How This Little Biopharma Could Beat Amgen, Teva to the Migraine Finish Line

On Jan. 8, Alder BioPharmaceuticals announced that its eptinezumab met its primary endpoint in its Phase III PROMISE 2 clinical trial for preventing migraine. This has led to analysts predicting the company will beat out larger biopharma companies such as Amgen, Eli Lilly, and Teva Pharmaceutical in migraine prevention.

Eptinezumab is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), which is linked to mediating and initiating migraine headaches. The antibody is combined with delivery by way of a quarterly infusion.

In the Phase III PROMISE 2 trial, eptinezumab versus placebo met the primary endpoint and all key secondary endpoints. "These clinically significant data clearly demonstrate that eptinezumab delivered by infusion provided rapid, effective and sustained migraine relief," said Randall Schatzman, Alder’s president and chief executive officer, in a statement. "With these PROMISE 2 results, we remain on track to submit our Biologics License Application (BLA) in the second half of 2018. If approved, eptinezumab has the potential to advance the treatment paradigm in chronic migraine prevention and be a meaningful treatment option for millions of the most severely impacted patients."

The primary endpoint met was a reduction of 8.2 monthly migraine days from baseline compared to 5.6 days for placebo. Secondary endpoints met were a 52 percent reduction in migraine risk from the first day after infusion compared to a 27 percent reduction for patients on placebo. For month one through month three, 61 percent of patients had a 50 percent or greater reduction in migraine days compared to 39 percent for placebo, and 33 percent had a 75 percent or greater reduction in migraine days compared to 15 percent for placebo. And for a 100 percent response, 15 patients had no migraines for three months, compared to five percent for those on placebo.

Danielle Brill, an analyst with Needham, gave Alder a "buy" rating, saying in a note to clients, "Alder is turning things around in 2018." She went on to say, "We believe the data also showcased intravenous eptinezumab’s differentiated profile. Rapidity of onset, and magnitude of benefit with intravenous eptinezumab were clearly distinguished from subcutaneous (injection) competitors’ data."

Vamil Divan, an analyst with Credit Suisse, prefers the intravenous route, although it’s doubtful patients would. Divan prefers it "because it will lead to regular office visits by patients where he can monitor their progress and ensure proper compliance to therapy."

Divan also noted that Alder will probably be the fourth company to bring an anti-CGRP to the market. However, analysts, Brill and Divan included, believe that eptinezumab differentiates itself from the others in the market.

Investor’s Business Daily notes, "Still, Alder and its rivals will face the same insurer obstacles and competition from likely less costly treatments like Allergan’s Botox, (Divan) said. In the U.S., about 40 percent of Botox sales come from use in chronic migraines."

Divan wrote, "Based on the cost of novel therapies, it is possible payers may push patients to try older (off-label) therapies as well as Botox before patients are given access to CGRP antibodies. But over time we would assume new patients and patients who are not having satisfactory responses to Botox will move over to the CGRP antibodies."

It would also seem like that the choice of therapies would depend greatly on just how debilitating the migraines are for the patients and how well they respond to various treatments.