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[verwijderd] 8 april 2009 14:04

7

There has been no news this year...nothing.
Wyeth here and gone...and a lot of news" about other possible suitors...but that is just gossip, not news.

Then earnings...good earnings...but that is last year's news.

Then a repeat of the Flu Antibody news...which is going nowhere...just like Factor V, West Nile and Biosimiliars. Nice piece of Science that will always be too expensive to implement on a large money-making scale.

Going on 4 months of no news.

Brus is out partying and buying more hair gel.

Stock is languishing because we need some news to add some zip to 2010. We have many analysts who have income going DOWN for 2010, because Quinvaxem sales will be diluted for 2010 to 2013 among newly approved vaccine makers(Hello India). After looking at the numbers I think the best Crucell can do is maintain Quinvaxem sales in the next Supranational contract.

We still don't know if Flucell is in Phase III, what Wyeth is working on, progress on Mederex etc. The only update we got was from comparing a couple of presentation slides from April to those from 6 months ago. and we were promised TB news.

And don't get me started on Flavimun.

Spring is the time when this company has traditionally announced big deals...before Brus and Kruimer go on vacation from May through September.
C'mon guys...give us something before you pull up the Speedo's and start sipping apple martinis.

B_B 8 april 2009 14:10

0

No News (about products) is GOOD NEWS.
It means the negotiations (of a takeover) is still going on.

News about products will have an impact on the share price (this will upset the buyer).

[verwijderd] 8 april 2009 14:18

0

[quote=ron banged]

Brus is out partying and buying more hair gel.

PROOF???????

I D I O T !!!!!!!!!

[verwijderd] 8 april 2009 14:19

0

quote:
B_B schreef:
No News (about products) is GOOD NEWS.
It means the negotiations (of a takeover) is still going on.

News about products will have an impact on the share price (this will upset the buyer).

News is news and it must be released if it is material, regardless of what a potential buyer might want. I would like to agree with you but cannot.

[verwijderd] 8 april 2009 14:23

1

quote:
oudje schreef:
[quote=ron banged]

Brus is out partying and buying more hair gel.

PROOF???????

I D I O T !!!!!!!!!

I'm sorry...are you taking that comment literally?
It is a mocking commentary, not a statement of fact.

We all know that DSM supplies Brus with all the hair gel he needs, whipped up at 27grams/liter.

And at least they haven't announced any multi-million euro parties on Lake Geneva to celebrate the 3 anniversary of momentous discovery of Factor V l/c.

josti5 8 april 2009 14:24

0

AB Ron; ik denk er precies zo over.

[verwijderd] 8 april 2009 14:31

0

quote:
josti5 schreef:
AB Ron; ik denk er precies zo over.

En een AB van mij, om dezelfde reden.

[verwijderd] 8 april 2009 14:46

0

udje schreef:

ron banged schreef:

Brus is out partying and buying more hair gel.

PROOF???????

I D I O T !!!!!!!!!

Ron, to understand this, you have to realize that Dutch speakers of English all too frequently fall into the trap of relying of literal translations from English into Dutch many of which go disastrously wrong.

[verwijderd] 8 april 2009 14:56

2

Product Update:
Product sales in the fourth quarter of 2008 amounted to €76.5 million and represent sales of paediatric vaccines (51%), travel and endemic vaccines (23%), respiratory vaccines (17%) and other products (9%).

For the full year 2008, product sales were €226.1 million, representing sales of paediatric vaccines (49%), travel and endemic vaccines (25%), respiratory vaccines (14%) and other products (12%).

Paediatric
Sales of our paediatric vaccines showed strong growth in the fourth quarter and the year 2008, mainly driven by Quinvaxem®.
Quinvaxem®: Fully liquid pentavalent vaccine against five important childhood diseases.
Hepavax-Gene®: Recombinant vaccine against hepatitis B.
Epaxal® Junior: Paediatric dose (0.25mL) of Epaxal®, the only aluminum-free vaccine against hepatitis A for use in children. The product is currently registered in selected countries worldwide. Sales in South America are progressing well and a European launch is planned this year.
MoRu-Viraten®: Vaccine for protection against measles and rubella (for all age groups).

Travel and Endemic
Our travel and endemic portfolio showed solid growth in 2008. We continue to see significant untapped demand and potential for geographical expansion of our travel portfolio.
Epaxal®: The only aluminum-free vaccine against hepatitis A.
Vivotif®: The only oral vaccine against typhoid fever.
Dukoral®: The only oral vaccine against cholera and diarrhea caused by ETEC (enterotoxigenic E. coli).

