AstraZeneca and Daiichi Sankyo will co-develop cancer antibody-drug conjugate (ADC) DS-8201 in a deal worth up to $6.9 billion.
AstraZeneca will pay $1.35 billion (€1.2 billion) upfront for rights to DS-8201 (trastuzumab deruxtecan). The UK firm will pay a further $5.5 billion if the drug achieves regulatory and sales targets.
Under the agreement, Daiichi will manufacture DS-8201. AstraZeneca will help develop and sell the drug worldwide, except in Japan where Daiichi has exclusive rights.
Spokesman Rob Skelding told us AstraZeneca’s background in cancer drug commercial development was key to the partnership.
“AZ is the chosen partner due to its scientific heritage in developing and marketing some of the most transformative drugs for the treatment of breast cancer over the past several decades, and recent scientific leadership in lung cancer,” he said.
Targeting cancer
DS-8201 is an antibody-drug conjugate (ADC) produced using Daiichi’s DXd ADC technology.
As their name suggests, ADCs combine an antibody able to bind protein targets on tumours and a drug that kills the diseased cells. A linking peptide that joins the components breaks down after the cell is bound.
Targeted ADCs are more effective and have fewer side effects than traditional chemotherapies.
Clinical development
DS-8201 has breakthrough therapy and fast track status for various forms of breast cancer in the US. It has accelerated review designation for gastric or gastroesophageal junction cancer in Japan.
DS-8201 is in trials as a treatment for several types of HER2-expressing tumours, including cancers of the breast, lung and gastric system.
Skelding said, “A broad and comprehensive global development program with trastuzumab deruxtecan is underway in North America, Europe and Asia including five pivotal studies” adding the firms will share all R&D costs 50/50.
He also told us AstraZeneca and Daiichi will seek approval for DS-8201 for the treatment of patients with breast cancer this year.
“A first regulatory submission is scheduled for the second half of 2019 for patients in the advanced or refractory breast cancer setting,” he said.