Beursonline.nl

[verwijderd] 8 januari 2009 17:47

0

quote:
oudje schreef:
Helaas zullen die dingen aan onze neus voorbijgaan.

Ik hou me vast aan het teleatlas-scenario. Er kan nog wel 100% bij. Daarom ook vandaag bijgekocht (en niet verkocht zoals Voda...),ga ik wellicht de komende weken nog meer doen.
Er komen immers jaarcijfertjes aan en een speculatief sfeertje rondom het aandeel; TEL uit je koerswinst.

On topic:goed bericht!

josti5 8 januari 2009 17:49

0

'Er komen immers jaarcijfertjes aan en een speculatief sfeertje rondom het aandeel; TEL uit je koerswinst.'

Hopelijk, in navolging van volgend jaar, morgenochtend een TU...

josti5 8 januari 2009 17:54

0

quote:
oudje schreef:
Helaas zullen die dingen aan onze neus voorbijgaan.

Ja, jammer Henk; het DDS-scenario van Louis (waar ben je trouwens, Louis???) lijkt hoe dan ook uit te draaien op de gevreesde nachtmerrie.
Want zo valt ieder bod onder de 30 euro toch wel te kwalificeren.

Al een beetje bijgekomen van de schok, trouwens?

Je weet: ik ben er al jaren bang voor, maar toch komt zo'n moment altijd weer onverwacht.
En als zelfs Josti hierdoor een korte, slechte nacht achter de rug heeft, hoe is het dan met Henk gesteld?

Cybertom 8 januari 2009 18:01

0

Jij kon dus ook al niet goed slapen, ondanks je 160% belegging John?
Goh, wat had ik gisteravond ook slechte zin, daar gaat Neerlands trots met zoveel potentie en mooie dingen in het verschiet. Men zegt wel eens: never fall in love with a stock, maar ik moet toegeven dat ik deze aandeeltjes het liefst mijn hele leven had kunnen houden en lekker had kunnen teren op het dividend later.

Helaas de droom is over, nu hopen dat er binnenkort een fatsoenlijk bod komt, want die € 1 mrd. gaat natuurlijk nergens over. Bijkopen is het devies dunkt mij.

Allen veel wijsheid gewenst!

Cyber

[verwijderd] 8 januari 2009 18:02

0

Wat is een TU ?

[verwijderd] 8 januari 2009 18:05

0

quote:
Arabica k. schreef:
Wat is een TU ?

Trading Update. Vorig jaar rond deze tijd werd de omzet in een TU een beetje naar beneden bijgesteld. Van 220 naar 213 of zo iets. Hommeles!! Nu andersom. Outlook was 213 + 20% = 255 MM. Maar dat zal vermoedelijk wel richting de 275-285 gaan. En dat zeggen ze dan voor de jaarcijfers in een TU.

[verwijderd] 8 januari 2009 18:06

0

dat is waar ook! thnx. Kortom alles valt één kant op.

josti5 8 januari 2009 18:07

0

Tnx, nix4nix.

[verwijderd] 8 januari 2009 18:24

0

TU zal niks geen invloed meer hebben op de koers. Alleen overnameberichten tellen nog.

BTW behalve Louis is het ook erg stil rondom ons Amerikaans lid banged

[verwijderd] 8 januari 2009 18:30

0

quote:
dedokter schreef:
TU zal niks geen invloed meer hebben op de koers. Alleen overnameberichten tellen nog.

BTW behalve Louis is het ook erg stil rondom ons Amerikaans lid banged

This says Ron:

First of all, I was glad to see the acknowledgement that this structure of these talks will give other interested parties the time to step up to the plate if they would like to. Yes, Sanofi, Novartis, Merck(because of the master file, and TB and Malaria deals), GSK and even Genentech(they know what STAR could and can do.

