Shionogi Strengthens Regulatory Leadership with the Appointment of Dr. Ramón Polo as Senior Vice President, Head of Regulatory Affairs

FLORHAM PARK, NJ, February 5, 2024 - Shionogi Inc., a U.S. subsidiary of Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereinafter “Shionogi”), announced the appointment of Ramón Polo, MBA, PharmD, Ph.D. as Senior Vice President, Head of Regulatory Affairs.

“Dr. Polo’s extensive regulatory leadership experience is a welcome addition to Shionogi at this pivotal time for the company in the U.S.,” said Nate McCutcheon, President and Chief Executive Officer, Shionogi Inc. “As a leader in infectious disease, our robust clinical development program includes a late-stage investigational oral antiviral for COVID-19 and early-stage antibiotic programs through our acquisition of Qpex. We are also progressing additional key programs in other therapeutic areas with an investigational treatment for Fragile X syndrome in Phase 2b/3 studies and studies underway for acute ischemic stroke, obesity and oncology.”

Dr. Polo’s diverse expertise includes overseeing clinical development operations, pharmacovigilance programs and regulatory strategies. He joins Shionogi Inc. from Johnson & Johnson, where he served as the Vice President, Head of Infectious Diseases, Vaccines & Global Public Health Regulatory Affairs.

“I was initially drawn to Shionogi because of the company’s rich heritage in infectious disease, and as I learned more about the pipeline, recent investments and acquisitions, as well as where Shionogi intends to be by 2030, I realized the significant opportunity ahead to contribute meaningfully across multiple disease states with unmet patient needs,” said Dr. Polo. “It’s an exciting time to join Shionogi and an incredible step in the next stage of my career.”

In his role at Johnson & Johnson, Dr. Polo was responsible for driving regulatory strategy across the U.S., Europe, Asia Pacific and Latin America. Prior to this, Dr. Polo led the development strategy of treatments for influenza, RSV and hepatitis C at Janssen Pharmaceutical Companies of Johnson & Johnson.

Dr. Polo received his PharmD, Master of Science and Ph.D. in Clinical Biochemistry from the Complutense University of Madrid in Spain. He obtained his Global MBA from the IESE Business School, University of Navarra, and attended the Program for Management Development at Harvard Business School.

Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a Japanese research-driven pharmaceutical company. Since 1878, we have been harnessing the full potential of science to address global health challenges. Over the past six decades, we have discovered several novel antibiotics and medications for HIV and influenza. Today, we're building on our scientific legacy by conducting ongoing research into established products and new antibiotic compounds, as well as developing an investigational antiviral for COVID-19. Beyond infectious disease, our pipeline includes clinical programs in Fragile X syndrome, acute ischemic stroke, obesity and oncology. Learn more at Shionogi.com.

Shionogi & Co., Ltd. is a 145-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is 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.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders.

For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.

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-related forward-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, lack of availability 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.