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Algeta Reports Positive Headline Phase II Data on Pain Palliation with Alpharadin

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 28 August 2008 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today announced that the primary objective of its BC1-03 Phase II pain palliation study was met. The study showed that even single doses of Alpharadin in patients with painful bone metastases could produce increasing clinical benefit with increasing dose. Pain palliation is an important quality of life benefit in metastatic cancer patients. The trial also confirmed Alpharadin’s benign side-effect profile and, importantly for a drug in this clinical setting, no significant bone marrow toxicity was observed.

In men with HRPC life expectancy can be as short as 18 months, and it is estimated that 100,000 men in the EU and USA die from the disease each year. In 85% of these men the tumor will have spread into the bones. These metastases are a significant problem as they can cause intractable and debilitating pain as well as contributing to a further reduction in life expectancy.

The BC1-03 study was a double-blind randomised pain control study comparing the palliative effects of four different single dose levels of Alpharadin in patients with bony metastatic HRPC. The drug was given by i.v. injection mainly on an outpatient basis. The palliative efficacy of Alpharadin was measured using an assessment of bone pain as well as the patient’s consumption of analgesia. The primary study objective was to investigate whether there was a dose-response relationship with respect to pain palliation in this patient group. The study has shown the beneficial palliative effect of a single dose of Alpharadin and that there is a clear dose-response effect, with higher doses providing better pain relief.

The study also showed a dose-dependent reduction in bone alkaline phosphatase (ALP) ranging from no effect in the lowest dose group to a marked reduction in the higher dose groups. ALP is a severity marker of bony metastatic disease and of prognostic importance.

The study has also further confirmed the safety of Alpharadin and shown its benign side-effect profile. In fact, the higher the dose of Alpharadin that patients received, the fewer adverse events were experienced. This reproduces the safety profile of the earlier BC1-02 Phase II study where the Alpharadin group experienced fewer adverse effects than the placebo comparator group. Importantly for a drug in this clinical setting no significant bone marrow toxicity was observed in patients receiving Alpharadin.

The full results of the BC1-03 study will be submitted for publication in a peer-reviewed journal.

The principal investigator of the study Professor Sten Nilsson at the Karolinska Hospital in Stockholm said:

“These results showing the beneficial impact of Alpharadin in terms of pain palliation are important, as improved quality of life, alongside increased survival, are the two key goals of anti-cancer therapy of patients with skeletal metastases.”

Commenting on today’s further positive news with Alpharadin, Algeta’s President and CEO, Dr. Thomas Ramdahl, said:

“These results build on the positive Phase II clinical data package that we have already assembled with Alpharadin, the highlight of which was the significant survival benefits that we have already reported in patients with HRPC.

Based on our clinical trials to-date I am very confident that Alpharadin has the potential to become an important new therapy for patients with prostate cancer. This view has been reinforced by the enthusiastic and positive response we have received from key opinion leaders around the world to our unique approach to treating HRPC.”

Algeta has recently started enrolling patients for the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. This international study will evaluate Algeta’s targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada. The Coordinating Investigator for the study is Dr. Christopher Parker, a leading clinical oncologist and specialist in prostate cancer, based at the Institute of Cancer Research and the Royal Marsden Hospital in the UK.

 

For further information, please contact

Dr. Thomas Ramdahl, CEO
Øystein Soug, CFO
+47 23 00 79 90 / +47 913 91 458 (mob)
+47 23 00 79 84 / +47 906 56 525 (mob)
post@algeta.com

For international enquiries:
Dr. Mark Swallow / David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

About Algeta
Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin, has commenced an international phase III clinical trial in hormone-refractory prostate cancer (ALSYMPCA) based on positive phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227. The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement:
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

Algeta receives IND Approval for Alpharadin(TM) to commence Clinical Development in the USA

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 21 February 2008 – Algeta ASA (OSE: ALGETA), the cancer therapeutics company, today announced that it will shortly commence clinical development of Alpharadin(TM) in HRPC patients in the USA. Algeta filed its Investigational New Drug (IND) application for its lead product Alpharadin(TM) with the United States Food and Drug Administration (FDA) in December 2007. The statutory 30 day consultation period was extended by the FDA for a further 30 days by agreement with the company and the IND has now been cleared by the FDA without any objections being made to the application. Alpharadin(TM) has already been studied in phase II clinical trials in Europe and has demonstrated a potential for a significant survival benefit in hormone-refractory prostate cancer (HRPC) patients with skeletal metastases.

