News Feed Item

Algeta results for the First Half and Second Quarter 2013

OSLO, NORWAY -- (Marketwired) -- 08/28/13 --

Intended for US media only

Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, announces its results for the first half and second quarter 2013.

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.

Post-period events

* Data from the phase III ALSYMPCA trial were published in the 18 July 2013 issue of the New England Journal of Medicine[1].

* 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.

Key financials

* 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[2], 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.

KS-Agenda Møtesenter

Haakon VIIs gate 9

0161 Oslo


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[3].

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.

About Algeta

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 (Ticker: ALGETA). For more information please visit www.algeta.com.

Forward-looking Statements

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.

[1] Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer, Parker, C. et al. New England Journal of Medicine 2013; 369 (3) 213-223.

[2] 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.

[3] XOFIGO Prescribing information. May 2013

Press release:


This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Algeta ASA via Thomson Reuters ONE


For further information, please contact:

Mike Booth / Bente Y. Robertsen
+47 22 02 45 31
Communications & Corporate Affairs
Email Contact

Media enquiries:
Mark Swallow
+44 207 638 9571
Citigate Dewe Rogerson
Email Contact

Kari Watson
+1 781 235 3060
MacDougall Biomedical Communications
Email Contact

Investor enquiries:
Tricia Truehart
+1 646 378 2953
The Trout Group
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
"We started a Master of Science in business analytics - that's the hot topic. We serve the business community around San Francisco so we educate the working professionals and this is where they all want to be," explained Judy Lee, Associate Professor and Department Chair at Golden Gate University, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Dion Hinchcliffe is an internationally recognized digital expert, bestselling book author, frequent keynote speaker, analyst, futurist, and transformation expert based in Washington, DC. He is currently Chief Strategy Officer at the industry-leading digital strategy and online community solutions firm, 7Summits.
DXWorldEXPO LLC announced today that Dez Blanchfield joined the faculty of CloudEXPO's "10-Year Anniversary Event" which will take place on November 11-13, 2018 in New York City. Dez is a strategic leader in business and digital transformation with 25 years of experience in the IT and telecommunications industries developing strategies and implementing business initiatives. He has a breadth of expertise spanning technologies such as cloud computing, big data and analytics, cognitive computing, m...
Digital Transformation and Disruption, Amazon Style - What You Can Learn. Chris Kocher is a co-founder of Grey Heron, a management and strategic marketing consulting firm. He has 25+ years in both strategic and hands-on operating experience helping executives and investors build revenues and shareholder value. He has consulted with over 130 companies on innovating with new business models, product strategies and monetization. Chris has held management positions at HP and Symantec in addition to ...
Cloud-enabled transformation has evolved from cost saving measure to business innovation strategy -- one that combines the cloud with cognitive capabilities to drive market disruption. Learn how you can achieve the insight and agility you need to gain a competitive advantage. Industry-acclaimed CTO and cloud expert, Shankar Kalyana presents. Only the most exceptional IBMers are appointed with the rare distinction of IBM Fellow, the highest technical honor in the company. Shankar has also receive...
DXWorldEXPO LLC announced today that Kevin Jackson joined the faculty of CloudEXPO's "10-Year Anniversary Event" which will take place on November 11-13, 2018 in New York City. Kevin L. Jackson is a globally recognized cloud computing expert and Founder/Author of the award winning "Cloud Musings" blog. Mr. Jackson has also been recognized as a "Top 100 Cybersecurity Influencer and Brand" by Onalytica (2015), a Huffington Post "Top 100 Cloud Computing Experts on Twitter" (2013) and a "Top 50 C...
Daniel Jones is CTO of EngineerBetter, helping enterprises deliver value faster. Previously he was an IT consultant, indie video games developer, head of web development in the finance sector, and an award-winning martial artist. Continuous Delivery makes it possible to exploit findings of cognitive psychology and neuroscience to increase the productivity and happiness of our teams.
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
Enterprises have taken advantage of IoT to achieve important revenue and cost advantages. What is less apparent is how incumbent enterprises operating at scale have, following success with IoT, built analytic, operations management and software development capabilities - ranging from autonomous vehicles to manageable robotics installations. They have embraced these capabilities as if they were Silicon Valley startups.
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of containers. It was one of the first and best-known examples of projects that make containers truly useful for production use. However, more recently, the container ecosystem has truly exploded. A service mesh like Istio addr...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...