Respiratory
In the fourth quarter of 2008, sales of our flu vaccine Inflexal® V were slightly down, compared to the same quarter of 2007 due to phasing into the third quarter of 2008.
Inflexal® V: A virosomal adjuvanted vaccine against influenza (for all age groups). Due to the seasonality of the product, we build inventory in the first half of the year to sell flu vaccines in the second half of the year.

Pipeline Update:
Flavimun® - Live Attenuated Yellow Fever Vaccine: Registration submission of the Yellow Fever vaccine in Switzerland and Germany is expected in the first quarter of 2009.
Influenza - Seasonal Flu Vaccine (FluCell collaboration with sanofi pasteur): This seasonal influenza vaccine is being developed by Crucell's partner sanofi pasteur, using PER.C6® technology. Phase II testing of the cell based influenza vaccine was initiated in the U.S. in November 2007. In the third quarter of 2008, Crucell received a milestone payment from sanofi pasteur for progress of the Phase II trials involving healthy adult volunteers in the U.S. The trials focus on the safety profile and immunogenicity of the cell-based vaccine.
Rabies Human Monoclonal Antibody Combination (CL 184): Crucell's monoclonal antibody combination against rabies is being developed in close collaboration with sanofi pasteur using Crucell's PER.C6® manufacturing technology. In 2008 Crucell initiated two Phase II studies in the U.S. and in the Philippines. Promising Phase I data in 2007 showed no serious adverse effects and demonstrated the expected rabies neutralizing activity upon administration. The rabies human monoclonal antibody combination was granted a Fast Track designation by the FDA Department of Health and Human Services. Under the terms of the collaboration agreement with sanofi pasteur, Crucell will be responsible for manufacturing of the final product and has retained exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations such as UNICEF, while sanofi pasteur will have exclusive distribution rights for all other territories and co-exclusive distribution rights in China. This antibody combination is to be used in combination with a rabies vaccine for post-exposure prophylaxis (PEP) against this fatal disease.
Positive preliminary results of our Phase II US study were presented to rabies experts at the 19th annual RITA meeting in Atlanta on October 1, 2008. These results triggered another milestone payment from sanofi pasteur at the end of September, as part of the total eligible amount of €66.5 million.
A second phase II clinical study evaluating the monoclonal antibody combination in combination with a vaccine in healthy children and adolescents was conducted in the Philippines from May to October 2008. The completion of this study triggered another milestone payment from sanofi pasteur, at the end of October. Final data from this study are expected to become available in the first half of 2009.
An additional phase II study in healthy adults evaluating Crucell's monoclonal antibody in combination with another major rabies vaccine is scheduled to start in India in the second quarter of 2009.
Tuberculosis Vaccine based on AdVac®/PER.C6® Technologies: Development of the candidate vaccine AERAS-402/Crucell Ad35 is being carried out in collaboration with the Aeras Global TB Vaccine Foundation. Data from all AERAS-402/Crucell Ad35 trials support the immunogenicity and acceptable safety profile of the TB vaccine candidate at all dose levels evaluated.
Phase I:
US Phase I trial in healthy adults not previously immunized with Bacille Calmette-Guérin (BCG), the traditional TB vaccine, has been completed and has demonstrated that AERAS-402/Crucell Ad35 is safe in this population.
Results of a second study in South Africa showed encouraging results, notably CD8-cell immune responses that are much higher than those seen in humans in any previous TB vaccine study.
A phase I study in healthy adults in St. Louis, USA focuses on the immunogenicity and safety of two AERAS-402/Crucell Ad35 boost doses administered at three to six month intervals after BCG priming in healthy adults. Data from this study specifically indicate that two injections of AERAS-402/Crucell Ad35 are immunogenic with an acceptable safety profile when used with a BCG-prime/AERAS-402/Crucell Ad35 boost interval of 84 days in BCG vaccinated healthy adults. This immune response is greater than that detected in the absence of BCG prime, supporting the possible utility of AERAS-402/Crucell Ad35 as a booster vaccine. BCG prime alone shows limited efficacy.
An ongoing study in St. Louis, USA is evaluating a longer prime-boost interval. The study has been fully enrolled and has discovered no safety issues. Immunological data is expected to be available in the first half of 2009.
In October 2008, a Phase I clinical trial of the jointly developed TB vaccine was started in Kenya. The study is being conducted by the KEMRI/Walter Reed Project-Kisumu at their Kombewa Clinical Trials Center near Kisumu, in Western Kenya. Its main objective will be to test the safety of the candidate vaccine in BCG-vaccinated adults with or without latent tuberculosis. This study is fully enrolled and now in its follow-up segment, with no safety issues identified.
Phase II:
In October 2008 enrollment for the first Phase II study of AERAS-402/Crucell Ad35 in Cape Town, South Africa was started. The study is being conducted by the University of Cape Town Lung Institute in conjunction with the South African Tuberculosis Vaccine Initiative. The candidate is being tested in 82 adults who have had active TB. No evidence of an unacceptable safety issue has been found in its dose escalation design.
Malaria Vaccine based on AdVac®/PER.C6® Technologies: Crucell and its collaborator, the US National Institute of Allergy and Infectious Diseases (NIAID), part of th

