Provention Bio, Inc. and Sanofi collaboration for potential launch of Type I diabetes therapeutic
Provention Bio, Inc. have granted exclusive right of first negotiation to Sanofi in exchange for commercial resources in the United States for the potential approval and launch of monoclonal antibody therapeutic teplizumab.
Biopharmaceutical company Provention Bio, Inc. (Red Bank, USA) announced their collaborative agreement with Sanofi U.S. (Bridgewater, USA) for the launch of Provention’s lead investigational drug candidate teplizumab, a monoclonal antibody (mAb) developed for the delay of clinical Type I diabetes.
By granting Sanofi exclusive right of first negotiation for a one-time nonrefundable payment of USD $20 million, Provention will gain access to Sanofi’s expertise, capabilities, and commercial resources leading up to the launch of teplizumab, currently under review by the US FDA. Sanofi pledges to commit its commercial resources in the United States, such as diabetes field specialists and medical science liaisons, to expand Provention’s reach of key healthcare professionals. A right of first negotiation grants Sanofi exclusive global rights for the commercialisation of teplizumab for indications in humans. While Provention may engage in certain discussions with third parties with respect to transactions, Sanofi can exercise this right until June 30 2023, with the collaboration open to extension under certain conditions. The two companies also entered into a Securities Purchase Agreement in which, should teplizumab gain US FDA approval, Sanofi will purchase USD $35 million of Provention’s common stock at a premium.
Teplizumab, the mAb in question, has been developed to delay clinical Type I diabetes in at-risk individuals. These individuals are determined by the presence of two or more Type I diabetes-related autoantibodies. Currently, there has been no disease-modifying therapeutic for diabetes since the advent of insulin in the 20th century. In multiple clinical studies, more than 800 patients have received a treatment of teplizumab. The drug is currently being evaluated in patients newly diagnosed with insulin-dependent Type I diabetes.
Co-Founder and CEO of Provention Bio Ashleigh Palmer commented: “The agreement brings significant resources to Provention and allows us to advance our mission of delivering therapies which intercept or delay debilitating and life-threatening autoimmune diseases... We look forward to working with our colleagues at Sanofi as we prepare to deliver, if approved, the first-ever disease-modifying therapy for [Type I diabetes].”
Sanofi’s Head of US General Medicines Olivier Bogillot echoed similar sentiments. “We are delighted by the prospect of supporting Provention Bio in bringing to the US what could become the first-in-class therapy to change the course of Type I diabetes,” he stated. “If approved, Sanofi U.S. will leverage its existing world-class capabilities in diabetes care to enhance efforts in both patient and healthcare provider access. We are prepared to tap into all of our internal expertise to support the successful launch of this innovative therapy.”
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance