Daiichi Sankyo and AstraZeneca Enter New Global Development and Commercialization Collaboration for Daiichi Sankyo’s ADC DS-1062
Daiichi Sankyo announced today that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s DS-1062, a TROP2 directed DXd antibody drug conjugate (ADC), currently in phase 1 clinical development for non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC).
Daiichi Sankyo and AstraZeneca will jointly develop and commercialize DS-1062 worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will manufacture and supply DS-1062.
This agreement represents the second global ADC collaboration between the two companies following a similar agreement in March 2019 for Daiichi Sankyo’s ENHERTU, a HER2 directed DXd ADC.
“DS-1062, one of our lead DXd ADCs that will form a pillar of our next mid-term business plan, has the potential to become a best-in-class TROP2 ADC in multiple tumors, including lung and breast cancers,” said Sunao Manabe, Representative Director, President and CEO of Daiichi Sankyo Company, Limited. “This new strategic collaboration with AstraZeneca, a company with extensive experience and significant expertise in the global oncology business, will enable us to deliver DS-1062 to more patients around the world as quickly as possible. As we have done with ENHERTU, we will jointly design and implement strategies to maximize the value of DS-1062.”
“We see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2,” said Pascal Soriot, Chief Executive Officer, AstraZeneca. “We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of ENHERTU to further expand our pipeline and leadership in oncology. We now have six potential blockbusters in oncology with more to come in our early and late pipelines.”
Under the terms of the agreement, AstraZeneca will pay Daiichi Sankyo an upfront payment of $1 billion, of which $350 million is due upon execution, $325 million after 12 months and $325 million after 24 months. Contingent payments of up to $5 billion include $1 billion for achievement of future regulatory milestones, and $4 billion for sales-related milestones. Total payments under the agreement have the potential to reach up to $6 billion.
Daiichi Sankyo and AstraZeneca will share equally development and commercialization costs as well as profits from DS-1062 worldwide, except for Japan. Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates. AstraZeneca is expected to book sales in other markets worldwide, including China, Australia, Canada and Russia.
The upfront payment and regulatory milestones will be booked as revenue over the period in which Daiichi Sankyo has contractual performance obligations under this collaboration. Impact on Daiichi Sankyo’s consolidated financials for fiscal year ending March 31, 2021 will be announced at an appropriate time in the future. The collaboration is expected to enhance the corporate and shareholder value for Daiichi Sankyo over the mid- to long-term.
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU (a HER2 directed ADC) in March 2019, and DS-1062 (a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of ENHERTU and DS-1062.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) currently is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial, and is under accelerated assessment in the EU for a similar potential indication.
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