Array to acquire rights for BRAF inhibitor, encorafenib

Array BioPharma has announced its agreement to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in phase 3 development, from Novartis Pharma AG.

The agreement on encorafenib (LGX818) is contingent upon regulatory approvals and the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) in April 2014, which are expected to be completed in the first half of 2015, according to a press release.

The European Commission is expected to issue a decision on Jan. 28 regarding the Novartis-GSK transaction.

There are currently 11 active clinical trials of ecorafenib, including the phase 3 COLUMBUS trial, in which encorafenib is being studied in combination with binimetinib, a phase 3 MEK inhibitor, for the treatment of patients with BRAF+ melanoma. Array also has a definitive agreement with Novartis to regain global rights to binimetinib, according to the release.

Array will acquire global rights to encorafenib upon satisfaction of all conditions. There are no milestone payments from either party except for a de minimis payment due to Novartis.

Transitional regulatory, clinical development and manufacturing services will be provided by Novartis, with all patent and intellectual property rights being assigned to Array, according to the release.

The COLUMBUS trial will be conducted by Novartis through June 30, 2016, or through completion of last patient’s first visit, whichever occurs earlier. Array will assume responsibility at that time, with Novartis reimbursing Array for out-of-pocket costs along with 50% of Array’s full-time equivalent costs in connection with completing the trial, the release stated.

Among interim results of a phase 1b trial of binimetinib and encorafenib presented by Novartis in 2013 at the International Myeloma Conference, a disease control rate of 100% and overall response rate of 89% was demonstrated in BRAF inhibitor-naïve patients with melanoma. The disease control rate was 64% in patients with melanoma who had been previously treated with a BRAF inhibitor, according to the release.

A combination of encorafenib, cetuximab and alpelisib demonstrated efficacy in patients with BRAF+ colorectoral cancer in phase 1 study data presented at the 2014 EORTC-NiC-AACR Symposium on Molecular Targets and Cancer Therapeutics.

Reference: www.arraybiopharma.com.