I think this is a win win, only if Crucell holds out for a much higher price or tells them to take a hike. Because of the nature of the deal, ...only Wyeth and Crucell know the value of the deal they struck about a year ago...much of the other information is on the table...Quinvaxem sales, rabies milestones and cut of gross, Flucell with Sanofi etc.
Even if it does not work out, the price denied will give the Street a better feel as to what Crucell is really worth. $1.35 billion is less than 3x next years revenues...and there are so many intangibles...such as approval of Flucell and the ability sell directly into Japan, or Ark Therapeutics Trinam being approved etc...

If it fall through, I see selling pressure, but it will not last. Crucell will be taken much more seriously. And if they turn down a large number...it must be because they have a better feel for the future than the Street does.

I could see 1.35 billion for a 50% stake in the company. If the numbers for Prevar 13 will be what has been implied, $1.35 billion would mean Wyeht would get Crucell for free (remember, Bru said it was the biggest deal ever)

flosz 8 januari 2009 18:33

0

Linkjes erbij...

messages.finance.yahoo.com/Stocks_%28...
www.investorvillage.com/smbd.asp?mb=2...
www.investorvillage.com/smbd.asp?mb=2...
www.investorvillage.com/smbd.asp?mb=2...
www.iex.nl/forum/topic.asp?forum=228&...

[verwijderd] 8 januari 2009 20:59

0

quote:
josti5 schreef:
[quote=oudje]
Helaas zullen die dingen aan onze neus voorbijgaan.
[/quote]

Ja, jammer Henk; het DDS-scenario van Louis (waar ben je trouwens, Louis???) lijkt hoe dan ook uit te draaien op de gevreesde nachtmerrie.
Want zo valt ieder bod onder de 30 euro toch wel te kwalificeren.

Al een beetje bijgekomen van de schok, trouwens?

Je weet: ik ben er al jaren bang voor, maar toch komt zo'n moment altijd weer onverwacht.
En als zelfs Josti hierdoor een korte, slechte nacht achter de rug heeft, hoe is het dan met Henk gesteld?

Ja, John, zelfs voor jou, die er rekening mee hield, was het een schok. Ik heb altijd, althans tot de 3e kwartaal-call, te vuur en te zwaard zitten bestrijden, dat er een overname zou komen. De laatste tijd was ik wel een beetje "om". Voor mijzelf is het niet zo dramatisch, maar ik heb in de loop der jaren de helft van mijn Crucell-aandelen aan mijn twee kinderen gegeven en er bij gezegd, dat ze beneden de 100 niet de deur uitmochten. Mijn zoon en dochter vinden dit (gelukkig!!) helemaal niet leuk.Dus was ik geschokt en heb niet best geslapen.
Maar, alles went, zelfs hangen.....
Ik reken er wel op, dat de uiteindelijke vangst tussen de 22 en 25 komt te liggen, euros vanzelfsprekend.
En de toekomst? Hoewel ik niet verliefd was op het aandeel, zal ik mijn speeltje heel erg missen.
Voor straks: slaap ze.

flosz 14 januari 2009 12:26

0

RNS Number : 5862L
Ark Therapeutics Group PLC
14 January 2009

Ark grants VEGF genes licence to Oy Lx Therapies Ltd for lymphatic disease

14 January 2009 - Ark Therapeutics Group plc ('Ark' or 'the Company') today announces that it has granted an exclusive sublicence to the Finnish company, Oy Lx Therapies Ltd ('Lx Therapies'), for the use of VEGF-C and VEGF-D genes in lymphatic disease. Ark has also granted Lx Therapies a licence to use its proprietary adenoviral vector gene-medicine manufacturing processes and know-how in gene therapy to deliver the genes. In return, Ark has received an equity holding of 5% in Lx Therapies and will also receive a single digit royalty on the net sales of any marketed product.

Lx Therapies, founded in 2008, is a drug discovery company focused on developing gene-mediated therapies for the prevention and treatment of diseases of lymphatic vasculature. The initial focus of the company is on breast cancer-related lymphoedema, a relatively common complication of breast cancer treatment for which there is currently no cure or effective treatment. Lx Therapies, based in Helsinki, has received a EUR 2 million investment from Inveni Capital, the Finnish-German life sciences venture fund and a founder of Lx Therapies.

