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Crucell & Ark Therapeutics

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Omlaag ↓

[verwijderd] 15 september 2009 20:13

quote:
Sir Piet schreef:
Optie strategie verandert? Moeten we puts kopen?

Beste Piet:

Nog iets bekend van die einde jaar +/- 200 miljoen euro op de bank bekend, of onderwerp maar laten rusten?

Met betrekking tot Trinam, nog steeds bezig:
clinicaltrials.gov/ct2/results?term=t...

flosz 15 september 2009 20:51

Nog even de tijd erbij...
(Uitspraak Kruimer Trinam eerste Percy op de markt)
Audio-wc Q&A 06:43
tinyurl.com/n67ktq

Crucell
Combating infectious diseases
Bank of America Merrill Lynch Global Healthcare Conference
London - September 15th, 2009
Leon Kruimer Chief Financial Officer
hugin.info/132631/R/1341450/320858.pdf

Voor info trial zie post hierboven van 19:48U.

Btw, ik krijg een punthoofd van al die forumverziekers hier!

[verwijderd] 15 september 2009 23:53

Dank je Flosz. Ik wist niet dat leon vandaag zou spreken.

Leon: Crucell is not for sale, period.
Profitable + a lot of projects progressing.
Korea new factory ahead of planning
expansion in Spain with the eye to export to US Hep A
+++

Dus alles prima voor LT aandeelhouders zoals ik.

[verwijderd] 16 september 2009 00:17

quote:
grapesharvester schreef:
Dank je Flosz. Ik wist niet dat leon vandaag zou spreken.

Leon: Crucell is not for sale, period.
Profitable + a lot of projects progressing.
Korea new factory ahead of planning
expansion in Spain with the eye to export to US Hep A
+++

Dus alles prima voor LT aandeelhouders zoals ik.

Overigens opmerkelijk dat het niet op de Crucell website stond als event maar wel:

22 Sep 2009 UBS Global Life Sciences Conference

Kennelijk wordt dat een belangrijker event.

[verwijderd] 16 september 2009 07:33

quote:
flosz schreef:
Nog even de tijd erbij...
(Uitspraak Kruimer Trinam eerste Percy op de markt)
Audio-wc Q&A 06:43
tinyurl.com/n67ktq

Crucell
Combating infectious diseases
Bank of America Merrill Lynch Global Healthcare Conference
London - September 15th, 2009
Leon Kruimer Chief Financial Officer
hugin.info/132631/R/1341450/320858.pdf

Voor info trial zie post hierboven van 19:48U.

Erg veel , Eh... eh... eh ...eh... in de Q&A.
Er zijn inderdaad grote problemen in de downstream.
"First product on PerC6 : " Could be Trinam , from Ark Therapeutics "

Ja ja , zo kan ie wel weer.

DWZ , eerste product op PerC6 op de markt op zijn vroegst pas in 2012.

Vraag 1 : Hoe zit het met de leugens op AVA 2008 EN 2009 : One is filing for approval in Europe.

Vraag 2 : AVA 2008 EN 2009 : Submission van Sanofi Influenza , is expected in 2010, een even grote leugen.

Het hele Biosimilars verhaal is ook in de Q&A session weggevaagd !

Over 5 years + , pas eventuele royalties van Licencies???!!!

Ik heb sterk de indruk , dat PerC6 , links EN rechts zal worden ingehaald, door andere cellijnen.

CruBUY ?? of toch weer CruSELL !

Voor mij , fundamenteel ,een SELL.

Reden: De ene leugen na de andere.

"Al is de leugen nog zo snel, de waarheid ( = de chart ) achterhaalt haar wel .

[verwijderd] 16 september 2009 09:34

quote:
wilb52 schreef:
[quote=flosz]
Nog even de tijd erbij...
(Uitspraak Kruimer Trinam eerste Percy op de markt)
Audio-wc Q&A 06:43
tinyurl.com/n67ktq

Crucell
Combating infectious diseases
Bank of America Merrill Lynch Global Healthcare Conference
London - September 15th, 2009
Leon Kruimer Chief Financial Officer
hugin.info/132631/R/1341450/320858.pdf

Voor info trial zie post hierboven van 19:48U.

