Amgen $AMGN posted some impressive results for its Phase II study of a closely-watched migraine drug, but the big biotech may still be forced to accept a shrinking share of what is shaping up as a highly competitive market as rivals crowd the same sector.
The key data on erenumab: 40 percent and 41 percent of the patients in the two dose arms (70 mg and 140 mg doses) experienced a reduction of 50% or more in the number of migraine days recorded at week 12, compared to about one in 4 (24%) of those taking a placebo.
In addition, Amgen’s investigators say the safety profile for their drug looked quite similar to a placebo.
If those numbers hold up in the soon-to-be-completed Phase III, Amgen and its partners at Novartis $NVS — which holds ex-US rights — should be looking at an approval.
This drug targets the calcitonin-gene-related-peptide (CGRP) receptor. And therein lies the rub for Amgen and Novartis. The giants have a drug that does something similar to what a pair of rivals from Alder $ALDR and Teva $TEVA does. And they may well have to wind up splitting the market among drugs that look remarkably similar.
Leerink’s Geoffrey Porges took a look at the data and figures that Amgen can still flirt with blockbuster success with what it has, even though the drugs from Alder and Teva bind directly to the ligand while Amgen/Novartis’ drug targets the receptor. But he’s cutting his peak revenue forecast.
Amgen, notes Porges:
(F)ailed to differentiate erenumab from competing programs from Alder (ALDR, [OP]) and Teva (TEVA, [OP]) – although the results continue to validate the class of CGRP targets for the treatment of migraines. Currently we anticipate first revenues for erenumab in 2018 totaling $85mm, increasing to $991mm by 2023, reflecting a probability of success weighted adjustment of 65%, and an initial market share of 50% declining to 23% as competing products enter the market. Our forecast is below recent consensus, which predicts 2018 revenues of $161mm expanding to $1.3bn in 2023. We are maintaining our forecast while awaiting greater disclosures from Amgen, including data from the more clinically meaningful endpoints of 75% and 100% reduction in migraine days and the phase 3 erenumab trial results for both episodic and chronic migraine.
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