8 July 2015. The pharmaceutical company Allergan is licensing therapies for treatment and prevention of migraines being developed by Merck, another pharma company. The agreement is expected to bring Merck $250 million over the next year, as well as undisclosed milestone and royalty payments from Allergan.
Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. Migraine Foundation says the syndrome is one of the top 20 disabling disorders and estimates some 36 million people suffer migraines in the U.S., including 14 million who experience migraines nearly every day or more often.
The drugs being acquired by Allergan block receptors for the calcitonin gene-related peptide, a protein found in parts of the brain and nervous system associated with migraine after these regions are stimulated, with levels of the peptide becoming elevated during migraine episodes. By blocking receptors for this peptide, these therapies were found to stop the pain and associated symptoms of migraine as effectively as triptans, current drugs that work by constricting blood vessels.
Merck’s first treatment for migraine was telcagepant, a blocker of calcitonin gene-related peptide receptors that was dropped due to reports of liver toxicity in some clinical trial participants. The newer drugs in development and licensed by Allergan, says Merck, also block these receptors, but use a different chemistry than telcagepant and have not been shown to cause liver problems.
The deal gives Allergan exclusive, worldwide rights to two small-molecule, or low molecular weight, compounds that block calcitonin gene-related peptide receptors. MK-1602 is being developed as a treatment for migraines, with an intermediate-stage clinical trial completed testing various dosages of the drug against a placebo. Merck says a late-stage trial is expected in 2016.
In addition, Allergan is gaining exclusive rights to MK-8031 that also blocks these receptors, but is being formulated for prevention of migraines. Clinical trials are expected to test this compound beginning in 2016. Allergan will be responsible for all further development and commercialization of these compounds.
Allergan, headquartered in Dublin, Ireland, is paying Merck $250 million, with half of the amount due upon completion of regulatory approvals in the U.S., and the remainder payable in April 2016. Merck will also be eligible for development and commercial milestone payments, as well as royalties on product sales.
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Hat tip: FirstWord Pharma
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