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Agreements

Date: 2015-12-21

Type of information: Development agreement

Compound: binimetinib (MEK162), encorafenib (LGX818)

Company: Array BioPharma (USA - CO) Pierre Fabre (France)

Therapeutic area: Cancer - Oncology

Type agreement:

development

commercialisation

Action mechanism:

kinase inhibitor/RAF kinase inhibitor/MEK (MAP kinase) inhibitor.The RAS/RAF/MEK/ERK pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal, ovarian and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway.

Disease:

Details:

* On December 21, 2015, Array BioPharma announced the closing of its definitive agreement with Pierre Fabre following approval of the agreement by the European Commission on Competition (ECC). The definitive agreement, announced on November 16, 2015, relates to globally developing and commercializing Array's late-stage novel oncology products, binimetinib and encorafenib. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, are currently advancing in three, global Phase 3 trials for melanoma and ovarian cancer.

* On November 16, 2015, Array BioPharma and Pierre Fabre announced a collaboration to globally develop and commercialize Array's late-stage novel oncology products, binimetinib and encorafenib. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, are currently advancing in three, global Phase 3 trials for melanoma and ovarian cancer (NRAS-mutant melanoma (NEMO, with binimetinib), low-grade serous ovarian cancer (MILO, with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with binimetinib and encorafenib). Top-line results from NEMO, a Phase 3 study of binimetinib in patients with NRAS-mutant melanoma, are anticipated before the end of 2015. NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing estimated in the first half of 2016. Array also projects a regulatory filing of binimetinib in combination with encorafenib in BRAF melanoma in 2016. The agreement remains subject to European Commission on Competition review and approval.

In April 2014, Novartis has agreed to acquire GSK oncology products for a $ 14.5 billion payment and up to $ 1.5 billion contingent on a development milestone. Array has recently announced agreements with Novartis to regain rights to binimetinib and encorafenib. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. 

 

 

Financial terms:

Under the terms of the agreement, Array will receive an upfront payment of $30 million and retains exclusive commercialization rights for binimetinib and encorafenib in the United States, Canada, Japan, Korea and Israel. Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Array is entitled to receive up to $425 million if certain development and commercialization milestones are achieved, and is eligible for robust, tiered double-digit royalties. Array and Pierre Fabre have agreed to split future development costs on a 60:40 basis (Array:Pierre Fabre) with initial funding committed for new clinical trials in colorectal cancer and melanoma. All ongoing binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis.

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