprodukt ist Cetilistat und da sind noch Colal-Pred und ATL-104.

uups, sorry, hab übersehen dass du es schon reingestellt hast heut morgen.

[Fruehrentner]

Nachdem Renza gescheitert ist, richten sich die Blicke bei Alizyme aof Colal-Pred.

In der EU ist man ja schon in Phase III mit Colal-Pred und ich glaube, bis Mitte des Jahres soll es Daten hierzu geben von Alizyme.

In USA gabs news vom Lizenzpartner:


Prometheus fires pellets for colon treatment

By Nick Taylor

26/05/2008- Prometheus Laboratories has initiated US Phase II trials of Colal-Pred, a treatment for ulcerative colitis which uses Alizyme's drug delivery technology to provide therapeutics solely to the colon.

By encasing a generic steroid (prednisolone sodium metasulfobenzoate) in Alizyme's delivery technology the drug is released only when it reaches the colon as the pellet is broken down solely by bacteria found there.

This protects patient from the side effects of steroids, which include weight gain, mood swings, 'moon face', osteoporosis and immunosuppression.

Roger Hickling, R&D director at Alizyme, explained the delivery system to in-PharmaTechnologist.com: "When the patient swallows a capsule, the capsule is dissolved in the stomach in the usual way releasing the coated pellets.

"The coated pellets pass through the stomach and small intestine intact. The coat on the pellets is only broken down once the pellets reach the colon, thus releasing the active steroid."

Alizyme's pellets are composed of ethylcellulose and a form of starch called 'glassy amylose'. This 'glassy amylose' cannot be broken down by human enzymes throughout the gastrointestinal tract.

Upon reaching the colon its bacterial enzymes begin degrading the 'glassy amylose' in the capsule, releasing the steroid directly into the affected area.

This has an anti-inflammatory effect on the affected region, alleviating the symptoms of abdominal pain, bleeding, cramping, fatigue and diarrhoea associated with the ailment.

The two million who suffer from ulcerative colitis in what Alizyme describes as the "major territories" currently have to use untargeted anti-inflammatory steroids or 5-ASA as treatments.

However, taking untargeted anti-inflammatory steroids can induce the raft of side effects mentioned previously. 5-ASA also has problems with side effects. In addition Hickling informed in-PharmaTechnologist.com that 5-ASA is suitable only for treating "mild to moderate ulcerative colitis".

Steroids could be used for all cases of ulcerative colitis if the side effects are negated, according to Hickling.

He said: "The reason corticosteroids are not used in more mild disease is because of the poor tolerability of systemically absorbed steroids."
The ability to minimise side effects and target the colon opens up the possibility of Alizyme's technology being used in the treatment of other ailments affecting the region.

Hickling said: "We have done feasibility work with other compounds up to Phase I but none beyond that at present."

Potential applications could include the treatment of colonic cancer or Crohn's colitis.

For now though, the focus is on Colal-Pred, with a new drug application anticipated in 201l. Developments are at a later stage in Europe, where the drug may be in the market in the second half of 2009.

http://www.in-pharmatechnologist.com/news/ng.asp?n=85491-ali…

[deltavention]

Trotz dem Flop mit Renzapride ist "der Ofen" bei Alizyme noch nicht aus. Im Juli sollen die europäischen Ergebnisse der Colal-Studie veröffentlicht werden. Danach kann man Marktzulassung in Europa beantragen.

Ferner bedient Cetilistat als Blutfett- und Colisterin-Senker einen enorm großen Markt (potentieller Block-Buster).

Dieser Tage ist ein deutsches Bio-Tech Unternehmen für 150 Mio. EUR an einen japanischen Pharmariesen gegangen. Die hatten nur drei Medikamente in der präklinischen Phase - bis zur Zulassung dauert es da noch sechs bis sieben Jahre. Hier ist Alizyme doch schon wesentlich weiter und von der Market-cap nunmehr günstig zu haben.

Kommt eines von den in der Pipeline befindlichen Präparaten durch, wird der Kurs einen riesen Satz machen. Natürlich ist ein Investment aber letztlich Roulett, da die Risiken (siehe Renza) enorm sind.

But, do your own research . . .

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.173.925 von deltavention am 26.05.08 19:06:26

Bei Colal-Pred sieht das Risikoprofil aber ganz anders aus als bei völlig neuen Wirkstoffen wie dem gescheiterten Renzaprid, denn im Ggs. zu Renzaprid ist Colol-Pred "Alter Wein in neuem Schläuchen", d.h., ein altbekannter und längst erprobter Wirkstoff (hier ein Kortisonabkömmling) in neuer "Verpackung", sprich neuartiger pharmazeut. Formulierung ("Drug delivery" bzw. Galenik), bei dem das Mittel durch eine neuartige Galenik gezielt nur am Wirkort, hier Dickdarm, lokal freigesetzt wird.

Vorteil: die Kortisontypischen Nebenwirkungen tauchen (theoret. zumindest) bei gezielter Freisetzung im Dickdarm (Colon) nicht auf, da es ausschliesslich lokal wirkt und nicht aufgenommen (resorbiert) wird, und damit wie gewünscht keine systemische Wirkung hat.

Das wäre ein Segen für alle CU-Patienten!!

Es gibt ja schon andere Wirkstoffe (Mesalamin) für CU-Patienten, die schon seit langem auf dem Markt sind und ebenfalls gezielt im Dickdarm freigesetzt werden, allerdings nicht so eine starke erwünschte Wirkung erzielen wie Kortisonpräparate.

Allerdings muss man auch sagen, dass COLAL-Pred eher ein Nischenpräparat ist, da CU keine Massenindikation ist und somit bei weitem nicht die magische 1 Mrd-Umsatzgrenze erreichen wird bei Zulassung. Big Pharmas haben daher wohl kein Interesse, eher andere Nischenplayer.

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.179.679 von Fruehrentner am 27.05.08 15:00:50

Hier zur Erinnerung die Colal-Pred Phase-II Ergebnisse aus 2002, die ja sehr gut aussahen und eine echte Hoffnung für CU-Patienten darstellen. Bemerkenswert ist, dass sich der natürliche Cortison/Steriod Level im Körper trotz Einnahme von Colal-Pred nicht erhöht hat und somit die gefürchteten Nebenwirkungen bei Cortisoneinnahme weitgehend ausbleiben sollten. Zugleich ist Colal-Pred aber im Vergleich zur normalen Prednison-Einnahme (systemisch) in seiner Wirkung gleichauf, was sehr erfreulich ist.

Jetzt kommt's natürlich darauf an, dass diese Ergebnisse aus der Phase II in der Phase III bestätigt werden.


ALIZYME ANNOUNCES POSITIVE PHASE II CLINICAL TRIAL RESULTS FOR TREATMENT OF ULCERATIVE COLITIS WITH COLAL-PRED™

Dated: Thursday 14 February 2002

Cambridge UK, 14 February 2002: Alizyme plc (LSE:AZM) has obtained positive preliminary results in a Phase II clinical trial with COLAL-PRED™ in ulcerative colitis patients with active disease.

COLAL-PRED™, consists of pellets of an approved steroid (prednisolone sodium metasulphobenzoate) coated with Alizyme's proprietary colon drug delivery system (COLAL™) presented in a capsule. The trial's objective was to demonstrate that the local release of the drug in the colon would provide efficacy without the usual undesirable side effects caused by steroid treatment.

A total of 37 patients with mild to moderate ulcerative colitis were enrolled into the randomised, double blind, parallel group study which was conducted in specialist gastroenterology clinics in the UK. The patients received either 60 or 40 mg of COLAL-PRED™ daily for four weeks, after which the dose was tapered off over the next three weeks. Patients' response was assessed by the Disease Activity Index ('DAI') and the Physicians Global Assessment ('PGA') which include patient symptoms, colonoscopic score and biopsy.

The preliminary results demonstrate an improvement in DAI and PGA in both the 60 and 40 mg patient groups of 63% and 35% respectively. This was associated with a clinical remission rate of 31% and 6% in these respective patient groups. These results are comparable with data from other clinical trials reported in the literature for conventional prednisolone formulations and dosing regimens.