[/quote]

Erg veel , Eh... eh... eh ...eh... in de Q&A.
Er zijn inderdaad grote problemen in de downstream.
"First product on PerC6 : " Could be Trinam , from Ark Therapeutics "

Ja ja , zo kan ie wel weer.

DWZ , eerste product op PerC6 op de markt op zijn vroegst pas in 2012.

Vraag 1 : Hoe zit het met de leugens op AVA 2008 EN 2009 : One is filing for approval in Europe.

Vraag 2 : AVA 2008 EN 2009 : Submission van Sanofi Influenza , is expected in 2010, een even grote leugen.

Het hele Biosimilars verhaal is ook in de Q&A session weggevaagd !

Over 5 years + , pas eventuele royalties van Licencies???!!!

Ik heb sterk de indruk , dat PerC6 , links EN rechts zal worden ingehaald, door andere cellijnen.

CruBUY ?? of toch weer CruSELL !

Voor mij , fundamenteel ,een SELL.

Reden: De ene leugen na de andere.

"Al is de leugen nog zo snel, de waarheid ( = de chart ) achterhaalt haar wel .

Ook geluisterd en toch een ander beeld als hierboven omschreven:

- van problemen in de downstream heb ik niks gehoord, wat gezegd wordt is dat als je dezelfde yield in je downstream houdt en upstream flink verhoogd je eindigt met veel meer produkt.

- Perc 6, ja er zullen echt wel andere cellijnen komen, maar patent tot 2025 en alles wat in kliniek zit en wil overstappen op andere lijn zal opnieuw de kliniek inmoeten, dus zo gemakkelijk is dat niet.

- pas over 5 jaar royalties op licenties is zo niet gezegd, immers produkt op de markt betekent royalties. Het gaat niet tot 2014 duren alvorens er een produkt op de markt is.

Ik vond het slot van Kruimer erg sterk, overtuiging van we zijn goed bezig, profit and generating loads of cash en dat allemaal met nog voldoende eigen produkten in de portefeuille.

Korte termijn handel prima aandeel maar met name lange termijn investering uitstekend. De meesten doen hier wel of lange termijn investeren een vies woord is maar voor een deel van mijn portefeuille vind ik de rust prima.

[verwijderd] 16 september 2009 09:40

In de downstream zijn wel degelijk problemen, oa bij Sanofi
Zie het antwoord op mijn vraag op de AVA.

Mbt het hele PerC6 gebeuren, en gezien de continue stroom aan beloftes, belazert Crucell de aandeelhouders.
Daar zijn inmiddels TE veel voorbeelden van.

Kruimer geeft perfect aan dat het 1-ste product Trinam wordt, met eh eh eh

Dus NOOIT voor 2012 ook maar 1 [product op de markt , basis PerC6.

Als dit bewaarheid wordt, deel ik de mening van Ron Banged:
They screwed the Pooh : Dan dus wegwezen.

z0n0p 16 september 2009 10:07

quote:
wilb52 schreef:
In de downstream zijn wel degelijk problemen, oa bij Sanofi
Zie het antwoord op mijn vraag op de AVA.

Mbt het hele PerC6 gebeuren, en gezien de continue stroom aan beloftes, belazert Crucell de aandeelhouders.
Daar zijn inmiddels TE veel voorbeelden van.

Kruimer geeft perfect aan dat het 1-ste product Trinam wordt, met eh eh eh

Dus NOOIT voor 2012 ook maar 1 [product op de markt , basis PerC6.

Als dit bewaarheid wordt, deel ik de mening van Ron Banged:
They screwed the Pooh : Dan dus wegwezen.

NEEE! Als je het echt zo ziet moet je nu je winst pakken en wegwezen.

Bij Sanofi zit zoals je maar al te goed weet, niet het gedoe in de techniek, maar in de commercie. Was het aossa niet de de vinger op de juiste plek legde door op te merken dat de flu-deal destijds met Aventis en niet Sanofi is gesloten. Ik kan me nog een gezamenlijke presentatie van Crucell en Aventis van een jaar of 3 (of al weer 4?) geleden herinneren waar de samenwerking prima was.

