Bayer's Investigational Compound Radium-223 Chloride Met its Primary Endpoint of Significantly Improving Overall Survival in a Phase III Trial in Patients with Castration-Resistant Prostate Cancer That Has Spread to the Bone

WAYNE, N.J., June 6, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial evaluating Bayer's investigational compound, radium-223 chloride, which is exclusively licensed from Algeta ASA, in patients with castration-resistant prostate cancer (CRPC) and bone metastases met its primary endpoint by significantly improving overall survival.  Based on a recommendation from the Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis, the study will be stopped and patients on the placebo arm will be offered treatment with radium-223 chloride.  The overall survival result was statistically significant (two-sided p-value = 0.0022, HR = 0.699, the median overall survival was 14.0 months for radium-223 chloride and 11.2 months for placebo).  The complete results from the study will be presented at an upcoming scientific meeting.

The safety and tolerability of radium-223 chloride were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of radium-223 chloride.  Common adverse events from the ALSYMPCA trial included diarrhea, neutropenia and thrombocytopenia.

Radium-223 chloride is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.

"We are pleased that radium-223 chloride met its primary endpoint of significantly improving overall survival in patients with CRPC and bone metastases, and are hopeful about the potential of radium-223 chloride for this patient population," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee.  

The company is evaluating the filing strategy for radium-223 chloride based on the IDMC's recommendation to stop this study and will offer patients in the placebo arm treatment with radium-223 chloride.

Phase III Trial Design

The ALSYMPCA trial is a Phase III, randomized (2:1), double-blind, multi-dose, placebo-controlled international study of radium-223 chloride plus current standard of care compared with placebo plus current standard of care in patients with symptomatic castration-resistant/hormone-refractory prostate cancer that has spread to the bone.  The primary endpoint of the study is overall survival.  Secondary endpoints include time to occurrence of skeletal related events (SRE), changes and time to progression in prostate-specific antigen (PSA) tests and alkaline phosphatase (ALP) tests, safety and impact on quality of life and health economics.  ALSYMPCA was initiated by Algeta ASA (Oslo, Norway) in June 2008.  Enrollment in the trial was completed in January 2011 and 922 patients were randomized.  

About Radium-223 Chloride

Radium-223 chloride is an investigational pharmaceutical containing an alpha-particle emitting nuclide in development for cancer patients with bone metastases.  In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium-223 chloride.  Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States.  

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in Northern European countries and the United States. In 2008, an estimated 903,000 men had prostate cancer and 250,000 died from the disease worldwide.

Castration-resistant prostate cancer (CRPC) was formerly known as hormone-refractory prostate cancer (HRPC).  Approximately 90 percent of men with CRPC have radiological evidence of bone metastases.  Once the cancer cells settle in the bone, they interfere with bone strength, often leading to bone pain, fracture and other complications that can significantly impair a man's health.  In fact, bone metastases are the main cause of disability and death in patients with CRPC.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women's Healthcare.  The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

BAYER (reg'd) and the Bayer Cross (reg'd) are trademarks of Bayer.

Forward-Looking Statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

SOURCE Bayer HealthCare Pharmaceuticals Inc.