OSLO, NORWAY--(Marketwired - Aug 28, 2013) -
Intended for US media only
Algeta ASA (
A presentation of the results in Oslo will be webcast live from 10:00 CET and can be accessed through www.algeta.com. An international conference call will take place at 14:30 CET/ 08:30 EST (US). Details of both events are at the end of this announcement.
"We were delighted that Xofigo(®) (radium Ra 223 dichloride) injection was approved and launched in the US in May. These major milestones reflect the significant effort and commitment of everyone involved in the drug's development over the past decade and more," said Andrew Kay, Algeta President & CEO. "With Bayer, we are now executing our launch strategy in the US and are pleased with the progress being made."
Oystein Soug, Algeta's Chief Financial Officer, added, "Algeta has received EUR 100m in milestone payments from Bayer during 2013 which will enable us to fully invest in the US launch of Xofigo alongside Bayer. In addition to our financial profile, our proven development expertise in oncology and our growing commercial experience and infrastructure provide us with the confidence to seek to build a broad portfolio of novel cancer therapeutics beyond Xofigo."
In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Xofigo. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US.
Highlights of the second quarter 2013:
Xofigo (radium Ra 223 dichloride) injection
* On 15 May 2013, the US Food and Drug Administration (FDA) approved Xofigo® (radium Ra 223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
* On 30 May, Algeta announced that Xofigo had been launched in the US and the first sale had been made, triggering a EUR 50m milestone payment to Algeta from Bayer. Algeta US, LLC and Bayer Healthcare are co-promoting Xofigo in the US.
* The launch of Xofigo is being executed by Algeta and Bayer to an agreed plan, and both companies are working in their respective territories to ensure that physicians are aware of Xofigo and its approved label. A key part of the launch activities is to provide information and support to administering centers to get licensed to procure and administer Xofigo.
* In June, Algeta celebrated the official opening of its commercial production facility for Xofigo, located at the Institute for Energy Technology (IFE) in Norway. All material for commercial sale and for clinical trials world- wide is currently produced in this facility.
Targeted Thorium Conjugates (TTCs)
* In May, and to facilitate the conjugation of thorium-227 to targeting molecules in its TTC research, Algeta announced the exercise of its option to take an exclusive worldwide license to patented Lumi4(®) bi- functional chelator technology from Lumiphore, Inc. and an extension of the collaboration to include additional chelator families.
* In June, Algeta announced a collaboration with Avipep Pty Ltd to evaluate a novel TTC that combines Algeta's thorium-227 payload with an Avibody™ from Avipep that targets a number of different solid tumor types.
* Data from the phase III ALSYMPCA trial were published in the 18 July 2013 issue of the New England Journal of Medicine.
* In August, Dr Andreas Menrad was appointed Chief Scientific Officer, bringing more than 20 years of experience in oncology and therapeutic antibody development. He was formerly CSO at Ablynx NV, and worked previously at Genzyme (Sanofi) as General Manager and Vice President of Antibody Therapeutics.
* Operating revenue for the second quarter 2013 amounted to NOK 444m compared with NOK 55m in the same period in 2012. Revenues were NOK 515m in the first half of 2013 vs NOK 128m in same period in 2012.
* In the second quarter 2013, net sales of Xofigo in the US market (recognized by Bayer) amounted to NOK 3m (USD 0.6m) compared to nil in the same quarter last year.
* Algeta's recognized share of the net result of US co-promotion activities for the second quarter 2013 was an expense of NOK 70m, compared with an expense of NOK 27m in the same period in 2012. Algeta recognizes 50% of the net result of Xofigo co-promotion activities in the US.
* Core operating expenses, which exclude currency effects, interest income and costs directly related to the commercial launch in the US, for the second quarter 2013 amounted to NOK 120m, compared with NOK 80m in the same period in 2012.
* Net cash amounted to NOK 565m as at 30 June 2013 compared with NOK 369m as of the 31 December 2012.
The First Half and Second Quarter Report 2013 and accompanying presentation will be available through www.algeta.com from 07:00 CET today.
Details of presentation and webcast
A presentation by Algeta's executive management team to investors, analysts and the press will take place in Oslo at 10:00 CET.
Haakon VIIs gate 9
The presentation will also be webcast live and can be accessed through www.algeta.com. Questions can be submitted live during the webcast.
Details of international conference call
An international conference call will take place at 14:30 CET/ 08:30 EST (US). To participate in the conference call, please dial the appropriate number below five minutes prior to the call:
US: +1 877 423 0830
UK: +44 20 7153 9154
Norway: +47 21 06 61 13
Sweden: +46 8-506 443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44 580 65 22
Participant pin code: 197187#
To access the replay, please dial:
US: +1 877 679 2989
UK: +44 20 3364 5200
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73
Conference reference: 348084#
A replay of the conference call will also be available at www.algeta.com.
About radium Ra 223 dichloride
Radium Ra 223 dichloride (radium 223) is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a Marketing Authorisation Application to the EMA for radium 223 in December 2012 and subsequently in other territories.
Radium 223 (as Xofigo(®) injection) is approved in the United States and is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
Radium 223 is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in radium 223 is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of radium- 223 may cause double-strand DNA breaks in adjacent cells, resulting in an anti- tumor effect on bone metastases. The alpha particle range from radium-223 is less than 100 micrometers which may limit the damage to the surrounding normal tissue.
Important Safety Information for Xofigo (radium Ra 223 dichloride) in the US
Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.
In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (less than 1%) was similar for patients treated with Xofigo and placebo. Myelosuppression - notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia - has been reported in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure.
Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than to equal to 1.5 × 10(9)/L, the platelet count greater than or equal to 100 × 10(9)/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 10(9)/L and the platelet count greater than or equal to 50 × 10(9)/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care.
Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued.
Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations.
The most common adverse reactions (greater than or equal to 10%) in the Xofigo arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (greater than or equal to 10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia (35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%).
For full US prescribing information visit www.xofigo-us.com.
Algeta is a company focused on developing, manufacturing and marketing novel targeted therapies for patients with cancer. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock Exchange (ALGETA.OL). For more information please visit www.algeta.com.
This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward- looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include statements regarding our co-promotion of Xofigo in the US and the development of our other product candidates. 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, general economic and business conditions, the impact of competition, the ability to successfully commercialize Xofigo, the risk that costs associated with the co-promotion of Xofigo may be greater than anticipated, the risk that research & business development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium 223 and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.
Xofigo® is a registered trademark of Bayer
Lumi4® is a registered mark of Lumiphore, Inc.
 Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer, Parker, C. et al. New England Journal of Medicine 2013; 369 (3) 213-223.
 Defined as the sum of External R&D expenses, Payroll and related costs, Depreciation (including change in inventory) and General and Administrative expenses. Core operating expenses do not include costs from co-promotion activities.
 XOFIGO Prescribing information. May 2013
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