Date: 2017-07-27
Type of information: Collaboration agreement
Compound: Imfinzi® (durvalumab), Keytruda® (pembrolizumab), Lynparza® (olaparib), selumetinib
Company: AstraZeneca (UK) Merck&Co (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration - development
Action mechanism:
- poly ADP ribose polymerase PARP inhibitor/PARP inhibitor/tyrosine kinase inhibitor/MEK inhibitor/immunotherapy product/monoclonal antibody/immune checkpoint inhibitor..
- Olaparib (Lynparza®) is an oral poly ADP ribose polymerase (PARP) inhibitor. It exploits DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies. PARP is associated with a range of tumour types, in particular with breast and ovarian cancers. The drug is currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
- Selumetinib is an oral, potent, selective MEK inhibitor, which has been shown to be effective as monotherapy and in combination with standard chemotherapy regimens in Phase I and Phase II clinical studies across a range of solid tumours, which support the development of selumetinib in patients with MEK-dependent cancers. MEK is part of the MAPK pathway which is frequently activated in cancer, and is elevated in many different solid tumour types, including those featuring the KRAS mutation, which is present in 20% of human cancers and 20-30% of NSCLC tumours. AstraZeneca acquired exclusive worldwide rights to selumetinib from Array.
- Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system.
- Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. This antibody is directed against B7-H1, have been shown to block the interaction between B7-H1 and its receptors, PD-1 and CD80 (B7-1). This blockade may help to overcome the immunosuppressive effects of B7-H1 on anti-tumor T cells.
Disease:
Details:
- • On July 27, 2017, AstraZeneca and Merck & Co announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca’s Lynparza® (olaparib) for multiple cancer types. Lynparza®’s pipeline has grown significantly in the last few years, with 14 indications currently being developed across several tumour types, including breast, prostate and pancreatic cancers. The strategic collaboration is expected to further increase the number of treatment options available to patients.
- The companies will develop and commercialise Lynparza® jointly, both as monotherapy and in combination with other potential medicines. Independently, the companies will develop and commercialise Lynparza® in combination with their respective PD-L1 and PD-1 medicines, Imfinzi® (durvalumab) and Keytruda® (pembrolizumab).
- The companies will also jointly develop and commercialise AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer.
Financial terms:
- Under the terms of the agreement, AstraZeneca and Merck & Co will share the development and commercialisation 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 & Co will fund all development and commercialisation costs of Keytruda® in combination with Lynparza® or selumetinib. AstraZeneca will fund all development and commercialisation 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 terms of the agreement, AstraZeneca anticipates approximately $1 billion to be recorded under Externalisation Revenue in 2017.
Latest news:
Is general: Yes
