October 16, 2018
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and Chief Executive Officer(Securities Code: 4582)

SymBio Begins Preparation for Own Sales Organization for
the Anti-Cancer Agent TREAKISYM®

TOKYO, Japan, October 16, 2018 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, Japan;"SymBio") today announced that SymBio has made its decision to initiate preparation to establish its
own sales organization for the sale of the anti-cancer agent TREAKISYM® (bendamustine HCl) inJapan, looking towards the expiration of its business alliance agreement with Eisai Co., Ltd.
(Headquarters: Tokyo, Japan; "Eisai") for the development and sale of TREAKISYM®. The businessalliance agreement, entered into in August 2008, will expire in December 2020.
While TREAKISYM® is currently sold in Japan through SymBio’s sales partner, Eisai, SymBio has
carefully examined all options, including potential alliances, to determine how best to achieve the key
management objectives of attaining profitability in fiscal year 2021, and maintaining sustainablegrowth thereafter. Considering the importance of understanding patient needs and responding to themarket with greater precision and speed, SymBio has determined that conveying the value of theproduct through information provided by in-house sales and marketing experts will benefit patients,and that building its own sales organization is the right choice to maximize the business value ofTREAKISYM®.
Looking toward 2021, SymBio will develop a sales organization highly specialized for hematologyrelated diseases and will achieve high productivity by selling rigosertib for myelodysplastic
syndromes (MDS) (both IV and oral rigosertib formulations currently under development) in addition
to TREAKISYM®, thereby increasing value for shareholders.
Statement from Fuminori Yoshida, President and CEO of SymBio: “With the positioning ofTREAKISYM® and rituximab combination therapy (BR therapy) established in July of this year as
the standard therapy for malignant lymphoma, the addition of new indications including
relapsed/refractory diffuse large B-cell lymphoma (r/ r DLBCL), and a number of new therapies underdevelopment in combination with a bendamustine regimen by pharmaceutical companies globally, weare optimistic that the intrinsic value of TREAKISYM® will continue to grow. It is a great strength ofSymBio that BR therapy has become the backbone for the treatment of malignant lymphoma, and we

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will fully take advantage of this strength in building our own sales organization and expanding ourbusiness. We are aiming to achieve sales of JPY 10 billion on a NHI drug price basis at the earliest
possible stage and realize the vision of SymBio's founding to become a Specialty Pharma.”
The financial forecast for 2018 and the mid-range business plan released by SymBio on February 7,
2018, are prepared on the basis that SymBio will have its own sales organization in place for 2021
and remain unchanged.

[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125

TREAKISYM® Business Strategy Developments
Since its founding in 2005, SymBio has actively promoted strategies of product life cycle management
to maximize the business value of TREAKISYM®.
1.

After obtaining marketing approval for relapsed/refractory low-grade B-cell non-Hodgkin'slymphoma (low-grade NHL) and mantle cell lymphoma (MCL) in October 2010, SymBio obtained
approval for (i) chronic lymphocytic leukemia (CLL) as an additional indication in August 2016, (ii)
TREAKISYM® Intravenous Infusion 25 mg in September 2016, and (iii) 1st line low-grade NHL andMCL as additional indications in December 2016. In August 2017, SymBio also initiated a phase III
clinical trial for the indication of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL),
which has the largest number of malignant lymphoma patients.
2.

For TREAKISYM® oral formulation, SymBio is currently conducting a phase I clinical study foradvanced solid tumors in addition to joint research with Keio University for systemic lupus
erythematosus (SLE), an autoimmune disease with high unmet medical need.
3.

In July 2018, TREAKISYM® was approved for use in combination with other new anti-CD20

antibodies in addition to rituximab. As a result, TREAKISYM® and obinutuzumab (GAZYVA®, withmarketing authorization held by Chugai Pharmaceutical Co., Ltd.) combination therapy is now
available for CD20 positive follicular lymphoma (FL), a typical histologic type of low-grade NHL.
In addition, in September 2018, SymBio filed a partial change application for the use ofTREAKISYM® as a pretreatment to regenerative medical products. Novartis Pharma K.K.
(headquarters: Tokyo) filed for the marketing approval of KymriahTM, the first chimeric antigen
receptor T-cell (CAR-T) therapy in Japan, on April 23, 2018. After both approvals are obtained,TREAKISYM® can be used as a pretreatment to KymriahTM .

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4.

In September 2017, SymBio signed an exclusive license agreement with Eagle Pharmaceuticals,Inc. for the development and commercialization in Japan of Eagle’s ready-to-dilute (“RTD”) and rapid
infusion (“RI”)

injection bendamustine HCl products, patent protected liquid formulations that will

extend the product life of TREAKISYM® through 2031.
In fiscal 2021, SymBio plans to launch the RTD liquid formulation and obtain approval for r/r
DLBCL, and by delivering the value of TREAKISYM® to healthcare providers with precision andspeed through its own sales organization, SymBio will continue to evolve its business to further
benefit patients.
Development Status of Rigosertib
Since entering into an exclusive licensing agreement with Onconova Therapeutics, Inc. (Onconova) inJuly 2011 for the development and commercialization of rigosertib in Japan, SymBio has been
actively developing rigosertib (both IV and oral formulations) for myelodysplastic syndromes (MDS),
for which there is high medical need.
1) For rigosertib IV, SymBio leads clinical development in Japan as part of an international phase III
clinical trial conducted by Onconova for patients with high-risk myelodysplastic syndrome (MDS) who
have failed to respond to hypomethylating agents, relapsed after treatment, or were intolerant of
hypomethylating agents. The trial in Japan began in December 2015, and 37 patients have beenenrolled as of the end of September 2018.
2) With respect to rigosertib oral, Onconova is conducting a phase I/II clinical trial in the UnitedStates targeting high-risk MDS for 1st line treatment (in combination with azacytidine) and a phase II
clinical trial targeting transfusion-dependent low-risk MDS. In June 2017, SymBio commenced aphase I clinical trial in Japan to confirm tolerability and safety, and the trial has progressed steadily
since the first patient enrollment in October 2017.
TREAKISYM® is currently used by hematologists at approximately 900 healthcare institutions acrossJapan, with the top 400 institutions accounting for approximately 90% of sales. It is anticipated that,as with TREAKISYM®, rigosertib will be used by hematologists of these 400 institutions.

3Current status of the SymBio pipeline

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 AmgenJapan. In May, 2016 SymBio incorporated its wholly-owned subsidiary in the U.S., called SymBio
Pharma USA, Inc. (Headquarters: Menlo Park, California, President: Mr. Fuminori Yoshida).
SymBio’s underlying corporate mission is to “deliver hope to patients in need” as it aspires to be aleading global specialty biopharmaceutical company dedicated to addressing underserved medical
needs with main therapeutic focus in oncology, hematology and pain management.

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