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.

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 standard nursing regimen significantly shortened the time to normalize platelet count (p ≤ 0.01); at any particular time point during the study period, the possibility of reaching normal platelet count in Cablivi treatment group was. The placebo group was 1.55 times as much as the placebo group. (2) compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly reduced aTTP-related deaths, aTTP recurrence or at least one major thromboembolism event by 74 percent throughout the study period (p < 0.001). (3) during the whole study period, compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly reduced the recurrence of aTTP by 67% (p < 0.001). (4) throughout the study period, 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 stay in intensive care units (a decrease of 65 percent) and hospitals (a decrease of 31 percent) is even shorter. (7) the safety of Cablivi is consistent with previous reports and accords with its mechanism of action, including the increased risk of bleeding; the most common bleeding-related adverse events are epistaxis and gingival bleeding.

Timeline

May 25, 2020

Sanofi announces it was dumping 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

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Role
LinkedIn

Madhukar Reddy

Founder

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Documentaries, videos and podcasts

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News

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September 1, 2020
WebWire
Sanofi today announced that the global Phase 3 trial investigating intravenously administered Kevzara® (sarilumab) at a dose of 200 mg or 400 mga in severely or critically illb patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpointc when Kevzara was compared to placebo added to usual hospital care. The 420-patient randomized trial was conducted outside the U.S. in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia...
Reuters
August 29, 2020
@bsindia
The company is working on two of the more than 150 potential vaccines being developed across the world to tackle the Covid-19 pandemic
James Paton | Bloomberg
August 2, 2020
@bsindia
Moves by the US and UK to secure supplies from Sanofi and partner GlaxoSmithKline Plc, and another pact between Japan and Pfizer Inc., are the latest in a string of agreements
July 31, 2020
WebWire
Sanofi and GSK today announce a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established pandemic adjuvant technology. Collaborating with the U.S. Department of Health and Human Services (HHS) and Department of Defe...
Bloomberg
July 31, 2020
@bsindia
Glaxo shares traded 1.6 per cent higher in London, with Sanofi up 1.4 per cent in Paris
Reuters
July 29, 2020
@bsindia
Sanofi is working on two of the more than 150 potential Covid-19 vaccines being developed across the world
Reuters
July 29, 2020
@bsindia
Sanofi and GSK said they had reached an agreement with Britain to supply it with up to 60 million doses of a potential Covid-19 vaccine, and that discussions with other governments were ongoing
Telegraph reporters
July 29, 2020
The Telegraph
UK signs deal for vaccine being developed by Sanofi and GlaxoSmithKline, its fourth such arrangement
Ben Adams
July 17, 2020
FierceBiotech
Still augmenting its R&D and trying to drive innovation internally, French Big Pharma Sanofi is preparing to spend billions on biotechs to help further this cause.
Amirah Al Idrus
July 14, 2020
FierceBiotech
Immuno-oncology drugs such as checkpoint inhibitors have transformed cancer treatment for some patients--the key word being "some." Sanofi aims to understand why these drugs work for some patients and not others, and it's teaming up with the MD Anderson Cancer Center to do it.
Ben Adams
July 9, 2020
FierceBiotech
While Sanofi is looking to move more of its R&D in-house, there is still room for deals, and today it's penned a big one with Fierce 15 winner Kymera Therapeutics.
Nick Paul
July 8, 2020
FierceBiotech
Sanofi has licensed natural killer cells from Kiadis Pharma to use in combination with its multiple myeloma drug Sarclisa. The backloaded, €875 million ($986 million) deal gives Sanofi global rights to therapies that could mitigate an efficacy-limiting shortcoming of anti-CD38 antibodies.
Amirah Al Idrus
June 23, 2020
FierceBiotech
Paul Hudson wasted no time when he took the reins at Sanofi, unveiling plans to ditch the company's weakest R&D units and double down on cancer, rare diseases and other "growth drivers" within his first 100 days. Six months on, head of development, Dietmar Berger, reflects on the R&D shakeup.
Prophecy Market insights
June 22, 2020
GlobeNewswire News Room
Covina, CA, June 22, 2020 (GLOBE NEWSWIRE) -- The global COVID-19 vaccines market accounted for US$ 2.6 billion in 2020 and is estimated to be US$ 1.5...
Reuters Editorial
June 16, 2020
IN
L-E'TOILE, France (Reuters) - Sanofi's Chief Executive Paul Hudson on Tuesday sought to set aside tensions with the French government and said the drugmaker was committed to helping France build up its healthcare independence.
Ian Sample Science editor
June 14, 2020
the Guardian
The NHS already offers free flu jabs to over-65s, pregnant women and people with weakened immune systems. Photograph: David Cheskin/PA
Ben Adams
June 11, 2020
FierceBiotech
French Big Pharma Sanofi, looking to bolster its cancer R&D, has penned a new pact with Alphamab Oncology that focuses on HER2-positive breast cancer.
Mark Terry
June 10, 2020
BioSpace
Denali Therapeutics and its development partner Sanofi announced data from its Phase Ib trial of DNL747 in Alzheimer's disease and amyotrophic lateral sclerosis (ALS).
Mark Terry
June 9, 2020
BioSpace
Alphamab Oncology, based in Suzhou, China, inked a collaboration deal with Sanofi (China) Investment Co. to advance clinical trials of Alphamab's KN026 with Sanofi's Taxotere (docetaxel) in HER2+ breast cancer.
Ben Adams
June 8, 2020
FierceBiotech
Oxford Biomedica is currently most well known for its work on COVID-19 vaccines and its tie-up with AstraZeneca, but a much older deal sits with French Big Pharma Sanofi.
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