AstraZeneca and Merck & Co. have formed a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s cancer drug, Lynparza (olaparib), for multiple cancer types in a deal worth up to $8.5 billion, including $1.6 billion upfront. Lynparza is an oral poly ADP ribose polymerase inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.

Lynparza is currently being developed in 14 indications across several tumor types, including breast, prostate, and pancreatic cancers.  The companies will develop and commercialize Lynparza jointly, both as a monotherapy and in combination trials with other potential medicines. Independently, the companies will develop and commercialize Lynparza in combinations with their respective PD-L1 and PD-1 medicines, AstraZeneca’s Imfinzi (durvalumab) and Merck & Co.’s Keytruda (pembrolizumab).

The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase pathway, currently being developed for multiple indications, including thyroid cancer.

Under the agreement, AstraZeneca and Merck & Co. will share the development and commercialization costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities. Gross profits from Lynparza and selumetinib product sales generated through monotherapies or combination therapies will be shared equally.

Merck will fund all development and commercialization costs of Keytruda in combination with Lynparza or selumetinib. AstraZeneca will fund all development and commercialization costs of Imfinzi in combination with Lynparza or selumetinib. AstraZeneca will continue to manufacture Lynparza and selumetinib.

As part of the agreement, Merck & Co. will pay AstraZeneca up to $8.5 billion in total consideration, including $1.6 billion upfront, $750 million for certain license options, and up to $6.15 billion contingent upon successful achievement of future regulatory and sales milestones. Under the agreement, AstraZeneca anticipates approximately $1 billion to be recorded under externalization revenue in 2017. 

Lynparza is currently approved by regulatory health authorities in the European Union for use as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive, relapsed BRCA-mutated (germline and/or somatic), high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in response (complete or partial) to platinum-based chemotherapy. It is also approved in the US as a monotherapy for patients with deleterious, or suspected deleterious, germline BRCA-mutated (as detected by a FDA test) advanced ovarian cancer, who have been treated with three or more lines of chemotherapy.

Source: Merck & Co. and AstraZeneca