Bayer and Algeta Enter Global Agreement for Development and Commercialization of Treatment for Bone Metastases in Cancer 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 €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.

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.

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.

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.

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