Under the terms of the licence, Ark will supply Lx Therapies with batches of adenovirus VEGF-C and adenovirus VEGF-D for research purposes. Subject to capacity, Ark has agreed to supply Lx Therapies with clinical batches at a commercial rate in due course.

The intellectual property to the genes being sublicensed to Lx Therapies was originally acquired by Ark through the purchase of Lymphatix Oy, in January 2008. That acquisition gave Ark exploitation rights to the vascular endothelial growth factor genes known as VEGF-C and VEGF-D for developing gene-based medicines in the angiogenesis and lymphangiogenesis areas. Ark already had VEGF-based programmes in pre-clinical development in these areas, notably refractory angina, wound healing, prevention of restenosis and foetal growth restriction. Results to date have shown that VEGF plays a key role in these diseases.

Dr Nigel Parker, Chief Executive Officer of Ark, commented: "This licence will allow Ark to take advantage of Lx Therapies' expertise in lymphatic disease and to use their focus in this area to optimise development. Lymphoedema is an extremely common disorder following cancer-related removal of the lymph gland and is an area of high clinical need. We look forward to working closely together with Lx Therapies and to moving this next area of gene-based medicines towards the clinic."
investors.arktherapeutics.com/servlet...

[verwijderd] 6 februari 2009 21:09

5

quote:
Ark Therapeutics schreef:
investors.arktherapeutics.com/pdf/Int...
Trinam® Background
• Market opportunity - 150,000 suitable cases per year (US and Europe)
• Potential $750+m per annum peak sales product
• US and EU Orphan Drug Status
[/quote]
[quote=flosz]
08 January 2009
Ark Therapeutics Group PLC completes potency test qualification enabling Trinam®
Phase III trial to commence
[/quote]
[quote=Crucell]
cws.huginonline.com/C/132631/PR/20090...
Crucell announced that its PER.C6® technology licensee Ark Therapeutics has entered a Phase III study with its product Trinam.
[/quote]
[quote=Circadian]
www.circadian.com.au/App_CmsLib/Media...
Ark Therapeutics Limited has received clearance by the US Food and Drug Administration (FDA) to commence Phase III human trials of Trinam® which is based on Vascular Endothelial Growth Factor (VEGF) intellectual property.

In the case of Trinam®, Ark has previously indicated that the Phase III studies will take approximately 18 months to complete. If the results of these studies are
positive for the measures agreed with the FDA, it’s possible the product could be approved within a year or so after completion of the clinical studies. Most drug
approvals take two or more years after completion of clinical studies.

We also continue to receive ongoing annual payments from Ark and will receive royalties on sales of the product.

At this point in time, there’s no competing product, so it’s very hard to do a comparable analysis seeing that current market estimates could potentially be an
underestimate.
Ark has previously published an estimate of up to US$500 million sales per annum as its goal for Trinam®

Ok, even samenvattend:
Trinam maakt in ieder geval gebruik van Crucell en Circadian technology. Beide bedrijven krijgen milestone betalingen en royalties van de verkoopomzet.

Uit beide presentaties varieert de verwachte omzet tussen USD 500 en USD 750 KK.
Indien Crucell een 5% van USD 625 KK op jaarbasis ontvangt (een lager royalty aangenomen i.v.m. een oude overeenkomst), dan draagt Trinam vanaf medio 2011 al voor USD 15 KK bij aan de omzet van Crucell.
Voor 2012, het eerste hele jaar, is dan USD 31,5 KK.
Met een voor 2009 toepasbare EUR-USD van 1,35 en een aanname van het uitstaande aandelen van 70 KK geldt dat Trinam alleen al voor EUR 0,33 per aandeel bijdraagt aan de winst van Crucell.
Dat is 50% meer dan de winst zoals deze nu over heel 2008 is gerealiseerd.
Op naar de volgende licentie waarderingen.

