DUBLIN & KENILWORTH, N.J.—Allergan plc and Merck, known as MSD outside the United States and Canada, have launched an agreement pursuant to which Allergan will acquire exclusive worldwide rights to Merck's investigational small-molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists. Per the terms of the agreement, Allergan will pay Merck $250 million up front for the rights, $125 million of which is payable upon receiving clearance under the Hart-Scott-Rodino Antitrust Act and the other $125 million of which will be payable in April of next year. Merck is entitled to receive potential development and commercial milestone payments and tiered double-digit royalties based on commercialization of the programs. Allergan will assume full responsibility for developing the CGRP programs, as well as manufacturing and commercialization upon approval and launch.
“We are pleased that this agreement will enable Allergan to advance these promising molecules for the potential benefit of migraine sufferers, and that Merck will be able to continue to further focus our research and development resources on our priority therapeutic areas,” commented Iain D. Dukes, senior vice president of Business Development & Licensing for Merck Research Laboratories.
Under this agreement, Allergan gains the rights to two CGRP receptor antagonists being developed for migraine. Those antagonists include MK-1602, an oral small-molecule antagonist for the acute treatment of migraines, and MK-8031, an oral small-molecule antagonist for the prevention of migraines. A Phase 2 study of MK-1602 has already been completed, with a Phase 3 study is slated to begin next year, and a Phase 2 study of MK-8031 is expected to begin in 2016 as well. In clinical trials to date, neither compound has shown any evidence of liver toxicity, and per a Merck press release, “The potential of the CGRP antagonist mechanism has received validation from episodic and chronic migraine studies of injectable candidates in development.”
“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,” David Nicholson, executive vice president of Global Brands Research and Development at Allergan, said in a press release about the deal. “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. We look forward to supporting the continued development of these programs and to potentially bringing these new therapies to market.”
According to the Migraine Research Foundation, approximately 36 million people suffer from migraines in the United States. These intense headaches consist of serious head pain that can last anywhere from four to 72 hours, and additional common symptoms include dizziness, nausea, vomiting and an increased sensitivity to light and sound.
SOURCE: Merck press release