June 9, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Thousand Oaks, California - Amgen announced positive results today of its Phase II clinical trial of erenumab (AMG 334) for chronic migraine prevention. It met the study’s primary endpoint, showing statistically significant reduction in migraine days in two dose groups.
“Migraine is the sixth leading cause of disability worldwide,” said Sean Harper, executive vice president of Research and Development at Amgen, in a statement. “Three to seven million Americans spend more than half of each month living with the debilitating symptoms of chronic migraine. These positive results are exciting because they add to the growing body of evidence supporting erenumab for the prevention of migraine. We look forward to Phase III episodic migraine data later this year.”
Amgen isn’t the only company battling its way into the migraine market. Alder Biopharmaceuticals , in Seattle, Israel’s Teva Pharmaceutical Industries , and Eli Lilly also have chronic migraine drugs in trials. Alder released data from its Phase II trial of ALD403 in March. ALD403 can be self-administered and can be dosed every three months.
Writing for Xconomy, Ben Fidler says, “The dosing frequency, and whether a drug can be self-administered as opposed to given at the hospital, will help differentiate between the candidates that Amgen, Alder, Teva, and Eli Lilly are developing. Teva got its drug when it bought San Mateo, California-based Labrys Biologics. Eli Lily, of Indianapolis, obtained its prospect through a deal with Cambridge, Massachusetts-based Arteaus Therapeutics. All four drugs are CGRP antibodies.”
Amgen’s drug is an injectable, given once monthly. Patients showed about a 6.6-day decrease in monthly migraine days, compared with a 4.2-day reduction in patients receiving a placebo. Amgen plans to release more detailed data in the future, including information regarding secondary endpoints like reduction of a minimum of 50 percent in monthly migraine days. It also has a study, which it expects to report on later this year, in patients with episodic migraines.
A chronic migraine is defined as at least 15 headache days per month over three months. Episodic migraine is defined as 4 to 15 headache days per month.
“Amgen and Novartis look forward to discussing these results with global regulators,” said Kristen Davis, a spokeswoman for Amgen, to CNBC. “We believe that together with the Phase III episodic data that we expect in H2, the data could potentially support both chronic and episodic indications being granted, at least by some of the global regulators.”
A Citi analyst in April projected that the drug could be worth $1.5 billion to Amgen, with a upside of $8 per share.
“We continue to view AMG 334 as one of the more important growth drivers for Amgen over the near-to-intermediate term and recognize the commercial potential that chronic and episodic migraine present,” the company indicated.
Mark Schoenebaum, an analyst with ESI Evercore, wrote in a research note yesterday that Amgen needed to provide more details about the trial. He noted that Amgen’s data was “roughly comparable” to data from Alder and Teva, but noted that the primary endpoint data was incomplete, and the secondary endpoint data was missing.