[verwijderd] 8 april 2009 15:00

1

Vervolg;

Malaria Vaccine based on AdVac®/PER.C6® Technologies: Crucell and its collaborator, the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), are conducting a Phase I trial in the U.S. The study is being carried out at two sites, Vanderbilt University in Nashville, Tennessee and Stanford University in Palo Alto, California. The first three cohorts have been enrolled and ongoing safety monitoring has revealed no significant safety concerns to date, but formal analysis awaits unblinding of the data. Enrollment for the fourth and final group of volunteers is ongoing. Preliminary results of the first three cohorts are expected before the end of the first quarter of 2009. Further updates on this program will be communicated in our first quarter 2009 results.
Multivalent Filovirus (Ebola & Marburg) Vaccine based on AdVac®/PER.C6® Technologies: In October 2008 Crucell announced that it has secured a NIAID/NIH contract aimed at advancing the development of Ebola and Marburg vaccines, ultimately leading to a multivalent filovirus vaccine. The contract provides funding of up to $30 million, with additional options that may be triggered at the discretion of the NIH worth a further $40 million. The Phase I study of an adenovirus 5 (Ad5)-based Ebola vaccine, being developed in partnership with the Vaccine Research Center (VRC) of the NIAID/NIH, showed safety and immunogenicity at the doses evaluated. Based on these results, a second Phase I study of an Ebola and/or Marburg vaccine is anticipated. This will use alternative adenovirus vectors that are able to by-pass pre-existing immunity against Ad5.
HIV Vaccine based on AdVac®/PER.C6® Technologies: The Investigational New Drug Application (IND) for Phase I of the trial with Harvard Medical School (supported by the NIH) was approved by the FDA in January 2008. In April, Crucell announced the start of a Phase I clinical study of the novel recombinant HIV vaccine, using adenovirus serotype 26 (rAd26) as vector, that Crucell is jointly developing with the Beth Israel Deaconess Medical Center. The rAd26 vector is specifically designed to avoid the pre-existing immunity to the more commonly used adenovirus serotype 5 (Ad5). The phase I clinical study is being conducted at the Brigham and Women's Hospital in Boston, USA and is focused on assessing the safety and immunogenicity of the vaccine. Enrollment is ongoing and involves 48 healthy volunteers. Dose escalation has proceeded without difficulty and the third cohort (10^11 vp/dose) is currently enrolling subjects.
Alternative Adenovirus Serotype Technologies: In November 2008, leading scientific journal Nature published a study that demonstrated the value of Crucell's alternative adenovirus serotype technologies. Using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology, scientists engineered the rare adenovirus serotypes Ad26 and Ad35 to express a protein of SIV, the non-human primate equivalent of HIV. Rare serotype adenoviral vectors - such as rAd26 and rAd35 vectors - have been developed by Crucell to provide more potent prime-boost vaccine regimens. The study, which investigated the immunogenicity and protective efficacy of different vaccination regimes using rAd26, rAd35 or rAd5 as a prime, followed by a boost with rAd5, showed that in particular the rAd26/rAd5 combination elicits a strong T-cell immune response and provides protection against the HIV-like virus in non-human primate models. Crucell has several vaccines in development using alternative rAd26 and rAd35 vectors, including vaccines against malaria and tuberculosis.
Human Monoclonal Antibodies against a broad range of Influenza: Crucell's scientists discovered a set of human monoclonal antibodies that provides immediate protection and neutralizes the broadest range of H5N1 strains in preclinical models. When tested in preclinical models for prevention or treatment of a potentially lethal H5N1 infection, this antibody was shown to prevent death and cure the disease.
In a preclinical study, Crucell's mAb CR6261 was compared with the anti-influenza drug oseltamivir in terms of their value for flu prevention and treatment. In December 2008 Crucell announced that its monoclonal antibody had strongly outperformed the most current anti-influenza drug in these tests. The results were presented at IBC's 19th Annual International Conference on Antibody Engineering in San Diego, USA.
The flu strains tested included the 'bird flu' strain H5N1, which, experts fear, has the potential to cause a pandemic, and H1N1, which is similar to the strain responsible for the devastating pandemic in 1918. Importantly, the study showed that CR6261 provides immediate protection against the influenza virus, suggesting that it will be able to prevent disease spread. In contrast, oseltamivir was less efficacious and in some cases not effective at all. The characterization of the antibody was described in the online journal PLoS ONE on December 16, 2008.
Blood Coagulation Factor VL/C: Preclinical work on this program continues but conclusive proof of concept is not expected in the near future.

