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Phase III compound represents potential therapy for life-threatening condition
Berlin, September 3, 2009 - Bayer Schering Pharma AG, Germany has entered into
a global agreement with Algeta ASA, Oslo, Norway for the development and
commercialization of AlpharadinTM, a novel alpha-emitting radiopharmaceutical,
based on radium-223. Alpharadin is currently being evaluated in a global Phase
III trial for the treatment of bone metastases in symptomatic
hormone-refractory prostate cancer (HRPC) patients.
"We recognize the tremendous potential of Algeta's Alpharadin as a possible
treatment for bone metastases in cancer patients - a serious, life-threatening
condition. The data we have seen suggest that Alpharadin may represent a highly
targeted treatment option that could potentially extend overall survival with
good tolerability, and offers convenient handling," said Kemal Malik, Head of
Global Development and member of the Board of Management of Bayer Schering
Pharma AG. "Bayer is committed to its global oncology franchise and has made
significant progress in building a comprehensive pipeline of promising
compounds that may provide innovative therapies to cancer patients in need of
treatment."
Andrew Kay, CEO of Algeta, said: "In Bayer, we have found the world-class
oncology company with a proven global track record of launching major cancer
products. We are very excited about working with the Bayer team to deliver this
novel and potentially first choice treatment option for cancer patients with
bone metastases."
Under the terms of the agreement, Bayer and Algeta will jointly develop
Alpharadin, with Bayer contributing a substantial majority of the costs of
future development. Bayer will commercialize Alpharadin globally and Algeta
will have the option to co-promote Alpharadin in the United States under a
profit sharing arrangement. Algeta will be responsible for manufacturing and
supply of the commercial product. Including an upfront payment of EUR 42.5
million, Algeta will receive cash payments upon achievement of certain
development, manufacturing and commercialization milestones, totaling up to
?560 million, and tiered double digit royalties on net sales.
About the Alpharadin Phase III Study
Alpharadin is currently being evaluated in a global Phase III clinical trial to
determine the efficacy and safety of the compound in 750 patients with HRPC and
skeletal metastases. The ALSYMPCA (Alpharadin in Symptomatic Prostate Cancer)
trial is a randomized, double-blind, placebo-controlled study with overall
survival (OS) as the primary efficacy endpoint.
About Alpharadin
Alpharadin (radium-223 chloride) represents a first in class opportunity of
cancer therapy based on alpha-radiation, offering highly targeted treatment of
bone metastases by delivering radiation directly to the tumor cells with low
exposure to the surrounding tissue. While Alpharadin is currently being
evaluated in patients with HRPC and skeletal metastases, the companies see
potential in investigating Alpharadin for the treatment of bone metastases from
other tumor types.
About Prostate Cancer and Skeletal Metastases
Worldwide, prostate cancer is the second most frequently diagnosed cancer in
men and a leading cause of cancer-related death in men. In 2007, 450,000 new
cases of prostate cancer were diagnosed. Bone metastases frequently occur in
advanced stages in major cancers, such as HRPC, breast, lung, kidney, and
thyroid cancers.
About Algeta
Algeta ASA is a cancer therapeutics company built on world-leading, proprietary
technology. Algeta is developing a new generation of targeted cancer
therapeutics (alpha-pharmaceuticals) that harness the unique characteristics of
alpha particle emitters and are potent, well-tolerated and convenient to use.
www.algeta.com
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Bayer Schering
Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
