A U.K. drugmaker and another pharmaceutical company based in Japan have entered a deal focused on an antibody-drug conjugate for multiple tumor types that could net the latter up to $6 billion.
London-based AstraZeneca and Tokyo-based Daiichi Sankyo said Monday that they had entered a global development and commercialization partnership around DS-1062, a TROP2-targeted antibody-drug conjugate, or ADC, a type of drug that works by using a monoclonal antibody to deliver an attached pharmaceutical payload directly to cells. Under the financial terms of the deal, AstraZeneca will pay Daiichi Sankyo $1 billion upfront in staged payments, including $350 million upon completion of the deal, $325 million 12 months later and another $325 million 24 months later. Daiichi Sankyo is eligible to receive another $1 billion for regulatory milestones and a further $4 billion for sales-related milestones.
Shares of Daiichi Sankyo were up 15% on the over-the-counter market Monday following the news. AstraZeneca’s announcement came at the same time that the Tokyo Stock Exchange, where Daiichi Sankyo’s stock primarily trades, closed for the day. Shares of AstraZeneca were mostly flat.
“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,” Daiichi Sankyo CEO Sunao Manabe said in a statement. “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.”
The agreement marks the second multibillion-dollar deal between the two companies to develop ADCs in oncology. The first was for Enhertu (fam-trastuzumab deruxtecan-nxki), which received accelerated Food and Drug Administration approval in December for HER2-positive breast cancer. That news came months after the companies signed a $6.9 billion agreement to develop the drug. However, it was the subject of a legal dispute between Daiichi Sankyo and Seattle Genetics, which had laid claim to intellectual property rights related to Daiichi Sankyo’s ADCs, in particular the linker technology used to attach the cytotoxic pharmaceutical agent to the antibody.
In an email, a Seattle Genetics spokesperson wrote that the linker used for DS-1062 is included in the arbitration. Spokespeople for AstraZeneca and Daiichi Sankyo declined to comment.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Two studies of DS-1062 are currently posted on ClinicalTrials.gov. One is a Phase I trial of 350 patients with non-small-cell lung cancer and triple-negative breast cancer that is listed as currently open for recruitment. The other is a Phase II study in 150 patients with advanced or metastatic NSCLC with actionable genomic alternations that as of Monday was not yet recruiting.
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