Shionogi : Janssen, and Alzheimer’s Drug Discovery Foundation Announced a “Clinical Sample Access Agreement” at WDC 2019 Summit

Press Release

Shionogi, Janssen, and Alzheimer's Drug Discovery Foundation

Announced a "Clinical Sample Access Agreement" at WDC 2019 Summit

OSAKA, Japan, October 18, 2019 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and

CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that Shionogi and Janssen Pharmaceuticals, Inc. (hereafter "Janssen") and the Alzheimer's Drug Discovery Foundation (ADDF) will jointly sign a "Clinical Sample Access Agreement." This policy was announced at the World Dementia Council (WDC) 2019 summit being held in Tokyo.

The impact of Alzheimer's disease (AD) is all too prevalent in our aging society. Identifying biomarkers for early detection of AD is one of the most important research goals today. Improving our ability to detect and monitor AD in the very early phases is a critical part of clinical trials and developing treatments for this devastating disease.

Shionogi and Janssen have partnered to provide the scientific community worldwide with access to critical data and samples from a discontinued AD clinical development program through collaboration with ADDF. Shionogi and Janssen will collaborate with the ADDF to make data and samples available through the ADDF Diagnostics Accelerator initiative, a program that funds selected research and development to identify and characterize biomarkers for AD. The clinical samples and imaging biomarker data which will be provided through this agreement were collected under informed consent to allow use of those samples for research purposes in the past clinical trials.

"Sharing clinical data and samples with the medical community is an important step forward that may lead to future breakthroughs in diagnosing, treating and potentially preventing AD. The collaboration with Janssen and ADDF reinforces our steadfast commitment to advancing cutting-edge science in central nervous system (CNS) disorders including AD," said Dr. Isao Teshirogi, President and Chief Executive Officer, Shionogi & Co., Ltd.

"Nearly 44 million people worldwide have AD or related dementia, with that number growing every day. Despite cutting-edge research and recent advancements, there is still much work to be done in the global fight against the disease," said Dr. Husseini K. Manji, M.D., Global Therapeutic Head for Neuroscience, Janssen Research & Development, LLC. "We are thrilled to announce our collaboration with Shionogi and ADDF, which builds upon our commitment and long-standing legacy to address the unmet needs of those living with neurodegenerative conditions. To be part of something that has potential to change the dynamic of how we examine and ultimately treat AD is truly remarkable."

"We are excited to partner with Shionogi and Janssen as an extension of the collaborative efforts of ADDF's Diagnostics Accelerator, a coalition of philanthropists who all share the common goal of

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combating the rising burden of AD," said Dr. Howard Fillit, Founding Executive Director and Chief Science Officer of the ADDF. "Our goal is to fast-track programs to prevent, treat, and ultimately cure AD, and these samples will play a significant role in helping to accelerate the development of new biomarkers for AD."

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and wellbeing of the patients we serve." Shionogi's research and development currently targets two therapeutic areas: infectious diseases, and pain/CNS disorders. For over 50 years, Shionogi has developed and commercialized innovative oral and parenteral anti-infectives. In addition, Shionogi is engaged in new research areas, such as obesity/geriatric metabolic diseases and oncology/immunology. Contributing to the health and QOL of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp/en/.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. For more details, please visit www.janssen.com.

About Alzheimer's Drug Discovery Foundation (ADDF)

Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, The ADDF has granted more than $130 million to fund over 600 programs for Alzheimer's and related dementias in academic centers and biotechnology companies in 19 countries. To learn more, please visit: http://www.alzdiscovery.org/.

The Diagnostics Accelerator, created in July 2018, is a partnership of funders with funding commitments totaling nearly $50 million from partners including ADDF Co-Founder Leonard Lauder, Bill Gates, Jeff and MacKenzie Bezos, the Dolby family, the Charles and Helen Schwab Foundation, and The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias.

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Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-relatedforward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

For Further Information, Contact:

Corporate Communications Department

Shionogi & Co., Ltd.

Telephone: [phone]

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