COLAL-PRED™ was well tolerated, with no steroid-related adverse events. Morning cortisol levels, a marker of systemic side effects of steroids, were not changed from baseline at any time during the treatment period.

The data obtained has formed the basis of a new patent application that has been filed for COLAL-PRED™.

"Obtaining a clinical response in ulcerative colitis patients without the usual debilitating steroid side-effects would be an important advance and these results with COLAL-PRED™ are very promising." said Prof. Christopher Hawkey, Consultant Gastroenterologist, Queens University Medical Centre, Nottingham, one of the investigators.

These results provide the basis for discussions with regulatory authorities in preparation for pivotal Phase III trials for treatment of active ulcerative colitis in Europe, which are planned to start by the end of 2002. This Phase III development is not expected to be as extensive as normally required for a new therapeutic agent, as it should be able to take advantage of the fact that the prednisolone derivative used is already approved in several European countries. The excellent safety profile demonstrated in this Phase II trial also underpins the rationale for a trial in the maintenance of remission. Approval by the UK Medicines Control Agency for a Phase III trial in this indication is separately announced today.

Approximately one million patients suffer from ulcerative colitis worldwide. The current market for ulcerative colitis drugs is estimated to be worth at least $500 million per annum and provides an attractive opportunity for a product with the profile of COLAL-PRED™, which could contribute substantially to the continued growth in the value of this market.

Dr. Richard Palmer (Chief Executive Officer) commented:

"I am extremely pleased with these results as they provide proof of the product concept for COLAL-PRED™ and validate the specificity of the COLAL™ colon delivery technology in patients. They provide the basis for moving this product into pivotal Phase III trials in preparation for product approval and commercialisation. In addition, the results enhance the opportunity for exploiting the COLAL™ technology platform with other drugs."

http://www.alizyme.com/alizyme/media/press/show.jsp?ref=74

[Fruehrentner]

Cambridge UK, 20 June 2008:

Alizyme plc (LSE: AZM) announces that Tim McCarthy, Chief Executive Officer, will be presenting at the 2008 Piper Jaffray Europe Conference on Tuesday, June 24, 2008 at 3.00pm (BST).

[Fruehrentner]

positive news!! Aktie ajteull + 15 %


Cambridge UK, 27 June 2008:

Alizyme plc (LSE: AZM) ("Alizyme") announces that its wholly owned subsidiary, Alizyme Therapeutics Limited, has granted an exclusive licence to Norgine B.V. ("Norgine"), an independent specialty pharmaceutical company, for the rights to COLAL-PRED® for the treatment and/or alleviation of the symptoms of ulcerative colitis in Europe, South Africa, Australia and New Zealand.

To read this announcement in full, please click on the link below and see ‘Latest News’:

http://www.alizyme.com

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.386.893 von Fruehrentner am 27.06.08 09:47:07

Das lässt auf positive Studiendaten (Phase III) zu COLAL-PRED hoffen, die jetzt im Juli kommen sollen!

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.386.893 von Fruehrentner am 27.06.08 09:47:07

hier die komplette Meldung:

Alizyme Licenses COLAL-PRED® to Norgine

Dated: Friday 27 June 2008

Please be aware that they will be an analyst meeting commencing at 11am at the offices of Buchanan Communications, 45 Moorfields, London, EC2Y 9AE where Tim McCarthy, Chief Executive Officer of Alizyme and Peter Stein, Chief Executive Officer of Norgine will be presenting. Simultaneously to the Analyst meeting there will be a webcast to connect to the webcast please follow the link below:

http://mediaserve.buchanan.uk.com/webcasts/livegold/lrframes…


Cambridge UK, 27 June 2008: Alizyme plc (LSE: AZM) ("Alizyme") announces that its wholly owned subsidiary, Alizyme Therapeutics Limited, has granted an exclusive licence to Norgine B.V. ("Norgine"), an independent specialty pharmaceutical company, for the rights to COLAL-PRED® for the treatment and/or alleviation of the symptoms of ulcerative colitis in Europe, South Africa, Australia and New Zealand.

Highlights

Norgine is a leading European specialty pharmaceutical company with a focus on gastroenterology

Exclusive licence agreement for COLAL-PRED® in Europe, South Africa, Australia and New Zealand

Upfront payment and development and sales milestones worth €42.75 million (US$67.0 million)
- €2.0 million payable immediately
- €40.75 million payable on future development and sales milestones

Double digit royalty rates that increase with higher annual net sales levels
Under the terms of the agreement, Norgine is granted an exclusive licence to develop and market COLAL-PRED® in Europe, South Africa, Australia and New Zealand. Alizyme will immediately receive an upfront payment of €2.0 million, followed by additional payments of up to €40.75 million on the achievement of future development and sales milestones. Norgine will be responsible for all commercialisation costs and will pay double digit royalty rates to Alizyme that increase with higher annual net sales levels.

In January 2008, Alizyme announced the completion of patient recruitment into the European pivotal registration Phase III trial of COLAL-PRED® in patients with active moderateߛtoߛsevere ulcerative colitis. Headline trial results are expected to be reported in July 2008.

Ulcerative colitis is an inflammatory disease of the colon that causes symptoms such as abdominal pain, bleeding, cramping, fatigue and diarrhoea. These conditions are characterised by episodes of acute flare of the inflammation, followed by periods of remission. In severe cases, surgery may be required to remove the diseased tissue.

The ulcerative colitis market is currently dominated by anti-inflammatory steroids and 5-ASA products, which have safety and/or efficacy issues. COLAL-PRED® is the combination of Alizyme's proprietary colonic drug delivery system, COLAL®, and prednisolone metasulfobenzoate sodium ("PMSBS"), an approved steroid in Europe. COLAL-PRED® has a coating that is broken down only in the colon, by locally occurring bacteria. This leads to topical delivery of PMSBS to the colon, rather than systemic delivery. It has been shown in a Phase II clinical trial to provide levels of efficacy comparable to that reported for conventional oral prednisolone, but without the debilitating side effects usually associated with steroids.

Currently around 2 million people in the major pharmaceutical territories around the world suffer from ulcerative colitis with projected sales of COLAL-PRED® in these territories in excess of US$250 million per annum.
Ferghana Partners Group acted as exclusive transaction advisor to Alizyme in relation to the agreement.

Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive Officer said:

“We are delighted to enter into this agreement with Norgine for the commercialisation of COLAL‑PRED®. We believe that Norgine, with its focus on gastroenterology and a strong and balanced pan-European presence, is uniquely positioned to maximise the commercial potential of COLAL‑PRED® in Europe as well as in the other territories included in this deal.”

Commenting on today's announcement, Peter Stein, Chief Executive Officer of Norgine said:

"We are excited to have entered into this partnership with Alizyme. COLAL-PRED® is a therapeutically and commercially attractive late stage development product that complements and strengthens our portfolio of marketed pharmaceutical therapies addressing gastrointestinal disorders."

-------------------------------------------------------------------

For further information, please contact:

Alizyme plc
Tim McCarthy, Chief Executive Officer
David Campbell, Finance Director
Tel: + 44 (0) 1223 896000

UK/Europe Enquiries
Buchanan Communications

Lisa Baderoon
Tel: + 44 (0) 20 7466 5000

Rebecca Skye Dietrich
Tel: + 44 (0) 7721 413 496

US Enquiries
Trout Group

Tim Ryan
Tel: + 1 [phone]

Lee Stern
Tel: + 1 [phone]

[deltavention]

Auch Jerini ist unerwartet von "den Toten" auferstanden. Vielleicht kommt auch unsere Alizyme irgendwann noch groß heraus. Für das Jerini Medikament erwartet man lediglich Umsätze von 400 Mio.USD, für Cetilistat von Alizyme aber über eine Mrd. USD! Tja, hohes Risiko - aber auch große Chancen. Ich denke, mit aktuell nur 40 Mio. Pfund ist die Company nicht fair bewertet. Aber warten wir ab, was kommt. Diesen Monat werden die Ergebnisse der Studie mit Colal-Pred publiziert.

