May 31, 2018 - 8:35 AM EDT
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Bayer Partners with U.S. Department of Energy to Produce Key Starting Material for Xofigo® (radium Ra 223 dichloride) Injection

Department of Energy's Oak Ridge National Laboratory to supply actinium-227

WHIPPANY, N.J., May 31, 2018 /PRNewswire/ -- Bayer is collaborating with the U.S. Department of Energy's Oak Ridge National Laboratory, based in Oak Ridge, TN, to produce actinium-227 (227Ac), the key radioisotope used in the production of the company's prostate cancer treatment Xofigo® (radium Ra 223 dichloride). The agreement is part of a long term contract between Bayer and the U.S. Department of Energy (DOE) Isotope Program.

 (PRNewsfoto/Bayer)

Actinium-227 is necessary to produce radium-223, which is the active ingredient in Xofigo, a drug used to treat patients with castration-resistant prostate cancer, symptomatic bone metasteses and no known visceral metastatic disease. As Xofigo becomes available in more countries around the world, additional sources of actinium-227 will be needed to ensure adequate supply. In addition, actinium-227 plays an equally important role in the production of Bayer's investigational Targeted Thorium Conjugate (TTC) Clinical platform.

"We are excited about this partnership with Bayer to ensure prostate cancer patients have a reliable supply of this drug," said Jehanne Gillo, Director of the Facilities and Project Management Division for the DOE Office of Science for Nuclear Physics. "This is a great example of the public and private sectors working together to address a vital need that affects thousands of lives each year."

The DOE Isotope Program, which produces high priority isotopes for the nation, is part of the Department's Office of Science, the single largest supporter of basic research in the physical sciences in the United States. Oak Ridge National Laboratory is DOE's largest science and energy laboratory and has decades of experience in isotope research and production.

"This collaboration underscores Bayer's commitment to prostate cancer patients by helping to ensure the adequate supply of Xofigo for all appropriate patients battling the disease in the U.S. and globally," said Carsten Brunn, president of Bayer Pharmaceuticals, Americas Region. "We are honored to be working with the Department of Energy and Oak Ridge National Laboratory's radioisotope production experts and their unique facilities to ensure a sustainable supply of this important drug into the foreseeable future."

About Castration-Resistant Prostate Cancer (CRPC) and Bone Metastases 
CRPC is an advanced form of prostate cancer. Approximately nine in 10 patients with CRPC (90 percent) develop bone metastases, impacting survival. In fact, bone metastases lead to an increased risk of death in patients with CRPC. Therefore, diagnosing and treating bone metastases at the earliest onset is critical for patients.

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

Important Safety Information for Xofigo® (radium Ra 223 dichloride) Injection

  • Contraindications: Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.
  • Bone Marrow Suppression: 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 leucopenia – 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.
  • Hematological Evaluation: 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 × 109/L, the platelet count greater than or equal to 100 × 109/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 × 109/L and the platelet count greater than or equal to 50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care.
  • Concomitant Use with Chemotherapy: 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.
  • Administration and Radiation Protection: 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.
  • Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia.
  • Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo.
  • Secondary Malignant Neoplasms: Xofigo contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow up for patients on the trial.
  • Subsequent Treatment with Cytotoxic Chemotherapy: In the randomized clinical trial, 16% patients in the Xofigo group and 18% patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy.
  • Adverse Reactions: The most common adverse reactions (≥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 (≥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 http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf.

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 four 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  
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.us.

© 2018 Bayer  
BAYER, the Bayer Cross and Xofigo are registered trademarks of Bayer.

Contact
Rose Talarico, Tel +1 862.404.5302 
Email: [email protected] 

Forward-Looking Statements 
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer 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.

1. XOFIGO® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Feb 2018.

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Source: PR Newswire (May 31, 2018 - 8:35 AM EDT)

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