Daiichi Sankyo : Announces Approval of MINNEBRO(TM) Tablets for the Treatment of Hypertension in Japan

For Immediate Release

2019.01.08

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Sunao Manabe, Representative Director, President and COO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Koji Ogawa, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: [phone]
https://www.daiichisankyo.com

Daiichi Sankyo Announces Approval of MINNEBRO(TM) Tablets for the Treatment of Hypertension in Japan

Tokyo, Japan (January 8, 2019) - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the receipt of marketing approval in Japan for MINNEBRO^TM Tablets 1.25 mg, 2.5 mg and 5 mg (generic name: esaxerenone; hereafter, the drug) for the treatment of hypertension.

MINNEBRO^TMis one of the compounds identified during the research collaboration with Exelixis, Inc. (based in Alameda, California, U.S.), and has subsequently been developed by Daiichi Sankyo. The application for approval was submitted in Japan in February 2018 on the basis of the results of a phase 3 clinical trial conducted in Japan (ESAX-HTN study) in patients with essential hypertension. Excessive mineralocorticoid receptor activation has been found to be involved in hypertension and the drug is considered to exert an antihypertensive effect by blocking these receptor activation.

Daiichi Sankyo expects the drug to benefit patients and healthcare professionals in Japan by providing a new therapeutic option for the treatment of hypertension.

The phase 3 pivotal study (ESAX-DN study) has been on-going in Patients with Diabetic Nephropathy in Japan.

< Product Outline >

Brand name	MINNEBROTMTablets 1.25 mg, 2.5 mg, 5 mg
Generic name	Esaxerenone
Date of approval for manufacturing and marketing	January 8, 2019
Indication	Hypertension
Dosage and administration	The recommended oral dose of esaxerenone is 2.5mg once daily. The dose for patients with inadequate response can be increased up to 5mg once daily.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a 'Global Pharma Innovator with Competitive Advantage in Oncology,' Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com.

About Exelixis

Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. We discovered our lead compounds, cabozantinib and cobimetinib, and advanced them into clinical development before entering into partnerships with leading biopharmaceutical companies in our efforts to bring these medicines to patients globally. We are steadfast in our commitment to prudently reinvest in our business to maximize the potential of our pipeline. We intend to supplement our existing therapeutic assets with targeted business development activities and internal drug discovery - all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of Standard & Poor's (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For the second consecutive year, Exelixis earned a spot on Deloitte's Technology Fast 500 list, a yearly award program honoring the 500 fastest-growing companies over the past four years. For more information about Exelixis, please visit www.exelixis.com or follow @ExelixisInc on Twitter.