(Quelle: FTD)

Briten kaufen Biotechfirma Jerini

Spektakuläre Offerte in der Biotechbranche: Der britische Biopharmakonzern Shire verleibt sich die Berliner Biotechfirma Jerini für rund 330 Mio. Euro ein. Für die Jerini-Aktionäre lohnt sich das Geschäft: Ende April kostete die Aktie unter einem Euro - Shire bezahlt nun mehr als das Sechsfache
Shire bietet 6,25 Euro je Stückaktie von Jerini. Das ist ein Aufschlag von 68 Prozent auf den letzten Kurs der Jerini-Aktie, die am Donnerstag vorübergehend vom Handel ausgesetzt wurde. Der Preis entspricht Jerini zufolge sogar einem Aufpreis von rund 199 Prozent auf den volumengewichteten Durchschnittskurs der Jerini-Aktie in Höhe von 2,09 Euro während der letzten drei Monate vor Ankündigung des Angebots. Ende April hatte das Papier noch 95 Cent gekostet.
Das seit Ende 2005 börsennotierte Unternehmen hatte die Investmentbank Credit Suisse Kreisen zufolge beauftragt, einen Verkauf zu prüfen. Jerini entwickelt Medikamente für Krankheiten, für die es bislang keine oder kaum Behandlungsmöglichkeiten gibt. Dazu zählt das hereditäre Angioödem (HAE). Das seltene Krankheitsbild ruft schmerzhafte Schwellungen an verschiedenen Regionen des Körpers hervor.
Jerinis Hauptprodukt Firazyr zur Behandlung vom HAE soll in Europa bis spätestens September auf den Markt kommen. Shire verspricht sich jährliche Umsatzerlöse von bis zu 400 Mio. $.
Die Briten haben sich von Vorstandschef und Firmengründer Jens Schneider-Mergener und anderen Altaktionären 53 Prozent der Anteile gesichert und werden zudem eine Kapitalerhöhung zeichnen, hieß es. Vorstand und Aufsichtsrat begrüßten die Übernahme. Der Vorstand werde nach der Übernahme zurücktreten.
Shire finanziert die Transaktion nach eigenen Angaben aus den Bargeldbeständen. Spätestens in der zweiten Jahreshälfte 2010 solle sich der Zukauf auszahlen. Shire fokussiert sich unter anderem auf humangenetische Therapien sowie Magendarm- und Harnwegserkrankungen.

[Fruehrentner]

aktuell an der Heimatbörse in London -15 %

Ob negative Phase-III news zu COLAL-PRED anstehen?? Diese sind für diesen Juli angekündigt.

[deltavention]

Antwort auf Beitrag Nr.: 34.512.572 von Fruehrentner am 15.07.08 16:50:15

Wer weiß - kann sein, muss aber nicht.

Bei der momentanen Achterbahnfahrt der Börsen und der Verpöntheit von Venture Capital Investmens in "irgendwelche Pharmaentwickler" kann auch die Marktlage der Grund dafür sein.

Alizyme ist sowiso kein "Colal Pred-Play" sonder ein "Cetilistat-Play". Wenn letzterer Wirkstoff wirklich gut und chanchenreich ist, kann Alizyme ein lockerer Tenbagger sein. Ist das Mittel Schrott, kann man Alizyme auch mit Colal Pred praktisch vergessen.

Zuletzt hat es ja einige betraglich sehr bedeutende Deals mit kleinen Biotech- und Pharmaentwicklern gegeben. Sollte Cetilistat mehr als eine Luftnummer sein, bin ich überzeugt, dass wir noch bessere Tage sehen, zumal selbst die fetteste Börsenbaisse irgendwann abgeritten ist.

Keine Empfehlung, nur meine Meinung. Do your own research !

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.514.402 von deltavention am 15.07.08 19:39:41

Alizyme ist sowiso kein "Colal Pred-Play" sonder ein "Cetilistat-Play".

Völlig zutreffen. Dennoch wird es jetzt spannend wird mit Colal-Pred.

[Fruehrentner]

Alizyme Announces Headline Results From its European Phase III Clinical Trial of Colal-Pred®

Dated: Thursday 24 July 2008

Cambridge UK, 24 July 2008: Alizyme plc (LSE: AZM) ('Alizyme') today announces headline results of its European Phase III clinical trial of COLAL-PRED® in patients with moderate to severe ulcerative colitis.

Highlights

* Results indicate safe treatment for acute ulcerative colitis

* COLAL-PRED® showed significantly improved risk-benefit profile compared to conventional prednisolone

* Non-inferiority of efficacy of COLAL-PRED® to conventional prednisolone in terms of DAI at 8 weeks was not shown

* COLAL-PRED® showed equivalent efficacy in terms of SCCAI compared to conventional prednisolone after 8 weeks' dosing, and at the 12 week follow-up visit

* Optimal dose shown to be 40 mg of COLAL-PRED®

* Results indicate further potential for COLAL-PRED® in the maintenance of remission of ulcerative colitis

* Delay to submission of MAA pending discussions with partners and regulatory advisors

Ulcerative colitis is a chronic relapsing inflammatory disease of the colon for which there is an unmet medical need for a therapy that is both effective and safe. The 'gold standard' in terms of efficacy is conventional oral prednisolone. However, this has significant adverse effects that limit its clinical use and restrict the duration for which it can be safely administered. COLAL-PRED® is the combination of Alizyme's proprietary colonic drug delivery system, COLAL®, and prednisolone metasulfobenzoate sodium ('PMSBS'), a form of prednisolone approved in Europe for the treatment of acute ulcerative colitis.

The European Phase III trial was designed to demonstrate that in individual patients, COLAL-PRED® was both an effective, and a safe and well tolerated treatment for ulcerative colitis, without the debilitating side-effects associated with conventional prednisolone. The study was a double blind comparison of COLAL-PRED® capsules and conventional prednisolone tablets in patients with moderate to severe ulcerative colitis.

COLAL-PRED® (40 mg, 60 mg or 80 mg once daily ('o.d.')), administered for 8 weeks, was compared with conventional prednisolone. The conventional prednisolone dosing regimen was 40 mg o.d. for 2 weeks, followed by a tapering regimen (to allow recovery from adrenal suppression) that reached 0mg by Week 8.

The study had two co-primary endpoints:

* Safety Response
Superiority compared to conventional prednisolone in the proportion of patients who were Safety Responders (patients whose early morning plasma cortisol was >150 nmol/l at Week 4 and at Week 8).

* Efficacy Response
Non-inferiority compared to conventional prednisolone in the proportion of patients who were Efficacy Responders (patients who showed a reduction of at least 3 points in their Disease Activity Index ('DAI') score at Week 8 (or time of withdrawal) compared to baseline). The required non-inferiority margin was 15%.

The key secondary endpoint that addressed the Target Product Profile was:

* Treatment Response

Superiority compared to conventional prednisolone in the proportion of patients who were Treatment Responders (individual patients who were both Efficacy Responders and Safety Responders).

Other efficacy endpoints included change in Simple Clinical Colitis Activity Index ('SCCAI') score.

Results

799 patients were randomised; approximately 200 per treatment group. Of these, 543 (68%) completed study medication (65% to 67% in the COLAL-PRED® groups and 74% in the prednisolone group). The mean initial DAI score was 8.1. Of the patients randomised, 40% had an initial DAI score of ≥9.

The Efficacy Responder rate in the COLAL-PRED® arms (approximately 56%) was about 18% lower than that in the prednisolone arm (74%). Thus non-inferiority of efficacy of COLAL-PRED® to conventional prednisolone was not shown.

The reduction in mean SCCAI in the COLAL-PRED® treatment groups was equivalent to that in the prednisolone treated group at Week 8 (reduction of 2.32 points and 2.42 points respectively in comparison with baseline) and at Week 12 (reduction of 3.06 points and 2.75 points respectively).

Early morning plasma cortisol was unchanged in the COLAL-PRED® treatment groups throughout the study, while there was a clinically significant reduction of 170 nmol/l in the prednisolone group at Week 4.

The incidence of typical steroid-related adverse events was significantly lower in the COLAL-PRED® groups compared to the prednisolone group. Cushingoid syndrome was reported by 5.3% patients in the prednisolone group compared to 0.0% to 1.0% in the COLAL-PRED® treated patients, 4.8% of patients in the prednisolone group reported insomnia compared to 1.0% to 1.5% in the COLALߛPRED® groups, and 4.8% of prednisolone patients reported acne compared to 0.0% to 1.5% of the COLALߛPRED® patients.