Note: andere percentages leveren natuurlijk een andere waarde op.

eddy59 6 februari 2009 21:54

0

Nu juichen we om een nieuwe licentie en er zijn er al te veel om op te noemen, ze worden door hun veelvuldigheid al per kwartaal gepubliceerd. Nu sluit je ogen en denk eens dat ........veel van deze licenties pure cash gaan opleveren. De R&D investering is reeds gedaan dus het gaat om pure winst tientallen cq honderden jaarlijkse dubbeltjes, kwartjes en euro´s per aandeel.
Whow dat is een lekker gevoel om als LT belegger 100% in Crucell aandelen te zitten. In de mindere tijden heb ik wel eens mijn bedenkingen gehad maar even rationeel nadenken heeft mij snel weer op het rechte pad gebracht.
Crucell de microsoft van de biotech was niet zo slecht bedacht.

Prettig weekend allemaal.
Jammer dat de beurs morgen gesloten is!

Eddy

flosz 16 februari 2009 08:22

0

13 February 2009
31 DECEMBER 2008 HALF-YEAR RESULTS
& OPERATIONAL ACHIEVEMENTS Circadian Technologies Limited

Licensee Ark Therapeutics received clearance to commence Phase 3 trial of Trinam®
Vegenics licensee Ark Therapeutics Group plc (LSE: AKT) announced in early January 2009
that it had been notified by the US Food and Drug Administration to commence patient
recruitment into its Phase 3 human trials of Trinam®, a novel treatment to improve quality of
care and quality of life for kidney dialysis patients.
Trinam® is a gene-based medicine to prevent blood vessels from blocking in kidney dialysis
patients who have undergone vascular access graft surgery.
Ark had previously reported that in a Phase 2 clinical trial the access grafts of patients given
Trinam® remained functional for dialysis, on average, up to three times longer than in untreated
controls.
Rights to employ the VEGF-D gene in Trinam® are licensed from Vegenics to Ark. Under the
terms of the Vegenics/Ark license agreement, Vegenics is entitled to receive milestone payments
on clinical development achievements and royalties on product sales. Trinam is one aspect of
Vegenics’ VEGF-D portfolio.

Trinam®, a novel treatment to improve quality of care and quality of life for kidney dialysis patients, is
being developed by licensee Ark Therapeutics Group plc, a company listed on the London Stock
Exchange. This VEGF-D gene therapy product recently commenced recruitment into its Phase 3
human trial.
********************************

RNS Number : 3412N
Ark Therapeutics Group PLC
16 February 2009

Ark Therapeutics Group plc

France gives first approval for Named Patient Supply of Cerepro®

London, UK 16 February 2009 - Ark Therapeutics Group plc ("Ark" or the "Company") (AKT:LSE) today announces that the first Named Patient Supply (NPS) for Cerepro® has been approved by the French Medicines Control Agency (AFSSAPS) following a 'nominative' ATU application (Autorisation Temporaire d'Utilisation) made by a neuro-surgeon in France. Cerepro® (sitimagene ceradenovec), Ark's novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma
investors.arktherapeutics.com/servlet...

flosz 17 februari 2009 20:58

0

RNS Number : 4569N
Ark Therapeutics Group PLC
17 February 2009

Notification of Major Interests in Shares

Date of transaction 12 February 2009
Date on which issuer notified: 17 February 2009

investors.arktherapeutics.com/servlet...
investors.arktherapeutics.com/servlet...

harvester 17 februari 2009 21:47

0

welcome to wellcome + barclays as shareholders of ARK

flosz 26 februari 2009 09:25

0

RNS Number : 9007N
Ark Therapeutics Group PLC
26 February 2009

Ark patents novel gene regulation technology as potential successor to RNA silencing

- Unique technology can turn defective genes both "up" and "down" using
existing delivery methods -

26 February 2009 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that it has filed a patent application relating to a breakthrough small hairpin RNA (shRNA) based technology that allows both the up- and down-regulation of multiple genes via Ark's existing method of gene delivery. The discovery, which was made by Ark's scientists in Finland, represents a major advance on existing RNA silencing technology and has the potential for use in the treatment of a variety of human diseases involving defective genes, either where the genes do not work or are overactive.