An initial Phase I pharmacokinetics, biodistribution and dosimetry study (BC1-08) with Alpharadin in HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York, one of the world’s leading oncology centers. This US trial will further expand the information obtained in a similar phase I study (BC1-05) conducted at the Royal Marsden Hospital in London, for which patient enrolment has recently been completed.

Following the start up of the BC1-08 trial, Algeta will continue discussions with the FDA to agree on the design of the further clinical development program for Alpharadin(TM)

“We are delighted to have been given the clearance by FDA to advance Alpharadin into clinical development in the United States, and to be working with one of the world’s leading cancer centers on our clinical program,”

said Dr. Thomas Ramdahl, President and CEO of Algeta.

“There is a great unmet medical need among men suffering from HRPC with skeletal metastases and the opening of this US clinical trial will be an important step in our overall clinical development of Alpharadin. As earlier announced, we plan to initiate an international pivotal phase III clinical trial with Alpharadin in HRPC patients during the first half of 2008.”

 

For further information, please contact

Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)
Geir Christian Melen, CFO
+47 23 00 79 90 / +47 913 02 965 (mob)
post@algeta.com

Dr. Mark Swallow / David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

 

About Algeta

Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin, is planned to enter Phase III clinical trials in hormone refractory prostate cancer before mid 2008 based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement

This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

Algeta provides update on its late-stage clinical programme for Alpharadin in prostate cancer

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 20 December 2007 – Algeta ASA (OSE: ALGETA), the cancer therapeutics company, is pleased to provide an update on its clinical development of Alpharadin in hormone refractory prostate cancer (HRPC).

 

Phase III trial programme:

Algeta has finalised the study design for its pivotal international Phase III trial programme. Regulatory filing for start up of the trial is planned to commence early in 2008, and the first patient is expected to enrol before mid-2008. Initially, the trial is planned to enrol a total of 450 patients and to include clinical centres in Europe, Asia/Pacific and South America.

The primary endpoint of the Phase III trial will be the overall survival benefit of Alpharadin in patients with skeletal metastases from HRPC. The double-blind, controlled trial will enrol symptomatic HRPC patients who will be randomised to receive Alpharadin plus best supportive care or placebo plus best supportive care. Patients will receive multiple injections of Alpharadin over a period of six months.

An independent safety and monitoring board will be established to review the safety data of the trial.

 

Ongoing Phase I and II trial programme:

Algeta’s Phase II clinical development programme of Alpharadin in HRPC involves three clinical studies. The major efficacy study (BC1-02) has already been reported, and demonstrated significant survival benefit and a benign side effect profile in HRPC patients. Algeta began preparing the Phase III trial based on these encouraging data.

In the second Phase II trial (BC1-03), a potential dose-response relationship of the pain palliating effect of a single injection of Alpharadin in patients with painful skeletal metastases from HRPC is being studied. Four different dose levels of Alpharadin, ranging from 5 to 100 kBq/kg will be evaluated in this randomised, comparative, double-blind design. Patient enrolment is now complete and preliminary data from this trial is expected to be available in Q2 2008.

In the final Phase II study (BC1-04), a potential relationship between dose and therapeutic effect in patients with symptomatic or non-symptomatic HRPC, as measured by levels of serum prostate specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer, is being explored. The patients in the trial have been randomised to three different dose levels of Alpharadin for a blinded evaluation. Patients will receive three injections of Alpharadin given at six-week intervals and patient recruitment is now complete. The preliminary results from this trial are expected to be available in Q3 2008.

Finally, patient enrolment in an open Phase I dosimetry trial (BC1-05) is ongoing and patient enrolment is expected to be complete during Q1 2008. This trial will provide additional biodistribution, pharmacokinetic, dosimetry and safety data for Alpharadin.

Together, these trials will provide additional clinical efficacy and safety data to supplement that provided by the highly successful Phase II efficacy trial (BC1-02).

Dr. Thomas Ramdahl, President and CEO of Algeta, said:

“We have achieved two further important milestones in our Phase II trials by completing the enrolment of patients and we look forward to the first results in Q2 and Q3 in 2008. While these additional trials are important to support our overall clinical package for Alpharadin, our main focus is now on finalising preparations for the start of Phase III trials. We are well advanced in this process and have finalised the study design, which will measure the overall survival benefit of Alpharadin in HRPC patients, an unequivocal and internationally accepted endpoint for developmental prostate cancer treatments. We are on target for entering the first patient into the trial before mid-2008.”

