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The agreement gives Allergan a foothold in migraine drug development.
Allergan and Merck have entered into an agreement that gives Allergan 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. The deal is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR).
Allergan will develop the CFRP programs and be responsible for the manufacturing and commercialization of the products when approved and launched. Under the agreement, the company acquires rights to two CGRP receptor antagonists:
· MK-1602 is an oral small molecule antagonist for the acute treatment of migraines. Phase II evaluation has been completed and discussions with FDA are under way with plans to initiate Phase III studies in 2016.
· MK-8031, for the prevention of migraines, is expected to start its Phase II trial in 2016.
In July 2011, Merck announced the discontinuation of its Telcagepant (MK-0974) development program following reports that some patients were experiencing liver toxicity. This molecule is an earlier investigational oral CGRP antagonist. The MK-1602 & MK-8031 molecules are not in the same group as Telcagepant and have not shown signs of liver toxicity in clinical trials to date.
Allergan will make an upfront payment of $250 million to Merck, of which $125 million will be paid upon HSR clearance and the remaining $125 million will be paid in April of 2016. Merck is also entitled to receive potential development and commercial milestone payments and tiered double-digit royalties based on commercialization of the programs.
The agreement gives Allergan a foothold in migraine drug development. According to Allergan, the acquisition has not changed its 2015 earnings-per-share forecast provided on May 11, 2015.