Allergan plc and Merck & Co., have formed an agreement under which Allergan will acquire the exclusive worldwide rights to Merck’s investigational small- molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for the treatment and prevention of migraine for an upfront payment of $250 million, $125 million of which is payable upon antitrust clearance and $125 million of which is payable in April of 2016. Merck will additionally be entitled to receive potential development and commercial milestone payments and tiered double-digit royalties based on commercialization of the programs. Allergan will be fully responsible for development of the CGRP programs, as well as manufacturing and commercialization upon approval and launch of the products.

The agreement gives Allergan rights to two CGRP receptor antagonists. The first is MK-1602, an oral small-molecule antagonist for the acute treatment of migraines. A Phase II study of MK-1602 has been completed and end of Phase II discussions with the US Food and Drug Administration are planned prior to initiating Phase III studies. A Phase II study is expected to begin in 2016. The second drug is MK-8031, an oral small-molecule antagonist for the prevention of migraines. A Phase II study of MK-8031 is expected to begin in 2016.

In July 2011, Merck announced that it had discontinued clinical development of an earlier investigational oral CGRP antagonist, Telcagepant (MK-0974), after some patients showed evidence of liver toxicity. The MK-1602 & MK-8031 molecules belong to a different chemical series than Telcagepant, and in clinical trials to date have not shown evidence of liver toxicity. The potential of the CGRP antagonist mechanism has received validation from episodic and chronic migraine studies of injectable candidates in development, according to information from Allergan.

Source: Allergan