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Sanofi (SNY), Blackstone Ink Deal for Subcutaneous Sarclisa

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Sanofi (SNY - Free Report) announced that it has inked a strategic, risk-sharing collaboration with a private, global investment platform of Blackstone (BX - Free Report) , Blackstone Life Sciences, to support the development of the subcutaneous formulation of Sanofi’s myeloma drug, Sarclisa.

Per the agreement, Blackstone Life Sciences will contribute up to €300 million (approximately $330 million), which will be used to accelerate the global pivotal studies and the clinical development program for subcutaneous Sarclisa to treat multiple myeloma (“MM”) patients. Blackstone Life Sciences is eligible to receive royalties on the future sales of subcutaneous Sarclisa, following the successful development and potential approval.

Sanofi is planning to start a pivotal study to evaluate subcutaneous Sarclisa in MM patients in the second half of 2022. The company has partnered with drug delivery technology innovator company, Enable Injections for the subcutaneous formulation delivery of Sarclisa.

We note that the subcutaneous formulation of Sarclisa is not yet approved anywhere. However, Sarclisa is approved as an intravenous injection for treating MM patients. The successful development of subcutaneous Sarclisa will be beneficial for patients for its convenience in administration compared to the intravenous injection.

Sanofi stock has gained 3.4% this year so far against a decrease of 1.9% for the industry.

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Sarclisa received its first FDA approval in combination with Bristol-Myers’ (BMY - Free Report) Pomalyst (pomalidomide) and dexamethasone for treating adults with relapsed/refractory MM having received at least two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor in 2020.

In December 2021, Sanofi announced that a phase III study evaluating Sarclisa in combination with standard-of-care treatment, Bristol-Myers’ Revlimid, bortezomib and dexamethasone in MM patients met its primary endpoint. The combination regimen achieved minimal residual disease negativity in transplant-eligible patients with newly diagnosed MM.

We note that Bristol-Myers’ Pomalyst and Revlimid  are both approved for treating MM.

Last year, Sanofi gained FDA approval for the label expansion of Sarclisa for the treatment of adult patients with relapsed/refractory MM in the second- to fourth-line setting in combination with Amgen’s (AMGN - Free Report) Kyprolis (carfilzomib) and dexamethasone.

Kyprolis is a key drug in Amgen’s oncology portfolio approved for multiple myeloma. Amgen is evaluating Kyprolis for additional indications. Kyprolis is being investigated for weekly dosing in combinations with lenalidomide and dexamethasone for relapsed multiple myeloma.

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