 

For further information, please contact:

Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)

Geir Christian Melen, CFO
+47 23 00 79 90 / +47 913 02 965 (mob)
post@algeta.com

Dr. Mark Swallow / David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

 

About Algeta

Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology.

Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin, is expected to enter Phase III clinical trials in hormone refractory prostate cancer based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

 

Forward-looking Statement:
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

Alpharadin treatment more than doubles survival rate in prostate cancer patients

By Algeta, Press Release
Press Release.

 

Algeta presents new Phase II clinical trial data at ECCO

 

Oslo, Norway, 25 September 2007 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today presents new two-year survival data from its Phase II clinical trial with Alpharadin (radium-223) as a treatment for hormone refractory prostate cancer (HRPC).

The new clinical data from the Phase II trial involving 64 HRPC patients shows that more than twice as many patients receiving Alpharadin were alive (10 of 33) two years following start of treatment compared to those that receive placebo (4 of 31).

Previous data from the trial, presented earlier this year at ASCO and in the Lancet Oncology[1], has also shown that Alpharadin significantly reduces levels of prostate-specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer, and other relevant biomarkers. The treatment regime of four injections of Alpharadin was well tolerated during the 12-week treatment period, and an extended treatment period may further delay disease progression.

Algeta’s CEO, Dr. Thomas Ramdahl said: “Alpharadin continues to demonstrate a very positive clinical effect in the treatment of prostate cancer and our preparations to begin pivotal Phase III trials with Alpharadin for the treatment of HRPC in 2008 remain on schedule.”

The clinical data will be presented today in a poster for the first time in Europe at the 14th European Cancer Conference (“ECCO 14”: 23–27 September 2007, Barcelona, Spain). A copy of the poster, entitled Placebo-Controlled, Randomized, Phase II study of Radium-223 in Metastatic Hormone Refractory Prostate Cancer (HRPC), is available at http://www.algeta.com/

###

For further information, please contact
Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)
post@algeta.com

Dr. Mark Swallow / Helena Galilee
Citigate Dewe Rogerson +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

About Algeta:
Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology.

Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin, is expected to enter Phase III clinical trials in hormone refractory prostate cancer based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement: This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

 

[1] Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study – Lancet Oncology 2007; 8: 587-594

Algeta’s Phase II Clinical Study Data for Alpharadin™ in Prostate Cancer Published in Lancet Oncology

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 4 June 2007 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, is pleased to announce that clinical Phase II study data for Alpharadin™ in prostate cancer, Algeta’s lead product candidate, has been published in the 3 June 2007 online issue of the leading peer-reviewed journal Lancet Oncology. This is first time comprehensive details and data from the Phase II trial have been published in this format.

The data was also presented by Professor Øyvind Bruland, of the Norwegian Radium Hospital, Oslo and founder of Algeta, in a Poster Discussion on 2 June at the American Society of Clinical Oncology’s annual meeting (1-5 June 2007, Chicago, USA).

In the paper, entitled “Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study” by Nilsson et al., data is presented that demonstrate the clear potential of Alpharadin as a new treatment for patients with late-stage hormone-refractory prostate cancer (HRPC). These data are supplemented by the ASCO presentation. Algeta is currently preparing to start pivotal Phase III studies of Alpharadin in this indication in 2008.

Alpharadin treatment showed a statistically significant effect on survival – In the randomized double-blind, placebo-controlled clinical trial involving 64 HRPC patients, those patients treated with at least two injections of Alpharadin, a novel radiotherapy based on radium-223, survived on median nearly 25 weeks (53%) longer than those receiving placebo (71.0 weeks compared to 46.4 weeks). At the time of the 18-months follow-up assessment (February 2007), 15 (48%) patients in the Alpharadin group were still alive compared to 6 (22%) in the placebo group.

PSA levels reduced – Alpharadin treatment resulted in a reduction in levels of prostate-specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer. The measurement of reduced PSA blood levels in response to Alpharadin treatment is indicative of a therapeutic effect. The beneficial effects on PSA levels lasted for up to three months after the end of treatment.

Positive effect on biomarkers – In addition, previously announced results on this trial to demonstrate its potential as a treatment for bone metastases in HRPC patients showed that Alpharadin has a significant positive effect on a range of biomarkers of bone turnover, including significantly reduced bone alkaline phosphatase (bone-ALP) levels compared with placebo.

