November 24, 2017
Not intended for U.S. and UK Media

Phase III study program with Amikacin Inhale in addition to standard of care in intubated and mechanically ventilated patients with Gram-negative pneumonia does not meet primary endpoint of superiority

Berlin, November 24, 2017 - Bayer today announced that INHALE, a global Phase III clinical study program investigating Amikacin Inhale in addition to standard of care in intubated and mechanically ventilated patients with Gram-negative pneumonia, did not demonstrate superiority versus standard of care and aerosolized placebo. The primary endpoint, as well as secondary endpoints were similar in both treatment arms, and were therefore not met. Amikacin Inhale is the development name of an integrated drug-device combination, consisting of a specially formulated Amikacin Inhalation Solution and a proprietary Synchronized Inhalation System with a vibrating mesh nebulizer.

The primary outcome measure was survival at day 28-32. Secondary outcome measures included pneumonia-related mortality through to day 28-32, early clinical response up to day 10, number of days on mechanical ventilation up to day 28-32, and number of intensive care unit (ICU) days up to day 28-32. Overall, there was a comparable safety profile across both treatment arms. Efficacy and safety analyses from this study will be published in due course.

"The results of the INHALE study are disappointing, considering that morbidity and mortality remain significant in these patients. However, the study provides important clinical data for this difficult-to-treat disease," said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Development.

About Gram-negative pneumonia
Gram-negative organisms are frequently found to be causative pathogens for pneumonia in intubated and mechanically ventilated patients. Many Gram-negative bacteria have become resistant to commonly used antibiotics. Hospital-acquired pneumonia accounts for up to a quarter of all infections in intensive care units patients. Up to 90% of these hospital-acquired pneumonia cases occur in patients who are on mechanical ventilators for breathing assistance. The incidence of pneumonia in ventilated patients has been shown to be 3.8- to 20-fold greater than in non-ventilated patients.

About Amikacin Inhale Amikacin Inhale (BAY 41-6551) is the development name for a drug-device combination product studied as a treatment in combination with standard of care for intubated and mechanically ventilated patients with Gram-negative pneumonia. Amikacin Inhale combines a specially formulated Amikacin Inhalation Solution with Nektar Therapeutics' proprietary Synchronized Inhalation System with a vibrating mesh nebulizer. Amikacin Inhale has been shown to achieve aerosol delivery of approximately 50% of the nominal dose into the lungs. This result as shown in in-vitro studies compares favourably to other commercially available nebulizers, which deliver 10-20% of the nominal dose to the lungs.

About the Phase III program INHALE
The global INHALE program is a multinational, randomized, placebo-controlled, double-blind, multi-centre study program which investigated the clinical efficacy and safety of Amikacin Inhale in combination with standard of care over IV standard of care and aerosolized placebo for the treatment of Gram-negative pneumonia in adult patients who are intubated and mechanically ventilated.

The program included 725 patients. Patients were randomized into two arms. Patients in the first arm received 400 mg of aerosolized amikacin every 12 hours for 10 days administered using the Synchronized Inhalation System. In the comparator arm patients received aerosolized placebo every 12 hours for 10 days, also administered using the Synchronized Inhalation System. Both groups received standard of care IV antibiotics in parallel in line with American Thoracic Society (ATS) guidelines or local guidelines.

The Amikacin Inhale program is being developed through a collaboration with Nektar Therapeutics (NASDAQ:NKTR).

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 2016, the Group employed around 99,600 people and had sales of EUR 34.9 billion. Capital expenditures amounted to EUR 2.2 billion, R&D expenses to EUR 4.4 billion. For more information, go to www.bayer.com.

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Forward-looking statements<br/>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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