[verwijderd] 8 april 2009 15:17

0

En===

MeawandMoo1 8 april 2009 15:19

3

quote:
ron banged schreef:
There has been no news this year...nothing.
Wyeth here and gone...and a lot of news" about other possible suitors...but that is just gossip, not news.
[/quote]
Volgens mij blijven deze roddels nog wel een aantal maanden aanhouden. Is een leuk beïnvloedbaar stuurmiddel die door handelaren met beide handen is /wordt aangegrepen.

[quote=ron banged]
Then earnings...good earnings...but that is last year's news.
[/quote]
D'accord.

[quote=ron banged]
Then a repeat of the Flu Antibody news...which is going nowhere...just like Factor V, West Nile and Biosimiliars. Nice piece of Science that will always be too expensive to implement on a large money-making scale.
[/quote]
Mijn grootste angst is en blijft het CEVEC-scenario. Een te late reactie op aantijgingen /inbreuk op (on)geldige patenten en daarmee het fundament van Crucell's producten proberen te ondermijnen.
Ik heb begrepen dat de bindingsplaatsen van Crucell's anti-bodies anders zijn dan die door Bogoch zijn beschreven.
Toch kan ik mij eveneens voorstellen dat een officiele reacte uitblijft, mede in het belang van het nog te publiceren artikel over de H3-streng. Indien de H3-streng weldegelijk overeenkomsten heeft met de Bogoch patenten, dan zijn vervolgbesprekingen met Bogoch onvermijdelijk. Aan de andere kant, indien geen overeenkomsten zijn, dan kan met de aankomende publicatie in één keer de claim van Bogoch teniet worden gemaakt.

Ten aanzien van de verdere ontwikkeling over Flucell antibodies ben ik van mening dat het versneld uitvoeren en vermarkten een risico met Sanofi meebrengt.
Crucell kan voor 10 jaar revenue inkomsten van Sanofi's griep-vaccin ontvangen. Het DAARNA samenvoegen van Crucell's anti-bodies met Sanofi's griep-vaccin kan een constante stroom van inkomsten opleveren, gebruikmakende van Sanofi's distributie netwerk.
Het nu al toevoegen van de beide producten geeft Crucell minder toegevoegde waarde, mede omdat Crucell's antibodies nog niet ver genoeg de ontwikkelingsfasen heeft doorlopen. Daarnaast geeft verdere ontwikkeling Crucell eveneens de mogelijkheid om met een derde partij in zee te gaan. (Minder logisch doordat Sanofi gebruik maakt van PerC6).

[quote=ron banged]
Going on 4 months of no news.
Brus is out partying and buying more hair gel.

Stock is languishing because we need some news to add some zip to 2010. We have many analysts who have income going DOWN for 2010, because Quinvaxem sales will be diluted for 2010 to 2013 among newly approved vaccine makers(Hello India). After looking at the numbers I think the best Crucell can do is maintain Quinvaxem sales in the next Supranational contract.

We still don't know if Flucell is in Phase III, what Wyeth is working on, progress on Mederex etc. The only update we got was from comparing a couple of presentation slides from April to those from 6 months ago. and we were promised TB news.
[/quote]
D'accord

[quote=ron banged]
And don't get me started on Flavimun.
[/quote]
Verzoek tot registratie in Zwitserland was medio maart ingediend. Duitsland is/was vertraagd.

[quote=ron banged]
Spring is the time when this company has traditionally announced big deals...before Brus and Kruimer go on vacation from May through September.
C'mon guys...give us something before you pull up the Speedo's and start sipping apple martinis.

Een aanbeveling ook namens mij. Ik verwacht dat met name dit jaar een grote schifting in licentie-houders. Veel bedrijven hebben in het verleden een onderzoekslicentie afgesloten op basis van een veel lager rendament met PerC6. In combinatie met DSM heeft Crucell veel aan het rendament op PerC6 verbeterd. Dat leidt tot hogere licentie kosten en een groter procentueel deel van de bruto productinkomsten.
Dat kan wel eens leiden tot verlengde onderhandelingen waarbij afbreken nog steeds een optie is.

aossa 8 april 2009 16:22

0

Morgen rondom deze tijd 'Happy Hour'.
Vervolgens vóór etenstijd 'Voetwassing'.