Although non-inferiority of efficacy of COLAL-PRED® to conventional prednisolone was not shown, COLAL-PRED® was statistically superior to prednisolone in the proportion of patients who were Treatment Responders, i.e. were both Efficacy and Safety Responders, thereby meeting the key secondary endpoint with respect to addressing the Target Product Profile.

The results of the study support the product profile for COLALߛPRED® of safety as well as efficacy in individual patients. The excellent safety profile, particularly the absence of an effect on plasma cortisol, also supports the long term administration of COLAL-PRED® for maintenance of remission.

There was no clinically relevant difference in response in terms of efficacy, safety and tolerability across the three COLALߛ-RED® treatment groups (40 mg, 60 mg or 80 mg o.d.), supporting a dose recommendation of 40 mg o.d.

Commenting on the results, Prof. CJ Hawkey, Chief Coordinating Investigator, said:

'These results indicate COLAL-PRED® to be a safe treatment for acute ulcerative colitis with fewer adverse effects than conventional prednisolone and support further development of COLAL-PRED® for maintenance of remission.'

Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive Officer said:

'We are pleased to report that the headline results of this study indicate that COLAL-PRED® is a safe steroid in the treatment of ulcerative colitis. The headline results also indicate that this product has potential for maintenance of remission of ulcerative colitis. We will continue to analyse the results and, in conjunction with our partners and regulatory advisors, establish the optimum way forward in commercialising this product.'


For further information, please contact:

Alizyme plc
Tim McCarthy, Chief Executive Officer
David Campbell, Finance Director
Tel: + 44 (0) 1223 896000

UK/Europe Enquiries
Buchanan Communications
Tel: + 44 (0) 20 7466 5000

Lisa Baderoon
Tel: + 44 (0) 7721 413496

US Enquiries
Trout Group

Tim Ryan
Tel: + 1 [phone]

Lee Stern
Tel: + 1 [phone]

Further information on Alizyme can be found on the Company's website: www.alizyme.com

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.576.756 von Fruehrentner am 24.07.08 12:03:25

Quelle: http://www.alizyme.com/alizyme/media/press/show.jsp?ref=137

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.576.756 von Fruehrentner am 24.07.08 12:03:25

Die Aktie stürzt ins bodenlose: -41 % aktuell

Mir tut's um die Patienten, die von COLAL-PRED sehr profitiert hätten, leid

[deltavention]

Tja, dann müssen wir wohl auch von COLAL-PRED Abschied nehmen. Jetzt steht in den Sternen, ob überhaupt noch was draus wird.

Statt 3x Phase III haben wir nun 2x nix und 1x ein großes Fragezeichen. Wie der Markt die Chancen einschätzt, dass Cetilistat ein Blockbuster wird, kann man wohl gut am aktuellen Kurs ablesen. Ein potentieller Investor würde sicherlich auch nicht zig Millionen dafür zahlen, wenn es die ganze Firma für ein Taschengeld zu kaufen gibt.

Wie schon gesagt, es gibt oder gab bei Alizyme große Chancen aber auch enorme Risiken. Habe mit gewettet und eine gute Stange Geld verloren - aber so ist halt Börse. Ich wußte, worauf ich mich eingelassen habe.

Vielleicht wird Cetilistat doch noch was und nicht alles ist komplett verloren. Vorerst jedenfalls wird es dunkel um die Company.

[Fruehrentner]

http://www.alizyme.com/alizyme/uploads/press/Alizymeplc-Inte…

interim results

[deltavention]

Der Kurs hat sich die letzten Tage ja wieder leicht bekrabbelt, wenn man bei diesem Penny-Stock Niveau überhaupt von einer relevanten Bewegung sprechen kann.

Vielleicht ist wieder mal was im Busch. Nach dem letzten Finanzbericht muss man immerhin ernsthaft befürchten, dass den Jungs in Britannien bald die Kohle zum Weiterforschen ausgeht.

Hoffnung stirbt ja bekanntlich zuletzt - Cetilistat könnte das Blatt immer noch wenden, wenn Takeda in Japan mit guten Ergebnissen herauskommt und Phase III anläuft.

[Fruehrentner]

Update on Board Change
Dated: Friday 05 September 2008

Cambridge UK, 5 September 2008: Alizyme plc (LSE: AZM) today confirms that following the announcement of Board changes as part of the Interim Results statement on 29 August 2008, David Campbell will step down from the Board as Finance Director and Company Secretary with effect from today.

Nick Blech, currently Corporate Projects Manager, will assume the day to day responsibilities related to the Company's accounting and financial administration, reporting directly to the CEO. Nick is also appointed as Company Secretary with immediate effect.

Tim McCarthy, CEO commented: 'The Board would like to thank David for his contribution to Alizyme over the last seven years and we wish him every success for the future.'

For further information, please contact:

Alizyme plc

Tim McCarthy, Chief Executive Officer
Tel: + 44 (0) 1223 896000

Buchanan Communications
Tel: + 44 (0) 20 7466 5000

http://www.alizyme.com/alizyme/media/press/show.jsp?ref=139

[Fruehrentner]

was ist denn da heute los? minus 18 % Kursrutsch heut! Gibt keine offiziellen news.

[Fruehrentner]

Antwort auf Beitrag Nr.: 35.051.157 von Fruehrentner am 10.09.08 17:17:57

naja jetzt wird's klar, gab kurz davor ja eine deutliche Kurserholung vom Boden. Mal weiter beobachten, ob das wirklich der Boden war ...

[Fruehrentner]

Kräftige Kurserholung in jüngster Zeit bei Alizyme. Ob wir den Boden gesehen haben? Mal weiter beobachten.

[Fruehrentner]

News!

Cambridge UK, 16 September 2008

Alizyme plc (LSE:AZM) is pleased to announce that it is to receive a US$3 million milestone payment from Takeda Pharmaceutical Company Limited (Takeda) as a result of Takeda’s decision to commence a Phase III clinical trial in Japan of cetilistat for the treatment of obesity

www.alizyme.com

[Fruehrentner]

Kurs steigt weiter kräftig an.

[Fruehrentner]

heute heiter weiter mit dem Kursanstieg

[deltavention]

Nachfolgender Artikel dürfte der Grund für die Kursbewegungen sein:

Endingen (aktiencheck.de AG) - Nach Meinung der Experten von
"Global Biotech Investing" verfügt die Alizyme-Aktie (ISIN GB0000374289/ WKN 901931) über riesiges Potenzial.

Bis vor wenigen Jahren habe die Biotechgesellschaft noch unter Branchenkennern zu denen mit der fortgeschrittensten Produktpipeline in Großbritannien gezählt. So seien Ende 2006 noch Kursziele von bis zu 180 GBp vergeben worden.

Inzwischen sei Renzabride "eingedampft" worden und die Zulassungschancen für Colal-Pred würden sich nach enttäuschenden Phase III-Testreihen gegen Null belaufen. Somit würden alle Hoffnungen auf Cetilistat ruhen. Es sei ein Präparat gegen Fettleibigkeit.

Der Markt scheine aber auch für Cetilistat nur wenig Hoffnung auf eine Zulassung zu sehen und Ende August seien zudem Sorgen über den rückläufigen Cash-Bestand aufgekommen, der sich auf 7,7 Mio. GBP belaufe. Damit habe der Titel bis auf zeitweise 5,50 GBp verloren.

Das Alizyme-Management habe reagiert und nahezu alle R&D-Kosten heruntergefahren und es suche nun nach finanzstarken Partnern für eine Fortsetzung der Cetilistat-Testreihen. Ein erster Erfolg habe am letzten Mittwoch gemeldet werden können. So habe man von Takeda Pharmaceuticals eine Milestonezahlung in Höhe von 3 Mio. USD für die Fortführung der Phase III-Testreihen in Japan erhalten.

Die Nachrichten seien vom Markt positiv aufgenommen worden und so habe das Papier rasch auf 16 GBp zulegen können. Die Analysten von Investec würden derzeit ein Kursziel von 41 GBp vergeben und zudem werde hinter vorgehaltener Hand von einem Übernahmeangebot zu 20 GBp je Aktie gesprochen.

