Innovation creates a unique new option for patients with bone metastases as a result of metastatic castration resistant prostate cancer

Bayer introduces Xofigo, a novel treatment for prostate cancer, now publicly funded for patients in Ontario

TORONTO, March 9, 2014 /CNW/ - Bayer Inc. announces today the availability of Xofigo (radium Ra 223 dichloride) in Ontario, for the treatment of patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease.1 Sunnybrook Health Sciences, which was a lead Canadian clinical trial site, saw the first commercial patient in Ontario and will be one of several institutions to continue to make Xofigo available to patients. Public funding for Xofigo in Ontario will be administered through Cancer Care Ontario's New Drug Funding Program, an important step for providing Ontario patients access to this new treatment.

Prostate cancer is the most commonly diagnosed cancer in men worldwide with 24,000 Canadian men diagnosed with the disease in 2014.2 Metastases result when the initial cancer spreads beyond the prostate to other areas of the body - often the bone. Bone metastases can significantly impact a patient's quality of life, causing severe pain and compromising the structure of the bone, which can result in increased fractures. Bone metastases are the main cause of death in patients with metastatic castration-resistant prostate cancer (mCRPC) and up to 80 per cent of patients with bone metastases suffer from debilitating pain.3

"Xofigo represents a novel approach to treating bone metastases," says Dr. Lawrence Klotz, Professor, Department of Surgery, University of Toronto; member of the Division of Urology, Sunnybrook; and investigator on the ALSYMPCA clinical trial of Xofigo. "It mimics calcium to locate bone metastases in a highly targeted manner, causing little damage to the surrounding healthy cells. Xofigo improves a patient's symptoms and prolongs survival, with very few side effects."

The active ingredient in Xofigo, radium 223 dichloride, is an alpha particle-emitting radioactive therapeutic agent that undermines the development and growth of bone metastases. The treatment is administered intravenously once per month for six months. Xofigo is the first and only alpha particle-emitting therapeutic radiopharmaceutical agent approved by Health Canada that has demonstrated an overall survival (OS) benefit. Unlike some other radio pharmaceuticals that restrict patients from being in close contact with people, patients receiving Xofigo have no contact restrictions.

Xofigo represents a significant advance in the current arsenal of hormonal, chemotherapeutic and immunotherapeutic options available to men with mCRPC. In the pivotal Phase III ALSYMPCA trial4, Xofigo demonstrated improvement in OS and delay in time to first symptomatic skeletal event compared to placebo in patients with castration-resistant prostate cancer and bone metastases.

"The everyday lives of prostate cancer patients with bone metastases are dramatically impaired as a result of debilitating pain," says Jackie Manthorne, President and CEO of the Canadian Cancer Survivor Network. "The prostate cancer community welcomes innovative options that allow patients to focus on staying active and create positive health outcomes. With the availability of these new options, the focus of our attention should be on access to ensure all patients can receive treatments that can have a benefit on their symptoms."

Xofigo is currently listed in Ontario and British Columbia and in the process of being reviewed by other provincial cancer agencies as a new treatment option for patients dealing with mCRPC.

About Oncology at Bayer
Bayer is committed to delivering Science for a Better Life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer Inc.
Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate headquarters for the Canadian operations. Founded in 1863, Bayer AG is an international research-based group with core businesses in healthcare, crop science and innovative materials committed to creating a better life for all through science.

In Canada, Bayer operates its healthcare business - Pharmaceuticals, Consumer Care, Diabetes Care, Animal Health and Radiology & Interventional - from its headquarters in Toronto, ON, and Bayer CropScience Inc. operates out of its head office in Calgary, AB. Together with its material science business, Bayer improves the quality of life for Canadians through products that fight disease, protect crops and animals, and provide high-performance materials for numerous daily life uses.

With more than 1,300 employees across the country, in 2013, Bayer had sales of $1.6 billion and invested $61 million in research and development in Canada. Globally, Bayer AG had sales of €40.2 billion and invested €3.2 billion in research and development.

For more information about Bayer, please visit www.bayer.ca .

Forward-Looking Statements
This 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.

REFERENCES

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1 Xofigo Canadian Product Monograph, December 12 2013
2 http://www.prostatecancer.ca/Prostate-Cancer/About-Prostate-Cancer/Statistics
3 The Oncologist - Perspectives on Treatment of Metastatic Castration-Resistant Prostate Cancer
4 C. Parker, et al.  Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer. N Engl J Med. 2013; 369:213-223 July 18, 2013.

 

SOURCE Bayer Inc.

For further information: Martha Linton, Bayer Inc., Martha.Linton@bayer.ca, 905-282-5341; Ethan Pigott, beSPEAK Communications, ethan@bespeakcommunications.com, 416-558-2783

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