Drugmakers race to prescribe preventive migraine remedies
Migraines are one of the most common illnesses worldwide, affecting about 1 in 7 people and more than 30m in the US alone. Many suffer without effective treatment to control their debilitating headaches.
“I can think of only a few examples of holy grails in medicine, which have existed for thousands of years, and this is one of them,” says Sean Harper, the top scientist at Amgen, a large biotech company developing a drug for the condition.
“There’s just no effective preventive therapy for migraine that’s worth taking,” he adds.
Although there are drugs intended for those who suffer migraines occasionally, there are far fewer options for “episodic” or “chronic” sufferers that experience an attack on more than 10 days a month.
Instead, these patients try to cope by avoiding factors that can trigger attacks, such as alcohol and stress, and by taking over-the-counter painkillers such as ibuprofen. Many are forced to take significant amounts of time off work.
However, that could be about to change as four drug companies race to develop a generation of “prophylactic”, or preventive medicines, designed to be taken regularly to reduce the number of attacks.
Last week, Alder BioPharmaceuticals, a tiny biotech group based in Washington state, reported results from a mid-stage study that showed its drug, codenamed ALD403, reduced the average number of migraine days by 75 per cent in a third of patients after three months.
If it can replicate those results in a larger study the drug is likely to be approved by the US Food and Drug Administration. Shares in the company jumped more than 50 per cent after the announcement, giving it a market capitalisation of almost $1bn.
Alder is hoping to grab a large chunk of the market for the new class of migraine drugs, which analysts say could generate as much as $10bn a year in peak global sales.
But the group faces a battle with three goliaths of drugmaking: Amgen, Eli Lilly and Teva, the Israeli drug group.
The companies are in the latter stage of developing medicines similar to Alder’s, which target a chemical known as calcitonin gene-related peptide or CGRP; it helps control the width of blood vessels and plays an important role in managing pain.
Scientists first identified the significance of CGRP in migraines in the 1980s, but earlier drugs developed by US-based Merck and Boehringer Ingelheim were abandoned amid signs that they caused liver damage. This latest crop appears to have few safety issues, according to data from clinical trials.
But some investors and analysts fear that with four companies chasing the same patients, the market for CGRP inhibitors could become crowded.
Randall Schatzman, Alder’s chief executive, disagrees, arguing that up to 13m US patients could benefit from taking one of the new migraine drugs. “It is not as crowded as some people are expecting it to be,” he says. “There’s plenty of room for multiple players.”
As is often the case when multiple drugmakers are running neck and neck, the companies developing CGRP inhibitors are keen to tout the relative benefits of their medicines.
Mr Harper argues that the advantage of Amgen’s drug, codenamed AMG 334, is that it is taken via a once-a-month injection that patients administer themselves. Meanwhile, Alder’s drug is delivered intravenously once a quarter, although it is also working on a quarterly injection.
“What patients really want is to grab an auto-injector out of their fridge once a month, to inject themselves, and to throw the rubbish in the trash,” he says.
Michael Yee, a biotech analyst at RBC Capital Markets, says intravenous delivery, which must be carried out at a doctor’s surgery, means that even if Alder’s drug is the most effective it will only be given to the sickest patients.
Mr Schatzman prefers to see it as a benefit: “All the 800lb gorillas are going down the same highway with a once-a-month injection,” he says, referring to the size of his much larger competitors.
Eli Lilly, meanwhile, is aiming to become the first group to win approval to use its CGRP inhibitor to treat cluster headaches, a rarer condition with about 200,000 sufferers in the US, but one where patients are still underserved by existing medicines.
“The enthusiasm in the field is warranted, and we’re trying to stay ahead of the pack in a very competitive space,” says John Lechleiter, Eli Lilly’s chief executive.
However, recent negotiations between drugmakers, the US government and insurers that pay for medicines show the best medicine may not necessarily win.
Last year, Express Scripts said it would no longer cover an expensive hepatitis C medicine made by Gilead for many of its patients. Instead, it recommended a drug from AbbVie, which is widely seen as inferior, after securing a big rebate from the drugmaker.
Mr Yee says: “Ultimately this will come down to some aggressive marketing and rebating.”