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January 26, 2017 - Sumitomo Dainippon Pharma Completes Acquisition of Tolero Pharmaceuticals, Inc. Line December 21, 2016 - Sumitomo Dainippon Pharma to Acquire Tolero Pharmaceuticals, Inc. Line November 15, 2016 - Tolero Pharmaceuticals to Present Progress of Leukemia and Anemia Programs at the 58th ASH Annual Meeting and Exposition Line October 11, 2016 - Tolero Pharmaceuticals to Present at the International Conference on Leukemia and Hematologic Oncology in Rome, Italy Line June 13, 2016 - Tolero Pharmaceuticals Presents Nonclinical Data Demonstrating Alvocidib Provides Drug Combination Strategies Due to the Targeting of MCL-1 Line June 6, 2016 - Tolero Pharmaceuticals to Present Updates on Clinical and Preclinical Programs at the 2016 EHA Congress Line June 6, 2016 - Tolero Pharmaceuticals to Present at the Jefferies 2016 Global Healthcare Conference Line April 20, 2016 - Tolero Pharmaceuticals Presents Nonclinical Data Demonstrating Alvocidib Provides Multiple Drug Combination Strategies Due to the Targeting of MCL-1 Line April 18, 2016 - Tolero Pharmaceuticals Presents Data Demonstrating AXL Inhibition Leads to a Reversal of a Mesenchymal Phenotype Sensitizing Cancer Cells... Line April 12, 2016 - Tolero Pharmaceuticals to Present Updates on Clinical and Preclinical Programs at the AACR Annual Meeting 2016 Line March 8, 2016 - Tolero Pharmaceuticals to Present at the 13th Annual BIO Asia International Conference Line January 4, 2016 - Tolero Pharmaceuticals to Present at the 34th Annual J.P. Morgan Healthcare Conference Line December 7, 2015 - Tolero Pharmaceuticals Presents Positive Preclinical Data on Hepcidin Inhibition for the Treatment of Anemia... Line December 7, 2015 - Tolero Pharmaceuticals Presents Preclinical Data Demonstrating Synergistic Activity with a Combination... Line December 7, 2015 - Tolero Pharmaceuticals Presents Data Demonstrating Inhibition of AXL Kinase in Cancer Cells Restores Drug... Line December 8, 2015 - Tolero Pharmaceuticals Announces Mechanistic Data Describing the Activity of Alvocidib within a Time-sequential Regimen... Line November 12, 2015 - Tolero Pharmaceuticals Presents Positive Clinical and Preclinical Data on Programs in Leukemia and Anemia... Line November 9, 2015 - Tolero Pharmaceuticals Executes Exclusive License with Eutropics for Novel Companion... Line November 9, 2015 - Tolero Pharmaceuticals Presents Results Providing Strong Rationale for Combining Alvocidib with... Line September 21, 2015 - Tolero Pharmaceuticals Announces Mechanistic Data Describing the Activity of Alvocidib... Line September 14, 2015 - Tolero Pharmaceuticals to Present Alvocidib Regimen Data at Upcoming Medical Conferences Line June 16, 2015 - Tolero Pharmaceuticals Presents Positive Preclinical Data that Inhibition of AXL Kinase Restores Tumor Response to Retinoic Acid Line June 16, 2015 - Tolero Pharmaceuticals Presents Positive Preclinical Data on Hepcidin Inhibition for the Treatment of Anemia... Line June 4, 2015 - Tolero Pharmaceuticals to Present Preclinical Pipeline Data at the 20th Congress of European Hematology Association, EHA Line June 2, 2015 - Tolero Pharmaceuticals and Eutropics Announce Results Demonstrating the Predictive Potential of a Biomarker... Line May 21, 2015 - Tolero Pharmaceuticals to Present Alvocidib Data at the 2015 American Society of Clinical Oncology Annual Meeting Line April 24, 2015 - Tolero Pharmaceuticals Presents Data Demonstrating Profound Synergy of Alvocidib and Bromodomain Protein Inhibitors... Line April 14, 2015 - Tolero Pharmaceuticals to Present Positive Advancement of Clinical and Preclinical Programs... Line February 27, 2015 - Tolero Pharmaceuticals Receives EMA Orphan Drug Designation for Alvocidib... Line January 9, 2015 - Tolero Pharmaceuticals, Inc., to Present at Biotech Showcase 2015 Line November 17, 2014 - Tolero Pharmaceuticals' Alvocidib Selected as 'Top 10 Most Interesting Oncology Project... Line November 13, 2014 - Tolero Pharmaceuticals Presents Positive Preclinical Data... Line November 5, 2014 - Tolero Pharmaceuticals Completes Second Tranche of Series B Financing... Line August 12, 2014 - Tolero Pharmaceuticals and Eutropics Announce Data Demonstrating Clinical Utility of Praedicare Dx... Line August 7, 2014 - Tolero Pharmaceuticals Closes $14.2 Million Series B Financing Line June 30, 2014 - Tolero's PIM Kinase Inhibitor Demonstrates Promising Activity in Preclinical Models... Line June 4, 2014 - Tolero Pharmaceuticals Presents Positive Interim Phase 2 Clinical Trial Results... Line May 15, 2014 - Tolero Pharmaceuticals Highlights Alvocidib Data to be... Line Apr 23, 2014 - Tolero Pharmaceuticals Receives FDA Orphan Drug Designation... Line Apr 7, 2014 - Tolero 2014 AACR Presentation Describes Relationship... Line May 1, 2013 - Tolero Pharmaceuticals announces Worldwide Agreement... Line Apr 10, 2013 - Tolero's Drug Development Pipeline Highlighted in... Line Jan 13, 2013 - Tolero Pharmaceuticals Spotlighted as an Emerging... Line Jan 7, 2013 - Clinical Cancer Research Article Demonstrates... Line Sep 14, 2012 - Tolero Pharmaceuticals Awarded Small Business... Line Jul 17, 2012 - Tolero Pharmaceuticals Acquires Drug Development Assets... Line Jul 13, 2012 - Tolero Pharmaceuticals Appoints Frank Zhan, MD, PhD... Line Apr 30, 2012 - Tolero and MannKind Sign Collaboration and License... Line Mar 30, 2012 - TP-0413 by Tolero Pharmaceuticals Named Finalist in... Line Jan 26, 2012 - Tolero Pharmaceuticals Appoints Gary P. Pisano, Ph.D... Line Jan 20, 2012 - Tolero Pharmaceuticals Appoints Professor Richard G. Hamermesh... Line Aug 5, 2011 - Tolero Pharmaceuticals Appoints Randall Peterson, Ph.D...

