Algeta ASA
oslo : ALGETA

May 30, 2013 01:29 ET

Algeta announces first sale of Xofigo® (radium Ra 223 dichloride) in the United States

Intended for US media only

First sale triggers EUR 50 million milestone payment from Bayer

OSLO, NORWAY--(Marketwired - May 30, 2013) - Algeta ASA (OSE: ALGETA) announces that Xofigo® (radium Ra 223 dichloride) injection, recently approved by the US Food and Drug Administration (FDA) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease, has been launched in the United States and the first sale has been made.

The first commercial sale of Xofigo triggers a EUR 50 million milestone payment to Algeta from Bayer under the terms of the 2009 development and licensing agreement. Bayer has worldwide exclusive marketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare are co-promoting the product in the US.

Algeta's President & CEO, Andrew Kay, commented: "We are delighted to announce the first sale of Xofigo, following its approval by the FDA for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. For these patients, we anticipate that Xofigo will be an important and welcome new addition to the treatment paradigm."

About Xofigo® (radium Ra 223 dichloride)

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo 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 Xofigo 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 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue[i].

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 US, LLC is co-promoting Xofigo with Bayer in the US.

Important Safety Information for Xofigo (radium Ra 223 dichloride)

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, Xofigon 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 patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema. 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 Xofigo-treated patients (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

For full prescribing information visit www.xofigo-us.com.

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Xofigo® is a registered trademark of Bayer

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. 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. 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 or uncertainties associated with the ability to identify and hire a sufficient number of qualified employees in the US, growth management, general economic and business conditions and the pricing environment, 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, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining additional regulatory approvals for radium 223 and the other risks and uncertainties described in our annual report.

[i] XOFIGO Prescribing information. May 2013

Press release: http://hugin.info/134655/R/1705687/564304.pdf

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

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Source: Algeta ASA via Thomson Reuters ONE

[HUG#1705687]

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