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Provention Bio
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Details:

Through the acquisition of Provention Bio, Sanofi adds to its portfolio, TZIELD (teplizumab-mzwv), a CD3-directed antibody, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D).


Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Sanofi

Deal Size: $2,900.0 million Upfront Cash: $2,900.0 million

Deal Type: Acquisition April 27, 2023

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Details:

Through the acquisition of Provention Bio, Sanofi adds to its portfolio, TZIELD (teplizumab-mzwv), a CD3-directed antibody, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D).


Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Sanofi

Deal Size: $2,900.0 million Upfront Cash: $2,900.0 million

Deal Type: Acquisition March 13, 2023

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The financing will be used to support the commercial launch of TZIELD (teplizumab-mzwv). TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D.


Lead Product(s): Teplizumab-mzwv

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Sanofi

Deal Size: $35.0 million Upfront Cash: Undisclosed

Deal Type: Agreement February 13, 2023

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Details:

Tzield (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D.


Lead Product(s): Teplizumab-mzwv

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Hercules Capital

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Financing February 02, 2023

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Details:

Under the agreement, AGC Biologics will manufacture TZIELD™ (teplizumab-mzwv), a new T1D treatment. TZIELD is the first and only immunomodulatory treatment that delays the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older.


Lead Product(s): Teplizumab-mzwv

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: ApprovedProduct Type: Large molecule

Recipient: AGC Biologics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement January 24, 2023

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Details:

Under the terms of the agreements held in 2018, Provention has acquired all rights to Tzield (teplizumab) to be further developed as PRV-031 and licensing rights to MGD010 for development as PRV-3279.


Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: ApprovedProduct Type: Large molecule

Recipient: MacroGenics

Deal Size: $395.0 million Upfront Cash: Undisclosed

Deal Type: Agreement November 17, 2022

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Tzield (teplizumab-mzwv) binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.


Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 17, 2022

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Details:

Teplizumab (PRV-031), is an investigational anti-CD3 monoclonal antibody that is being evaluated for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies.


Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: PRV-031

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Sanofi

Deal Size: $55.0 million Upfront Cash: $20.0 million

Deal Type: Agreement October 06, 2022

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Details:

PRV-101 is an investigational polyvalent vaccine being developed for the prevention of acute coxsackievirus B (CVB) infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease.


Lead Product(s): PRV-101

Therapeutic Area: Infections and Infectious Diseases Product Name: PRV-101

Highest Development Status: Phase IProduct Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 28, 2022

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Details:

Teplizumab, an investigational anti-CD3 mAb developed for delay of clinical type 1 diabetes at-risk individuals, company resubmitted BLA for teplizumab has been considered a complete, class 2 response by USFDA.


Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: PRV-031

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 21, 2022

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