- Amgen and Novartis on Wednesday unveiled positive top-line results from a Phase 3 study of their co-developed migraine treatment AMG 334 (erenumab).
- Erenumab combats episodic migraines through blocking CGRP, a protein that studies have shown correlates with the severe headaches, though researchers are unsure of exactly how. In this latest trial, patients receiving the drug experienced migraines three days a month on average versus eight days on average at baseline.
- The study comes seven weeks after the drugmakers announced erenumab reached its primary endpoint in another Phase 3 study. Across the two late-stage studies and an earlier Phase 2 study, the companies have tested their treatment on 2,200 patients, according to a Nov. 16 statement.
At the onset of the randomized, double-blind study, patients reported experiencing migraines 8.3 days of each month on average. They were then given either 70 mg or 140 mg doses of the drug or a placebo once a month for six months. Data from the study showed the number of days patients reported migraines decreased by 3.2, 3.7 and 1.8 days, respectively, across the three treatment groups.
"The results of this study are important because they confirm the results from our previous studies and add to our body of research in episodic migraine," Sean Harper, Amgen's executive vice president of research and development, said in the statement.
The companies' partnership gives Novartis manufacturing and marketing rights to any of Amgen's migraine drugs or investigational molecules in any country besides the U.S., Canada and Japan. The collaboration also includes the co-development of Novartis's beta-secretase 1 (BACE1) inhibitor molecule CNP520.
Should erenumab gain approval, it would be Amgen's first drug in the neuroscience space and would open new growth opportunities for Novartis' Innovative Medicines division, which saw sales fall 1% in the third quarter compared to the same period in 2015.
What's more, it would give the drugmakers a leg up against Alder Biopharmaceuticals, Eli Lilly and Teva in the fight to commercialize an injectable migraine drug, according to a Nov. 17 Jefferies note about Novartis. The investment bank gave the company a "Buy" rating, and expected peak sales of erenumab to reach $1.5 billion.
In its Nov. 16 statement, Amgen said it will continue to analyze the drug's newest Phase 3 data, and plans to submit the analysis for publication as well as to an upcoming medical conference.