Gene expression is the process by which information from a gene is made into a functional product such as a protein. In this process, ribonucleic acid (RNA) acts as a form of messenger which reads the DNA code and then "tells" a structure (ribosome) in the cytoplasm precisely what protein to make. If a gene is defective, existing gene silencing methods can "switch off" the gene effect using a technology known as small interfering RNA (siRNA) which interferes with the messenger RNA, but this technology only has the ability to suppress the effect of the gene. The technology is also limited by current delivery mechanisms. siRNA is usually delivered to cells using synthetic oligonucleotides in very large quantities in an attempt to get them into the nucleus and cytoplasm of cells. In disease models various liposome type approaches have been used but they still deliver less siRNA to the cytoplasm than is generally required. Alternatively, adenoviruses can be used to deliver the siRNA but this method does not always place it in the right compartment in the cytoplasm for correct processing.

Therefore, although conventional siRNA technology is able to silence the target gene, the technology is in many ways limited in terms of its medical application. Earlier attempts to modulate gene effects, such as the zinc finger protein-based approach to down-regulate or up-regulate endogenous gene expression, have also encountered problems such as lack of specificity.

Ark's new shRNA technology is unique in that it appears to be actively taken to the nucleus of the cell where it acts on the promoter of the target gene via an epigenetic mechanism. After processing in the nucleus, it can both down-regulate (silence) or up-regulate (increase) gene expression within the cell (endogenous gene expression). Ark's new technology can also perform multiple gene up- or down-regulation with the same vector construct. Importantly, it can be delivered using Ark's existing and established viral vector technologies according to the length of time an effect is needed.

Professor John Martin, Chief Scientific Officer of Ark, commented: "Since the Human Genome Project, the link between disease development and an individual's DNA is increasingly being recognised. RNA silencing to block a defective gene has been an area of great interest for the pharmaceutical industry in recent years but this technology moves it to a different level. Many diseases are caused by under or over expression of multiple genes and so the potential ability to 'turn up' or 'turn down' the effects of the 'in situ' existing genes, without having to insert new genes to correct the pathology, is a groundbreaking step forward both for patients and medical science."

Dr Nigel Parker, CEO of Ark, added: "This is extremely exciting technology which in many respects complements our previous discovery of targeted gene insertion two years ago and which we believe has the potential for broad utilisation in the treatment of disease. We now have a full toolkit which provides the flexibility to both selectively insert beneficial genes or correct defective genes, enabling us to develop a wide range of DNA based medical treatments, for example to switch off cell proliferation or migration in the treatment of cancer and vascular disease. It is becoming increasingly evident that DNA based medicines have the potential to provide therapeutic solutions to a number of presently untreatable diseases and Ark continues to operate at the forefront of this highly innovative area of medicine."
investors.arktherapeutics.com/servlet...

flosz 11 maart 2009 09:31

0

RNS Number : 6539O
Ark Therapeutics Group PLC
11 March 2009

Ark Therapeutics Group plc

Preliminary results for the year ended 31 December 2008

London, UK, 11 March 2009 - Ark Therapeutics Group plc today announces its unaudited preliminary results for the year ended 31 December 2008.
HIGHLIGHTS
Trinam® • FDA Special Protocol Assessment granted and IND requirements met allowing Phase III to commence in USA

Dr Nigel Parker, CEO of Ark, commented:

"In 2008 we continued to make solid progress in pioneering and building our specialist gene-based medicine products and capabilities. Not only have the Phase III leads moved successfully through key late-stage regulatory milestones, but we have strengthened the underlying pre-clinical pipeline to be in a position to take three more gene-based products into the Phase I/IIa trial stage in 2009.