Professor Sten Nilsson, Head of Department of Oncology Radiumhemmet at the Karolinska Hospital and Institute in Stockholm, Principal Investigator of the trial and lead author of the Lancet Oncology paper, commented:

“The positive results we have seen from this Phase II trial with Alpharadin are very encouraging and have been reinforced at each follow-up stage. Most importantly, patients treated with Alpharadin in this study demonstrated a statistically significant increased survival time and showed an overall benign side effect profile. Further positive effects on lowering blood PSA levels, the common biomarker of disease progression, and other biomarkers confirm our belief in the potential of Alpharadin in the treatment of late-stage hormone-refractory prostate cancer.”

Dr. Thomas Ramdahl, CEO of Algeta, said:

“The publication in Lancet Oncology and presentation at ASCO provide important endorsement of the quality of our Phase II trial of Alpharadin in prostate cancer. As we progress towards Phase III trials next year, we are very encouraged by the survival benefit shown in the present study, which is consistent with all other efficacy measures, as well as Alpharadin’s excellent side-effect profile.”

A reprint of the Lancet Oncology article is available from Algeta by request.

 

For further information, please contact:
Dr. Thomas Ramdahl, CEO: +47 23 00 79 90 / +47 913 91 458 (mob);
Dr. Roger Harrison, CBO: +47 23 00 79 90 / +47484 01302 (mob);
Geir Christian Melen, CFO: +47 23 00 79 90 / +47913 02965 (mob);
post@algeta.com Dr. Mark Swallow/Helena Galilee,
Citigate Dewe Rogerson: +44 (0)207 638 9571,
mark.swallow@citigatedr.co.uk

Further details of the BC1-02 Alpharadin™ Phase II clinical trial
The present trial was initiated in 2004 to study therapeutic efficacy of Alpharadin (based on radium-223) in 64 HRPC patients with painful skeletal metastases using biomarkers and clinical endpoints as outcome measures. Safety and changes in biomarkers are reported based on analyses at 12 months after the start of treatment. The double-blind placebo-controlled trial was conducted at 11 centres in Norway, Sweden and the UK.

All patients initially received palliative external beam radiotherapy before being randomized to receive four intravenous injections of Alpharadin (50 kBq per kg body weight) or saline (placebo), administered four weeks apart over a 12-week period. Levels of bone-ALP (primary endpoint), S-PINP (serum procollagen I N propeptide), S-CTX-I (serum C-terminal crosslinking telopeptide of type I collagen), S-ICTP (serum type I collagen cross-linked C-telopeptide) and PSA were analysed (Alpharadin versus saline) at regular time points throughout the study. 33 patients received Alpharadin and 31 patients received saline (placebo).

The results for all included patients (Intent-to-Treat) showed an increased median time of survival from 46.4 weeks in the placebo group to 65.3 weeks in the Alpharadin-treated group, a 41% increase in median survival time. The Cox proportional hazard ratio adjusted for covariates was 0.472 (p=0.020), indicating that patients receiving Alpharadin treatment had a 53% decreased risk of death at each time point compared with those receiving placebo. At the time of the 18 months follow-up assessment, 15 (45%) patients in the Alpharadin group were still alive compared to 8 (26%) in the placebo group.

For the Per-Protocol population (patients that have received at least two injections with study medication with preserved blinding), the results showed an increased median time of survival from 46.4 weeks in the placebo group to 71.0 weeks in the Alpharadin treated group, a 53% increase in median survival time. At the time of the 18 months follow-up assessment, 15 patients in the Alpharadin group were still alive compared to 6 in the placebo group.

Data presented also demonstrated a statistically significant effect on a range of biomarkers of bone turnover, including significantly reduced bone alkaline phosphatase (bone-ALP) levels from baseline to four weeks after the last injection compared with placebo (-65.6 % versus +9.3% in the placebo group, p<0.0001).

Furthermore, the median change of blood PSA level from baseline to four weeks after the last injection for Alpharadin (33 patients) was -23.8 % versus +44.9% in the placebo group (31 patients), P=0.003. The median time to PSA progression was 26 weeks with Alpharadin vs. 8 weeks with placebo (p=0.048).

In addition to this encouraging evidence of efficacy, Alpharadin was well tolerated with little or no myelotoxicity and demonstrated an overall benign side effect profile.

Algeta has two further pain palliation and therapeutic Phase II trials ongoing during 2007.

References:

1. Nilsson, S. et al A Randomized, Placebo-Controlled, Phase II Study of Radium-223 in the Treatment of Metastatic Hormone Refractory Prostate Cancer (HRPC). Presented at the ASCO Prostate Cancer Symposium, Orlando, FL, USA, February 22-24, 2007.

