MK-3207

July 7, 2015 By Mark Terry , BioSpace.com Breaking News Staff Dublin, Ireland-based Allergan plc announced today that it inked an agreement to acquire worldwide rights to two of Merck & Co. ’s small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists to treat migraine. Allergan Inc. will pay $250 million upfront and another $125 upon Hart-Scott-Rodino (HSR) antitrust clearance, and the other $125 million on April 2016. There are also potential double-digit royalties and various milestone payments possible upon commercialization. Under the terms of the deal, Allergan will be solely responsible for the CGRP program development, as well as manufacturing and commercialization, if it gets that far. There are two CGRP receptor antagonists as part of the agreement, MK-1602 and MK-8031. MK-1602 completed a Phase II study and discussions for a Phase III study are ongoing with the U.S. Food and Drug Administration (FDA) . A Phase III study is expected to start in 2016. MK-8031 is expected to start a Phase II study in 2016. In 2009, Merck , which had been working on the CGRP receptor antagonists for migraine, announced it was discontinuing its clinical development program for MK-3207. In a Phase II study the compound showed efficacy, but some subjects in the Phase I study experienced delayed, asymptomatic liver abnormalities. Two years later, it discontinued clinical development of another CGRP antagonist, telcagepant (MK-0974) for the same reasons. The MK-1602 and MK-8031 involved in today’s deal belong to a different chemical series and to date clinical trials have shown no liver toxicity. “The agreement to acquire exclusive worldwide rights to Merck ’s CGRP migraine development program builds on our existing strength in neurosciences and helps position Allergan as a potential leader in the acute treatment of migraine and prevention of migraine for millions of patients,” said David Nicholson , executive vice president, Global Brands Research and Development at Allergan in a statement. “With two novel oral therapies in development for treating and preventing migraines, we have the opportunity to provide therapies that could alleviate an intensely debilitating and immobilizing condition for patients worldwide.” Work appears to be accelerating in the migraine space. Amgen , headquartered in Thousand Oaks, Calif. recently announced results from a Phase II trial for AMG 334 for migraine headaches. The compound appeared to reduce the number of days per month of migraines in participants by about an additional day. AMG 334 is a human monoclonal antibody that inhibits CGRP receptors. In April 2015 Bothell, Wash.-based Alder Biopharmaceuticals Inc. announced that it was planning to begin a Phase III clinical trial for ALD403, a monoclonal antibody for migraine that also targets CGRP. In 2013 Allergan acquired MAP Pharmaceuticals for almost $1 billion. MAP had an experimental migraine drug called Levadex, which is a reformulation of dihydroergotamine, or DHE. The FDA rejected a new inhaled version of Levadex, called Semprana, because of issues related to the delivery device. News of Semprana is expected from the FDA sometime this month. The most common approach to migraine treatment are triptans, although not all patients respond to them. In the U.S., triptans are marketed as Imitrex and Amerge, both manufactured by GlaxoSmithKline . Other drugs include Zomig, manufactured by IMPAX Laboratories, Inc. , Maxalt by Merck , Axert by Janssen Pharmaceuticals , a Johnson & Johnson company, Frova by Endo Pharmaceuticals and Relpax ( ( Pfizer Inc. . Triptans constrict blood vessels in the brain and are not preventative. After Bristol-Myers Squibb Wonder Drug Meets Endpoints, Will FDA Process Be Up to Snuff? Our most popular story last week was about a new wonder drug that wowed the FDA . An experimental anticoagulant drug under joint development between Portola Pharmaceuticals, Inc. , Bristol-Myers Squibb Company and Pfizer Inc. met all primary and secondary endpoints in a Phase III study determining safety and efficacy—and our readers responded. The hope now is it will be sped to patients as fast as possible. That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas. var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "after-bristol-myers-wonder-drug-meets-endpoints-will-fda-process-be-up-to-snuff", placeholder: "pd_1435601218" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));