Nach Meinung der Experten von "Global Biotech Investing" verfügt die Alizyme-Aktie über riesiges Potenzial. (Ausgabe 18 vom 22.09.2008) (23.09.2008/ac/a/a) Analyse-Datum: 23.09.2008

[Fruehrentner]

Und wieder ein Kandidat gegen Fettleibigkeit weg vom Fenster:


02.10.2008 15:08:00

Merck & Co stellt Entwicklung von Medikament ein

Whitehouse Station, NJ (aktiencheck.de AG) - Der US-Pharmakonzern Merck & Co. Inc. (ISIN US5893311077 / WKN 851719) hat die Entwicklung eines Medikaments zur Behandlung von Fettleibigkeit eingestellt.
Wie aus einer am Donnerstag veröffentlichten Pressemitteilung hervorgeht, hätten die Daten einer klinischen Phase-II-Studie für das Medikament Taranabant gezeigt, dass das Präparat nicht die gewünschten Wirkungen bei der Behandlung von übergewichtigen Patienten erzielt habe. Den Angaben zufolge habe es sich gezeigt, dass die Effizienz einer Behandlung mit Taranabant bei höherer Dosierung gestiegen sei, wobei unerwünschte Nebenwirkungen zugenommen hätten.

Die Aktie von Merck & Co notierte zuletzt bei 32,09 Dollar. (02.10.2008/ac/n/a)

Quelle: Finanzen.net / Aktiencheck.de AG

© Aktiencheck.de AG
Quelle:AKTIENCHECK.DE



Bleibt als spannend mit Alizyme's Cetilistat.

[Fruehrentner]

Antwort auf Beitrag Nr.: 35.380.065 von Fruehrentner am 02.10.08 15:19:15

Haben Taranabant und Alizyme' Cetilistat denselben oder ähnlichen Wirkmechanismus bzw. Angriffspunkt im Körper?

[Fruehrentner]

Antwort auf Beitrag Nr.: 35.239.549 von deltavention am 23.09.08 19:18:15

"... Nach Meinung der Experten von "Global Biotech Investing" verfügt die Alizyme-Aktie über riesiges Potenzial."


.. bei riesigem Risiko, muss man aber auch dazusagen.

[deltavention]

Antwort auf Beitrag Nr.: 35.591.119 von Fruehrentner am 16.10.08 13:21:16

Jau, so ist das.

Bei einer Firma, die Medikamente entwickelt, es das aber schon so selbstverständlich, dass man es kaum mehr erwähnen muss.

Ist Cetilistat ein Flop, heißt das Kursziel Null Euro.

Ist es der Knaller, für den es Alizyme hält, sind historische Kurshöhen sicher nicht illusorisch.

Aller guten Dinge sind doch oft "drei": Renza war ein Flop, Colal Pred war es auch - so wird Cetilistat dann halt der Blockbuster !

[Fruehrentner]

Und wieder ein Rückschlag für ein Mittel gegen Übergewicht (engl. obesity):

Acomplia's EU suspension dispels illusion of blockbuster future
01 Nov 2008

The EMEA has suspended Acomplia due to the risk of serious psychiatric disorders. The anti-obesity agent had been promised a sure success by numerous analysts, as it addressed indications beyond obesity. However, Acomplia failed to win approval in the US, and just two years after the EU approval its sales have been completely halted, leaving the potentially vast anti-obesity market bare again.

Over a year after the FDA concluded that Acomplia's benefits did not outweigh its risks (June 2007), the EMEA's Committee for Medicinal Products for Human Use (CHMP) has come to the same conclusion, forcing Sanofi-Aventis to withdraw the drug. Under the suspension, Sanofi can still continue the Phase III research, and if additional supportive data are available in the future, the agent may reappear on the market.

However, such an outcome is very unlikely given the current post-marketing experience, which indicates that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine. As for the US, Sanofi is planning to reapply to the FDA in 2009 Q4, but for a diabetes indication this time. This may be a strategic move to avoid the non-reimbursement of obesity drugs as lifestyle agents. However, the current regulatory climate in the US is very conservative, and growing more so. It is therefore hard to visualize a drug with known serious adverse effects successfully reaching the US market.

The CHMP confirmed that "there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking placebo." Even in pre-marketing studies with rimonabant, depression and other psychiatric side effects were the biggest concern. The clinical trials excluding patients with depression alarmed opinion leaders and physicians with their rate of depressed mood disorders. The side effects profile limited the patient potential of rimonabant dramatically, since a lot of the obese patients tend to have an inclination to depression.

Moreover, it appears that the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the trials, because available data indicate that patients generally take Acomplia only for a short period. As previously highlighted in Datamonitor research, the main reason behind low compliance is the non-reimbursement of obesity medication in most of the major markets. Together with the concerns raised by Acomplia's safety profile, this low level of compliance led Datamonitor to believe that the drug would not become a blockbuster, in contradiction to the many forecasts predicting success. At one point, Sanofi forecasted the annual sales of the agent to be over $3 billion - now it is clear that even if Acomplia returns to the market, these expectations will not be realised.

The recent discontinuation of Merck & Co's taranabant, another CB1 endocannabinoid receptor modulator, due to psychiatric side effects, further darkens the shadows around the development of this class of agents (including Pfizer's otenabant, currently in Phase III development) for the treatment of obesity, a highly prevalent condition presenting high unmet needs.

The number of available drugs in each of the seven major markets is marginally low. Most of the markets have only orlistat and sibutramine approved for treatment of obesity. Orlistat is preferred to sibutramine in all countries, due to its good safety profile, but is plagued with poor tolerability, which makes special patient education regarding the optimal use of the drug crucial. Sibutramine is not popular with physicians due to its side effects, particularly the raising of blood pressure. Since a lot of obese people develop hypertension, a large proportion of obese population has to be screened out of treatment with sibutramine. The compound also does not boast high efficacy.

Apart from concerns specific to each of the available drugs, a major issue is the efficacy of the agents being far below the patients' expectations. The high cost together with the lack of reimbursement, poor safety/tolerability, and low efficacy compared to expectations lead to poor compliance and high discontinuation rates, significantly limiting the size of the anti-obesity market and minimizing the prospects of novel agents. This in turn leads to low interest in obesity R&D, which has been demonstrated by Pfizer announcing its exit from the heart and obesity development arena for more lucrative areas. The vicious circle results in obesity remaining the blind spot of pharmaceutical progress.

http://www.pipelinereview.com/content/view/23093/309/


Ob Alizyme mit Cetilistat den Durchbruch schafft?

[Fruehrentner]

news:

http://www.alizyme.com/alizyme/uploads/press/19-11InterimMan…

[Fruehrentner]

Und hier der nächste, der die Entwicklung eines Wirkstoffes gegen Übergewicht vorzeitig einstellt:

Solvay Pharmaceuticals discontinues R&D activities of its anti-obesity compound SLV319

17 Nov 2008

Solvay Pharmaceuticals announced today its decision to discontinue all R&D activities for its investigational compound SLV319

Brussels,Belgium | November 17, 2008 | Solvay Pharmaceuticals announced today its decision to discontinue all R&D activities for its investigational compound SLV319. This compound, a selective cannabinoid type 1 antagonist, was currently in phase 2 development for the treatment of obesity. The phase-2 results recently confirmed its clinical activity and its efficacy.

As announced in the nine month results press release of 30 October, Solvay Pharmaceuticals was analyzing the next step for the development of this molecule in the current regulatory framework, after the return of worldwide rights to Solvay at the end of September 2008.

“While the discontinuation is not related to any adverse events or the efficacy of the compound, we have made this decision after careful evaluation of the current regulatory environment, leading to new and high regulatory hurdles for approval of a compound of this class”, said Dr Claus Steinborn, Head of Global R&D, Solvay Pharmaceuticals.

SOLVAY PHARMACEUTICALS is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health. Its 2007 sales were EUR 2.6 billion, and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.

SOLVAY GROUP is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 28,000 people in 50 countries. In 2007, its consolidated sales amounted to EUR 9.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay is listed on the NYSE Euronext stock exchange in Brussels (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR). Details are available at www.solvay.com.

