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Crucell & Ark Therapeutics

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Omlaag ↓

flosz 18 december 2009 17:47

quote:
wilb52 schreef:
Entschuldigung

He jarige job, gefeliciflapstaart!
Kusje erbij… www.youtube.com/watch?v=wFh-rX_Sfhs

Cerepro-> vector Adenovirus type 5, E1 E3 deleted. Cell line HEK293.
www.iex.nl/forum/topic.asp?forum=228&...

flosz 18 december 2009 22:17

quote:
aossa schreef:
investors.arktherapeutics.com/servlet...
_client_id=4553&transform=newsitem_new

Ark expects to close the financial year with over £20m of cash. While Ark remains confident that it has strong data to support the re-examination in early 2010, the delay which the appeal process introduces means that the Company believes that it is prudent to undertake actions now to reduce its cost base.
****************

17 December 2009
EMA/828428/2009
EMEA/H/C/1103
Questions and answers on the recommendation for the refusal of the marketing authorisation for Cerepro (sitimagene ceradenovec)
www.emea.europa.eu/pdfs/human/opinion...
**************
11/11/2009
We reported in our half-year results' announcement on 26 August 2009 that the Company had £28.6m in cash and money market investments at 30 June 2009

Late in the first half of the year we reported the recruitment of the first patient into the Trinam® US Phase III study. Following clearance of a technical manufacturing issue, efforts have been concentrated on site initiations and training of investigators in the procedure. With the recent regulatory clearance of the key opinion leader and Principal Investigator's site for patient recruitment and an increased number of sites now open, it is anticipated that enrolment will accelerate.

[verwijderd] 18 december 2009 22:25

Liedje erbij

"ik zit hier in mijn eentje stil te dromen"...........

etc etc , ik kan niet zingen (:->)

harvester 18 december 2009 22:27

Met een koers van 15 ipv 30 (en eerder 40) en zonder het geldverslindende kankeronderzoek cerepro (Crucell heeft zelf eerder bewust afscheid genomen van kankeronderzoek en gekozen voor vaccins) past Ark nu beter bij crucell dan tot nu toe.

aossa 18 december 2009 22:28

Professor Seppo Ylä-Herttuala, Consultant Director of Molecular Medicine at Ark commented: "Cerepro® has produced good safety and efficacy data in a difficult to treat disease where new treatments are much needed. It has the potential to be the first gene-based medicine to be approved and, as such, is navigating uncharted waters from a regulatory perspective. It is perhaps unsurprising therefore that the approval process is taking longer than patients would hope for, but it is significant that the adenovirus platform technology has no outstanding issues and I believe it is a matter of time before the product gains approval."

Nigel Parker, CEO at Ark, added: "We are naturally very disappointed with this opinion. We have a considerable body of evidence from the study which we believe will address the main objection with respect to re-intervention. We are planning to file for re-assessment in a matter of days and expect the appeal process to take about four months. Despite this setback, we are pleased that Ark's underlying adenovirus platform has cleared all other barriers to a full approval. This is a major milestone both for Ark and the industry and gives us the confidence to progress development of our complete adenovirus portfolio."

voda 18 december 2009 22:30

quote:
wilb52 schreef:
Liedje erbij

"ik zit hier in mijn eentje stil te dromen"...........

etc etc , ik kan niet zingen (:->)

www.youtube.com/watch?v=6KpoLYumUA0
(lol)

flosz 18 december 2009 22:34

Hans je vergeet hem helemaal te feliciteren, dat kan toch niet de bedoeling zijn.

flosz 18 december 2009 22:35

Uit de Emea-link:

What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Because Cerepro is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT). Taking into account the assessment performed by the CAT, the CHMP concluded that the results of the main study did not show that Cerepro was effective. In addition, Cerepro was associated with an increased risk of serious side effects such as hemiparesis (slight paralysis on one side of the body) and seizures (fits). These side effects were a concern, considering the lack of proven effectiveness.
At that point in time, the CHMP was of the opinion that the benefits of Cerepro did not outweigh its risks and recommended that it be refused marketing authorisation.

[verwijderd] 18 december 2009 23:51

quote:
harvester schreef:
Met een koers van 15 ipv 30 (en eerder 40) en zonder het geldverslindende kankeronderzoek cerepro (Crucell heeft zelf eerder bewust afscheid genomen van kankeronderzoek en gekozen voor vaccins) past Ark nu beter bij crucell dan tot nu toe.

