Gilead Sciences, the maker of coronavirus drug remdesivir, today announced it has reached a deal to acquire cancer drugmaker Immunomedics for $21 billion. According to the announcement, the offer will be funded through about $15 billion in cash on hand and $6 billion in newly issued debt. The transaction is anticipated to close during the fourth quarter of 2020.
Founded in 1983 by David M. Goldenberg, Immunomedics is a biopharmaceutical company developing monoclonal antibody-based products for the treatment of cancer and other serious diseases.
The acquisition will provide Gilead access to Immunomedics’ cancer treatment drug called Trodelvy. Trodelvy 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 the 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 significantly improved progression-free survival (PFS) and overall survival (OS) in previously treated patients with advanced mTNBC. Detailed results from this study are expected to be presented at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020.
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. Additional clinical data for Trodelvy in bladder cancer and other solid tumors will also be presented at ESMO this coming week.
“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. 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,” said Daniel O’Day, Chairman, and Chief Executive Officer, Gilead Sciences. “We look forward to welcoming the talented Immunomedics team to Gilead so we can continue to advance this important new medicine for the benefit of patients with cancer worldwide.”
Immunomedics currently has a market value of roughly $10 billion after the company’s shares nearly doubled this year. The acquisition comes as Gilead’s hepatitis C business has struggled in recent years and its overall sales have fallen as the coronavirus pandemic weakens demand for some drugs.
“We are very pleased that Gilead recognized the value of Trodelvy – both for the important role it has already begun to play for patients with metastatic triple-negative breast cancer and for its potential to help many other patients with cancer in the future,” said Behzad Aghazadeh, Ph.D., Executive Chairman of Immunomedics. “We are excited about 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.”