Shionogi Submits New Drug Applications In Japan And The U.S. For Naldemedine For The Treatment Of Opioid-Induced Constipation

OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)– Shionogi today announced that the company submitted New Drug Applications (NDAs) in Japan and the U.S. for a once-daily, oral 0.2 mg tablet of naldemedine, for the treatment of opioid-induced constipation (OIC). In Japan, the proposed indication is for the treatment of OIC in adult patients. In the U.S., the proposed indication is for the treatment of OIC in adult patients with chronic non-cancer pain.

Naldemedine is an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) being studied for the treatment of OIC. OIC is characterized by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency after initiating opioid therapy.1

About Shionogi

Shionogi & Co., Ltd., is a Japanese pharmaceutical company with a 138-year history discovering and developing innovative therapies. Shionogi Inc., the U.S. based subsidiary of Shionogi & Co., Ltd., continues this focus on the development and commercialization of high quality medicines that protect the health and well-being of the patients we serve. The company currently markets products in several therapeutic areas including women’s health, anti-infectives, pain and cardiovascular diseases. Our pipeline is focused on infectious disease, pain, CNS, and oncology. For more details, visit www.shionogi.com. For more information on Shionogi & Co., Ltd., visit www.shionogi.co.jp/en

Forward Looking Statement

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, 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.

1 Camilleri. M, Drossman D.A., Becker G.,Webster L.R., Davies A.N., Mawe G.M. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterology Motil. 2014. 26, 1386-1395

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