Initiation of Phase 3 Clinical Trial on the Patient-controlled Pain Management Drug "SyB P-1501"
(Thomson Reuters ONE) -
TOKYO, June 13, 2016 (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.
[Contact]
Investor Relations
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
visit http://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.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: SymBio Pharmaceuticals Ltd via GlobeNewswire
[HUG#2020032]
Datum: 13.06.2016 - 07:45 Uhr
Sprache: Deutsch
News-ID 477117
Anzahl Zeichen: 3112
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Kategorie:
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