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

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

People

Name
Role
LinkedIn

Abdul Karim

Employee

Abdul Karim Syed

Employee

Abhijeet Singh

Employee

Abraham CHERFI

Employee

Adriaan Hart de Ruijter

Employee

Adrien BESSON

Employee

Aftab Wasim Siddiqui

Employee

Ahmed Hani

Employee

Alain Curaudeau

Employee

Alanna Kennard

Employee

Alcides Colomine

Employee

Alex Novak

Employee

Alexandre Chanay

Employee

Alexandre Galopin

Employee

Alexandre Serra Jaumot

Employee

Alfredo Romero

Employee

Alice Tilin

Employee

Alison Dowsett (Trundle)

Employee

Alison Schecter

Employee

Aman

Employee

Aman Batta

Employee

Amanda Sofía Gonzalez Abi-Saab

Employee

AMIT RAJ GOGIA

Employee

Andrew Wilson

Employee

Andrey Shutov

Employee

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Further reading

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Documentaries, videos and podcasts

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Companies

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News

Title
Author
Date
Publisher
Description
Ben Adams
February 24, 2021
FierceBiotech
French Big Pharma Sanofi is teaming up with Germany's Sirion Biotech for its viral-vector-based gene delivery tech.
Vectra
February 23, 2021
www.prnewswire.com:443
/PRNewswire/ -- Vectra AI, a leader in network detection and response (NDR), today reported that in calendar 2020, sales continued to grow at a compound annual...
Regeneron Pharmaceuticals, Inc.
February 22, 2021
www.prnewswire.com:443
/PRNewswire/ -- Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics...
Nick Paul
February 22, 2021
FierceBiotech
Sanofi and GlaxoSmithKline have begun a phase 2 clinical trial of a new version of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. The study start comes around two months after weak clinical data forced the partners to rethink the antigen formulation.
Ben Adams
February 17, 2021
FierceBiotech
Sanofi is funneling €2.5 million into French clinical trial simulation specialist Novadiscovery as it looks to beef up its COVID-19 trial response.
Nick Paul
February 12, 2021
FierceBiotech
A phase 3 clinical trial of Amicus Therapeutics' late-onset Pompe disease prospect has missed its primary endpoint. Yet, Amicus looked past the failure of AT-GAA to improve statistically on Sanofi's market incumbent Lumizyme, zeroing in on details of the data to justify forging ahead with plans to seek approval of the candidate.
Regeneron Pharmaceuticals, Inc.
February 12, 2021
www.prnewswire.com:443
/PRNewswire/ -- Libtayo was superior in extending overall survival compared to chemotherapy even with a high crossover rate Data are the basis for multiple...
Regeneron Pharmaceuticals, Inc.
February 9, 2021
www.prnewswire.com:443
/PRNewswire/ -- Following Priority Review Libtayo receives full approval in locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic...
Nick Paul
February 8, 2021
FierceBiotech
Sanofi has revised the dosing scheme in its phase 3 assessment of RNAi drug fitusiran to reduce the risk of vascular thrombotic events in hemophilia patients. The revised scheme is intended to prevent the low levels of clot inhibitor antithrombin (AT) associated with vascular thrombotic events.
Research and Markets
February 5, 2021
www.prnewswire.com:443
/PRNewswire/ -- The "Biosimilar Interleukins Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's...
Nick Paul
February 5, 2021
FierceBiotech
A phase 2 clinical trial of venglustat in Parkinson's disease patients has failed, prompting Sanofi to stop work in the indication. Sanofi disclosed the setback alongside news that it is stopping work on a clutch of other midphase programs.
Regeneron Pharmaceuticals, Inc.
February 5, 2021
www.prnewswire.com:443
/PRNewswire/ -- Fourth quarter 2020 revenues increased 30% to $2.42 billion versus fourth quarter 2019(4) Fourth quarter 2020 EYLEA® U.S. net sales increased...
Beth Mole
February 3, 2021
Ars Technica
GSK, Sanofi, Novartis step up to help boost global COVID-vaccine supply.
Kim Willsher
January 26, 2021
the Guardian
Laboratory technicians at the Pasteur Institute in Paris. Photograph: Christophe Archambault/AFP/Getty Images
Kim Willsher
January 26, 2021
the Guardian
Laboratory technicians at the Pasteur Institute in Paris. Photograph: Christophe Archambault/AFP/Getty Images
January 25, 2021
WebWire
Sanofi, Capgemini, Generali and Orange announce plans to create a joint venture in France to fast-track the development of concrete healthcare solutions and to make them available to the market for the benefit of patients. The project, on a scale that is unique in Europe, will bring together leading scientific and technological expertise in France and Europe. It will benefit from both a virtual platform and a physical base located in Paris, linked to the « PariSanté Campus » initiative an...
Research and Markets
January 22, 2021
www.prnewswire.com:443
/PRNewswire/ -- The "Insulin Delivery System Market Research Report by Product Type (Insulin Jet Injectors, Insulin Pens, Insulin Pumps, and Syringes), by End...
Dynacure
January 21, 2021
www.prnewswire.com:443
/PRNewswire/ -- Dynacure, a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare...
Ben Adams
January 12, 2021
FierceBiotech
Welcome to Day 2 of the annual J. P. Morgan Healthcare Conference. Here's your need to know, as Sanofi as it again with a second deal in as many days, Novartis talks about the positives of the pandemic on its processes and Boehringer turns to the dark side.
Nick Paul
January 12, 2021
FierceBiotech
Sanofi is paying Biond Biologics $125 million upfront for global rights to a novel immune checkpoint inhibitor. The agreement gives Sanofi a near-clinical anti-ILT2 monoclonal antibody designed to turn the innate and adaptive immune systems against tumors.
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References

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