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portefeuille (99.59)

biopharmaceuticals Algeta

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May 03, 2010 – Comments (16)

Algeta is a Norwegian company that a few might have seen mentioned after they announced a deal with Bayer for Alpharadin.

September 3, 2009, Bayer to Pay Up to $800 Million for Algeta’s New Drug

more recent news.

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Algeta completes successful sample size re-estimation of pivotal ALSYMPCA trial

Current study on schedule; opportunity taken to boost patient numbers without impacting time to filing
 
Oslo, Norway, 3 May 2010 - Algeta ASA (OSE: ALGETA), the focused oncology company, is pleased to announce that the sample size re-estimation of its pivotal ALSYMPCA clinical trial, which was pre-planned for the first half of 2010, was completed on schedule.
 
The sample size re-estimation confirmed that the current plan to recruit 750 patients into the ALSYMPCA study will meet the goals originally set for the study.  
 
Algeta and its partner Bayer Schering Pharma AG ("Bayer") have in parallel decided to increase recruitment for ALSYMPCA to 900 patients. This will increase the statistical power of the trial to 90% thereby further increasing the likelihood of proving the efficacy of Alpharadin. It will also allow the study to recruit US patients, and allow US clinical oncologists to gain experience with the use of Alpharadin. Recruitment in ALSYMPCA passed 600 patients during April.
 
Importantly, based on the rapid recruitment already seen in this pivotal study, Algeta and Bayer anticipate the enrolment of ALSYMPCA will still complete as planned in the second half of 2010 with results of the trial anticipated in 2012. This would allow for a filing in 2012 as planned.
 
Andrew Kay, Algeta's President & CEO, said: "We are very pleased with the outcome of the sample size re-estimation as it confirms ALSYMPCA is a robust and well-designed trial. The trial recruitment rate is currently very good, and is expected to be boosted over the next few months as world-leading cancer centers in the USA come on-stream. This leads us to believe that the additional 150 patients can be enrolled in only a few months enabling us to complete recruitment in the second half of 2010."

Notes to Editors
 
A sample size re-estimation/confirmation used in major pivotal trials is a pre-planned checkpoint, and agreed with the regulators in the ALSYMPCA trial protocol. The purpose of the analysis was to check that sufficient events (deaths) will occur in the study within the required time period to detect the anticipated effect (overall survival benefit) of Alpharadin in these patients - i.e. to ensure the study has sufficient power.
 
The protocol amendment describing the increase in number of patients will be submitted to regulatory authorities before implementation.
 
ALSYMPCA (ALpharadin in SYMptomatic Prostate Cancer Patients) is a global phase III clinical trial evaluating the potential of Alpharadin (radium-223 chloride) to treat bone metastases resulting from castration-resistant (hormone-refractory) prostate cancer (CRPC). Bone metastases are the main cause of disability and death in patients with CRPC and approximately 90% of men with this disease have radiological evidence of bone metastasis. Alpharadin is being developed by Algeta and Bayer Schering Pharma AG and is a first-in-class alpha-pharmaceutical that has a potent and highly targeted antitumor effect on bone metastases combined with a highly favorable side-effect profile. In phase II trials, Alpharadin showed a statistically significant improvement in overall survival compared to placebo.

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Algeta schedules First Quarter 2010 Presentation

Oslo, Norway, 3 May 2010 - Algeta ASA (OSE: ALGETA), the focused oncology company, will announce its first quarter 2010 results on Friday, 7 May 2010. A presentation to investors, analysts and the press will take place in Oslo at 09:45 CET. Algeta's President and CEO Andrew Kay and CFO Øystein Soug will present.
The presentation will also be webcast live and can be accessed from www.algeta.com/webcast where questions can be submitted live during the presentation.

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#27) On September 08, 2009 at 5:09 AM, portefeuille (99.97) wrote: ALGETA.OL - 9.97 (59.25 NOK) - outperform

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(from here

16 Comments – Post Your Own

#1) On May 03, 2010 at 9:04 PM, portefeuille (99.59) wrote:

a recent presentation (pdf).

 

Algeta in Oslo trading.



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#2) On May 03, 2010 at 9:29 PM, portefeuille (99.59) wrote:

That spike on April 30 is related to DNDN by the way.

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April 14, 2009, Algeta får hjelp utenfra

Farmasiselskapet Algeta er blant dagens mest populære aksjer på børsen.

DnB Nor skriver i en oppdatering at det amerikanske biotekselskapet Dendreon er ventet å få FDA-godkjenning for prostatakreftvaksinen Provenge innen 1. mai. Dette bidrar til å sende Algeta-aksjen oppover fordi en godkjenning av Provenge kan bety at nåløyet blir større for Algetas Alpharadin, som også brukes i behandlingen av prostatakreftpasienter.

...

Ifølge analytiker Espen Tidemann Jørgensen viser opsjonsprisingen av Dendreon at investorene venter en effekt på 24 prosent, hvor retningen vil avhenge av utfallet.

