Dive Brief:

• Sanofi is partnering with Provention Bio on a medicine that could become the first approved treatment to alter the course of Type 1 diabetes.

• The French drugmaker agreed to pay Provention $20 million for a co-promotion contract and the right to negotiate first for a potential license to the drug, known as teplizumab. Sanofi will also make a $35 million equity investment in Provention if teplizumab wins Food and Drug Administration approval. A decision from the FDA is due by Nov. 17.

• The vote of confidence from Sanofi sent Provention shares up by 20% in early trading. The biotech’s stock has suffered over the past two years as the FDA asked for more data on teplizumab and then rejected the company’s first application for approval in July 2021 even after an advisory panel of outside experts backed the drug.

Dive Insight:

While teplizumab has the potential to be a new type of diabetes medicine, it’s had a checkered past, and the contingencies in the deal with Sanofi reflect that. In 2010, Eli Lilly and partner MacroGenics were developing the drug and decided to shelve it after a study failed to reduce insulin use in patients with recent-onset Type 1 diabetes.

Provention got interested as continuing academic studies suggested benefits for the drug and bought the rights in 2018. By 2019, the purchase seemed like a good bet as researchers published a study in The New England Journal of Medicine that found the drug could delay the onset of disease with a single 14-day course of treatment.

The trial included 76 relatives of Type 1 diabetes patients who were themselves at high risk of developing the disease. Many of the patients went on to be diagnosed with the condition, but the median time to diagnosis for patients taking teplizumab was four years, compared with two years in the placebo group.

A reprieve of two years is significant for Type 1 diabetics, who need to take insulin and rigorously monitor their blood sugar levels to avoid complications. Provention decided to seek FDA approval, and the agency gave the drug a “Breakthrough Therapy” designation, which can speed up a review.

But in April 2021, the FDA cited “deficiencies” in the company’s application. The pivotal study had used teplizumab produced by Lilly, and Provention planned to use a different manufacturer. It conducted a “bridging study” to show the new product worked similarly well, but the FDA wasn’t convinced.

Provention regrouped to address the concerns. After meeting with regulators again, Provention in January 2022 said it would resubmit its application for approval. After yet another delay during that process, the FDA is due to give an answer by Nov. 17, with discussions of proposed labeling and possible post-marketing requirements happening by Oct. 17 if the drug is on track.

The service agreement with Sanofi means Provention will have access to a sales staff already well versed in diabetes if the drug wins approval. Sanofi sells Lantus, a long-acting insulin that had sales of 2.5 billion euros, or $2.5 billion, last year.

In the event of an approval, Provention will contract Sanofi’s sales teams to sell the drug, but will retain all commercial rights and remain responsible for duties like monitoring and production.