has signed a definitive agreement to acquire cancer therapies developer for a total consideration of approximately $21bn, or $88 per share.
uses antibody-drug conjugate (ADC) technology to develop medicines for hard-to-treat cancers. After the acquisition, its lead candidate Trodelvy will become part of Gilead’s oncology portfolio.
Trodelvy is a Trop-2 directed ADC that secured accelerated approval from the US Food and Drug Administration (FDA) for adults with metastatic triple-negative breast cancer (mTNBC) who had at least two previous therapies for metastatic disease.聽
Immunomedics intends to file a supplemental biologics licence application (BLA) with the FDA seeking full approval for the drug in the fourth quarter of this year, with plans to seek European regulatory approval in the first half of next year.
Trodelvy’s Phase III ASCENT clinical trial was stopped early due to positive efficacy data. Results showed that the drug led to significant improvement in progression-free survival and overall survival in previously treated advanced mTNBC patients.
The drug is also part of an ongoing Phase III trial in third-line HR+ / HER2- breast cancer and a registrational Phase II trial in bladder cancer, with additional studies conducted for the treatment of non-small cell lung cancer and other solid tumours.
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By GlobalDataImmunomedics and independent investigators are evaluating Trodelvy as a monotherapy and also in combination with checkpoint inhibitors and other non-immuno-oncology products.
Gilead Sciences chairman and CEO Daniel O鈥橠ay 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.”
The acquisition, approved by boards of directors of both parties, should close during the fourth quarter of this year.
After completion, Gilead plans to conduct multiple additional mid and late-stage studies of Trodelvy.
The company will leverage its commercial, medical, regulatory and manufacturing expertise to advance the drug through development.
Furthermore, Gilead’s infrastructure and operations in Europe and Japan should support the launch of Trodelvy in those regions, pending approval.
Post-closing, Gilead will hold global rights to the drug outside of greater China, South Korea and some Southeast Asian countries.
In July, Gilead agreed to acquire a 49.9% equity interest in cancer immunotherapies maker Tizona Therapeutics through an investment of $300m.
