Ramosetron Hydrochloride

PDF (112KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Sunao Manabe, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Junichi Onuma, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 https://www.daiichisankyo.com Tokyo, Japan (October 15, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it agreed with Astellas Pharma Inc. (hereafter, Astellas Pharma) that Astellas Pharma local subsidiaries companies in six Asian countries will transfer three products to Daiichi Sankyo. The products to be transferred and the countries where they are sold are as follows. Product [generic name (brand name)] Korea China Taiwan Thailand Philippines Indonesia Ramosetron (Nasea) Antiemetic ○ ○ ○ ○ Nicardipine (Perdipine) Anti-hypertensive ○ ○ ○ Barnidipine (Oldeca) Anti-hypertensive ○ Product [generic name (brand name)] Korea China Taiwan Thailand Philippines Indonesia Ramosetron (Nasea) Antiemetic ○ ○ ○ ○ Nicardipine (Perdipine) Anti-hypertensive ○ ○ ○ Barnidipine (Oldeca) Anti-hypertensive ○ ○ indicate the countries where the products are sold The antiemetics are expected to have synergistic effects with mirogabalin and the cancer drugs that Daiichi Sankyo is currently developing in Asia, and the two antihypertensives are expected to effectively utilize Daiichi Sankyo’s current infrastructures in combination with its cardiovascular products, such as olmesartan and edoxaban. The total net sales of Astellas Pharma's three products in fiscal year 2018 were approximately 5.0 billion yen. Daiichi Sankyo will take over the rights and obligations, including manufacturing and marketing approvals, for each of the products, and from December 2019 onwards, the manufacturer, LTL Pharma Co., Ltd., will supply them for sale in Asia by Daiichi Sankyo’s local subsidiaries and other companies. Daiichi Sankyo will pay 9.6 billion yen to Astellas Pharma for the products to be taken over; moreover, in order to ensure continuous supplies of the products to patients, both companies will cooperate to smoothly transfer manufacturing and marketing approvals in the targeted countries. Daiichi Sankyo is strengthening its presence in each region by providing a rich range of regional value products in line with the market characteristics in each region, and the company strengthens its presence in Asia and plans to further contribute to healthcare in the region by acquiring these products. About Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

Japan, October 6, 2008 - Astellas Pharma Inc. (headquarters: Tokyo, president and CEO: Masafumi Nogimori, “Astellas”) today announced that its serotonin 5-HT3 receptor antagonist Irribow® Tablets 2.5μg, 5μg (generic name: ramosetron hydrochloride) will become available in Japan on October 7, 2008, with the indication of “diarrhea-predominant irritable bowel syndrome in male.” Irritable bowel syndrome (IBS) is a functional but not organic disorder which causes abdominal pain and/or discomfort with abnormal bowel movement including diarrhea and constipation. These gastrointestinal symptoms persist for a long period with frequent remissions and exacerbations. Abdominal pain/discomfort and abnormal bowel movement are often associated with many factors such as stress, which is considered to cause the acceleration of intestinal transit resulted from the over-activation of enteric nervous system. IBS is classified into three types consisted of diarrhea, constipation and both alternating between diarrhea and constipation. In Japan, it is reported that prevalence rate of all type of IBS in adult is expected to be 12.5% and the number of patients is estimated to be approximately 12 million. IBS is more likely to be observed in younger people, and the symptoms in male tend to develop diarrheal type. Irribow is a serotonin 5-HT3 receptor antagonist discovered by Astellas. Serotonin is a member of neurotransmitter which is greatly related to gastrointestinal motility, secretion and sensation. Stress may stimulate the serotonin release and activate the 5-HT3 receptors on enteric nerve, which induces the acceleration of intestinal transit resulting in diarrhea. In addition, the increase in intracolonic pressure also induces serotonin release, and it will bind to 5-HT3 receptor at the terminal of afferent neuron, causing intestinal nociceptive transmission to central nervous system. Irribow improves abnormal bowel movement associated with the acceleration of intestinal transit by inhibiting 5-HT3 receptor selectively. It also improves visceral hypersensitivity by suppressing the transmission of intestinal nociception. Astellas expects Irribow to provide a new option for IBS medication. Details of Irribow are as follows: Brand name: Irribow® Tablets 2.5μg, 5μg Generic name: ramosetron hydrochloride Indication: diarrhea-predominant irritable bowel syndrome in male Dosage and administration: For oral use, the usual adult male dosage is 5 μg of ramosetron hydrochloride once daily. The dosage may be adjusted according to the patient’s symptoms. The maximum daily dose is 10 μg. Approval holder: Astellas Pharma Inc. Packaging: Tablets 2.5μg: 100 tablets (10T×10 PTP), 140 tablets (14T×10, PTP), 500 tablets (bottle), 700tablets (14T×50 PTP) Tablets 5μg: 100 tablets (10T×10 PTP), 140 tablets (14T×10, PTP), 500 tablets (bottle), 700tablets (14T×50 PTP) NHI reimbursement prices 86.30 Japanese yen/2.5μg tablet 141.10 Japanese yen/5μg tablet Date of NHI price listed : September 12, 2008 Date of launch: October 7, 2008 *100 tablets (10T×10 PTP) and 500 tablets (bottle) will be available around December.