A few days after leaving Insmed to take up an “employment opportunity on the West Coast,” Paul Streck, M.D., has popped up at migraine drug developer Alder BioPharmaceuticals.
Streck is taking on the same chief medical officer role at the Bothell, Washington-based biotech, just as Alder is preparing to file for approval of its CGRP inhibitor eptinezumab for migraine sometime this quarter.
He is replacing Alder’s interim CMO Eric Carter, M.D., Ph.D., who stepped into the role last April following the resignation of Timothy Whitaker at the end of 2017.
Alder’s CEO Bob Azelby—another relatively new hire who joined the company from a job as Juno Therapeutics’ chief commercial officer last June—says Streck has “extensive experience with regulatory interactions, clinical trial execution, and product lifecycle management,” which will be invaluable as the company gears up for its first product launch.
He said Alder is in the process of building out its medical and commercial capacity for eptinezumab “in anticipation of the potential launch in the first quarter of 2020.”
Even though Amgen and Novartis’ Aimovig (erenumab) is already out of the blocks and speeding away in migraine prevention after an FDA OK last year, with some predicting sales could knock on the door of $3 billion at peak, analysts at Leerink Partners reckon there is plenty of room in the CGRP inhibitor market for new players.
Eli Lilly’s Emgality (galcanezumab) and Teva’s Ajovy (fremanezumab) have also been approved by the FDA in the interim, but Leerink analysts still think Alder’s latecomer could achieve blockbuster status. While the three marketed drugs are all given by injection, eptinezumab is delivered by an infusion—and that means it can get to work reducing migraine attacks more quickly, according to Alder.
Azelby told the J.P. Morgan Healthcare Conference in San Francisco earlier this month that speed of onset is really important, particularly for patients at the severe end of the migraine spectrum who may be experiencing four attacks a week.
“They want to get a reduction in migraines as quickly as humanly possible,” he said. Whereas the other injectables can a separation from placebo in migraine days after a few days, Alder’s drug achieved a statistically significant difference “within 24 hours”.
Eptinezumab’s delivery route means it is also being tested as an acute migraine treatment, which could differentiate it from its rivals. Meanwhile, the company has a first-in-class anti-PACAP antibody—called ALD1910—heading for clinical trials that could expand its migraine prevention franchise.
“This is an important time for Alder and for migraine patients,” said Streck. “I look forward to working with the Alder team to ensure the successful approval and launch of eptinezumab and the growth of Alder as a leader in novel migraine therapeutics.”