Sanofi, Provention Bio ink pact for launch of Diabetes drug Teplizumab
Teplizumab is an anti-CD3 monoclonal antibody that is being developed for the delay of clinical T1D in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies.
Red Bank, N.J.: Provention Bio, Inc. has announced that the Company has entered into a co-promotion agreement with Sanofi U.S. for the launch of Provention's lead investigational drug candidate teplizumab.
The agreement enables Provention Bio to leverage Sanofi's expertise, capabilities and commercial resources to support the potential launch of teplizumab currently under review by the U.S. Food and Drug Administration ("USFDA"), for the delay of clinical type 1 diabetes in at-risk individuals, with a user fee goal date of November 17, 2022 for the Biologics License Application.
Teplizumab is an anti-CD3 monoclonal antibody that is being developed for the delay of clinical T1D in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies.
"This collaboration with Sanofi U.S. allows us to significantly expand our planned commercial footprint during launch to support increased screening and product awareness as we work to launch a new therapy that, if approved, will dramatically impact the lives of the patients and families we serve," said Jason Hoitt, Chief Commercial Officer, Provention Bio. "In particular, Sanofi's long-standing relationships with key U.S. healthcare professionals will complement our focus on pediatric endocrinologists and help us address a larger patient population with greater efficiency."
Olivier Bogillot, Head of U.S. General Medicines, Sanofi, stated, "We are delighted by the prospect of supporting Provention Bio in bringing to the U.S. what could become the first-in-class therapy to change the course of type 1 diabetes. 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."
"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," said Ashleigh Palmer, Co-Founder and Chief Executive Officer, Provention Bio. "We look forward to working with our colleagues at Sanofi as we prepare to deliver, if approved, the first-ever disease-modifying therapy for T1D."
Under the terms of the agreement, Sanofi will commit commercial resources in the United States, including diabetes field specialists, account directors, field-based reimbursement and medical science liaisons to expand the number of key healthcare professionals reached in the United States. In exchange, Provention will reimburse field force-related expenses that Sanofi will incur in connection with commercializing teplizumab under the agreement.
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