Xofigo® (radium Ra 223 dichloride) Injection Recommended for Approval in the European Union

 Xofigo® (radium Ra 223 dichloride) Injection Recommended for Approval in the
                                European Union

PR Newswire

WHIPPANY, N.J., Sept. 20, 2013

WHIPPANY, N.J., Sept. 20, 2013 /PRNewswire/ --Bayer HealthCare announced
today that the the European Committee for Medicinal Products for Human Use
(CHMP) recommended Xofigo^® (radium Ra 223 dichloride) for approval with a
proposed indication for the treatment of adults with castration-resistant
prostate cancer (CRPC), symptomatic bone metastases and no known visceral
metastases. The decision of the European Commission on the approval is
expected in the second half of 2013. Xofigo was approved by the U.S. Food and
Drug Administration in May for the treatment of patients with CRPC,
symptomatic bone metastases and no known visceral metastatic disease and is
now available in the United States at licensed facilities.^1

"We are encouraged by the positive CHMP opinion issued today, and look forward
to potentially providing radium 223 to more patients upon approval of the
European Commission," explained Kemal Malik, MD, Member of the Bayer
HealthCare Executive Committee and Head of Global Development.

About Xofigo^® (radium Ra 223 dichloride) Injection
Xofigo is indicated in the United States for the treatment of patients with
castration-resistant prostate cancer, symptomatic bone metastases and no known
visceral metastatic disease.^1

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.^1

In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway)
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) Injection
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 (<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 or 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, Xofigo
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 the Xofigo
arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25%
vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). 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 the Xofigo arm (greater than or equal to 10%) vs the placebo arm,
respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%),
leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18%
vs 5%).

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

About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in the United States
(other than skin cancer).^3 Approximately 4% of prostate cancer cases are
considered distant, which means that the cancer has spread beyond the prostate
to distant areas of the body (metastasized).^4 If prostate cancer starts to
spread to other areas of the body, it most commonly goes to the bone.^3

Bone is the most common site in the body to be affected by metastatic cancer,
and bone metastases are particularly prevalent in patients with prostate
cancer.^5 Approximately 90% of patients with metastatic prostate cancer show
evidence of bone metastases.^6,7,8,9 Bone metastases can lead to an increase
in frequency of skeletal events and are shown to be the main cause of death in
patients with CRPC.^10,11

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 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, Medical Care, and Pharmaceuticals divisions. As a specialty
pharmaceutical company, Bayer HealthCare provides products for 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^® and the Bayer Cross^® and Xofigo^® are registered trademarks of Bayer.

Forward-Looking Statement
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.

^1XOFIGO^® (radium Ra 223 dichloride) [Prescribing Information]. Whippany,
NJ: Bayer HealthCare Pharmaceuticals, May 2013.

^2Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and
survival in metastatic prostate cancer. N Engl J Med 2013;369:213-23.

^3American Cancer Society. Prostate Cancer: Detailed Guide. Available
at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf

^4National Cancer Institute, Surveillance Epidemiology and End Results
(SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008.

^5Coleman R. Metastatic bone disease: clinical features, pathophysiology
and treatment strategies. Cancer Treat Rev.2001;27:165-176.

^6Petrylak DP, et al. Docetaxel and estramustine compared with mitoxantrone
and prednisone for advanced refractory prostate cancer. N Engl J Med.
2004;351:1513-1520.

^7Tannock IF, et al. Docetaxel plus prednisone or mitoxantrone plus
prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.

^8Scher, HI, et al. Increased Survival with Enzalutamide in Prostate Cancer
after Chemotherapy. N Engl J Med. 2012;DOI10.1056

^9Fizazi, K, et al. Abiraterone acetate for treatment of metastatic
castration-resistant prostate cancer: final overall survival analysis of the
COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet
Oncol 2012; 13:983-92.

^10 Saad, MD, et. al. "Guidelines for the management of castration-resistant
prostate cancer." Can Urol Assoc J 2010;4(6):380-4.

^11 Lange PH, Vasella RL. Mechanisms, hypotheses and questions regarding
prostate cancer metastatic to bone. Cancer & Metastasis
Reviews.1999;17:331-336.



Intended for U.S. Media Only



SOURCE Bayer HealthCare Pharmaceuticals Inc.

Website: http://www.bayer.com
Contact: Rose Talarico, +1 862-404-5302, Email: rose.talarico@bayer.com
 
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