The agreement sees Provention Bio receive a non-refundable US$20m (€20.4m) payment and, in return, Sanofi has the exclusive right of first negotiation to in-license teplizumab for type 1 diabetes.
Everything hinges on whether Provention can secure US Food and Drug Administration (FDA) approval for the treatment, which is currently under review for the delay of clinical type 1 diabetes in at-risk individuals.
Sanofi and Provention do not have long to wait, with a user fee goal date of November 17, 2022, set for the biologics license application. Should the treatment secure approval, Sanofi has inserted an option to buy $35m worth of Provention stock at a premium over the average share price in the five trading days leading up to the closing date, no later than February 16, 2023.
If Sanofi takes up the option to in-license the treatment, it will engage in co-promotion of the product. This would involve Sanofi leveraging its expertise, capabilities and commercial resources to support the launch of the treatment.
Jason Hoitt, CFO of Provention, stated that the potential collaboration with Sanofi would allow for a ‘significantly expanded’ commercial footprint during launch – including increased screening and greater product awareness. In particular, Hoitt outlined that there would be a focus on pediatric endocrinologists to “help us address a larger patient population with greater efficiency.”
Manufacturing challenges
Teplizumab has the potential to become a first-in-class and first disease-modifying therapy for type 1 diabetes. The drug candidate is an anti-CD3 monoclonal antibody that counteracts immune cells that destroy insulin-producing beta cells in type 1 diabetes.
It is thought that the action of the treatment allows people at-risk of type 1 diabetes to produce sufficient insulin for a longer period. In clinical trials, it was shown that patients receiving the treatment were, on average, diagnosed with type 1 diabetes three year later than those who had received a placebo.
However, despite the positive results in the clinic, this did not translate into an approval at the first time of asking for Provention. The company received a complete response letter (CRL) in July 2021 from the FDA, where it asked for more data on the product.
Specifically, the CRL stated that a bridging study to compare planned commercial product with drug product originating from drug substance manufactured for historic clinical trials had failed to show pharmacokinetic comparability.
The FDA also highlighted other manufacturing issues, such as additional considerations in relation to product quality, and certain deficiencies at a fill/finish manufacturing facility used by Provention.