Ik voel me niet zo belazerd met de meer dan 80 openbare licenties. Als daar 10% van op de markt komt dan is het BINGO!

[verwijderd] 16 september 2009 10:11

quote:
wilb52 schreef:
In de downstream zijn wel degelijk problemen, oa bij Sanofi
Zie het antwoord op mijn vraag op de AVA.

Volgens mij was het antwoord dat het Sanofi problemen waren.

Mbt het hele PerC6 gebeuren, en gezien de continue stroom aan beloftes, belazert Crucell de aandeelhouders.
Daar zijn inmiddels TE veel voorbeelden van.

Ieder zijn zienswijze, wel verbaasd me de kritiek van velen op de directie en vraag me af
wie er ooit eindverantwoordelijkheid heeft gedragen. Hoeveel biotechbedrijven zijn er
vandaag winstgevend?

Kruimer geeft perfect aan dat het 1-ste product Trinam wordt, met eh eh eh

Hij geeft aan dat hij dat verwacht en concreet zegt hij "your guess when it comes out of
phase 3 is as good as mine". Niet sterk, ben ik met je eens.

Dus NOOIT voor 2012 ook maar 1 [product op de markt , basis PerC6.

In je vorige post was het nog 2014, ben blij dat je dat nu met me eens bent.

Als dit bewaarheid wordt, deel ik de mening van Ron Banged:
They screwed the Pooh : Dan dus wegwezen.

Ieder zijn mening.

aossa 16 september 2009 10:24

Re: webcast

Is er iemand die de audiowebcast kan vertalen, desnoods in goed engels, want uit de commentaren hier begrijp ik er niets van...

Overigens of het nu CruSELL is of CruBAH interesseert me niet. Alles hangt af van de percentage van de port waarmee je erin zit en/of je je geld op een bepaald ogenblik broodnodig hebt, al dan niet.

flosz 16 september 2009 10:56

quote:
wilb52 schreef:
DWZ , eerste product op PerC6 op de markt op zijn vroegst pas in 2012.

Als Trinam het eerste PER.C6-pr. op de markt zal zijn klopt dit helemaal.

flosz 16 september 2009 10:58

AVA(05-06-2009)
Ronald Brus - Crucell - President, CEO(nav vraag Bill, shareholder)

I'll be happy to answer those questions. First, that interview in the Wall Street Journal usually does bother us. And I think that Sanofi has a
problem with it too. Second, some of your statements are not entirely accurate. And I'm going to try to refute them as openly as I can.
In 2004, we signed a licensing agreement with the Sanofi Board, Sanofi Aventis. And one of the consequences is that they have the exclusive
rights and they're in charge. That's the disadvantage of such deals. That's why we stopped doing such deals.
We're only allowed to disclose what they allow us to disclose. Last year, we said that public statements by Sanofi Pasteur indicate that they
assumed that in 2010, they will make a submission. And that's the scripted text, we're allowed to disclose.

That interview with Viehbacher seems to suggest, and I agree with you entirely, that cell-based flu growing influenza on cells in a large
bioreactor is still experiencing some problems. If those problems exist, then they're attributable entirely to the downstream process. I'll try to
explain how that works.

There's nothing wrong with cell-based flu from PER.C6. At the end of the day, it does have to be channeled into 100 million tubes, which means
that there's some aspects in the downstream process that separates the virus and the antigens. And this is not the same as what was done with
chicken eggs.
I'll give you an example. We use something called detergents in our industry. You can compare that to soap which should enable separating
certain things.
Now if you're exiting a large bioreactor and use the same type of soap as you would with all those eggs, then you're doing something wrong. So
the hiccups that Sanofi encountered, do not relate to the PER.C6 section, rather they relate to the part that concerns large scale production of
vaccines in tubes.

Bill - Shareholder
Is it a continuous or a discontinuous reactor?

