Bayer : ayer Launches Immunostimulant Zelnate® for Animal Health Following Authorization in the US

News Release

Bayer HealthCare AG Communications

51368 Leverkusen

Germany

Tel. +49 214 30-1 www.bayerhealthcare.com

 US Department of Agriculture authorizes first cytosine-phosphate-guanine (CpG)

motif-based immunostimulant shown to effectively reduce Bovine Respiratory Disease
(BRD) associated mortality and lung lesions in cattle
Zelnate®jumpstarts animals' innate immunity, offering an innovative non-antibiotic approach to help mitigate BRD, potentially reducing the need for therapeutics

Leverkusen, Germany, September 3, 2015 - Bayer launched Zelnate®, an innovative immunostimulant for animal health in the United States. It is the first cytosine-phosphate- guanine (CpG) motif-based immunostimulant authorized by the US Department of Agriculture that has demonstrated effectiveness in reducing bovine respiratory disease (BRD) associated mortality and lung lesions in cattle.1Indicated to aid in the treatment of BRD due to Mannheimia haemolytica bacteria, Zelnate offers veterinarians and farmers a novel non-vaccine, non-antibiotic approach to help mitigate BRD, a complex infectious disease that has long impacted the cattle industry.
'For years, scientists have evaluated ways to effectively enhance animals' natural defenses so they are better able to fight off infections,' said Prof. Amelia R. Woolums, Institute of Pathobiology & Population Medicine, Mississippi State University, U.S. 'The availability of Zelnate marks a promising development in the field of
veterinary immunology. Immunostimulants offer the potential of significant benefit to the livestock industry, as they could help reduce the need for antibiotics to treat animals that are ill.'
'Zelnate is a very good example of our commitment to deliver innovative approaches to address unmet veterinary needs around the world,' said Dr. Dirk Ehle, Head of Bayer HealthCare Animal Health. 'Our customers face a growing challenge to ensure the health and well-being of their animals, and reduce antibiotic use at the same time.'
- 1/3 -
The innate immune system is a natural and potent defense mechanism against infectious diseases. Zelnate jumpstarts an animal's innate immune system, which has been shown to provide a potent, rapid, and broad protective response to infectious agents.
'This CpG motif-based immunostimulant is an important innovative breakthrough not just for Bayer, but also for veterinary medicine,' said Dr. Doug Hutchens, Head of Global Development and Chief Veterinary Officer at Bayer HealthCare Animal Health. 'Zelnate has demonstrated effectiveness in reducing BRD-associated mortality and lung lesions in cattle in challenge models and field studies.1We look forward to further exploring the potential of this technology across other species and indications.'
BRD remains a challenge in the livestock industry. BRD is associated with a loss of up to USD1502per head of cattle, and an overall economic impact of about USD1 billion a year in the U.S. alone.3A key contributing factor of BRD is stress arising from co-mingling and shipping, among others. Immunostimulants offer game-changing potential in the livestock industry, as they enable an animal to help itself, potentially reducing the incidence of disease and the need for antibiotics.

Zelnate is Bayer's latest innovation in animal health that changes the way veterinarians and farmers are able to approach BRD. It is a novel, non-antibiotic technology and the first CpG motif-based immunostimulant that jumpstarts the animal's own defense system to help fight this disease. Zelnate is authorized by the USDA and indicated to aid in the treatment of BRD due to Mannheimia haemolytica.
Administered to cattle at risk of respiratory disease, Zelnate was shown to effectively mitigate BRD by reducing mortality by 88%1and lung lesions by 50%1, potentially reducing the need for therapeutics. Zelnate complements current approaches for BRD and offers an attractive non-antibiotic option that can help address current challenges in the management of this infectious disease.
Zelnate is based on technology developed by Juvaris BioTherapeutics and is patent protected. Animal Health applications are being exclusively developed by Bayer HealthCare Animal Health and are the subject of Bayer patent applications. Bayer (reg'd), the Bayer Cross (reg'd), ZELNATE (reg'd) are trademarks of Bayer. A comprehensive
- 2/3 -
research and development program is ongoing at Bayer to explore the potential of immunostimulants in animal health, across indications and species.

The Bayer Group is a global enterprise with core competencies in the fields of health care and agriculture. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), 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 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
Our online press service is just a click away: press.healthcare.bayer.com

Contact:

E-Mail: janice.chow@bayer.com jc (2015-0310e)

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 atwww.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

1 Nickell, J., Keil, D., Settje, T. Zelnate: A novel approach to BRD management in cattle (2014). Abstract submitted and accepted for presentation at the American Association of Bovine Practitioners Annual Conference, Sept 2015.

2 Texas A&M Ranch to Rail data (1993-2001)

3 Horwood, P.F., Schibrowski, M.L., Fowler, E.V., Gibson, J.S., Barnes, T.S., Mahony, T.J., 2014. Is Mycoplasma bovis a missing component of the bovine respiratory disease complex in Australia? Aust. Vet. J. 92 (6), 185-191

- 3/3 -