For Immediate Release

2016.01.12

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Executive Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/

Daiichi Sankyo Announces Results of Phase 3 International Joint Trial (RApsody) of Investigational Etanercept Biosimilar

TOKYO, Japan (January 12, 2016) - Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) today announced that they have achieved major objectives in the Phase 3 international joint trial (RApsody) of CHS-0214, an investigational etanercept (genetical recombination) biosimilar in rheumatoid arthritis (RA) under development with the U.S. company, Coherus BioSciences, Inc. (hereinafter, Coherus).

The trial compares the efficacy and safety of CHS-0214 with Enbrel [generic name: etanercept (genetical recombination); hereinafter, reference product] in RA patients (including Japanese patients) with inadequate response to methotrexate.

The primary endpoint (ACR20), evaluating the disease activity of rheumatoid arthritis at 24 weeks after the administration of CHS-0214, met the criteria of equivalence as defined in advance in CHS-0214 and reference product groups, achieving the intended purpose. No significant difference was noted in the reported adverse events between CHS-0214 and reference product groups. Currently, this trial is continued in open-label extension study following the 24-week double-blind phase.

Daiichi Sankyo will continue the development of CHS-0214 based on the strategic alliance with Coherus, concluded for the biosimilar business in Japan in 2012, aiming to enter the biosimilar market to meet diverse medical needs.

1Biosimilars are biologic medical products that are similar to already approved biotechnology applied pharmaceuticals but are developed by a different manufacturer.

2ACR20 is 20% improvement according to American College of Rheumatology criteria. Subjects will be considered an ACR20 responder if : compared to Baseline (Day 0), they achieve : 20% decrease in swollen joint count, 20% decrease in tender joint count, and 20% improvement in 3 of the following 5 measures: 1) CRP 2) Health Assessment Questionnaire - Disability Index 3) Subject's pain assessment 4) Subject's Global Assessment 5) Physician's Global Assessment.

About Coherus BioSciences, Inc.

1. Representative: Dennis M. Lanfear

2. Head office: California, USA

3. Established year: 2010

4. Business: Coherus is a leading pure-play global biosimilar platform company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products.

5. Web site: www.coherus.com.

Daiichi Sankyo Co. Ltd. issued this content on 2016-01-12 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 2016-01-12 02:05:16 UTC

Original Document: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006396.html