SOURCE: SOLVAY PHARMACEUTICALS

[deltavention]

Anbei eine kongeniale Analyse des Aktiencheck:

Alizyme möglicherweise Reißleine ziehen

Endingen (aktiencheck.de AG) - Anleger sollen nach Meinung der Experten von "Global Biotech Investing" bei der Alizyme-Aktie (ISIN GB0000374289/ WKN 901931) möglicherweise die Reißleine ziehen.

Wie aus einer Untersuchung der Investmentgesellschaft KBC hervorgehe, operiere rund ein Drittel der in Großbritannien ansässigen Biotechgesellschaften mit minimaler Cashdecke, so dass sehr rasch weitere Liquiditätsspritzen notwendig seien.

Bereits im September hätten die Experten bei Alizyme darauf hingewiesen, dass die finanzielle Situation nicht unterschätzt werden solle, obwohl die Testreihen zu Cetilistat mit Takeda Pharmaceutical vorankommen würden. Dabei handle es sich um das einzige Präparat der Gesellschaft.

Anleger sollen nach Meinung der Experten von "Global Biotech Investing" bei der Alizyme-Aktie möglicherweise die Reißleine ziehen. (Ausgabe 24 vom 15.12.2008) (15.12.2008/ac/a/a)

Analyse-Datum: 15.12.2008

Meine Meinung: Wer bei 7 Cent noch nicht die Reißleine gezogen hat, braucht es jetzt wohl auch nicht mehr zu tun. Um das zu wissen, brauche ich allerdings keinen Analysten, der mir einen Verkauf "möglicherweise" (!) empfiehlt.

[deltavention]

Mit Cetilistat geht´s weiter (Quelle: alizyme.com)

TAKEDA COMMENCE CETILISTAT (ATL-962) PHASE III PROGRAMME IN JAPAN

Dated: Monday 22 December 2008

Cambridge UK, 22 December 2008: Alizyme plc (LSE:AZM) is pleased to announce that Takeda Pharmaceutical Company Limited ("Takeda") has commenced a Phase III clinical study in Japan of cetilistat (ATL-962) for the treatment of obesity.

Takeda, Alizyme's partner for the development and commercialisation of cetilistat in Japan, has today announced the commencement of its Phase III study for cetilistat in the treatment of obesity in Japan.

In September 2008, Alizyme announced that it was to receive a milestone payment of US$3 million under the licence and development agreement between Takeda and Alizyme, following the decision by Takeda to commence Phase III development of cetilistat in Japan. Takeda has today announced the formal commencement of the study.

Tim McCarthy, Chief Executive Officer, Alizyme plc, commented:

"We are delighted with Takeda's rapid progression into their Phase III study for cetilistat. We have an excellent working relationship with Takeda, developed over the past five years, and we look forward to continuing to work together as cetilistat is progressed through Phase III development and on to commercialisation in Japan."

[Fruehrentner]

News vom Wettbewerb zu Entwicklungskandidaten gegen Übergewicht:

Orexigen reports promising results from first Phase III obesity study

12th January 2009

Orexigen Therapeutics, a biopharmaceutical company, has announced that the first of four Phase III trials of its lead investigational product Contrave met its co-primary and key secondary endpoints, showing a significant reduction in body weight, improvements in markers of cardiovascular risk and reductions in selected food craving measures.
In this trial, which included an intensive diet and exercise behavior modification regimen, obese patients treated with Contrave, based on intent-to-treat and completer analyses, lost an average of 20.3 pounds to 25 pounds, or 9.3% to 11.5% of their baseline body weight, versus 11 pounds to 16 pounds, or 5.1% to 7.3% of baseline body weight, for patients treated with placebo. Contrave was generally well tolerated by patients.

In addition, in the categorical weight reduction analysis, the percentage of patients who lost greater than or equal to 10% of their body weight was 20.2% in the placebo group compared to 41.5% in the Contrave group. All of these findings were highly statistically significant and satisfy the categorical FDA efficacy benchmark for clinically significant weight loss, the company said.

The 56-week, double-blind, placebo-controlled trial conducted at nine US centers evaluated the efficacy and safety of Contrave (32mg naltrexone SR/360mg bupropion SR) compared to placebo in 793 obese patients who participated in an intense behavioral program consisting of counseling, diet and exercise. The objective of this NB-302 trial was to determine the additional weight loss and health benefits of Contrave when added to an intensive diet and exercise program.

Patient enrollment has been completed in the three other Phase III trials. Orexigen expects to announce top-line results from these trials in mid-2009 and, pending additional positive results, submit a new drug application with the FDA in late 2009.

Eduardo Dunayevich, chief medical officer of Orexigen, said: "The results of this trial indicate that additional, clinically significant weight loss can be achieved when Contrave is added to a rigorous program of diet and exercise. We are also very pleased with the safety profile demonstrated by Contrave thus far.

"We look forward to the results from the remaining Phase III trials which will further examine the efficacy, safety and tolerability of Contrave with less intensive behavior modification as well as in patients with type 2 diabetes patients."

http://www.pharmaceutical-business-review.com/article_news.a…


Contrave ist ofenbar eine Kombination schon bereits bekannter zugelassener Wirkstoffe, die als Monopräparat auf dem Markt sind. Das reduziert natürlich das Entwicklungsrisiko erheblich.

[sacha1978]

Antwort auf Beitrag Nr.: 36.363.475 von Fruehrentner am 13.01.09 14:43:43

Hallo fruehrentner

ich schaue mir diese gerade genauer an......
...wo werden die denn gehandelt??

Das Volumen scheint mir sehr sehr mager!

Wie schätzt du die situation ein?

Greez

[Dorfmeister]

Antwort auf Beitrag Nr.: 36.364.843 von sacha1978 am 13.01.09 16:58:50

Uebergewicht? Wie wärs mit einem Medi ohne Nebenwirkungen und bis zu 50% Gewichtsverlust?

Unigene Reports Positive Results on a Novel Peptide for Reducing Food Consumption
Tuesday January 20, 8:30 am ET
Animal Studies Show Significant Decreases in Food Intake and Body Weight


BOONTON, N.J.--(BUSINESS WIRE)--Unigene Laboratories, Inc. (OTCBB: UGNE http://www.unigene.com) will present data this week regarding a novel peptide that has been shown to reduce food consumption in animals. The poster, entitled “Reduction in Food Consumption and Weight in Dogs by Oral Delivery of a Novel Anorexigenic Peptide,” will be presented at the Keystone Symposium Conference on “Obesity: Novel Aspects of the Regulation of Body Weight” in Alberta, Canada.
ADVERTISEMENT


The peptide, currently designated UGL269, is an analog of a natural peptide hormone, and was designed by Unigene scientists. It was tested against two other peptides in a placebo-controlled crossover study and demonstrated significant reductions in food intake and body weight when orally administered to dogs. The ability of UGL269 to reduce food intake was superior to that of other peptides reported to decrease food intake, including an analog of peptide PYY.

In the studies, oral administration of UGL269 resulted in a decrease in food intake by up to 50% and a significant decrease in body weight. Oral administration of an analog of peptide PYY resulted in a smaller reduction in food intake and minimal change in weight. Cessation of treatment with UGL269 resulted in a resumption of food intake to pre-dosing levels. Administration of placebo capsules had no effect on food intake.

“Therapies that modify feeding behavior and result in weight loss represent a significant unmet medical need,” commented Dr. Warren Levy, President and CEO of Unigene. “UGL269, which can be manufactured and orally delivered using our patented Secrapep® and Enteripep® technologies respectively, may offer a new, orally administered approach for weight loss through appetite reduction.”

[Fruehrentner]

Antwort auf Beitrag Nr.: 36.422.310 von Dorfmeister am 21.01.09 20:48:32

Finger weg von OTCBB-Werten!

[Fruehrentner]

Antwort auf Beitrag Nr.: 36.364.843 von sacha1978 am 13.01.09 16:58:50

@sacha,

bin jetzt auch überfragt, ob und wo man in D am besten kaufen kann.

Aber bedenke: Alizyme ist highest risk! Also alles oder nix Wette!

Totalverlust möglich.