About Algeta
Algeta ASA (www.algeta.com) is a Norwegian cancer therapeutics company built on world-leading, proprietary technology.

Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin™, is expected to enter Phase III clinical trials in hormone refractory prostate cancer based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products

Advent Venture Partners’ portfolio company Algeta raises NOK 250 million in successful offering

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 26 March 2007 – Algeta ASA, the Norwegian cancer therapeutics company, today announced the successful closing of its initial public offering. The offering was more than two times oversubscribed and was priced in the upper half of the price range at NOK 47 per share. Gross proceeds (before over-allotment) amount to NOK 250 million ($41 million). The offering took place in conjunction with Algeta’s listing on the Oslo Stock Exchange. Algeta shares are expected to begin trading on the Oslo Stock Exchange (ticker: ALGETA) on Tuesday, 27 March 2007.

The equity offering attracted a substantial number of international institutional investors, including many European and US investors with a focus on life science investments.

John Berriman, Chairman of the Board of Algeta, said:

“We are delighted to have successfully closed this offering, and very pleased to add so many international institutional specialist investors to our shareholder base. I would like to thank all those involved in the IPO process for their hard work, but special thanks are due to Thomas Ramdahl and his team for their unstinting efforts since the very early days of the company.”

Thomas Ramdahl, President and CEO of Algeta, said:

“With the recently announced Phase II data demonstrating a survival benefit for our lead product, Alpharadin, Algeta is at an exciting stage in its development. The funds raised from this offering will now allow us to accelerate the clinical development of Alpharadin and advance our pipeline of preclinical product candidates towards the clinic. I look forward with confidence to continued progress in the future.”

ABG Sundal Collier Norge and DnB NOR Markets acted as Joint Lead Managers and Terra Securities has acted as Co-Lead Manager. The issue comprises 5,319,148 new shares, and a further 797,852 shares have been allocated under the manager’s over-allotment option. The issued share capital of Algeta ASA after the equity offering (before over-allotment) will be NOK 8,231,654, equalling 16,463,308 shares of NOK 0.50 par value.

 

For further information, please contact:

Dr Thomas Ramdahl, CEO or Geir Christian Melen, CFO, +47 23 00 79 90 / +47 913 91 458 (mob), +47 23 00 79 84 / +47 913 02 965 (mob), post@algeta.com

Dr Mark Swallow / Helena Galilee, Citigate Dewe Rogerson, +44 (0)207 638 9571, mark.swallow@citigatedr.co.uk

About Algeta

Algeta ASA is a Norwegian therapeutics company built on world-leading expertise in nuclear medicine and oncology and dedicated to the development of novel anticancer therapeutics based on alpha particle emitting radionuclides.

By harnessing the unique characteristics of alpha emitters, such as high potency and short range, Algeta is developing new therapeutic candidates and technologies targeting metastatic and disseminated tumors and promising unrivalled potency without unacceptable toxicities.

Algeta’s lead product candidate, Alpharadin, has completed one Phase II trial and is currently in two further Phase II clinical trials as a potential new treatment of hormone refractory prostate cancer. Based on results to date, it is expected to progress to clinical Phase III trials. Alpharadin is a novel bone-seeking radiopharmaceutical based on the alpha particle emitter radium-223 and may potentially target skeletal metastases from multiple cancer types.

Algeta is also developing other technologies for delivering alpha emitters including microparticles, liposomes and its receptor targeting technology, which is designed to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997 as Anticancer Therapeutic Inventions.

Alpharadin and Algeta are trademarks of Algeta ASA.

Important Notice

This press release is not for distribution to United States, Canada or Japan news services or for dissemination in the same countries or elsewhere where such dissemination is not appropriate. This news release is not and under no circumstances is to be construed as a solicitation, offer, or recommendation, to buy or sell securities issued by Algeta. This press release may not be relied upon by any person to whom it was not intended to be provided. These materials are not an offer of securities for sale in the United States, Canada or Japan. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Algeta ASA has not registered, and does not intend to register, any portion of the offering in the United States

This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

Advent Ventures Portfolio Company Algeta Applies for Listing on the Oslo Stock Exchange

By Algeta, Press Release
Press Release.

 

Oslo, Norway, February 1st, 2007 – Algeta ASA, the Norwegian therapeutics company, today announced its application for listing on the Oslo Stock Exchange (Oslo Børs). Algeta is taking this step to accelerate the late-stage clinical development of its lead product – Alpharadin – and to provide a strong platform for further growth.