Ronald Brus - Crucell - President, CEO
These are batches. So it's basically discontinuous. They produce a batch and that's where they derive it from.
Well, you're knowledgable enough to know that it's a very meticulous process. We supply this technology. And we're convinced that Sanofi has
resolved such hiccups, with our help as well. But we would not sign a deal with such a company under those conditions. But we entrust
development of the product entirely to the product, rest assured about that.
But in 2004, Crucell was a far smaller firm, and this was a major deal. But we're convinced that there will be a PER.C6 vaccine. And we don't see
any reason why that wouldn't happen. But major breakthroughs take time.
*********

Uit de presentatie(van gisteren)
Key licensing agreements
• Upfront payments
• Annual
maintenance
payments
• Milestone
payments
• Royalty payments*
as a % of net sales
• Service fees

* = 10-15 years after launch

Sanofi Pasteur
Vaccines
• Influenza: cell culture vaccine (FluCell)
• PER.C6® cells in bioreactors of 20,000 liters
• Production agreement Lonza
• Upfront and milestones of €30 mln

MedImmune
Antibodies
(AstraZeneca)
• Bacterial antibodies for treatment and prevention
of hospital-acquired bacterial infection
• MAbstract® technology programs
• Milestone payments may exceed US$ 40 mln
• Undisclosed royalty on product sales
Slide 35

hugin.info/132631/R/1341450/320858.pdf

flosz 22 september 2009 13:16

quote:
flosz schreef:
Nog even de tijd erbij...
(Uitspraak Kruimer Trinam eerste Percy op de markt)
Audio-wc Q&A 06:43
tinyurl.com/n67ktq

Notulen erbij…..

It could be a product from - actually and English company that conducts the trial in America. The company's called Ark Therapeutics. And the
product is called Trinam. It is for, basically, vascular repair after surgery. The product is Phase III and your guess is as good as mine when it
comes out of Phase III.
hugin.info/132631/R/1342823/321550.pdf

I'm curious about the PER.C6 cell. There was a lot of controversy last year when you achieved very high yields.
And I think some of your competitors were arguing that the main challenge is not to produce very high yields, but more the downstream prices
(inaudible) whatever you have in those deals --.
LEON KRUIMER - CFO
Right.
Unidentified Speaker
-- if you can comment on what you view that as. And what they're getting wrong --?
LEON KRUIMER - CFO
Well, I think -- not actually wrong; I think that downstream processing is a challenge where you go from 100% what you produce to significantly
lower amounts that you have of pure product, pure protein or antibody after you do the downstream processing.
The question is, what was the curve from downstream processing? As long as the percentage that you will have left at the end of the day is the
same - right, when your yield is very high, your production, 100% so to speak, will be higher than otherwise. And as accordingly, when you do
the same amount of effectiveness in downstream processing, you will have more product in the end. So, we think that the yield on your primary
production of the protein is extremely important because it will determine the amount of product that you have left after downstream processing.
Unidentified Speaker
Has any product produced in the PER.C6 cell line already been approved?
LEON KRUIMER - CFO
No. No.
Unidentified Speaker
If not, what's the --?
LEON KRUIMER - CFO
It's all in clinical trials.
Unidentified Speaker
Are there any specific safety concerns with the cell line in terms of being carcinogenic or --?
LEON KRUIMER - CFO
No. None. And I think in previous years, starting in 19 -- starting in 2000, we worked intensively with Merck, North America Merck, in order to
come up with a biologics master file and address any safety concerns that the FDA would have, which allowed Merck to use PER.C6 as a
production system in their HIV trials. And those trials were suddenly aborted because the product -- there were product issues, but not with the
way that the vaccine was actually produced.
So I think safety concerns have never been an issue, although we have to prove that it was very safe, but they are certainly not an issue today in
the use and use (inaudible).
There was a question over there.
Unidentified Audience Member
The FDA, so far, has been pretty reluctant on improving new adjuvant (inaudible) before it can happen. Does the model (inaudible) PER.C6,
both (inaudible-microphone inaccessible).
LEON KRUIMER - CFO
The -- just to repeat it for the microphone. The question was that the FDA has been reluctant to approve new adjuvants, so how likely is it that
PER.C6 would produce something, which needs an adjuvant? Or --?
Unidentified Audience Member
No, no, no, no. No which needs an adjuvant -- there is (inaudible-microphone inaccessible)
LEON KRUIMER - CFO
Right.
Unidentified Audience Member
And does that prevent its approval of the (inaudible)? I'm wondering, will it be -- (inaudible-microphone inaccessible)?
LEON KRUIMER - CFO
Well, the -- what we do in terms of making a vaccine is basically growing the virus on a cell-based production system. Right? That is somewhat
apart from the fact whether that vaccine -- that raw material for the vaccine [CAP] needs to be adjuvated. So far a number of the recombinant
vaccines, because they're live vaccines, are powerful enough not to be adjuvated. Virtually the products we have in our pipeline are not adjuvated.
Maybe I understand it wrong, but --.
Unidentified Audience Member
Yes. I'm not talking about the latent or potential (inaudible-microphone inaccessible) adjuvant.
LEON KRUIMER - CFO
Right.
Unidentified Audience Member
I'm just talking about --.
LEON KRUIMER - CFO
Adjuvants period?
Unidentified Audience Member
How likely is it that we will see (inaudible) to approval with (inaudible-microphone inaccessible) in PER.C6 as a whole?
LEON KRUIMER - CFO
Well, I -- all I can say is that for the studies that we do, and as far as they're with the FDA, we agree to clinical endpoints and once that is agreed,
the study -- maybe we need to talk about (inaudible) with the adjuvant. Adjuvant is something that's particularly controversial at certain times.
But --
Unidentified Speaker
I don't think you're referring to (inaudible) at all -- I think it's more of a question -- yes?
LEON KRUIMER - CFO
Right.
Unidentified Audience Member
Okay. Fine.
www.youtube.com/watch?v=4NZjHKfbbiQ

