BASEL (dpa-AFX) - Array BioPharma Inc. (ARRY) Friday said it has reached a definitive agreement with Novartis Pharma AG to acquire worldwide rights to encorafenib or LGX818, a BRAF inhibitor currently in Phase 3 development.
This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline Plc. on April 22, 2014, which are expected in the first half of 2015.
Array had previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib. The material terms of that deal remain in place following this agreement.
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.
The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28.
Regarding the deal for encorafenib, other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services and will assign or license to Array all patent and other intellectual property rights Novartis owns relating to encorafenib.
As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner, a trustee would have the right to sell such European rights.
Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, and Novartis will reimburse Array for out-of-pocket costs along with 50 percent of Array's full time equivalent costs in connection with completing the COLUMBUS trial.
Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50 percent of Array's FTE costs in connection with completing the trials.
Copyright RTT News/dpa-AFX
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