[Dorfmeister]

Antwort auf Beitrag Nr.: 36.422.730 von Fruehrentner am 21.01.09 21:47:10

naja, manchmal passierts halt dass man unter die dollar grenze rutscht und dann ist man obb.
Das kann und darf deshalb nicht das einzige Kriterium sein.
Im Uebrigen haben die wenigstens schon ein Medikament auf dem Markt und setzen so jährlich fast 20 mio um. Dann kommen da noch 2 blockbuster medis in der phase III zusammen mit Novartis dazu und was ich hoffe, bald noch ein weiteres phase III mit einem neuen partner (siehe PR's vom letzten Jahr) plus geht möglicherweise die Kooperation mit GSK weiter. Der Titel scheint mir hier Boden gefunden zu haben (Market Cap von 50 Mio bei 20 Mio Umsatz, genügend Cash für 3 Jahre plus die Pipeline von oben --> viel weiter runter kanns ja nicht mehr!)

[Fruehrentner]

Noch ein Mittel - diesmal Lorcaserin - gegen Übergewicht (engl. obesity) vom Wettbewerber Arena. Hier scheint es in Kürze entscheidende Phasse-III Ergebnisse zu geben:


Global Biotech Investing stuft ARENA PHARMACEUT. auf

Endingen (aktiencheck.de AG) - Für die Experten von "Global Biotech Investing" ist die Aktie von Arena Pharmaceuticals (ISIN US0400471027/ WKN 939027) ein glasklarer Kandidat für ihr Musterdepot.

Für die Gesellschaft und ihren Hoffnungsträger Lorcaserin gehe es 2009 in die heiße Phase. Das Unternehmen konzentriere sich voll und ganz auf einen erfolgreichen Ausgang der Testreihen zu Lorcaserin. Für Ende März sei die Veröffentlichung der Phase III-Tests datiert.

Bei einem positiven Bescheid könne nach Ansicht der Experten ein entsprechender NDA bereits für Ende 2009 bei der US-Zulassungsstelle beantragt werden. Die Spanne der Kurszieleinschätzungen für die Aktie liege zwischen 4 USD und 20 USD. Zuletzt hätten die wenig überzeugenden Phase III-Daten des Konkurrenzproduktes Contrave vom Mitbewerber Orexigen die Aktie von Arena beflügelt. Aber auch wenn das Konkurrenzprodukt ebenfalls die Marktzulassung erhalte, würden die Analysten von Oppenheimer das Marktpotenzial von Lorcaserin für Arena Pharmaceuticals immer noch auf über eine Milliarde USD schätzen.

Für die Experten von "Global Biotech Investing" ist die Aktie von Arena Pharmaceuticals ein glasklarer Kandidat für ihr Musterdepot. (Ausgabe 2 vom 26.01.2009) (26.01.2009/ac/a/a)

Analyse-Datum: 26.01.2009


Es bleibt also spannend im Bereich der Kandidaten gegen Übergewicht.

[Fruehrentner]

Notice of Preliminary Results

Dated: Monday 16 March 2009

Alizyme plc (London Stock Exchange: AZM), will be announcing its Preliminary Results for the year ended 31 December 2008 on Monday 23 March 2009.

Meetings:
An analyst briefing will be held at 10:00 am on the day. The venue for the meeting will be Buchanan Communications, 45 Moorfields, London, EC2Y 9AE.

Web cast:
Simultaneously to the analyst briefing, there will be a live audio web cast of the presentation.

To connect to the web cast facility, please go to: http://mediaserve.buchanan.uk.com/webcasts/room8audio/lrfram… approximately 10 minutes (09:50 am) before the start of the briefing. The presentation will also be available on Alizyme's website for replay shortly after the conclusion of the presentation.


For further information, please contact:

Lisa Baderoon / Rebecca Skye Dietrich
Buchanan Communications
Tel No: + 44 (0) 20 7466 5000

http://www.alizyme.com/alizyme/media/press/show.jsp?ref=143

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.773.656 von Fruehrentner am 16.03.09 12:49:54

Hör mir bloss auf mit Alizyme das ist ne Scheiß Aktie seit dieser neue CEO die leitung übernommen hat gings nur noch bergab .

2500 € hab ich verbrannt weil ich an diesen Fischkopf geglaubt habe aber es waren nur leere versprechungen .

Es besteht immer noch einwenig Hoffnung aber für mich ist Alizyme gestorben .

[Fruehrentner]

Antwort auf Beitrag Nr.: 36.774.016 von BrauchGeld am 16.03.09 13:29:36

Ja, nachdem die noch nicht mal COLAL-PRED hinbekommen haben.

Aber immerhin ist Takeda beim Cetilistat mit dabei. Die werden sich was dabei gedacht haben.

Der Wert bleibt auf der watch list, spannend zu beobachten allemal.

Und ganz tot ist Colal-Pred ja auch noch nicht.

[deltavention]

Antwort auf Beitrag Nr.: 36.774.016 von BrauchGeld am 16.03.09 13:29:36

Nur 2,5 TEUR ? Glückspilz ! Da habe ich doch schon entscheidend mehr "versenkt".

@Fruehrentner

Stimmt, m. W. durchlaufen die für Colal-Pred derzeit das EMA-Verfahren, also die europäische Zulassung. Kommt die durch, würde das sicher schon mal einen guten Schub für den Kurs geben. Colal wirkt zwar nicht besser als das Benchmarkpräparat, weist aber immerhin ein besseres Nebenwirkungsprofil auf.

Kommt Takeda mit Cetilistat durch die Phase III, würde der Wert sogar noch tüchtig abheben. Aber das steht natürlich total in den Sternen.

Ich warte mal die Zahlen ab, wieviel Cash die noch in der Kasse haben, denn hier liegt natürlich der Knackpunkt. Kann man noch eine Weile durchhalten, werde ich ein paar TKilo nachkaufen.

[Fruehrentner]

Cambridge UK, 23 March 2009

Alizyme plc (LSE:AZM) announces the appointments of Dr Roger Lloyd and Mr Richard de Souza as Non-Executive Directors with effect from 1 April 2009 and the resignation of Mr William Edge as a Non-Executive Director with effect from 1 April 2009.

www.alizyme.com

[Fruehrentner]

Cambridge UK, 23 March 2009

Alizyme plc (Alizyme) (LSE: AZM) today announces its unaudited preliminary results for the year ended 31 December 2008.

To read this announcement in full, please click on the link below and see 'Latest News':

http://www.alizyme.com/alizyme/uploads/press/03.23Preliminar…

[deltavention]

Heute in London nachrichenlos um 40 % gestiegen.

Zufall oder kommen die hierzu passenden Meldungen noch ?

[Fruehrentner]

Antwort auf Beitrag Nr.: 36.982.913 von deltavention am 16.04.09 19:32:53

oha! Was ist denn da im Busch?

Wie hoch waren denn heute die Umsätze in London?

[deltavention]

Heute wieder Pluszeichen in ähnlicher Höhe !

Da sind wohl "News" unterwegs !

[Fruehrentner]

hier steigt's ja heiter weiter!


Wie so oft gilt wohl auch hier:

Kurse machen Nachrichten - und nicht umgekehrt.


Bin mal gespannt was da kommt ...

[Fruehrentner]

Cambridge UK, 23 April 2009:

Alizyme plc (LSE:AZM) announces that Sir Brian Richards has informed the Board that he intends to step down as Chairman and retire as a Director of Alizyme plc at the conclusion of the forthcoming Annual General Meeting, to be held on 24 July 2009. Sir Brian has been Chairman of Alizyme since its formation.

To read this announcement in full, please click on the link below and see 'Latest News':

http://www.alizyme.com

[Fruehrentner]

Cambridge UK, 30 April 2009

Alizyme plc (LSE: AZM) gives notice that copies of the 2008 Annual Report and Accounts have been sent to shareholders.

These documents are available on the Investor Relations - Financial Reports page of the Company's web site at:

http://www.alizyme.com/alizyme/uploads/press/AlizymePressRel…

[Fruehrentner]

Interim Management Statement

Dated: Tuesday 19 May 2009

Cambridge UK, 19 May 2009:

Alizyme plc ("Alizyme" or "the Company") (LSE: AZM) today publishes its Interim Management Statement ("IMS") for the period from 1 January 2009 to 18 May 2009. The IMS provides an update of the Company's operations for the period.

