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US Firm Teams up With Leading Pharma Co. To Delay T1D Onset
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Provention Bio Inc.'s shares traded 25% higher yesterday after the company reported it is joining forces with Sanofi U.S. to support the potential upcoming U.S. launch of its teplizumab for use in delaying the onset of clinical type 1 diabetes in at-risk patients. The U.S. FDA is expected to rule on the firm's Biologics License Application in mid-November 2022.

Biopharmaceutical company Provention Bio Inc. (PRVB:NASDAQ), which is working to develop medicines that are able to seek out autoimmunity early to intercept and prevent debilitating and life-threatening diseases, yesterday announced that "the company has entered into a co-promotion agreement with Sanofi U.S., part of Sanofi SA (SNY:NYSE), for the launch of Provention's lead investigational drug candidate teplizumab."

The report indicated that the joint-marketing agreement will allow Provention Bio to benefit from Sanofi's vast experience and resources, which will be helpful in supporting the potential launch of teplizumab.

The company advised that it has filed a Biologics License Application (BLA) for teplizumab with the U.S. Food and Drug Administration (FDA), which is currently under review. The BLA for teplizumab was submitted for use in delaying clinical Type 1 diabetes in at-risk individuals. The FDA has set an extended user fee goal date of November 17, 2022, for its response.

Provention Bio's Chief Commercial Officer Jason Hoitt stated, "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 . . . 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."

Sanofi's Head of U.S. General Medicines, Olivier Bogillot, commented, "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.

Sanofi's Head of U.S. General Medicines, Olivier Bogillot, commented, "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."

Provention Bio's Co-Founder and CEO Ashleigh Palmer remarked, "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 . . . 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 co-promotion agreement, Sanofi has agreed to commit its extensive U.S.-based network of diabetes field specialists, account managers, and medical science experts and liaisons to promote and expand the distribution of teplizumab to key healthcare professionals.

In return, Provention Bio advised it will fully reimburse Sanofi for all field force-related expenses resulting from teplizumab-related promotional activities. Throughout the process, Provention will retain all rights for teplizumab and will maintain charge of all strategic commercialization decisions.

Sanofi has contracted to pay Provention a nonrefundable payment in the amount of US$20 million in exchange for "an exclusive, one-time right of first negotiation (ROFN) to obtain exclusive global rights to commercialize teplizumab for Type 1 diabetes indications in humans."

The report indicated that Sanofi has contracted to pay Provention a nonrefundable payment in the amount of US$20 million in exchange for "an exclusive, one-time right of first negotiation (ROFN) to obtain exclusive global rights to commercialize teplizumab for Type 1 diabetes indications in humans, subject to certain retained rights of the company to engage in discussions with third parties with respect to certain transactions."

The agreement stipulates that at its discretion, Sanofi can elect to exercise its ROFN until June 30, 2023, which could possibly extend to the end of 2023 under certain pre-established conditions.

The two companies advised that, in addition, they entered into a Securities Purchase Agreement, whereby in the event that teplizumab is granted approval by the FDA, Sanofi has agreed to purchase US$35 million of Provention's common stock.

The purchase would occur no later than February 16, 2023, and would be based upon an unspecified premium above the 5-day volume-weighted average per share price.

The company explained that "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."

To date, more than 800 individuals have been treated with teplizumab in multiple clinical trials. Provention is currently evaluating the use of teplizumab to treat patients with newly diagnosed insulin-dependent T1D in its Phase 3 PROTECT study.

Provention Bio is a biopharma firm based in Red Bank, N.J, engaged in developing and commercializing new therapies capable of intercepting and preventing serious debilitating and life-threatening immune-mediated diseases.

The firm has filed a BLA for its lead investigational drug candidate, teplizumab, with the U.S. FDA. The company submitted the application for the use of teplizumab in delaying the progression of Type 1 diabetes in at-risk individuals to Stage 3 levels.

Some of the firm's other drug pipeline candidates are being developed to address other autoimmune diseases, such as lupus and celiac disease.

Sanofi is a US$100 billion market cap global pharmaceutical and healthcare company headquartered in Paris, France. The firm is engaged in all phases of research, development, manufacturing, and marketing of medicines and vaccines.

The has over 100,000 employees in around 100 countries. Its pharmaceuticals division develops and markets therapeutics for a wide range of treatment areas, including diabetes, cardiovascular, multiple sclerosis, oncology, and rare diseases. In addition to its prescription brand, generic and consumer healthcare products, the firm has built a large vaccine business that operates as Sanofi Pasteur.

Provention Bio started yesterday with a market cap of around US$403.67 million, with approximately 81.55 million shares outstanding and a short interest of about 3.4%. PRVB shares opened nearly 17% higher yesterday at US$5.78 (+$0.83, +16.77%) over the previous day's US$4.95 closing price. The stock traded between US$5.75 and US$6.48 per share and closed for trading at US$6.22 (+$1.27, +25.66%). It is currently trading at US$6.78.

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