flosz 29 september 2009 18:29

Barclays nu ook in Ark gedoken:

Number of voting rights
11,584,888
Percentage of voting rights
5.59
9. Chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held, if applicable:

BARCLAYS BANK PLC
BARCLAYS GLOBAL INVESTORS LTD
BARCLAYS STOCKBROKERS LTD
WALBROOK TRUSTEES (GUERNSEY) LTD

tinyurl.com/y8q243k
**************
Post van go erbij:
gocrucellgo

2009-08-18
Barclays Global Investors Uk Holdings Ltd

Added More
www.mffais.com/crxl
www.iex.nl/forum/topic.asp?forum=228&...

***************
Laten we deze toko maar inlijven imo.

josti5 29 september 2009 18:49

Lijkt mij goed plan, beste flosz, en het begint er inderdaad naar uit te zien, want: 'Barclays Capital acted as financial advisor to Crucell', zoals wij gisteren mochten vernemen...

Waarbij de aantekening: een nieuw biotech-conglomeraat onder de paraplu van J & J, met behoud van zelfstandig opereren: hoe realistisch zou dat zijn in de Grote Boze Mensenwereld???

flosz 30 september 2009 14:50

Via slimmie, erik-forum:

3. Full name of person(s) subject to the notification obligation:
STANDARD LIFE INVESTMENTS LTD

4. Full name of shareholder(s) (if different from 3.):
VIDACOS NOMINEES

5. Date of the transaction and date on which the threshold is crossed or reached:
28.9.09

6. Date on which issuer notified:
29.9.09

7. Threshold(s) that is/are crossed or reached:
9%

tinyurl.com/ycutmke

harvester 30 september 2009 23:34

hoeveel jaar mocht genentech dat doen?

quote:
josti5 schreef:
Lijkt mij goed plan, beste flosz, en het begint er inderdaad naar uit te zien, want: 'Barclays Capital acted as financial advisor to Crucell', zoals wij gisteren mochten vernemen...

