- Amgen and Novartis have reworked a 2015 collaboration on the migraine treatment erenumab, adjusting how commercialization rights and costs are split ahead of a planned regulatory submission for the drug later this quarter.
- Under the new deal terms, the companies will now co-commercialize erenumab in the U.S., with Amgen booking sales and paying a "significant" royalty to the Swiss pharma on net sales. Novartis also picks up exclusive rights to sell and market erenumab in Canada.
- In return, Novartis will fund share commercialization costs and will line up a string of milestone payments that could exceed $400 million in total. Erenumab is part of a class of promising migraine drugs called CGRP inhibitors that are rapidly nearing regulatory review, potentially upending the current market of preventative treatments.
Amgen and Novartis hope to quickly push erenumab through to market in what could become a crowded field.
Most existing options for migraine prevention were originally designed for other uses (Botox, for example), while other treatments do little to mitigate the underlying triggers which lead to episodic or chronic migraines. And side effects and toxicity lead to discontinuation of treatment for many patients.
Given the large patient population in the U.S. of migraine sufferers, biotech and pharma companies have bet on drugs designed to target and block the calcitonin gene-related peptide receptor, a protein though to be involved in the intense pain signaling characteristic of migraines.
Eli Lilly, Teva and Alder Pharmaceuticals, for example, are all currently moving their own CGRP-targeting monoclonal antibodies through late-stage development. Other than Amgen, Lilly appears closest to market, and plans to submit its drug galcanezumab for approval sometime in the second half of this year.
Teva's fremanezumab is in Phase 3 testing for both chronic and episodic migraines, as well as cluster headache, while Alder Pharmaceuticals is a little further out with a regulatory submission planned for the second half of 2018 after two Phase 3 studies.
In clinical trials, the drugs have reduced the number of monthly migraine days experienced by patients, with some differentiation between each.
It's difficult to read the tea leaves of Amgen and Novartis' decision to adjust their collaboration. In its release on the news, Amgen notes sharing commercialization in the U.S. will help leverage "Novartis' strong and established presence in neuroscience to more effectively reach people with migraine."
But, by doing so, Amgen gives up part of its exclusive commercialization rights in the U.S., likely one of the more lucrative markets for a successful migraine drug. While Novartis will help out with costs, and Amgen could realize some milestones from the Swiss pharma, it looks like Amgen has mitigated some of its risk in return for sharing a greater portion of potential profits.
Outside of the U.S. and Japan, Novartis will book any sales of erenumab and pay Amgen royalties. Japan remains an exclusive Amgen territory.
Migraines often involve severe pain with flickering visual symptoms, nausea, vomiting, and sensitivity to lights, sounds and smells. Aside from the extreme physical discomfort, migraines can also lead to time out of work or education. Novartis and Amgen estimate as many as 10 million people in the U.S. could benefit from a preventative medication like CGRP-targeting drugs.