The deal is part of a previously announced co-promotion agreement and securities purchase agreement, Provention Bio said in a Feb. 13 statement.
According to Jason Hoitt, chief commercial officer of Provention Bio, the investment will support the commercial launch of TZIELD (teplizumab-mzwv), which he described as “the first immunomodulatory therapy approved to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with stage 2 T1D.”
“TZIELD’s recent FDA [U.S. Food and Drug Administration] approval advances our purpose to intercept autoimmunity in its earlier stages, rather than waiting to manage end-stage disease when symptoms, irreversible tissue damage, and serious complications appear,” Hoitt continued.
In October 2022, Provention entered into the co-promotion agreement with Sanofi US for the launch of TZIELD. As part of the agreement, Sanofi will commit commercial resources in the U.S. – including diabetes field specialists, account directors, field-based reimbursement and medical science liaisons – to reach more health care professionals in the country.
Olivier Bogillot, Sanofi’s head of U.S. general medicines, said the company was excited to support Provention Bio for the U.S. commercial launch of TZIELD.
“We have been leveraging our established infrastructure and expertise in endocrinology to enhance patient and health care provider access,” Bogillot added. “The closing of our equity investment in Provention further strengthens this key collaboration.”
Provention will reimburse field force-related expenses that Sanofi will incur in connection with commercializing teplizumab under the agreement, the company said.
Provention retains all rights to TZIELD and maintains responsibility for the commercialization strategy.
As part of the purchase agreement, Sanofi bought more than 2.7 million shares of Provention Bio’s common stock, par value $0.0001 per share, at a price of $12.90 per share.
Editor’s note: This headline was updated at 8:05 a.m. Feb. 20 to reflect the $35 million investment.