BASEL, Switzerland & THOUSAND OAKS, Calif.—Novartis and Amgen are doubling down on a 2015 collaboration in neuroscience with news of an expanded agreement to commercialize AMG 334 (erenumab), Amgen's drug candidate in development for preventing migraine. Under the expanded agreement, the companies will co-commercialize AMG 334 in the United States, with Amgen retaining exclusive commercialization rights in Japan while Novartis retains exclusive rights to commercialize the drug in the rest of the world and gains commercialization rights in Canada. Amgen and Novartis will continue to co-develop the program.
The original global collaboration covered the joint development and commercialization of treatments for Alzheimer's disease and migraine, with Amgen and Novartis partnering to develop and commercialize a beta-secretase 1 (BACE) inhibitor program for Alzheimer's. CNP520, an oral therapy from Novartis, was slated at the lead molecule for the partnership, with additional compounds from the preclinical BACE inhibitor programs of both companies considered as novel follow-on molecules. The 2015 deal also included investigational migraine drugs from Amgen, AMG 334 and AMG 301, the latter of which is in a Phase 1 study.
"Migraine is a debilitating neurological disease associated with significant personal, economic, and societal burden. There is an urgent need for effective and well-tolerated preventive treatments that positively impact the lives of people with migraine," Paul Hudson, CEO of Novartis Pharmaceuticals, commented in a statement. "We are excited to expand our collaboration with Amgen. We look forward to combining capabilities and leveraging our strong heritage in neuroscience in the U.S. and Canada to bring erenumab to more patients in need, as fast as we can."
The agreement stipulates that Novartis will make milestone payments to Amgen, and both companies will share U.S. commercialization costs. Amgen will book sales of the drug in the United States and pay Novartis a royalty on those net sales. In turn, Novartis will book sales in the rest of the world, excluding Japan, and pay Amgen royalties on net sales in those countries. As for Japan, Amgen will be the one to book sales in that country. Novartis will be assuming agreed-upon remaining global development costs, up to a cap, and will share those costs afterward.
AMG 334 is a fully human monoclonal antibody designed to prevent migraine by targeting and blocking the Calcitonin Gene-Related Peptide (CGRP) receptor. In a Phase 2 study and two Phase 3 studies of the drug, once-monthly subcutaneous administration resulted in significant reduction of monthly migraine days vs. placebo. AMG 334 has also shown a comparable safety profile to placebo. Regulatory filing for the drug is expected to begin in the second quarter of this year.
"Migraine is a debilitating disease and today many patients are sub-optimally treated due to tolerability issues with existing therapies," said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. "Combining the U.S. capabilities of Amgen and Novartis in preparation for the launch of erenumab can create meaningful value over the life of this first-in-class program by enabling us to more effectively, and perhaps even more rapidly, reach people who live with the impact of migraine on a daily basis."
The World Health Organization (WHO) has declared migraine as one of the top 10 causes of years lived with disability for both women and men. WHO reports on its website that an estimated 25 million work- or school-days are lost annually due to migraine, while the Migraine Research Foundation estimates healthcare and lost productivity costs in the United States at up to $36 billion each year, with 113 million lost work days. According to the Migraine Research Foundation, roughly 38 million people live with migraine in the United States, with some 1 billion affected worldwide, making it the third most prevalent illness globally.