Gilead Sciences (Gilead) and Immunomedics have entered into a agreement pursuant to which Gilead will acquire Immunomedics for $88 per share in cash.
The agreement will provide Gilead with Trodelvy (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate which was granted accelerated approval by the 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 III Ascent study, which was halted early due to efficacy based on the unanimous recommendation of the independent Data Safety Monitoring Committee, Trodelvy significantly improved progression-free survival and overall survival in previously treated patients with advanced mTNBC.
Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences said: “Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments."
Behzad Aghazadeh, PhD, Executive Chairman of Immunomedics said: “We are excited for the opportunities ahead of us as we join with Gilead to advance our shared mission in defeating cancer. By working with Gilead, we have the opportunity to accelerate our progress and improve care for patients in need of new therapies.”
Gilead will bring to Immunomedics an infrastructure and operations in Europe and Japan to support the launch of Trodelvy in those regions, pending approval. After closing, Gilead will retain global rights to Trodelvy outside of greater China, South Korea and certain Southeast Asian countries.
