Gilead Sciences has offered to buy biotech company Immunomedics for $21 billion in a bid to strengthen its cancer drug development pipeline.
As part of the deal, Gilead will have access to a breast cancer treatment called Trodelvy created by Immunomedics. Trodelvy has been cleared by the US Food and Drug Administration (FDA) through the regulator’s accelerated approval pathway, with the company receiving their approval in April.
It is used to treat an aggressive and tough type of breast cancer called metastatic triple-negative breast cancer (mTNBC). This type of tumor makes up 15 to 20 percent of breast cancers. The drug is used in patients who have received at least two prior therapies for metastatic disease.
If the deal goes through, Gilead will acquire the company for $15 billion in cash and use $6 billion for newly issued debt.
“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 CEO at Gilead Sciences, in a statement. “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 has plans to submit a Supplemental Biologics License Application to support the full approval of Trodelvy in the US in the last quarter of 2020.
According to a statement by Gilead, “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 (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.”
Trodelvy is being studied in an ongoing Phase III trial as third line treatment for HR+/HER2- breast cancer and a Phase II study in bladder cancer. Additionally, it is being studied for non-small cell lung cancer and other solid tumor types. After closing the deal, Gilead plans to initiate numerous additional mid and late studies to determine which patients will benefit from Trodelvy as a monotherapy or in combination with other products.
Trodelvy is an antibody-drug conjugate (ADC). It has been described by researchers as “guided missiles” that target tumors to release cytokines that then deliver up to 10,000 times the potency of standard chemotherapy while minimizing the damage done to healthy tissue.
Gilead brings a lot of expertise in the areas of commercialization, medical knowledge, regulatory experience and manufacturing know-how, which will help advance Trodelvy through development and research processes. Immunomedics will also launch Trodelvy in Europe and Japan. They are on track to file for regulatory approval for Trodelvy in Europe, in the first half of 2021. The rights for Trodelvy will be retained by Gilead in greater China, South Korea and specific Southeast Asian countries.
“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, PhD, Executive Chairman of Immunomedics. “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.”
The deal is expected to close in the last quarter.