Since taking over the role of chief executive officer at Bothell, Wash.-based Alder BioPharmaceuticals in June 2018, Robert Azelby has maintained his focus on moving the company closer to launching its first commercial product in the migraine treatment space.
Since taking over the role of chief executive officer at Bothell, Wash.-based Alder BioPharmaceuticals in June 2018, Robert Azelby has maintained his focus on moving the company closer to launching its first commercial product in the migraine treatment space.
And, as of February, the company has moved closer to its goal. In February, Alder submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Azelby anticipates that the company will be on track for a commercial launch in the first quarter of 2020. The first step though is the acceptance of the BLA, which Azelby said is expected to be announced later this month.
“People don’t realize it takes a lot of effort to get ready for a BLA,” Azelby told BioSpace in an exclusive interview.
Azelby quietly assumed the reins of Alder in June of 2018. He succeeded Randall Schatzman, who stepped down from the CEO position in March 2018. Azelby came over to Alder from Juno Therapeutics, where he had served as CCO until that company was acquired by Celgene for $9 billion in January 2018. Since taking over, Azelby said he has been busy “dotting the i’s and crossing the t’s” to ensure that the BLA was ready for submission.
“We may have been quiet, but we’ve been busy,” Azelby said.
But now, Azelby and Alder hope that eptinezumab will make some noise in the increasingly crowded migraine space. The medication is being developed for the prevention of both chronic and episodic migraine. If approved, Azelby said eptinezumab will be the first quarterly infusion therapy for migraine prevention that is designed specifically for rapid, effective and sustained suppression of migraine. Clinical data has shown that following the 30-minute infusion time, there is a 100 percent bioavailability of the medication in a patient. Azelby said that is important because that means that 100 percent of the medicine is available to block CGRP and migraine prevention begins in 24 hours.
Phase III data showed that eptinezumab was effective in significantly reducing the average number of migraine days in patients with both episodic migraine, 14 migraines or less per month, and chronic migraine, 15 migraines or more per month. Azelby said in both trials, there was a “strong depth of response” from patients.
Drugs that target CGRP have become a cornerstone of migraine treatment. There are currently three approved anti-CGRP treatments on the market and more are coming. In May 2018, the FDA approved Aimovig, a medication jointly developed by Amgen and Novartis for the preventive treatment of migraine in adults. Then in September, the FDA approved two anti-CGRPs. Teva Pharmaceutical snagged approval for Ajovy for the preventive treatment of migraine in adults. Eli Lilly’s Emgality for migraine prevention was also approved in September.
Allergan is also inching closer to approval of its migraine treatment. Last month the FDA accepted a New Drug Application for Allergan’s ubrogepant for the acute treatment of migraine. Ubrogepant, if approved, will become a complementary treatment to the company’s migraine backbone of its blockbuster neurotoxin Botox, which is widely used to treat chronic migraines.
Based on the late-stage data and the ease of quarterly IV treatments, Azelby said the company believes that eptinezumab will have a lot of advantages that prescribers will want to take advantage of for their patients. He was confident that eptinezumab will be able to find its own share of the market.
In anticipation of the potential approval, Azelby said Alder is rapidly scaling its infrastructure. The company is planning to hire between 75 and 100 sales representatives and is also hiring in other areas. Most of the non-sales positions positions will be in Bothell, Azelby said.
Azelby said Alder is focused on treating migraine and wants to find ways to treat the neurological disease in order to give sufferers their lives back.
“Migraine is a debilitating disease. It is far more than a headache. It impacts the entire body. When people get one or two a week, it leads to other problems like sleep disorders, anxiety and gastrointestinal issues,” Azelby said. “We want to develop medicines that will help people get back to their life as quickly as possible.”
