Allergan to acquire migraine program from Merck
Allergan, headquartered in Dublin, Ireland, has entered into an agreement with Merck & Co., known as MSD outside the U.S. and Canada, to 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.
Allergan will acquire these rights for an upfront payment of $250 million, $125 million of which is payable upon Hart-Scott-Rodino Antitrust Improvements Act of 1976 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.
The agreement gives Allergan rights to two CGRP receptor antagonists:
- 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 FDA are planned prior to initiating phase III. A phase III study is expected to begin in 2016.
- 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 and 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.
Migraine is a common disorder of the brain that affects approximately 36 million Americans. Migraines are characterized by attacks of intense, usually one-sided, throbbing head pain that can last from four to 72 hours. The pain associated with migraine is frequently accompanied by other symptoms, including nausea, vomiting, dizziness and increased sensitivity to light and sound.