A New Migraine Therapy That Can Address a Major Demand
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Note: This article has been amended to better reflect Levadex's position in this market.
One-fourth of all migraine patients suffer nasty side effects from the market's dominant migraine-fighting treatments. Now, a new, convenient inhaled version of one of the few drugs these patients can use -- previously only available as an IV administered by doctors -- could lead to big benefits for Allergan (NYSE: AGN).
The $4 billion global migraine market is dominated by triptan derivative drugs. For those who cannot use triptan for various medical reasons, Levadex intravenous infusion is one of the only 4 non-triptan drugs available in the market. Now, Allergan has developed an inhaler version of DHE, Levadex, whose ease of use could make it very popular with these patients.
Around 35 million people in the US alone suffer from migraine attacks; including 6 other developed countries, the number goes up to a staggering 75 million. As per Decision Resources, the global market for migraine (including the United States, France, Germany, Italy, Spain, the United Kingdom and Japan) was $3.3 billion in 2011, and is expected to reach $5.8 billion by 2021.
Physicians always recommend non-triptan drugs for those migraine patients unable to use triptans, despite the former's lower efficacy compared to triptans. Physicians believe that one-fifth of migraine patients with periodic attacks and one quarter of chronic migraine patients receive non-triptans worldwide.
Getting to know Levadex
DHE has been used for decades in acute migraines. The Levadex inhaler is similar to inhalers used by asthma patients, can be self-administered and carried along on travels and such.
However, its approval is on hold due to manufacturing issues related to the inhaler canister. I am guessing those will be solved very soon, because Allergan has gone ahead and purchased the canister manufacturer so it can take a hands-on approach to the process.
Besides DHE, CoLucid’s Lasmiditan, NuPathe’s Zecuity patch and OptiNose’s intranasal sumatriptan powder -- each in various development stages -- are the non-triptan options.These four non-triptan therapies expect sales of $1.2 billion by 2020.
Challenges for Levadex
Lasmiditan from CoLucid Pharmaceuticals is used for treatment of acute migraine attacks. It may be a first-line therapy for migraine patients with cardiovascular (CV) disease because triptans do not mix well with other heart medicines.
Zecuity from NuPathe Inc (NASDAQ: PATH) is a transdermal patch that delivers a key ingredient (sumatriptan) to treat early migraine attacks in adults. Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh of patients during migraine. In January 2013, the FDA approved Zecuity for treatment of migraine in acute conditions.
In addition to upcoming non-triptan drugs, a product from Arteaus Therapeutics is a novel therapy for migraine headaches. Arteaus is developing a monoclonal antibody (LY2951742) in collaboration with Eli Lilly (NYSE: LLY) for the prevention of migraine attacks. Y2951742 can be administered subcutaneously once every other week. It can block the Calcitonin Gene Related Peptide or CGRP from binding to its receptor. CGRP has been identified as the principal reason migraine occurs. Unlike other drugs for migraine, this candidate has the potential to attack migraine to its root cause and eradicate it.
The product is in Phase II trial and may be a potential therapy on successful completion of development stages. However, it needs to be noted that CGRP is a useful element of the body physiology and a lot of research still needs to be done to make sure that its blockage does not cause harm to the body.
Currently, Allergan controls about a fifth of the total market share for non-triptan drugs. Its main problem has been its delivery mode. Now, with the inhaler, that problem is about to be resolved. This will give the drug a fighting chance to gain market share in the non-triptan market.
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