[verwijderd] 14 april 2009 12:52

0

quote:
aossa schreef:
Morgen rondom deze tijd 'Happy Hour'.
Vervolgens vóór etenstijd 'Voetwassing'.

Well, we are done with the foot washing and it is now another week with no news.

Brus needs to quit playing hide the salami and give us some good news!

aossa 14 april 2009 12:58

0

Coming soon ...

[verwijderd] 14 april 2009 13:48

0

quote:
aossa schreef:
Coming soon ...

DE quote was ( van Jaaaaaaren geleden )

" very very soon "
" het is nog geen zomer "
" voor eind januari 2005 "

Jammer genoeg word ik voor " bashen " niet betaald.
Realist Willemn ook niet.
Anders waren wij allebei toegetreden tot de Quote 500.
(:->D)

De koers is "Vleesch , noch , Visch "
Om iedereen te ontmoedigen??
Of gewoon omdat de markt niet meer wil betalen dan de huidige koers.
En die markt heeft nog altijd gelijk gehad,
dus ook in het geval van Crucell.
Maw: Als de markt een positief resultaat verwacht bij Q1 , dan zit dat in de huidige koers verdisconteerd, mits het resultaat ook + zal zijn.
Als de markt negatieve cijfers verwacht hangt het van het resultaat af
of de koers zal stijgen of dalen.
En al dit alles heb ik zo-even op de achterkant van een sigarendoosje
beredeneerd.
(:->D)

[verwijderd] 14 april 2009 22:44

0

Nieuwe les: De markt heeft nimmer gelijk,maar bestaat uit pure manipulatie.
VB; 3 weken terug;ING low 2,78 ,vandaag zelfs 6,90.
Hoe bedoel je de markt heeft gelijk? Heb met ING mooie deals gemaakt. Crucell daarentegen gaat na 1q cijfers echt schitteren,met overname als toetje. De handel weet dit drukt nu koers en zet deze week voor 1q cijfers de koers fors hoger.

gogogoo 14 april 2009 22:51

0

quote:
paul63 schreef:
Nieuwe les: De markt heeft nimmer gelijk,maar bestaat uit pure manipulatie.
VB; 3 weken terug;ING low 2,78 ,vandaag zelfs 6,90.
Hoe bedoel je de markt heeft gelijk? Heb met ING mooie deals gemaakt. Crucell daarentegen gaat na 1q cijfers echt schitteren,met overname als toetje. De handel weet dit drukt nu koers en zet deze week voor 1q cijfers de koers fors hoger.

Als je de low van ING pakt. Tja.
Een maandje daarvoor weer stond ING ook op dat nivo.
Nog een maandje eerder op 9
Een jaar daarvoor op 25.

Appels en Peren.

[verwijderd] 14 april 2009 23:42

0

quote:
ron banged schreef:
[quote=B_B]
No News (about products) is GOOD NEWS.
It means the negotiations (of a takeover) is still going on.

News about products will have an impact on the share price (this will upset the buyer).
[/quote]
News is news and it must be released if it is material, regardless of what a potential buyer might want. I would like to agree with you but cannot.

Only news that is individually significant has to be published. With the growing turnover, a lot of individual deals are not significant enough for individual press releases. Also some clients request no publicity, at the signing of the agreement. We will see what 6 May wil bring.

[verwijderd] 15 april 2009 07:30

0

quote:
gogogoo schreef:
[quote=paul63]
Nieuwe les: De markt heeft nimmer gelijk,maar bestaat uit pure manipulatie.
VB; 3 weken terug;ING low 2,78 ,vandaag zelfs 6,90.
Hoe bedoel je de markt heeft gelijk? Heb met ING mooie deals gemaakt. Crucell daarentegen gaat na 1q cijfers echt schitteren,met overname als toetje. De handel weet dit drukt nu koers en zet deze week voor 1q cijfers de koers fors hoger.
[/quote]
Als je de low van ING pakt. Tja.
Een maandje daarvoor weer stond ING ook op dat nivo.
Nog een maandje eerder op 9
Een jaar daarvoor op 25.

Appels en Peren.

Sterker nog: je zou alleen centjes hebben gehad om te investeren, wanneer je daarvoor niet aan bodemvissen in Fortis op 4 had gedaan. Maar daar hoeven we het kennelijk niet over te hebben?!

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