Er is gekozen voor vaccins en ja..... je hebt helemaal gelijk dat Crucell bewust afscheid genomen heeft OOIT voor kankeronderzoek.
Was WEL uitgangspunt ook ooit van het bedrijf en gaande weg is er gekozen voor wat directere geldstromen in de vorm van vaccins.
Zijn ook bedrijven voor overgenomen en is nu de moter onder het bedrijf.
Is allemaal NU , maar antibodys en de technologische mogelijkheden die Crucell EN DSM samen bieden binnen Percivia gaan imho uiteindelijk ook meer breedte geven binnen de mogelijkheden van biotech en kankeronderzoek is daar zeker een onderdeel van.
Per saldo .... wat is het verschil tussen een lichaamsvreemd eiwit/ virus die het lichaam /afweersysteem op het verkeerde been zet en daardoor een ziekte veroorzaakt EN een lichaamscel die ontspoort en waar het afweersysteem geen weg mee weet.

Is reden tot onderzoek en ik denk dat een ieder zichzelf respecterend biotechtech bedrijf daar op de een of andere manier me bezig is.
Crucell is daar zeker een van..denk ik

[verwijderd] 19 december 2009 17:35

www.youtube.com/watch?v=0Bmhjf0rKe8

Babs

flosz 19 december 2009 19:27

But Ark Therapeutics lost half its value, dropping 15p to 15p after European regulators recommended against approving the company's key brain cancer drug Cerepro, on the data presented so far. In a sell note Paul Cuddon at KBC Peel Hunt said:
The European regulator EMEA has rejected Ark's Cerepro for the treatment of brain cancer. It was concerned about both the lack of efficacy and the safety risk from a novel gene therapy. Ark now has to consider writing off Cerepro altogether, or funding more trials. We reduce our target price to the value of Ark cash per share, 10p.

The failure for Cerepro will allow Ark to preserve cash for its earlier-stage trials and save shareholders from a cash call to fund a sales force.

Also, we have yet to be convinced by the commercial potential in Vitor (for cancer cachexia) and have concerns over the intellectual property on Trinam (kidney dialysis grafts).

www.guardian.co.uk/business/marketfor...

flosz 27 december 2009 19:10

Ark's travails highlight biotech risk

All of this leaves analysts and the market uncertain as to what happens next, which is probably why the shares fell nearly 50 per cent on the day of the announcement. Analyst Paul Cuddon at KBC Peel Hunt said EMEA had now rejected Cerepro on the basis of efficacy, safety and now on the integrity of the trial. He does not rate the company's chances of success in an appeal and that Ark's priority now is to decide how to make its cash reserves last into 2011. A renewed fund-raising is unlikely unless the company can show something interesting with either muscle wasting medicine Vitor or its Trinam blood vessel treatment, both of which have their own problems, he added.

www.investorschronicle.co.uk/Companie...
Regulatory/Analysis/article/20091221/2f4d755e-ee45-11de-a13e-00144f2af8e8/Arks-travails-highlight-biotech-risk.jsp

Ark's travails illustrate the age old risks in investing in biotech stocks. The rewards can be significant, but the downside is potentially disastrous. The UK biotech industry has had its fair share of disappointments, of which Ark is not likely to be the last. Biotech investing remains a minefield.

harrysnel 5 januari 2010 10:07

RNS Number : 0035F
Ark Therapeutics Group PLC
05 January 2010

Ark files for re-examination of Cerepro®

Final decision from the European Agency anticipated early Q2

London, UK, 5 January 2010 - Ark Therapeutics Group plc (AKT: LSE) ("Ark" or "the Company"), announces that it has filed the formal request to the European Medicines Agency (EMEA) for re-examination of its marketing authorization application (MAA) for Cerepro®, Ark's novel gene-based therapy for operable malignant glioma (brain cancer). This follows the adoption of a negative opinion by the European Committee for Medicinal Products for Human Use (CHMP) in December 2009. Ark will provide data to support re-examination on the main underlying objection from its "904" phase III trial and expects to receive a final decision from the EMEA in early Q2 2010.