Algeta develops novel and proprietary therapeutics and technologies based on alpha particle emitting radionuclides targeting a broad range of metastatic and disseminated tumors. By harnessing the unique characteristics of alpha emitters, such as high potency and short range, Algeta’s products offer the potential of unrivalled potency without unacceptable toxicities.

Algeta’s lead product based on this technology is Alpharadin, a product being developed as a new treatment for skeletal metastases in patients with late-stage, hormone refractory prostate cancer. Algeta believes Alpharadin will also have potential in treating skeletal metastases originating from other types of cancer, such as breast and lung. This indication represents a large and unmet medical need, with more than 300,000 patients worldwide per year developing skeletal metastases from cancer.

Alpharadin is expected to progress to pivotal Phase III clinical studies based on positive Phase II data, which show that Alpharadin delays the progress of prostate cancer and reduces the extent and effect of metastasis. Detailed results from the first of several Phase II studies to be completed will be presented at the ASCO Prostate Cancer Symposium, which will be held on 22-24 February 2007 in Orlando, Florida, USA.

In addition to Alpharadin, Algeta is actively developing a portfolio of proprietary projects to deliver alpha particle emitting radiotherapies to various other tumor types, including breast, ovarian and gynecological cancers. The most advanced of these, TH-1, has experimentally linked alpha emitters to tumor-targeting peptides and clinically validated antibodies to deliver a lethal radiotherapeutic dose specifically to the tumor.

Commenting on today’s announcement, Algeta’s CEO Thomas Ramdahl, said:

“We believe our technology has tremendous potential for treating a wide range of cancers; alpha particle emitters, when targeted appropriately, are among the most potent sources for the lethal irradiation of tumor cells and metastases, causing minimal damage to normal tissues. With Alpharadin demonstrating good efficacy and safety in clinical trials, we are very excited about both the therapeutic and commercial potential of this product. This, in addition, to our advancing pipeline of novel alpha emitter delivery technologies, gives us great confidence that we can create a business with significant value and growth potential.”

Algeta’s Chairman, John Berriman, said:

“We have decided to take the Company public both to provide better visibility for Algeta’s unique products and technology and to provide sufficient flexibility and strategic funding options for their future development. In particular, a key focus and value driver for Algeta is Alpharadin, which we aim to progress through the next crucial stages of clinical development towards the market where we believe it has the potential to be very successful.”

ABG Sundal Collier and DnB NOR Markets have been appointedas lead financial advisors and Terra Securities isco-lead manage

For further information, please contact

Dr Thomas Ramdahl, CEO, +47 23 00 79 90, thomas.ramdahl@algeta.com

Geir Christian Melen, CFO, +47 23 00 79 84, geir.melen@algeta.com

Dr Mark Swallow / Helena Galilee, Citigate Dewe Rogerson, +44 (0)207 638 9571, mark.swallow@citigatedr.co.uk

About Algeta

Algeta ASA is a Norwegian therapeutics company built on world-leading expertise in nuclear medicine and oncology and dedicated to the development of novel anticancer therapeutics based on alpha particle emitting radionuclides.

By harnessing the unique characteristics of alpha emitters, such as high potency and short range, Algeta is developing new therapeutic candidates and technologies targeting metastatic and disseminated tumors and promising unrivalled potency without unacceptable toxicities.

Algeta’s lead product candidate, Alpharadin, has completed one Phase II trial and is currently in two further Phase II clinical trials as a potential new treatment for pathologies caused by skeletal metastases from prostate cancer. Based on results to date, it is expected to progress to clinical Phase III trials. Alpharadin is a novel bone-seeking radiopharmaceutical based on the alpha particle emitter radium-223.

Algeta is also developing other technologies for delivering alpha emitters including microparticles, liposomes and its receptor targeting technology, which is designed to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

In September 2005, Algeta raised NOK 185 million (€23 million) in a venture fundraising involving new and existing investors. Currently, Algeta’s largest shareholders include venture capital firms HealthCap, Advent Venture Partners, Selvaag Venture Capital, SR One and NorgesInvestor.

The Company is headquartered in Oslo, Norway, and was founded in 1997 as Anticancer Therapeutic Inventions.

Forward-looking Statement: This news release is not and under no circumstances is to be construed as a solicitation, offer, or recommendation, to buy or sell securities issued by Algeta.

The information contained herein is not for publication or distribution, directly or indirectly, in or into the United States of America, Canada or Japan.

This news release contains forward-looking statements and forecasts based on uncertainly, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non- approvals of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.