Sumitomo Dainippon Pharma Completes Acquisition of Tolero Pharmaceuticals, Inc. (US Biotechnology Company)

Sumitomo Dainippon Pharma Co., Ltd. (Head office: Osaka, Japan; President: Masayo Tada; Securities Code: 4506, First Section of TSE, "Sumitomo Dainippon Pharma") announced today that it has completed the acquisition of Tolero Pharmaceuticals, Inc. (Head office: Lehi, UT, U.S., CEO: David J. Bearss., "Tolero") as of January 25, 2017 (U.S. Pacific Standard Time).

Through this transaction, Sumitomo Dainippon Pharma has acquired six compounds, including a cyclin-dependent kinase 9 (CDK9) inhibitor alvocidib, which is under clinical development by Tolero for the treatment of hematologic malignancies, and has strengthened its development pipeline in oncology, one of its focus therapeutic areas. Alvocidib is currently being investigated in a Phase 2 study for biomarker-positive patients with acute myeloid leukemia (AML) in the U.S., and a New Drug Application (NDA) is expected to be submitted to the U.S. Food and Drug Administration (FDA) in fiscal 2018 at the earliest.

Going forward, Sumitomo Dainippon Pharma, Boston Biomedical and Tolero will collaborate in drug discovery activities and we, as part of the Sumitomo Dainippon Pharma group, will aim to create a continuous flow of innovative products in the oncology area. David J. Bearss will continue to serve as the CEO of Tolero, as he did prior to the acquisition.

A description of this acquisition was disclosed in the announcement "Sumitomo Dainippon Pharma to Acquire Tolero Pharmaceuticals, Inc. (US Biotechnology Company)" made on December 21, 2016.

About Cyclin-dependent kinase (CDK) 9 inhibitor; alvocidib
Alvocidib targets CDK9, a member of the cyclin-dependent kinase family, which activates the transcription of cancer-related genes. The subsequent down-regulation of MCL-1, an anti-apoptotic gene, may be responsible for the potential clinical anti-cancer activity observed with alvocidib.

Alvocidib is an investigational intravenous small-molecule agent and has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of acute myeloid leukemia (AML). The National Cancer Institute (NCI) conducted alvocidib’s Phase 2 study(J-1101/NCI-8972, Haematologica 2015;100(9))comparing the ACM regimen (alvocidib, cytarabine and mitoxantrone) to the standard-of-care (cytarabine and daunorubicin) in frontline AML patients who had one or more poor-risk features. In this study, the ACM regimen (alvocidib combination therapy) demonstrated a statistically significant improvement in the complete remission (CR) rate, one of primary endpoints for AML therapy, compared to the standard-of-care, 70% and 46%, respectively. Moreover, the tolerability of both regimens was similar.

Alvocidib is licensed from Sanofi S.A. (Head office: France) to Tolero for exclusive worldwide rights to develop and commercialize. Torelo will make payments to Sanofi on the successful achievement of milestones related to the commercialization and pay tiered royalties on sales of alvocidib.

Disclaimer Regarding Forward-looking Statements
The statements made in this press release are forward-looking statements based on management’s assumptions and beliefs in light of the information available up until the day of the announcement, and involve both known and unknown risks and uncertainties.

Actual financial results may differ materially from those presented in this document; as such results are dependent on a number of factors. Information concerning pharmaceuticals (including compounds under development) contained within this press release is not intended as advertising or medical advice.

Contact:
Public Relations/Investor Relations
Sumitomo Dainippon Pharma Co., Ltd.
TEL: +81-6-6203-1407 (Osaka)
TEL: +81-3-5159-3300 (Tokyo)

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