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Sanofi

Sanofi

Sanofi is a french pharmaceutical company founded in 2004 by Madhukar Reddy.

Product
Cablivi

The single-domain antibody (sdAb) drug Cablivi (caplacizumab) combined with plasma exchange and immunosuppressive therapy, for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) adult patients with acquired thrombotic thrombocytopenic purpura. The approval makes Cablivi the first drug in the United States to specialize in the treatment of aTTP.

Cablivi was acquired after Sanofi spent $4.8 billion on Belgian biotechnology Ablynx, which was approved by the European Union at the end of August 2018 for adult patients who have experienced an aTTP attack. The approval makes Cablivi the world's first approved sdAb drug and the first drug specifically designed to treat aTTP. Cablivi has been granted orphan drug qualifications for the treatment of aTTP in the United States and the European Union, as well as fast-track qualifications and priority review qualifications in the United States.

The active drug component of Cablivi is caplacizumab, which is a potent and selective bivalent anti-von Willebrand factor (vWF) sdAb, which can block the interaction between very large vWF polymer (ULvWF) and platelets. It has an immediate effect on platelet aggregation and the subsequent formation and accumulation of small blood clots (microclot). In patients with aTTP, this tiny blood clot can lead to severe thrombocytopenia, tissue ischemia, and organ dysfunction. This transient effect of Cablivi (immediate effect,) can not only dismantle the potential disease process, but also protect the clinical manifestations of aTTP patients.

Approval

The approval of Cablivi was based on data from the Phase III Clinical study HERCULES (NCT02553317). The study was a randomized, double-blind, placebo-controlled study of 145 adult patients with aTTP. In the study, patients were randomly assigned to Cablivi or placebo and received standard care regimens (plasma exchange and immunosuppressive therapy).

The results showed that: (1) in terms of the main endpoints, compared with placebo + standard nursing regimen, Cablivi combined with a standard nursing regimen significantly shortened the time to normalize platelet count (p ≤ 0.01); (2) compared with placebo + standard nursing regimen, Cablivi + standard nursing regimen significantly reduced aTTP-related deaths, aTTP recurrence, or at least one major thromboembolism event by 74 percent during the study period (p < 0.001); (3) Cablivi + a standard nursing regimen significantly reduced the recurrence of aTTP by 67% (p < 0.001); (4) during the study, there were 0 refractory diseases in the Cablivi group and 3 refractory diseases in the placebo group, although there was no significant difference (p ≤ 0.06); (5) compared with the placebo group, the normalization of three organ injury markers (lactate dehydrogenase, cardiac troponin I, serum creatinine) occurred earlier in Cablivi group (p did not detect significant due to stratified statistical test); (6) the use of plasma exchange in Cablivi group was significantly lower than that in the placebo group (mean 5.8 days vs 9.4 days, a decrease of 38%), and the stay in intensive care units (a decrease of 65 percent) and hospitals (a decrease of 31 percent) was shorter; (7) the safety of Cablivi was consistent with previous reports and accords with its mechanism of action, including the increased risk of bleeding, most commonly epistaxis and gingival bleeding.

Timeline

August 3, 2021
Sanofi acquires Translate Bio.

Sanofi will acquire all outstanding shares of Translate Bio for $38.00 per share in cash, which represents a total equity value of approximately $3.2 billion (on a fully diluted basis).

Sanofi's recent acquisition of Tidal Therapeutics expanded the company's mRNA research capabilities in both immuno-oncology and inflammatory diseases.

May 6, 2021
Sanofi establishes three-year collaboration with Stanford Medicine to accelerate immunology research.
November 13, 2020
Sanofi invests €50 million ($59 million) in venture capital firm Jeito Capital.
May 25, 2020
Sanofi announces it was selling billions of dollars' worth of Regeneron stock as it looked to exit its investment in the company.

May 2020
Sanofi achieves 990 million euros of cost cuts in the first half and made $11.7 billion from selling shares in Regeneron.
January 2020
Sanofi acquires Synthorx, Inc. for $2.5 billion.
2020
Sanofi acquires Principia Biopharma for $3.7 billion.

Sanofi picks up the BTK inhibitor in the $3.7 billion acquisition of Principia Biopharma in 2020, a unit now known as Principia Sanofi.

The French drugmaker's biggest molecule in immunology--and the leading seller for the entire company--is Dupixent, which brought in €3.5 billion ($4.2 billion) globally in 2020.

2018
Sanofi launches its long-acting insulin product, Toujeo, in India.

Acquisitions

Invested in

People

Name
Role
LinkedIn

Abdul Karim

Employee

Abdul Karim Syed

Employee

Abhijeet Singh

Employee

Abraham CHERFI

Employee

Adriaan Hart de Ruijter

Employee

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News

Title
Author
Date
Publisher
Description
Ben Adams
October 8, 2021
FierceBiotech
Mirati may have been beaten to the punch by Amgen after it nabbed a speedy FDA approval for its KRAS drug Lumakras this year, but it's still pushing to try to wring the most efficacy out of its rival therapy.
Ben Adams
October 6, 2021
FierceBiotech
After a short tenure at Gilead running its cancer R&D, Valeria Fantin, Ph.D., has been poached by French Big Pharma Sanofi.
September 28, 2021
AP NEWS
PARIS (AP) -- French drugmaker Sanofi said Tuesday it was shelving plans for a COVID-19 vaccine based on messenger RNA despite positive results from early stage testing.The Paris-based company said it will continue to develop another vaccine candidate that is already undergoing late stage human trials.
Nick Paul
September 28, 2021
FierceBiotech
The ink on Sanofi's $3.2 billion takeover of Translate Bio is barely dry but the French big pharma is already tweaking its plans, dumping a COVID-19 vaccine prospect after seeing interim phase 1/2 data and accelerating its switch to modified mRNA.
Robert King
September 22, 2021
FierceHealthcare
HRSA is pushing for six drugmakers to get monetary penalties for restricting sales of 340B discounted products to contract pharmacies.
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