Sanofi US News

Sanofi completes acquisition of Provention Bio, Inc.

Paris, April 27 2023. Sanofi announced today the completion of its acquisition of Provention Bio, Inc. (“Provention Bio”). The acquisition adds TZIELD (teplizumab-mzwv), an innovative, fully owned, first-in-class therapy in type 1 diabetes to Sanofi’s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile. 

Olivier Charmeil
Executive Vice President, General Medicines, Sanofi
“We are excited to finalize our acquisition of Provention Bio, Inc. This strategic fit for Sanofi lies at the intersection of our growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need.”

On November 17, 2022 the U.S. Food and Drug Administration approved TZIELD injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

The tender offer for all of the outstanding shares of Provention Bio common stock expired at one minute after 11:59 P.M., Eastern Time, on Wednesday, April 26, 2023. The minimum tender condition and all of the other conditions to the offer have been satisfied and on April 27, 2023, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, Sanofi completed its acquisition of Provention Bio through the merger of a wholly owned subsidiary of Sanofi with and into Provention Bio, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Provention Bio continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi.

In connection with the merger, all Provention Bio shares not validly tendered in the tender offer have been converted into the right to receive the same $25.00 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer.

As of April 27, 2023, Provention Bio common stock will cease to be traded on the NASDAQ Global Select Stock Market.

PJT Partners acted as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP acted as its legal counsel. BofA Securities, Inc. and Centerview Partners LLC acted as financial advisors to Provention Bio and Ropes & Gray LLP acted as its legal counsel.

What is TZIELD™ (teplizumab-mzwv)?

TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body can't make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 8 years of age and older who have Stage 2 type 1 diabetes. This means they have tested positive for 2 or more type 1 diabetes-related autoantibodies, have abnormal blood sugar levels, and do not have type 2 diabetes. It is not known if TZIELD is safe and effective in children under 8 years of age.


What is the most important information I should know about TZIELD?

TZIELD may cause serious side effects, including:

  • Cytokine Release Syndrome (CRS). Signs and symptoms of CRS problems may include:
  • fever
  • feeling tired (fatigue)
  • muscle and joint pain
  • nausea
  • headache
  • increased liver enzyme in your blood

These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD.

  • Decrease in white blood cells. TZIELD may cause a decrease in a type of white blood cell called lymphocytes. A decrease in white blood cells is a serious, but common side effect that can affect your body's ability to fight infections.

Your healthcare provider will do blood tests to check your liver and your complete blood counts before you start treatment and during treatment with TZIELD. During and after your treatment with TZIELD, your healthcare provider will check for serious side effects, as well as other side effects, and treat you as needed. Your healthcare provider may temporarily or completely stop your treatment with TZIELD, if you develop liver problems, have a serious infection, or if your blood counts stay too low.

Before or after receiving TZIELD, tell your healthcare provider about all your medical conditions, including if you:

  • have a serious infection or an infection that does not go away or that keeps coming back.
  • have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with TZIELD before receiving a vaccine.
  • are pregnant or plan to become pregnant. TZIELD may harm your unborn baby. Do not receive TZIELD during pregnancy and at least 30 days before a planned pregnancy.
  • are breastfeeding or plan to breast feed. It is not known if TZIELD passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive TZIELD. If you are breastfeeding, you may consider pumping and throwing away your breast milk during treatment with TZIELD and for 20 days after receiving TZIELD treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TZIELD?

The most common side effects of TZIELD include:

  • rash
  • leukopenia (decrease in white blood cell counts)
  • headache

These are not all of the possible side effects of TZIELD. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at or 1-800-FDA-1088, or to Provention Bio at 1-844-778-2246.

Please see Medication Guide and Prescribing Information.

Talk to your doctor about TZIELD.


About Sanofi
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