AstraZeneca, Merck & Co. enter cancer drug development deal focused on PARP inhibitor Lynparza

AstraZeneca and Merck & Co. entered a deal potentially worth up to $8.5 billion to jointly develop and market the UK drugmaker's PARP inhibitor Lynparza (olaparib) for multiple cancer types, including breast, prostate and pancreatic cancers, the companies reported Thursday. The drug, which generated sales of $218 million last year, is currently approved as monotherapy in the EU and US for BRCA-mutated ovarian cancer in multiple lines of treatment.

Under the agreement, AstraZeneca and Merck will develop Lynparza both as monotherapy and in combination trials with other potential medicines, including their respective PD-L1 and PD-1 medicines, Imfinzi (durvalumab) and Keytruda (pembrolizumab). The companies will also jointly develop AstraZeneca's MEK inhibitor selumetinib, which was in-licensed from Array BioPharma and is currently being investigated for multiple indications including thyroid cancer.

AstraZeneca CEO Pascal Soriot noted that the deal "builds on scientific evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumours." Under the agreement, Merck will pay AstraZeneca $1.6 billion upfront, $750 million for certain license options and up to an additional $6.15 billion contingent upon successful achievement of future regulatory and sales milestones.

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The companies noted that they will share development and commercialisation costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities. Meanwhile, Merck will fund all costs associated with investigating the combinations of Keytruda with Lynparza or selumetinib, with AstraZeneca responsible for costs linked to combinations with Imfinzi. AstraZeneca and Merck added that gross profits from sales of Lynparza and selumetinib through monotherapies or combination therapies will be shared equally.

Separately on Thursday, AstraZeneca announced initial results from the Phase III MYSTIC study, with the combination of Imfinzi and the CTLA-4 inhibitor tremelimumab failing to improve progression-free survival versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic first-line non-small-cell lung cancer. Shares in the company, which also released second-quarter financial results on Thursday, fell as much as 16 percent on the news. For related analysis, see ViewPoints: More uncertainty at AstraZeneca as initial MYSTIC data falls short.

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