We anticipate a busy period of newsflow during the coming year, with the outcome of the Cerepro® marketing application in Europe, the read-out of the results for the VitorTM Phase III pilot study and progress on the recruitment for the Phase III trial for Trinam®. Our objectives remain focused on strengthening our leadership position in the DNA-based medicine area and increasing our commercial effectiveness, enabling Ark to become a leading, sustainable provider of advanced biomedicines."

Trinam®

We continued to work closely with the US regulators to progress the SPA process through the first half of the year and this was formally awarded in June 2008. Concurrently, the Investigative New Drug ("IND") application reviewer requested that one of the battery of batch release assays be 'qualified' with further data. Work on qualification commenced immediately as did work with US investigator sites to enable enrolment of the first patient into the trial as soon as clearance of the assay was received.

A suitable assay was qualified late in the period in line with the revised draft guideline covering this area issued by the FDA in October. Post-period we have filed the requisite IND updates with the FDA and recruitment of the first patient is expected shortly.

PRE-CLINICAL

Following the progress we made with our clinical stage gene-based technology and manufacturing we took the decision late in 2007 to invest in a number of the most promising pre-clinical gene-based programmes in order to move up to three into Phase I/IIa development.

The most advanced of these (EG011) is a short-form VEGF-D gene in our adenoviral delivery platform (as used in Cerepro® and Trinam®) under development for treatment of refractory angina. This reported very promising pre-clinical results in June 2008. In a heart attack model, treatment with EG011 restored the ejection fraction (the amount of blood pumped from the affected ventricle), a key measure of heart function, from 60% to 90% of the level observed before the heart attack occurred.

A further programme (EG013), also based on adenovirally delivered VEGF, is under development for foetal growth restriction, a serious disorder caused through insufficient blood supply to the placenta. This also showed promising results by producing improved blood flow for up to 50 days in an in vivo model. In April we held a meeting with the Gene Therapy Working Party ("GTWP") at the EMEA to discuss these findings, which clarified the indication of severe foetal growth restriction and the method of administration. They also commented positively both on a proposed programme of in vivo and in vitro work to be completed prior to Phase I/IIa and on the nature of the Phase I/IIa trial endpoints.

In addition, during the first half of 2008 we had a successful meeting with the GTWP to discuss Scavidin® in pre-clinical development for non-operable gliomas. The combination status of the product was confirmed as well as the manufacturing process and route of administration. In another of our pre-clinical programmes, EG014, a neuropilin-1 ("NP-1") receptor antagonist, we reported the discovery and understanding of the precise NP-1 receptor pocket structure and molecular binding site characteristics, allowing us to continue what we believe is the last stage of lead optimisation work to provide a compound to take into the clinic.

Through the latter half of the year we prioritised our pre-clinical programmes further and as well as making the determination to take our short-form adenoviral VEGF-D construct into Phase I/IIa in both myocardial ischaemia (EG011) and foetal growth restriction (EG013) we also selected, following early academic trials results, peripheral vascular disease prior to by-pass surgery as a clinical opportunity. All these programmes utilise the adenoviral vector platform on which Cerepro® and Trinam® are based with the short-form D gene allowing us to leverage both the 'approvable status' of this delivery technology and a single manufacturing process.

The combination of our DNA-based research capability and manufacturing expertise has put us in a unique position to develop these pioneering products, all of which address large markets with high clinical need. Whilst remaining attractive, our other pre-clinical programmes have been de-prioritised to give priority in time and resources to the most promising. Work on these will continue in academia capitalising on our academic partnerships, an important strength of Ark's approach to research.

Overall, our pre-clinical programmes have developed encouragingly towards the key value-creating Phase I/IIa trial milestones. We believe that such progress in these gene-based programmes is uniquely possible at Ark through the capabilities developed in our lead clinical products.

Going forward we expect to announce in the first half of 2009 the commencement of at least two of the Phase I/IIa programmes with our short-form VEGF-D construct in collaboration with academia.

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