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Teva’s CGRP migraine drug aces PhIII while rivals pile up at the FDA finish line

Positive late-stage data are starting to pile up in the CGRP migraine drug category, likely signaling a sudden influx of new drugs with remarkably similar data sets looking to carve up the market in their field.

Ernesto Aycardi, R&D leader for migraine and headache at Teva

The latest entry: Teva, which badly needs some good news after a series of corporate and R&D setbacks, says its Phase III HALO study came through on fremanezumab, setting up a new FDA application that will follow shortly as it prepares to publish another batch of Phase III data on episodic migraine in a matter of weeks.

Patients in the study experienced an average 2.5-day reduction in migraine days per month. That’s an important improvement, but the problem is that at this stage of the game, it’s comparable to the whole wave of late-stage therapies Teva will likely be competing again.

Teva’s shares $TEVA were up a few cents in mid-day trading Wednesday.

A couple of weeks ago it was Eli Lilly’s $LLY turn to celebrate its Phase III results for galcanezumab, with a consistent 2-day reduction in monthly migraines. Little Alder $ALDR is also planning to wage a commercial war with their drug. And Allergan $AGN has a late-stage program underway for an oral CGRP therapy it in-licensed from Merck in 2015 with a $250 million upfront.

Novartis $NVS and Amgen $AMGN — credited as the frontrunners in the race to the first OK — were the first to come up with positive Phase III data for erenumab (AMG 334) last fall, when a 70 mg dose scored an average 1.1 day per month drop in migraine episodes. Then their STRIVE study delivered an average reduction of 3.2 and 3.7 days from baseline in monthly migraine days for the 70 mg and 140 mg doses, respectively, as compared to a 1.8-day reduction in the placebo arm. The data so far have all indicated that these drugs can consistently reduce migraine days by one or two days, as analysts try to make comparisons with different patient populations and a variety of baseline scores to start with.

As a result, analysts are looking for ways to differentiate these drugs to help them evaluate their potential. Barclays’ Douglas Tsao today noted:

Success with quarterly dosing regimen (for Teva) marks an incremental advance for fremanezumab since it wasn’t tested in Phase 2 and, assuming approved, it would be a differentiator compared to the Amgen and Eli Lilly programs.  Also not to be overlooked, patients that were on monotherapy and stable doses of prophylactic medications were included in TEVA’s trial.

Despite the number of CGRP drugs angling for the lead here, Biohaven $BHVN recently in-licensed a similar drug from Bristol-Myers Squibb and scored a very successful IPO with it just weeks ago.


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RAPS Regulatory Convergence 2017