AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, the companies announced. The US Food and Drug Administration’s (FDA) decision makes the long-acting antibody the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The approval, which also applies to children aged up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, was based on results from the Beyfortus clinical development programme spanning three pivotal late-stage clinical trials and follows a unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of the drug. Across all clinical endpoints, a single dose of Beyfortus ...
Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent. By FRANK VINLUAN Photo: Nathan Laine/Bloomberg, via Getty Images Sanofi is a dominating presence in inflammation and immunology with Dupixent, a blockbuster drug whose sales continue to grow in multiple approved indications. That product is an antibody administered by injection, so several companies are vying to compete by developing oral alternatives. Now Sanofi is joining them. The Paris-based pharmaceutical giant has struck up a partnership with Recludix Pharma. The deal focuses on the biotech’s preclinical oral small molecules, which have potential applications in a range of immunological and inflammatory diseases. Sanofi has committed to $125 million in near-term payments to Recludix to begin the alliance. San ...
Sanofi and Scribe Therapeutics have announced an expanded collaboration agreement worth over $1.2bn to advance in vivo genetic medicines for sickle cell and other genomic diseases. The agreement follows the launch of the companies’ existing partnership focused on developing ex vivo editing of natural killer cell therapies for cancer. Under the latest deal, Sanofi will gain an exclusive licence to use Scribe’s CRISPR X-Editing genome editing technologies to develop in vivo therapies. In exchange, Scribe will receive a $40m upfront payment and will also be eligible for more than $1.2bn based on the successful completion of certain development and sales milestones. Sanofi will largely be responsible for any resulting candidates, but Scribe will have the opportunity to opt into sharing the development costs and profits on one future programme in the US. Christian Mueller, global head of Genomic Medicine Unit at Sanofi, said: “We’re ...
Tyler Patchen News Reporter https://endpts.com/ In June, Saudi Arabia’s Public Investment Fund established Lifera, a contract developer and manufacturer in the pharmaceutical field, and now the company has secured a major client. On Wednesday, Lifera and the Saudi-based vaccine manufacturer Arab Pharmaceutical Company, or Arabio, signed a memorandum of understanding with Sanofi to boost the local vaccine production within Saudi Arabia. Under the terms of the agreement, all three companies will search for opportunities to collaborate to form a localization strategy for developing and producing vaccines. This will include Lifera acting as a contract manufacturer to Sanofi and leveraging Arabio’s distribution experience as well. According to the release, the French pharma will plan to manufacture seven vaccines that are part of the “mandatory immunization schedule” with the intention of making these vaccines more readily available in Saudi Arabia and to potentially export as well. However, the specific vaccines that will be ...
After AstraZeneca and National Resilience made recent inroads into the United Arab Emirates, Sanofi has emerged as the next pharmaceutical giant setting its sights on the Middle East.The French pharma is linking up with Saudi drugmakers Arabio and Lifera—the latter of which is wholly owned by the kingdom’s sovereign wealth fund PIF—to bolster production of vaccines in Saudi Arabia. Under a newly minted memorandum of understanding, the companies will explore a range of potential prophylactic initiatives, including the enlistment of Lifera as a contract manufacturer to Sanofi, plus the build-out of a new manufacturing plant utilizing the latest vaccine tech. Sanofi will further share biotechnological know-how to initially manufacture seven vaccines included in Saudi Arabia’s mandatory immunization schedule, the partners said in a press release Wednesday. Arabio, for its part, will leverage its local and regional distribution strength to help supply the shots and other biopharmaceutical products to the Saudi ...
While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. Boasting prophylactic prospects in respiratory syncytial virus (RSV), pneumococcal disease and flu—including a clutch of promising mRNA candidates—the French pharma feels confident its shots can deliver billions of dollars by the end of the decade. By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five innovative phase 3 vaccine programs by 2025. “When developing new vaccines, our scientists can now choose from nine distinct platforms—probably the largest number in the industry,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said of the company’s future immunization prospects. And despite big things on the horizon—principally in the form of ...
Sanofi has announced positive results from a phase 2b trial of amlitelimab in adults with moderate-to-severe cases of atopic dermatitis, one of the most common inflammatory skin diseases. Typically referred to as eczema, atopic dermatitis affects an estimated 16.5 million adults in the US, with nearly 40% affected by moderate-to-severe cases. The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck. Sanofi’s amlitelimab is an investigational anti-OX40-ligand monoclonal antibody that is designed to rebalance the immune system by blocking inappropriate activation and proliferation of pro-inflammatory effector T cells and promoting expansion of anti-inflammatory regulatory T cells. The company says the candidate “has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders”, including moderate-to-severe atopic dermatitis and asthma. The dose-ranging STREAM-AD study has been evaluating amlitelimab in adult patients ...
By Tristan Manalac https://www.biospace.com/ Pictured: Atopic dermatitis patient scratches their arm/iStock The company announced Tuesday that topline data from the Phase IIb STREAM-AD trial showed that Sanofi’s investigational antibody amlitelimab met the study’s primary outcome and strongly eased symptoms in patients with moderate-to-severe atopic dermatitis. After 16 weeks of treatment, patients in the amlitelimab group saw significant improvements in their average Eczema Area and Severity Index (EASI) scores compared to placebo. Amlitelimab retained its statistical edge over the placebo across all four studied doses. Sanofi’s candidate also cleared the study’s key secondary endpoints, including biomarker measurements, which suggested that amlitelimab had therapeutic effects on both type 2 and non-type 2 inflammatory pathways, according to the company’s news release. Improvements in primary and secondary measures persisted through 24 weeks of follow-up. These Phase IIb results support amlitelimab’s mechanism of action and indicate that “targeting OX40-Ligand has the potential to provide a ...
Sanofi and Sobi’s once-weekly haemophilia A treatment has demonstrated highly effective bleed protection in children with severe forms of the disease, according to late-stage data presented at the International Society on Thrombosis and Haemostasis (ISTH) annual meeting. The phase 3 XTEND-Kids study evaluated a once-weekly 50IU/kg dose of the factor VIII replacement therapy, Altuviiio, for 52 weeks in previously treated patients aged under 12 years. The oral presentation at ISTH detailed results from the study and confirmed that the therapy met the primary endpoint, with no inhibitor development to factor VIII detected. Key secondary endpoints were also met, including annualised bleeding rate and maintenance of factor VIII activity above pre-specified levels. Sanofi added that the therapy was well-tolerated and demonstrated a safety profile similar to the phase 3 XTEND-1 trial, confirming safety and efficacy in both adults and children. Haemophilia A is a rare, lifelong bleeding disorder in which a ...
Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.Thursday, experts on the FDA’s Antimicrobial Drugs Advisory Committee voted 21 to 0 that nirsevimab boasts a favorable benefit-risk profile to protect against RSV-associated lower respiratory disease in infants born during or entering their first RSV season. On a separate question of whether the drug has a favorable benefit-risk profile in children up to 24 months of age who remain vulnerable through their second RSV season, the vote was 19 to 2 in favor of the drug. “Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Sanofi’s executive vice president of vaccines, Thomas Triomphe, said in a Thursday statement. “We are encouraged by the Advisory Committee’s positive ...
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