Pharma BD Deal Intelligence

Blackstone Life Sciences / Sanofi S.A. (Sarclisa subQ co-development)

2022 · Co-Development · $331M · Complete

A risk-sharing bet that's paying off: Blackstone's EUR 300M (~$331M) funded Sanofi's subcutaneous Sarclisa program, and the IRAKLIA trial delivered non-inferior efficacy (71.1% vs 70.5% ORR) with far fewer infusion reactions (1.5% vs 25%), though full approval still awaits beyond the March 2026 CHMP opinion.

Outcome grade pending — assessed 5 years post-close.

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The coverage arc

Mar 15, 2022 BioPharma Dive Bullish

Sanofi has struck a strategic financing deal with Blackstone Life Sciences worth up to EUR 300 million to accelerate development of a subcutaneous version of…

Mar 15, 2022 Fierce Biotech Bullish

Blackstone Life Sciences is putting up to EUR 300 million ($331 million) on the line to help Sanofi catch up to Johnson & Johnson's runaway myeloma success…

Mar 16, 2022 Fierce Pharma Bullish

Blackstone Life Sciences is pouring up to EUR 300 million into Sanofi's effort to develop a subcutaneous version of its anti-CD38 multiple myeloma drug…

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In March 2022 Sanofi and Blackstone Life Sciences (BXLS) announced a strategic, risk-sharing collaboration under which funds managed by BXLS contribute up to EUR 300M (~$331M) to accelerate the global pivotal program for a subcutaneous formulation of the anti-CD38 antibody Sarclisa (isatuximab) in multiple myeloma, delivered via Enable Injections' enFuse on-body delivery system. Sanofi retains full rights and control; BXLS is eligible for royalties on future subcutaneous sales. The bet has since largely de-risked: the pivotal Phase 3 IRAKLIA study (NCT05405166) met its co-primary endpoints in January 2025, showing non-inferiority of subQ on-body administration versus IV on objective response rate (71.1% vs 70.5%) and steady-state C-trough, with markedly fewer infusion reactions (1.5% vs 25%). In March 2026 the EU CHMP adopted a positive opinion recommending approval of Sarclisa SC via on-body injector across all approved MM indications. US approval remains pending: in April 2026 the FDA extended its review by up to three months to a revised action date of July 23, 2026. If approved, Sarclisa would be the first anticancer therapy administered via on-body injector.

Key facts

Disease & market context

Multiple myeloma (subcutaneous Sarclisa development)

36K US cases/yr · $40.0B Global multiple myeloma therapeutic market forecast (2030) · 331 BXLS funding commitment for Sarclisa subQ pivotal program (USD MM, EUR 300M)

Disease Overview

Multiple myeloma is the second most common hematologic malignancy in the US, with approximately 35,780 new cases and 12,540 deaths projected in 2024 (SEER/ACS). Standard-of-care has evolved into anti-CD38-anchored frontline triplets and quadruplets — daratumumab plus bortezomib/lenalidomide/dexamethasone (D-VRd) in transplant-eligible patients and daratumumab plus lenalidomide/dexamethasone (D-Rd) in transplant-ineligible patients — followed by lenalidomide maintenance and a deep menu of relapsed/refractory options including pomalidomide, carfilzomib, ixazomib, BCMA CAR-T (Abecma, Carvykti) and BCMA bispecifics (Tecvayli, Elrexfio). Despite class-leading efficacy, virtually all patients eventually relapse and the field is now consolidating around regimen convenience, depth-of-response (MRD-negativity), and chronic outpatient administration. Subcutaneous formulations of anti-CD38 antibodies — Darzalex Faspro (J&J) was approved in 2020 in 5-minute SC injection format and rapidly cannibalized IV daratumumab — have set the new convenience benchmark. Sarclisa (isatuximab) IV requires multi-hour infusions and faces meaningful share loss to D-Faspro absent a competitive SC option. The global multiple myeloma therapeutic market was approximately $24B in 2023 and is forecast to exceed $40B by 2030 (EvaluatePharma).

Competitive Landscape

The anti-CD38 myeloma class is a duopoly with structural advantage to Johnson & Johnson's daratumumab (Darzalex/Darzalex Faspro, ~$9.7B 2023, growing double-digit). Sarclisa (isatuximab, Sanofi, ~$370M 2023) holds a distant second position despite differentiated CD38 epitope binding, primarily because IV-only administration and a later FDA approval (March 2020 in IKEMA combination, vs. 2015 for daratumumab) have constrained uptake. Frontline standard-of-care now includes D-VRd (ICARIA, GRIFFIN, PERSEUS data) and D-Rd (MAIA), with isatuximab building Phase 3 evidence in IMROZ (transplant-ineligible) and IsKia (transplant-eligible). Subcutaneous Sarclisa development is the single highest-leverage program for restoring competitive parity. Other myeloma classes shaping the competitive set: IMiDs Revlimid (lenalidomide, BMS, now generic) and Pomalyst (pomalidomide); proteasome inhibitors Velcade (bortezomib), Kyprolis (carfilzomib, Amgen) and Ninlaro (ixazomib, Takeda); BCMA CAR-T Abecma (BMS/2seventy) and Carvykti (J&J/Legend); BCMA bispecifics Tecvayli (J&J) and Elrexfio (Pfizer); GPRC5D bispecific Talvey (J&J, August 2023). Blackstone's risk-sharing structure with milestone-based royalties is a recurring template across BXLS's portfolio (Alnylam, MeiraGTx, Reata) and aligns capital structure with launch trajectory.

Deal timeline

Related deals — scored

DealYearValueOutcome
Blackstone Life Sciences / Sanofi S.A. (Sarclisa subQ co-development) (this deal)2022$331M
Amgen Inc. / Micromet Inc.2012$1.2B88
Servier / Shire plc (Oncology Business)2018$2.4B88
AstraZeneca PLC / Alexion Pharmaceuticals Inc.2020$39.0B86
Swedish Orphan Biovitrum AB / Biovitrum2001$493M84
Otsuka Pharmaceutical Co. Ltd. / Astex Pharmaceuticals2013$886M79
AbbVie Inc. / Pharmacyclics Inc.2015$21.0B79

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