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Onco from Bayer (but old!)...Nexavar....

ASCO GU 2015 to Feature Latest Oncology Research from Bayer
Includes data from studies evaluating radium-223 dichloride, sorafenib and investigational agent ODM-201
Abstracts: 160, 182, 195, 202, 230, 247, 253, 254, 403

Berlin, February 24, 2015 – Bayer HealthCare announced today that new data from its oncology portfolio will be presented at the 2015 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO GU) taking place February 26 – 28 in Orlando, FL (USA). The presentations will include data on Xofigo® (radium-223 dichloride) and Nexavar® (sorafenib), as well as ODM-201, an investigational therapy Bayer is jointly developing with Orion Corporation.

Notable studies evaluating Bayer's products and pipeline candidates at ASCO GU 2015 are listed below:

Radium-223 Dichloride (radium-223)
1. Effect of radium-223 dichloride (Ra-223) on pain from US EAP
- Abstract 160, Board G22, General Poster Session A: Prostate Cancer
- Thursday, February 26, 11:30 AM – 1:00 PM (EST)
2. External beam radiation therapy (EBRT) use and safety with radium-223 dichloride (Ra-223) in patients (pts) with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases (mets) from the ALSYMPCA trial
- Abstract 182, Board H18, General Poster Session A: Prostate Cancer
- Thursday, February 26, 11:30 AM – 1:00 PM (EST)
3. 3-Year Safety Follow-up of Radium-223 Dichloride (Ra-223) in Patients (Pts) With Castration-Resistant Prostate Cancer (CRPC) and Symptomatic Bone Metastases (Mets) From ALSYMPCA
- Abstract 195, Board J5, General Poster Session A: Prostate Cancer
- Thursday, February 26, 11:30 AM – 1:00 PM (EST)
4. Effects of radium-223 dichloride (Ra-223) with docetaxel (D) versus D on prostate-specific antigen (PSA) and bone alkaline phosphatase (bALP) in patients (pts) with castration-resistant prostate cancer (CRPC) and bone metastases (mets): A phase 1/2a clinical trial
- Abstract 202, Board J12, General Poster Session A: Prostate Cancer
- Thursday, February 26, 11:30 AM – 1:00 PM (EST)
5. Radium-223 dichloride (Ra-223) in U.S. expanded access program (EAP)
- Abstract 247, Board C16, General Poster Session B: Prostate, Penile, Testicular, and Urethral Cancers, and Urothelial Carcinoma
- Friday, February 27, 12:15 – 1:45 PM (EST)
6. Prior and concurrent use of abiraterone and enzalutamide with Ra-223 in an expanded access setting
- Abstract 253, Board C22, General Poster Session B: Prostate, Penile, Testicular, and Urethral Cancers, and Urothelial Carcinoma
- Friday, February 27, 12:15 – 1:45 PM (EST)
7. Effect of radium-223 dichloride (Ra-223) on risk for and duration of hospitalization in ALSYMPCA by docetaxel (D) subgroup
- Abstract 254, Board C23, General Poster Session B: Prostate, Penile, Testicular, and Urethral Cancers, and Urothelial Carcinoma
- Friday, February 27, 12:15 – 1:45 PM (EST)

Sorafenib
1. Initial results from ASSURE (E2805): Adjuvant sorafenib or sunitinib for unfavorable renal carcinoma, an ECOG-ACRIN-led, NCTN phase III trial
- Abstract 403, Board B1, General Poster Session C: Renal Cell Cancer
- Saturday, February 28, 7:00 AM – 7:55 AM (EST)

ODM-201
1. Pharmacokinetics, activity and safety of ODM-201 in chemotherapy-naïve patients with metastatic castration resistant prostate cancer: An open-label phase I trial with long-term extension
- Abstract 230, Board B24, General Poster Session B: Prostate, Penile, Testicular, and Urethral Cancers, and Urothelial Carcinoma
- Friday, February 27, 12:15 – 1:45 PM (EST)

About Radium-223 Dichloride (Xofigo®)
Radium-223 dichloride (radium-223) is a therapeutic alpha particle-emitting pharmaceutical with an anti-tumor effect on bone metastases. Radium-223 mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters leads to a high frequency of double-strand DNA breaks in adjacent tumor cells, resulting in a potent cytotoxic effect. The alpha particle range from radium-223 is less than 100 micrometers, which minimizes damage to the surrounding normal tissue.

Radium-223 dichloride has been approved under the brand name Xofigo® in more than 40 countries worldwide, including the U.S. and the EU. In Europe, it is approved for the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases.

About Sorafenib (Nexavar®)
Sorafenib, an oral anti-cancer therapy, is approved under the brand name Nexavar® in more than 100 countries worldwide. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma (HCC); for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; and for progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.

In preclinical studies, sorafenib has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is co-developed by Onyx Pharmaceuticals, Inc., an Amgen subsidiary, and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S., excluding Japan, Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally.

About ODM-201
ODM-201 is an investigational novel androgen receptor (AR) antagonist with unique chemistry that is designed to block the growth of prostate cancer cells. ODM-201 binds to the AR with high affinity and inhibits receptor function. In nonclinical models, ODM-201 has shown to only minimally penetrate the blood-brain barrier.

In 2014, Bayer and Orion had entered into a global agreement under which they will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. Bayer will commercialize ODM-201 globally and Orion has the option to co-promote ODM-201 in Europe. Orion will be responsible for the manufacturing of the product.

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
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

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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.