Operational

Cetilistat (obesity and type 2 diabetes)

Cetilistat is continuing through its Phase III clinical development in Japan with our partner Takeda Pharmaceutical Company Limited. Details of the study are available on Takeda's website (see link below).

Cetilistat has successfully completed an extensive Phase I and Phase II clinical development programme and has been prepared for the commencement of Phase III development outside of Japan.

Negotiations are progressing with potential partners to license cetilistat for territories outside of Japan.

COLAL-PRED® (ulcerative colitis)

Norgine BV, Alizyme's partner for COLAL-PRED® in Europe, South Africa, Australia and New Zealand, is primarily responsible for further development and submission of a Marketing Authorisation Application ("MAA") for the EU. The strategy for the submission of the EU MAA is being progressed with Norgine in conjunction with ongoing discussions with regulatory authorities.

Prometheus Laboratories Inc, Alizyme's partner for COLAL-PRED® in North America, is progressing a Phase II study in the US, whilst TSD Japan Inc, Alizyme's partner in Japan, is progressing a Phase I study in Japan. Details of the Prometheus Phase II study are available at 'www.clinicaltrials.gov' (see link below).

ATL-104 (mucositis)

Having successfully completed a Phase IIa 'proof of concept' clinical trial in patients with lymphoma and myeloma, the preparation for a further Phase II study, this time in head and neck cancer, and the transfer of the recombinant protein to a large scale manufacturer in advance of Phase III development and potential commercial supply will continue when financial resources permit.


Financial

The Company had cash, cash equivalents and money market investments of £2.2 million at 31 December 2008. Subsequently, in Q1 2009, an R&D tax credit of £1.4 million was received by the Company. Internal overhead costs have been substantially reduced from previous years, as has external research and development expenditure. Furthermore, in order to ensure that overall Board remuneration is in line with the generally reduced costs going forward, in March 2009 the Directors waived one third of their future entitlement to remuneration and fees, with effect from 1 April 2009. Headcount also reduced from 13 to 11 in the period.

There remains a material uncertainty over the Company's ability to continue as a going concern, as previously reported in the 2008 Annual Report, published on 30 April 2009.

Other than disclosed above, there have been no material changes to the financial position of the Company since 31 December 2008.

Board changes

Roger Lloyd and Richard de Souza were appointed as Non-Executive Directors with effect from 1 April 2009. At the same time Bill Edge resigned as a Non-Executive Director. On 23 April 2009 Mr Alan Goodman joined the Board as a Non-Executive Director and it is intended that he will assume the role of Chairman at the conclusion of the forthcoming Annual General Meeting, when Sir Brian Richards will retire as a Director.

Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive Officer said:

"The year to date has seen our commercial partners progress the clinical development of our licensed products. We remain focused on the further commercialisation of our product portfolio."

For further information, please contact:

ALIZYME PLC
Tim McCarthy, Chief Executive Officer
Tel: + 44 (0) 1223 896000

BUCHANAN COMMUNICATIONS
Lisa Baderoon
Rebecca Skye Dietrich
Tel: + 44 (0) 20 7466 5000

http://www.alizyme.com/alizyme/media/press/show.jsp?ref=148

[Fruehrentner]

BOARD CHANGE

Dated: Tuesday 23 June 2009

Cambridge UK, 23 March 2009: Alizyme plc (LSE:AZM) announces that Mr Richard de Souza resigned as a Non-Executive Director on 22 June 2009.

http://www.alizyme.com/alizyme/media/press/show.jsp?ref=149

[Fruehrentner]

News zur finanziellen Situation:

http://www.alizyme.com/alizyme/uploads/press/06.29TradingUpd…

[Fruehrentner]

minus 60 % - Totalabsturz

[Fruehrentner]

Change of date of Annual General Meeting

Dated: Thursday 02 July 2009

Cambridge UK, 2 July 2009: Alizyme plc (LSE:AZM) announces re-scheduling of the Annual General Meeting.

In the 2008 Annual Report and Accounts published on 30 April 2009, it was stated that the Annual General Meeting would be held on 24 July 2009. The Annual General Meeting has been re-scheduled for 29 July 2009. A Notice of Meeting will be sent to shareholders in due course.

For further information, please contact:

ALIZYME PLC
Alan Goodman, Director
Tel: + 44 (0) 1223 896000

http://www.alizyme.com/alizyme/media/press/show.jsp?ref=151

[deltavention]

Wenn man nicht bald neue Finanzmittel auftreibt, könnte diese HV die letzte bei Alizyme sein.

Scheinbar findet sich so schnell keiner, der noch Geld für die Entwicklungen der Company geben will.

Das läßt leider auch gewisse negative Rückschlüsse auf die Erfolgseinschätzungen zu Cetilistat zu, auf die ich meine Hoffnungen gestützt hatte.

Wird wohl ein Totalverlust werden . . .

[Fruehrentner]

Board change

Dated: Monday 06 July 2009

Cambridge UK, 6 July 2009:

Alizyme plc (LSE:AZM) announces that as part of the reconstruction of the Company going forward, Mr Tim McCarthy stepped down as Chief Executive Officer and resigned as a director of the Company on 3 July 2009. During this period of ongoing reconstruction, Mr Alan Goodman will take charge of the day to day affairs of the Company.

Commenting on today’s announcement, Alan Goodman said:

“On behalf of the Board, I would like to thank Tim for his commitment and immense contribution to Alizyme from its inception and wish him every success for the future.”

For further information, please contact:

ALIZYME PLC
Alan Goodman, Director
Tel: + 44 (0) 1223 896000
BUCHANAN COMMUNICATIONS
Lisa Baderoon Tel: + 44 (0) 20 7466 5000
Tel: + 44 (0) 7721 413496

[deltavention]

... die Ratten verlassen das sinkende Schiff ...

[Fruehrentner]

Antwort auf Beitrag Nr.: 37.526.135 von deltavention am 06.07.09 19:06:16

jo sieht so aus

[Fruehrentner]

Das war's!!! Alizyme am Ende!



Suspension of Shares

Dated: Friday 24 July 2009

Alizyme plc (LSE: AZM) (“Alizyme” or the “Company”)

Cambridge UK, 24 July 2009: Alizyme PLC announces that, at its own request, trading in the Company's ordinary shares has been suspended with effect from 3.30 pm on 24 July 2009, following which the Board has agreed to appoint Ian Carr and Nigel Morrison of Grant Thornton UK LLP to act as Administrators of the Company.

On 29 June 2009, the Company announced in a trading update that it did not expect to have sufficient funding to last beyond the end of August 2009 and that it would be unable to continue as a going concern without urgently raising additional funds. As part of the trading update, the Company also announced that it was in discussions with its commercial partners to mitigate potential increased funding obligations under its licensing and development agreements with regard to COLAL-PRED®.

The Company was today notified by Prometheus Laboratories Inc (“Prometheus”) that a complaint had been filed with the United States District Court, Southern District of California, regarding an alleged breach of a Licence Agreement between Prometheus and Alizyme Therapeutics Limited, a wholly owned subsidiary of Alizyme. The complaint was filed on 21 July 2009, but has not been served on Alizyme Therapeutics Limited or Alizyme.

The Company no longer believes that it will be able to conclude successfully the discussions with its commercial partners, and therefore does not believe that refinancing of the Company could now be completed, within a timeframe during which the Company would have sufficient cash reserves to continue trading.

As a result, the Board of Alizyme has taken advice and with great regret no longer believes that the Company is in a position to continue its operations. It is expected that the appointment of Administrators will take place either today or on Monday 27 July 2009, following which the Administrators will take such measures as they believe appropriate, including seeking a buyer for the Company and/or its assets.

The Board of Directors of Alizyme Therapeutics Limited (“ATL”) has also agreed to appoint the above named persons from Grant Thornton UK LLP to act as administrators of ATL.

In addition, the Annual General Meeting, which had been convened for 12.00 pm on Wednesday, 29 July 2009, will no longer take place.

For further information please call:

Ian Carr
Grant Thornton UK LLP
Byron House
Cambridge Business Park
Cambridge
CB4 0WZ
Telephone: [phone]
Email: [e-mail]

Press Enquiries:
Cathy Connan
PR and Communication
Connan Limited
Telephone: [phone]
Email: [e-mail]

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