Date: 2015-07-07
Type of information: Licensing agreement
Compound: MK-1602, MK-8031
Company: Allergan (Ireland) Merck&Co (USA - NJ)
Therapeutic area: CNS diseases
Type agreement: licensing
Action mechanism: calcitonin gene-related peptide (CGRP) receptor antagonist. MK-1602 (ubrogepant) and MK-8031 are oral small molecule antagonists for the treatment and prevention of migraines. 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.
Disease: treatment and prevention of migraine
Details: * On July 7, 2015, Allergan and Merck&Co announced that they have entered into 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, subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR). The agreement gives Allergan rights to two CGRP receptor antagonists, MK-1602 and MK-8031. Allergan will be fully responsible for development of the CGRP programs, as well as manufacturing and commercialization upon approval and launch of the products. A phase 2 study of MK-1602 has been completed and end of phase 2 discussions with FDA are planned prior to initiating phase 3. A phase 3 study is expected to begin in 2016. A phase 2 study of MK-8031 is expected to begin in 2016.
Financial terms: Under the terms of the agreement, Allergan will acquire these rights for an upfront payment of $250 million, $125 million of which is payable upon HSR clearance and $125 million of which is payable in April of 2016. Merck&Co will additionally be entitled to receive potential development and commercial milestone payments and tiered double-digit royalties based on commercialization of the programs. Allergan said its 2015 earnings-per-share forecast provided on May 11, 2015 is unchanged as a result of the acquisition. Allergan remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016.
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