Gilead Sciences, Inc. (Nasdaq: GILD), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need, acquired Immunomedics (Nasdaq: IMMU), a leader in next-generation antibody-drug conjugate (ADC) technology, for $88.00 per share in cash.
The transaction, which valued Immunomedics at approximately $21 billion, was unanimously approved by both the Gilead and Immunomedics Boards of Directors and is anticipated to close during the fourth quarter of 2020.
The agreement will provide Gilead with TrodelvyTM (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the United States in the fourth quarter of 2020. Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021.
In the Phase 3 ASCENT study, which was halted early due to efficacy based on the unanimous recommendation of the independent Data Safety Monitoring Committee, Trodelvy improved progression-free survival (PFS) and overall survival (OS) in previously treated patients with advanced mTNBC. Beyond mTNBC, Trodelvy is also being studied in an ongoing Phase 3 trial in third line HR+/HER2- breast cancer and a registrational Phase 2 study in bladder cancer. Additional ongoing studies are evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other solid tumor types. Trodelvy is being studied as both a monotherapy and in combination with checkpoint inhibitors and other non-immuno-oncology products by Immunomedics and independent investigators.