After a slew of setbacks at the FDA, Provention Bio is finally nearing the regulatory finish line for its Type 1 diabetes contender teplizumab in the U.S. And, apparently feeling good about its odds, the New Jersey-based immunology outfit has tapped Big Pharma Sanofi to help bring the med to market should an approval come through next month.
The “co-promotional” pact centers around teplizumab’s prospective U.S. launch and gives Provention access to Sanofi’s “expertise, capabilities and commercial resources,” the companies said in a release.
Teplizumab, which has weathered several blows from the FDA over the years, is up for approval by Nov. 17 following a three-month delay unveiled at the end of June.
Under the new commercial deal, Sanofi will let Provention call on its diabetes field specialists and account directors, plus field-based reimbursement and medical science liaisons, which should help Provention fill out its Rolodex of local healthcare professionals in the field.
Sanofi is also throwing down a one-time payment of $20 million to lock up the right of first negotiation on exclusive global marketing rights for the drug in Type 1 diabetes should additional approvals follow worldwide. As for that part of the deal, Provention notes it has retained certain rights to hold talks with “third parties with respect to certain transactions,” too.
Sanofi can exercise its early negotiation ritght until June 30, 2023, and it has the option to extend “within 2023 under certain conditions,” according to the press release.
That’s not all Provention’s getting, either. Alongside the marketing accord, Sanofi has forged a securities purchase agreement with Provention good for $35 million in common stock upon an FDA approval for teplizumab.
The closing date will be at Provention's discretion but no later than Feb. 16, 2023, per the release.
Teplizumab is designed to help delay clinical Type 1 diabetes in at-risk patients. In the clinic, Provention has shown teplizumab delayed disease onset by a median of two years, which can help patients avoid diabetic ketoacidosis, a life-threatening complication of diabetes.
Back in January, meanwhile, Provention got the green light from the FDA to resubmit its teplizumab filing, which had been on hold as the agency weighed whether the planned commercial product was comparable to the drug used in clinical trials. The company said it resolved the issue, and the FDA accepted its resubmission in March.
Shortly thereafter, the FDA told Provention that a response to an information request constituted a major amendment to the company’s application, saying it would need another three months to review teplizumab.
Provention seems relatively undeterred despite the delay. In July, the company sold off 13,318,535 shares of common stock in a private placement, ginning up some $60 million in gross proceeds. The reason for the sale? To pad the war chest for teplizumab’s potential launch, Provention said at the time.