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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

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

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
July 29, 2021
FierceBiotech
Sanofi has made a small trim to its pipeline today, though its near-term R&D focus remains on the 35,000-strong COVID vaccine test it started last quarter.
Amirah Al Idrus
July 27, 2021
FierceBiotech
As SynOx Therapeutics gears up to test its anti-CSF1R antibody in registrational trials, the Dublin-based biotech is getting a pair of new leaders. Ray Barlow, formerly the chief business officer of Kiadis Pharma, signs on as CEO and Ton Logtenberg, Ph.D. becomes the company's new non-executive chairman.
July 21, 2021
International Business Times UK
Sanofi and GSK said in May that they would launch final trials after finding their drug "achieved strong rates of neutralising antibody responses" in Phase 2 clinical trials.
Kyle LaHucik
July 20, 2021
FierceBiotech
Sanofi and GlaxoSmithKline passed a small phase 2 COVID-19 vaccine test in mid-May and began enrollment for a global phase 3 later that month, with hopes for a fourth quarter approval. That process picked up steam Tuesday with the European Medicines Agency saying it started a rolling review of the potential vaccine.
Ben Adams
July 13, 2021
FierceBiotech
Biogen is paying $125 million upfront to work on InnoCare's orelabrutinib, an oral small molecule Bruton's tyrosine kinase inhibitor that the pair hope can cut it in multiple sclerosis.
July 8, 2021
The Times of India
India News: NEW DELHI: Sanofi and GSK have received approval for their Phase 3 clinical study in India to assess the safety, efficacy and immunogenicity of their .
Sohini Das
July 8, 2021
@bsindia
India part of 35,000 volunteer global efficacy trial
BioSpace
July 8, 2021
BioSpace
Biophytis SA announces the strengthening of its leadership teams with three new appointments of highly experienced healthcare executives.
Leroy Leo
July 6, 2021
mint
If the firm gets approval, it will be the first global trial for a foreign covid vaccine in the country
Mark Terry
July 6, 2021
BioSpace
It was another busy week for clinical trial news ahead of the July 4 holiday in the U.S. Here's a look.
BioSpace
July 6, 2021
BioSpace
Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing and commercializing novel high-quality medicines for patients living with rare diseases, today announced the appointment of Dr. Preethi Sundaram as Chief Product Development Officer.
Kyle LaHucik
July 6, 2021
FierceBiotech
Sanofi will fork over an undisclosed upfront payment but a major $1 billion in biobucks to Eureka and Memorial Sloan Kettering for the exclusive rights to a potential treatment for multiple myeloma.
Kyle LaHucik
July 1, 2021
FierceBiotech
Carlos Garcia-Echeverria, Ph.D., was global head of research platforms at Sanofi and now takes the helm of drug discovery for EQRx, which has gained $750 million since January 2020 to advance its portfolio.
Mark Terry
June 29, 2021
BioSpace
The groundbreaking success of the mRNA vaccines for COVID-19 by Pfizer-BioNTech and Moderna has led the way for other companies with a vested interest in vaccine development.
Nick Paul
June 29, 2021
FierceBiotech
Sanofi is set to invest €400 million ($476 million) a year in a dedicated vaccines mRNA Center of Excellence. The commitment is intended to establish Sanofi as a frontrunner in the race to develop mRNA vaccines against a wide range of infectious diseases.
June 29, 2021
mint
The French drug giant, lagging its American competitors on the COVID vaccines front, added on Tuesday that its "mRNA Center of Excellence" would bring together approximately 400 employees
Amirah Al Idrus
June 28, 2021
FierceBiotech
Hanmi Pharmaceuticals may no longer have a diabetes partner in Sanofi, but newly released results for its GLP-1 drug could move the needle for Type 2 diabetes patients with a history of cardiovascular disease, kidney disease or both. Efpeglenatide reduced their risk of heart attack, stroke and death and also slowed decline in patients' kidney function, new data show.
Brandon May
June 28, 2021
BioSpace
The trial is the third study in a set of pivotal trials to report positive data for the therapy.
American Diabetes Association
June 28, 2021
www.prnewswire.com:443
/PRNewswire/ -- The American Diabetes Association® (ADA), along with the nation's leading diabetes organizations, unveiled Let's Talk Insulin today, a campaign...
Nick Paul
June 28, 2021
FierceBiotech
AstraZeneca and Sanofi's respiratory syncytial virus drug candidate nirsevimab has performed similarly to the incumbent product Synagis in a phase 2/3 assessment of safety and tolerability.
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References

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