SymBio Pharmaceuticals Ltd
Initiation of Phase 3 Clinical Trial on the Patient-controlled Pain Management Drug "SyB P-1501"
TOKYO, 2016-06-13 07:32 CEST (GLOBE NEWSWIRE) --
SymBio Pharmaceuticals Limited (Headquarters: Tokyo, “SymBio”) announced today that the Phase 3 clinical trial on “SyB P-1501” – a drug for patient-controlled short-term management of acute postoperative pain during hospitalization, was initiated in Japan, (“the Product”).
SymBio obtained the exclusive development and commercialization rights to the Product in Japan from The Medicines Company (Headquarters: New Jersey, U.S.) in October, 2015. The Product, launched in the U.S., was approved by the U.S. Food and Drug Administration (FDA) in April, 2015 and also approved by the European Medicines Agency (EMA) in November, 2015.
SymBio will actively proceed with this Phase 3 clinical trial, aiming for the Product’s manufacturing and marketing approval in Japan in 2019.
This event will not impact the Company’s current financial forecast.
Tel: +81 (0)3 5472 1125
About The Medicines Company
The Medicines Company was founded in 1996 in the U.S. and is led by a multidisciplinary team with significant experience in pharmaceutical product development and commercialization.
The Company’s purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on the leading acute and intensive care hospitals worldwide. The Company’s vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care and serious infectious disease care. For more information, please visithttp://www.themedicinescompany.com/.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Limited was established in March, 2005, by Fuminori Yoshida who previously served concurrently as Corporate VP of Amgen Inc. and founding President of Amgen Japan. In May, 2016 the Company incorporated its wholly-owned subsidiary in the United States, called SymBio Pharma USA, Inc. (Headquarters: Menlo Park, California, USA, President: Mr. Fuminori Yoshida).
The Company’s underlying corporate mission is to “deliver hope to patients in need” as it aspires to be a leading global specialty biopharmaceutical company dedicated to addressing underserved medical needs with main therapeutic focus in oncology, hematology and pain management.
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