Wednesday - December 21, 2016

Not intended for U.S. and UK Media - Personalized Medicine:

Bayer Develops Companion Diagnostic Test for Cancer Patients Together with Leica Biosystems

Companion diagnostics network supports Bayer’s personalized medicine approach

Leverkusen, December 21, 2016 – Bayer has entered into an agreement with Leica Biosystems to collaborate on the development of companion diagnostic tests based on tissue samples using RNAscope® (a multiplex nucleic acid hybridization technology) and immunohistochemistry for cancer patients. Companion diagnostic tests aim to unlock molecular information from each patient to guide treatment decisions with targeted medications for cancer and other diseases. Early screening for patient-specific tumor markers will also help to design more efficient clinical trials and eventually increases the overall probability of therapeutic success for patients suffering from cancer.

“We are looking forward to working with Leica Biosystems to develop companion diagnostic tests for our novel anti-cancer agents,” said Prof. Andreas Busch, member of the Executive Committee of Bayer AG's Pharmaceuticals Division and Head of Drug Discovery. “This represents another important step for Bayer towards a more personalized approach in the fight against cancer.”

“The promise of personalized medicine relies upon high quality diagnostic tests to identify the specific patient populations that are most likely to benefit from the therapy”, said Jonathan Roy, Vice President of Pharma Partnerships at Leica Biosystems. “We are very pleased that this agreement with Bayer will help to expand our menu of companion diagnostic tests on the BOND technology and supports our overall mission of advancing cancer diagnostics for the benefit of patients and clinicians who care for them."

While much progress has been made in the treatment of cancer over the last years, there is still a need for improved diagnosis and treatment of cancer. Bayer is committed to advancing the science in the field of cancer, and translating this science into therapies that can help people with cancer live longer and to improve patients’ quality of life. In this context, Bayer has already established partnerships with a number of external partners specialized on the development of companion diagnostic tests based on blood or tissue samples.

Under the terms of the agreement with Leica Biosystems the partners will use Leica Biosystems expertise in assay development, regulatory approval and commercialization of companion diagnostic tests based on the automated BOND technology platform for novel targeted anti-cancer therapies developed by Bayer. Financial terms of the agreement were not disclosed.

About RNAscope®

RNAscope® in-situ hybridization technology with its proprietary double Z probe design and reagents enable reliable detecting of RNA biomarkers at a single molecule sensitivity with native morphological context for formalin-fixed paraffin-embedded (FFPE) tissue.These assays have been adopted across the globe by major pharma, biotech and leading academic research institutions at more than 3000 labs. Leica Biosystems and Advanced Cell Diagnostics, Inc have collaborated to automate the RNAscope assay on the Leica Bond instrument platform providing unattended operation and automated analysis making it well suited for clinical diagnostics and companion diagnostics.

About BOND technology

Built on a foundation of over 150 years of histology experience, the BOND fully automated IHC/ISH staining platform by Leica Biosystems assures delivery of crisp and specific staining for unsurpassed diagnostic confidence. Full automation coupled with BOND’s propriety Covertile technology reduces the chance of variability resulting in superior staining consistency. The BOND platform is built upon the pillars of speed, efficiency and quality which helps laboratories deliver what really matters: better patient care.

About Leica Biosystems

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, they are uniquely positioned to break down the barriers between each of these steps. Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of their corporate culture. Their easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com for more information.

Bayer: Science For A Better Life

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 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.com.

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.

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