June 14, 2012
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer

SYMBIO ANNOUNCES ORPHAN DRUG DESIGNATION FOR TREAKISYM® (BENDAMUSTINE)
IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)TOKYO, Japan, June 14, 2012 – SymBio Pharmaceuticals Limited (JASDAQ: 4582) announced
today that bendamustine hydrochloride (Brand Name: TREAKISYM®) has been designated as anorphan drug by the Ministry of Health, Labour, and Welfare (MHLW) for the treatment of chronic
lymphocytic leukemia (CLL).
Drugs and biologics with orphan drug designation in Japan are defined as those intended for thesafe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer
than 50,000 patients (maximal incidence of four per ten thousand), with incentives for sponsors todevelop orphan products such as priority review of New Drug Applications (NDAs) by the
Pharmaceuticals and Medical Devices Agency (PMDA), 10 years of market exclusivity, and grantfunding for sponsors.
CLL is is a cancer of the blood characterized by a progressive accumulation of functionally
incompetent lymphocytes, a type of white blood cell, produced by the bone marrow and by organs ofthe lymph system. The number of CLL patients in Japan is estimated to be around 2,000. In the U.S.
and EU, bendamustine has been approved for the treatment of CLL where the disease accounts foran estimated 30% of all leukemia cases. Due to a lack of effective therapies in Japan, CLL patientsare seriously underserved and the development of an effective alternative therapy is needed. In
Japan, a Working Group of MHLW has designated TREAKISYM® as a prioritized unapproved drug
having high potential for the treatment of unmet needs in CLL.
In partnership with Eisai Co., Ltd., SymBio received marketing approval of TREAKISYM® (SyB L0501) in October, 2010, for the treatment of patients with relapsed/refractory (r/r) low-grade nonHodgkin’s lymphoma (NHL) and mantle cell lymphoma (MCL) in Japan. A Phase II study for SyB L0501 in r/r Aggressive NHL has been completed, with two Phase II studies in frontline low-grade
NHL and MCL, and relapsed/refractory multiple myeloma patients currently underway.
[Contact]
Hiroki MaekawaBoard Director, Corporate Officer, Chief Financial Officer
Tel: +081(0)3 5472 1125

About Bendamustine Hydrochloride (SyB L-0501)
Bendamustine was first synthesized in the early 1960s in the former ‘East Germany’ by Jenapharm,and is currently marketed in Germany under the brand name “Ribomustin®” as a treatment for nonHodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. Mundipharma hasreceived market authorization in a number of EU countries for bendamustine under the brand name“Levact®”. In the United States, the drug has been approved by the U.S. Food and Drug
Administration and is marketed as TREANDA® for the treatment of chronic lymphocytic leukemia
and relapsed indolent B-cell non-Hodgkin's lymphoma. SymBio Pharmaceuticals Limited originallyacquired the exclusive right to develop and commercialize bendamustine in Japan (December, 2005)
from Astellas Deutschland GmbH (Headquarters: Munich, Germany, formerly Astellas PharmaGmbH) followed by a second license agreement for the exclusive right to China, Hong Kong, Taiwan,
South Korea and Singapore (March, 2007).

About TREAKISYM®
Brand Name:TREAKISYM® for Injection, for intravenous infusion 100 mg
Generic Name:bendamustine hydrochloride
Indications and Usage:
For the treatment of relapsed/refractory forms of the following indications:・ low-grade B-cell non-Hodgkin’s lymphoma
・ mantle cell lymphoma
Dosage and Administration:
The standard adult dose of bendamustine hydrochloride is 120 mg/m2 infused intravenously over 60
minutes on Days 1 and 2 of repeated 21-day cycles. The dose may be reduced as deemed
appropriate according to the patient’s condition.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Ltd. was established in March, 2005, by Fuminori Yoshida, who previouslyserved concurrently as Corporate Vice President of Amgen Inc. and founding President of Amgen
Japan (currently Takeda Bio Development Center Limited). The company’s underlying corporate
mission is “delivering hope to patients in need” as it aspires to be a leading specialty pharmaceuticalcompany in Asia Pacific dedicated to addressing underserved medical needs in oncology,
hematology and autoimmune disease.