Waarbij de aantekening: een nieuw biotech-conglomeraat onder de paraplu van J & J, met behoud van zelfstandig opereren: hoe realistisch zou dat zijn in de Grote Boze Mensenwereld???

harvester 1 oktober 2009 00:10

Beste Flosz

Ark heeft wel wat producten in de pijplijn, maar momenteel slechts een eigen vermogen van GBP 42.7 miljoen (inclusief GBP 2.4 miljoen geactiveerde goodwill) GBP 119 miljoen aan verliezen +
half-jaarverlies 2009 van GBP 12.6 miljoen.

De te verrichten studies gaan nog veel geld kosten.

Hier zitten dus ook nadelen aan (en daarom heb ik zelf nog geen aandelen er van gekocht).
Ze hebben een fabriek in Finland. Dat ligt toch ook weer even uit de route (+ ver van de US markt) en Crucell sluit net haar Zweedse fabriek.

Ik denk eerder aan iets in de US, wellicht na een tip van J+J.

flosz 11 oktober 2009 13:38

Its crunch time for pharmaceutical funding

Big banks, big pharma, big problems
07 October 2009 by John Martin
MONEY has thrown society out of kilter. Banks that once appeared to have mountains of cash have collapsed. As a consequence of the global recession, governments now recognise that banking is too important to be left to the bankers. States have taken action, from wresting control of financial institutions to introducing new regulations.
I believe the financial meltdown has implications for pharmaceutical research. The running of large pharmaceutical companies carries a social responsibility that is as heavy as running any bank. Recently, however, this unwritten contract between society and drug companies has not been fulfilled. Is our health now too important to be left to big pharma?
To illustrate my concerns, let's look at the treatment of heart disease. Many important cardiovascular drugs have been invented: statins, ACE inhibitors, beta blockers, fibrinolytics. But in the last 10 years, few of significance have emerged, even though the pharmaceutical industry has spent unprecedented amounts of money on research and development: in each year of that decade, Pfizer spent about $6 billion, Eli Lilly $3bn, and GlaxoSmithKline $2.5bn.
This splurge is reminiscent of how banks misused their funds before their collapse, but the industry has been insulated from the recent economic changes and has accumulated vast cash piles from the sales of medicines (in the UK, mostly through sales to the National Health Service). On average, each top-20 pharmaceutical company has access to about $7.5bn in cash.
Could the cash piles of big pharma be mobilised in a more efficient way for the public good? Two years ago such a suggestion would have been scorned. Now, however, it should be considered. As was the case with the banking sector, I believe that there is a real risk that the big pharma industry might collapse.

Meer via: www.newscientist.com/article/mg204272...

(John Martin is professor of cardiovascular medicine at University College London and founder of Ark Therapeutics)
*****************

Btw: Gigantisch fantastisch he, die slimmerikken bij CRXL, regeren is vooruitzien!

flosz 14 oktober 2009 09:38

Research Update
Ark Therapeutics Group plc

Ark announces further Cerepro® Phase III results to be presented by Investigator at Society of Neuro-Oncology Conference in New Orleans

London, UK, 14 October 2009 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that further results from its Phase III study (ASPECT) of Cerepro®, the Company's novel gene-based therapy for the treatment of malignant glioma, will be presented at the American Society of Neuro-Oncology Conference in New Orleans on 22 October 2009.

The results update will be presented by Professor Zvi Ram, of the Tel Aviv Medical Centre, Israel, one of the principal investigators for the ASPECT Study, at the Top Scoring Abstracts Session of the Conference between 2.45pm and 3.00pm CDT. Ark will also sponsor a satellite symposium for healthcare professionals at the Conference later in the day entitled, "Future Treatment of High Grade Glioma (HGG)" chaired by Professor Manfred Westphal, of University Hospital, Hamburg. Professor Manfred Westphal will also present an update on the Cerepro® clinical programme. Other scheduled speakers include Professor Martin van den Bent, of Erasmus MC, Rotterdam and Professor Zvi Ram who will review the current and future management of HGG.

Data from the conference will be available on the Company website at the end of the abstract presentation.
investors.arktherapeutics.com/servlet...
RNS_NEWS&item=268830593024054&ir_client_id=4553&transform=newsitem_new

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