The MAA application for Cerepro® was filed in December 2008 and has undergone formal review via the centralised procedure. Cerepro® has Orphan Drug Status in both Europe and the USA and is manufactured by Ark in Finland.

Nigel Parker, CEO at Ark, commented; "In the last two weeks we have assessed the full range of evidence from the Phase III study. We are confident that we have the necessary data to address the main underlying objection concerning the re-intervention decision in the Cerepro® trial. The body of evidence is substantial and robust and we are thus comfortable to file for re-examination.

"Ark has successfully pioneered the adenovirus platform to an approvable standard and we are now dealing with a final clinical issue, through the standard EMEA regulatory process. The trial endpoints and analyses used in Study 904 reflect the latest published recommendations from international expert working groups reviewing glioma trial design."

harrysnel 5 januari 2010 10:08

Link:
investors.arktherapeutics.com/servlet...

harrysnel 9 februari 2010 12:40

Een ouder bericht (28 jan) over de gevolgen van afkeuring Cerepro:

investors.arktherapeutics.com/servlet...

"As a result, the Company's operational focus will be on completing Cerepro® and Trinam® programmes and ensuring the key pre-clinical programmes in refractory angina (EG011), (see separate announcement today) peripheral vascular disease (EG016) and foetal growth retardation (EG013) progess in Phase I/IIa development. The measures currently being implemented should mean that the Company's current cash will fund its operations into the second half of 2011."

[verwijderd] 19 februari 2010 12:27

Ark signs Preferred Supplier Memorandum with Merck

to Manufacture Adenoviral Medicines

London, UK, 19 February 2010 - Ark Therapeutics Group plc (AKT: LSE) ("Ark" or "the Company"), announces today that it has signed a non-binding Preferred Supplier Memorandum with Merck Sharpe & Dohme Corp. for the production of gene-based medicines at Ark's cGMP licensed facility in Kuopio, Finland. The appointment as preferred manufacturing supplier is subject to the signing of a binding detailed manufacturing agreement.

Nigel Parker, CEO at Ark, commented; "Ark's cGMP manufacturing facility has been validated to both EU and US standards. We are able to provide a unique full manufacturing service and supply high level expertise and regulatory support documentation through our experiences with our own late stage adenoviral products. We look forward to progressing this initiative with Merck."

For further information:

Ark Therapeutics Group plc
Tel: +44 (0)20 7388 7722

Dr Nigel Parker, CEO

Martyn Williams, CFO

[verwijderd] 9 maart 2010 15:19

Ark withdraws Cerepro® MAA after SAG-O requests further trial before approval

"The Company has received a number of approaches and has initiated further discussions with a number of parties which may or may not lead to an offer being made for the Company. However, there can be no certainty that an offer will be made for the Company. A further announcement will be made in due course.

Ark is therefore deemed to be in an Offer Period for the purposes of the Takeover Code.

www.arktherapeutics.com/main/index.php

maxen 9 maart 2010 15:52

quote:
winx08 schreef:
Ark
...
"The Company has received a number of approaches and has initiated further discussions with a number of parties which may or may not lead to an offer being made for the Company.
...

Valt nochtans niet in het door Crucell over te nemen company profiel want niet winstgevend...

[verwijderd] 9 maart 2010 16:00

Dacht dat ze ook interesse hadden in bedrijven die er tegen aan zitten cq goed gevulde pijplijn.

Maar los van overname speculatie door Crucell gaat de huidige situatie cq nieuwe eigenaar die er gaat komen wellicht wel impact hebben op Trinam.
Spannende tijden.

maxen 9 maart 2010 16:21

quote:
winx08 schreef:
Dacht dat ze ook interesse hadden in bedrijven die er tegen aan zitten cq goed gevulde pijplijn.

Maar los van overname speculatie door Crucell gaat de huidige situatie cq nieuwe eigenaar die er gaat komen wellicht wel impact hebben op Trinam.
Spannende tijden.

Share price van 150p in 2007 naar 11.75p nu.
Market cap 24m pound (binnen het budget).
Twee producten in/uit phase III (waarvan 1, CerePro, vandaag is teruggetrokken voor market approval), twee in phase II (waaronder Trinam).

Crucell zou het alleen om Trinam veilig te stellen kunnen overnemen, en de rest er gratis bij krijgen.

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