"Ved en godkjennelse vil et kursløft til over 48 dollar pr aksje ha implikasjoner for den implisitte verdsettelse av Algeta. Basert på vår modell kan vi i tilfelle få en fair verdi på opp mot 300 kroner pr aksje", heter det.

...

DnB Nor Markets anslår en pris per pasient på 75.000 dollar for Provenge, mens prisen på Algetas Alpharadin anslås til 22.000 dollar dersom det blir godkjent.

Skulle Provenge-prisen bli bekreftet kan både konsensus og investorforventningene til prisen på Alpharadin komme opp, mener Jørgensen.

I løpet av andre kvartal vil Algeta også komme med oppdateringer om den pågående fase III-studien for Alpharadin, ALSYMPCA. Ifølge Jørgensen kan antallet pasienter bli økt fra nåværende 750, noe som også kan gi positiv kursutvikling.

...

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#3) On May 03, 2010 at 10:18 PM, portefeuille (99.59) wrote:

I used google translate and tried to improve the results (I don't speak Norwegian, but apparently I could more or less read a Norwegian newspaper if I tried, hehe ...), leading to ...

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Algeta get outside help

Pharmaceuticals company Algeta is among today's most popular stocks on the exchange.

DnB Nor writes in an update that the U.S. biotech company Dendreon is expected to receive FDA approval for prostate cancer vaccine Provenge by May 1. This helps to send Algeta shares up as an approval of Provenge could mean that the eye of the needle is greater for Algeta Alpharadin, which is also used in the treatment of prostate cancer patients.

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According to analyst Espen Tidemann Jørgensen option pricing of Dendreon shows that investors expect an effect of 24 percent, which direction will depend on the outcome.

"By an approval, a rise to over $48 per share has implications for the implied valuation of Algeta. Based on our model, we can in this event get a fair value of up to 300 kroner per share," he says.

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DnB NOR Markets estimates a cost per patient of $75,000 for Provenge, while the price of Algeta Alpharadin is estimated at $22,000 if it is approved.

Should Provenge approval be confirmed, both consensus and investor expectations for the price of Alpharadin come up, says Jørgensen.

During the second quarter Algeta will also come with updates on the ongoing Phase III study for Alpharadin, ALSYMPCA. Jørgensen said the number of patients will be increased from current 750, which also can lead to positive price movements.

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#4) On May 03, 2010 at 10:19 PM, portefeuille (99.59) wrote:

Algeta get

Algeta gets 

 

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#5) On May 03, 2010 at 10:24 PM, portefeuille (99.59) wrote:

DNDN closed at 55.43 USD on 05/03/10 and Provenge costs per patient are now estimated to be $93000 (see here) per patient, so DnB Nor might have to raise its price target (from 300 NOK), hehe ...

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#6) On May 03, 2010 at 10:25 PM, portefeuille (99.59) wrote:

costs per patient

costs

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#7) On May 03, 2010 at 10:28 PM, portefeuille (99.59) wrote:

... and yes, 300 NOK is of course not the "general price target" of DnB Nor for Algeta shares ...

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#8) On May 03, 2010 at 10:32 PM, portefeuille (99.59) wrote:

DnB Nor is another Norwegian company I like, by the way. As is Yara.

#773) On September 06, 2009 at 12:03 AM, portefeuille (99.97) wrote: YAR.OL - 29.88 (179.30 NOK) - outperform

#817) On October 05, 2009 at 9:18 PM, portefeuille (99.97) wrote: DNBNOR.OL - 11.39 (65.15 NOK) - outperform

(from here)

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#9) On May 03, 2010 at 10:37 PM, portefeuille (99.59) wrote:



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#10) On May 04, 2010 at 10:45 AM, NYCFOOLIO (< 20) wrote:

port,

you are recommending yara, dnbnor, algeta at todays prices?

sorry , but i coulndt follow the target prices above for each...

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#11) On May 04, 2010 at 11:57 AM, portefeuille (99.59) wrote:

I don't recommend them more than the other stocks I recommended. Algeta might be interesting to diversify if you hold DNDN shares. They will not publish phase 3 results for their main product candidate until 2012, so I guess it is not really an "urgent" recommendation ...

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#12) On May 04, 2010 at 2:33 PM, NYCFOOLIO (< 20) wrote:

oh ok....

i have had some glw for a little while now; and added some aixg recently...taken a 15% dive since i bought some; haha...but good time to buy some more aixg? or wait and see what happens...

same question with atpg////

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#13) On May 04, 2010 at 3:07 PM, portefeuille (99.59) wrote:

Okay, 15% is currently not much more than the average one day move for AIXG ...

 

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#14) On May 04, 2010 at 9:40 PM, NYCFOOLIO (< 20) wrote:

so just stay put on AIXG and not add?

 same with ATPG? in your best judgement

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#15) On November 13, 2010 at 1:41 AM, portefeuille (99.59) wrote:

ALGETA:NO.



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#16) On November 26, 2013 at 5:27 AM, portefeuille (99.59) wrote:

continued here.

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