Pharma BD Deal Intelligence

Sumitomo Dainippon Pharma Co., Ltd. / Tolero Pharmaceuticals, Inc.

2016 · Acquisition/Merger · $780M · Complete

A ~$780M Sumitomo Dainippon bet on Tolero's oncology pipeline that produced zero approved drugs. Lead asset alvocidib (CDK9 inhibitor for AML/MDS) was terminated in 2021, and the deal ultimately fed into hundreds of millions in goodwill and asset impairments.

WRONG BY 56 POINTS

A $780M bet on Tolero's oncology pipeline produced zero approved drugs and fed into hundreds of millions in goodwill/asset impairments

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The coverage arc

Dec 21, 2016 BioCentury Neutral

BioCentury detailed the alvocidib licensing chain (originally from Sanofi, retaining downstream royalty obligations) and characterized the acquisition as a…

Dec 21, 2016 Endpoints News Neutral

Sumitomo Dainippon Pharma has stepped up with a $200 million down payment on its purchase of Salt Lake City-based Tolero... Tolero has been building a case for…

Dec 22, 2016 BioPharma Dive Bullish

Sumitomo CEO Masayo Tada framed the acquisition as reinforcing the oncology pipeline to offset declining Latuda revenues; alvocidib was positioned with…

Source summaries from our enrichment pipeline; follow links for originals.

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Sumitomo Dainippon Pharma agreed to acquire Salt Lake City-based Tolero Pharmaceuticals for $200M upfront plus up to $580M (development milestones up to $430M plus commercial milestones up to $150M), totaling up to $780M. Lead asset alvocidib, a CDK9 inhibitor in midphase trials for AML/MDS. Tolero later merged with Boston Biomedical to form Sumitomo Dainippon Pharma Oncology in 2020.

Did it work? Outcome assessment

A $780M bet on Tolero's oncology pipeline produced zero approved drugs and fed into hundreds of millions in goodwill/asset impairments

Strategic verdict
Failed to Achieve
Financial impact
Dilutive
Sumitomo Dainippon acquired Tolero for $200M upfront plus up to $430M in development milestones and $150M in commercial milestones (total up to $780M). Through the five-year window no acquired asset reached approval or generated meaningful sales, and milestone tranches tied to development/commercial progress were not triggered, leaving the deal value-negative.
Pipeline outcome
Assets Stalled
Tolero's lead asset alvocidib (a CDK9 inhibitor) was pursued in biomarker-driven AML and MDS studies; an NDA had been signaled for FY2018 at the earliest but never materialized within the window. The biomarker Phase 2 AML study (NCT02520011) was ultimately terminated for slow enrollment and an MDS combination study was also halted on company strategy grounds. Tolero was rebranded Sumitomo Pharma Oncology, but no acquired candidate won approval in the five years post-deal.

Key facts

Disease & market context

Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS)

22K US cases/yr

Disease Overview

Acute myeloid leukemia is an aggressive hematologic malignancy of myeloid progenitors with a median age at diagnosis of 68 and 5-year survival around 32%. Myelodysplastic syndromes are clonal bone marrow failure disorders that frequently progress to AML. Both conditions remain difficult to treat in older or unfit patients who cannot tolerate intensive chemotherapy, driving demand for targeted oral agents and biomarker-guided therapy.

Competitive Landscape

Sumitomo Dainippon's December 2016 Tolero acquisition (closed January 26, 2017) brought in alvocidib (formerly flavopiridol), a CDK9 inhibitor that down-regulates MCL-1 to overcome anti-apoptotic resistance in AML. Alvocidib achieved a 70% complete remission rate vs 46% with standard care in an NCI Phase 2 study and held FDA/EMA Orphan Drug Designations. The 2016-2017 AML competitive landscape was rapidly transforming: midostaurin (Rydapt, Novartis) gained FDA approval April 2017 for FLT3-mutant AML; enasidenib (Idhifa, Celgene/Agios) approved August 2017 for IDH2-mutant relapsed/refractory AML; and venetoclax (Venclexta, AbbVie/Genentech)—itself a BCL-2 inhibitor with a complementary apoptotic mechanism—was on track for the 2018 AML approval that would reshape front-line care for unfit patients. Ivosidenib (Tibsovo) followed for IDH1-mutant AML in 2018. Alvocidib's MCL-1-dependent biomarker positioning was differentiated but NDA submission slipped past the original 2018 target. Sumitomo merged Tolero with Boston Biomedical in 2020 to form Sumitomo Dainippon Pharma Oncology; alvocidib was eventually combined with venetoclax in Phase 1b trials but never reached approval.

Related deals — scored

DealYearValueOutcome
Sumitomo Dainippon Pharma Co., Ltd. / Tolero Pharmaceuticals, Inc. (this deal)2016$780M24
Sumitomo Dainippon Pharma Co., Ltd. / Cynapsus Therapeutics Inc.2016$624M28
Sumitomo Dainippon Pharma Co., Ltd. / Otsuka Pharmaceutical Co., Ltd.2021$270M
Sumitomo Dainippon Pharma Co., Ltd. / Roivant Sciences Ltd. (Sumitovant five-Vant deal)2019$3.0B
Amgen Inc. / Micromet Inc.2012$1.2B88
Servier / Shire plc (Oncology Business)2018$2.4B88
AstraZeneca PLC / Alexion Pharmaceuticals Inc.2020$39.0B86

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