Gilead Sciences has completed its previously announced acquisition of Immunomedics, a Morris Plains, New Jersey-based clinical-stage biopharmaceutical company focused on antibody-drug conjugates (ADCs), for approximately $21 billion. Gilead had announced the acquisition in September (September 2020).

Immunomedics’ lead product is Trodelvy (sacituzumab govitecan-hziy), an ADC that was granted accelerated approval by the US Food and Drug Administration (FDA) earlier this year (April 2020) for treating adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. Immunomedics says it plans to submit a supplemental biologics license application (BLA) to support full approval of Trodelvy in the US in the fourth quarter of 2020. Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021.

Earlier this month (October 2020), the FDA granted orphan-drug status for Trodelvy for another indication, for treating adult and pediatric patients with glioblastoma, a type of brain cancer. The drug is being evaluated in multiple other studies: metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.

As a result of the completion of the acquisition, Immunomedics has become a wholly owned subsidiary of Gilead.

Source: Gilead Sciences and Immunomedics (Trodelvy update)