Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Sanofi
Deal Size : $2,900.0 million
Deal Type : Acquisition
Sanofi Completes Acquisition of Provention Bio, Inc.
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).
Product Name : Tzield
Product Type : Antibody
Upfront Cash : $2,900.0 million
April 27, 2023
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Sanofi
Deal Size : $2,900.0 million
Deal Type : Acquisition
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Sanofi
Deal Size : $2,900.0 million
Deal Type : Acquisition
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).
Product Name : Tzield
Product Type : Antibody
Upfront Cash : $2,900.0 million
March 13, 2023
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Sanofi
Deal Size : $2,900.0 million
Deal Type : Acquisition
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase II
Sponsor : Sanofi
Deal Size : $35.0 million
Deal Type : Agreement
Provention Bio Announces Completion of $35 Million Equity Investment from Sanofi US
Details : 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.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Undisclosed
February 13, 2023
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Sponsor : Sanofi
Deal Size : $35.0 million
Deal Type : Agreement
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Hercules Capital
Deal Size : Undisclosed
Deal Type : Financing
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.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Undisclosed
February 02, 2023
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Hercules Capital
Deal Size : Undisclosed
Deal Type : Financing
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes
Details : 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 i...
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
November 17, 2022
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase II
Sponsor : Sanofi
Deal Size : $55.0 million
Deal Type : Agreement
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.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : $20.0 million
June 10, 2022
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Sponsor : Sanofi
Deal Size : $55.0 million
Deal Type : Agreement
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
March 21, 2022
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway
Details : FDA approved the Company proceeding to populate the popPK model with data collected from patients receiving therapeutic doses of teplizumab in a pharmacokinetic/pharmacodynamic substudy of the ongoing PROTECT Phase 3 trial in newly diagnosed type 1 diabe...
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
November 22, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
September 13, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : As part of its ongoing review of the Company's BLA for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
Product Name : Tzield
Product Type : Antibody
Upfront Cash : Inapplicable
August 04, 2021
Lead Product(s) : Teplizumab
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable