Neuroscience specialist Biohaven Pharmaceuticals has teamed up with Pfizer to commercialise its recently launched migraine drug Nurtec ODT (rimegepant) outside the United States.
The deal will see US-based Biohaven receive $500m upfront plus milestone payments of up to $760m and tiered double-digit royalties on net sales outside the US.
Since its launch in May, Nurtec ODT (orally disintegrating tablet) has grown rapidly, outpacing forecasts to bring in $336m from more than a million prescriptions in the US.
It is the ‘first and only’ oral drug to inhibit calcitonin gene-related peptide (CGRP) receptor antagonists for the acute and preventive treatment of migraine and currently accounts for more than half of all ‘new-to-brand’ prescriptions, according to Biohaven.
The drug, originally developed at Bristol Myers Squibb, targets a root cause of migraine by reversibly blocking CGRP receptors, stopping the biologic cascade that results in a migraine attack. The class of drugs – known as gepants – was investigated 15 years ago but the first-generation drugs were abandoned due to liver toxicity issues.
As part of the deal, Pfizer will also gain the rights outside the US for zavegepant, a third-generation CGRP receptor antagonist currently in phase 3 trials for migraine in an intranasal delivery and soft-gel formulation.
“We believe this collaboration, which brings together the winning combination of Biohaven’s Neuroscience R&D with Pfizer’s industry-leading expertise and large global footprint will help accelerate access to rimegepant for patients around the world,” said Biohaven CEO, Dr Vlad Coric. “With this alliance, Biohaven and Pfizer believe there is an opportunity to change the paradigm in migraine treatment and potentially establish a new standard of care.”
Moving forwards, Biohaven will continue to lead research and development globally and Pfizer will execute commercialisation globally, outside the US.
Nurtec ODT is currently under review by the European Medicines Agency and several other regulatory authorities around the world.
It may take the scientific community longer to accept the gepants, however. A recent systematic review published in JAMA Network Open suggests that newer migraine pharmacotherapies – including rimegepant – appeared to be less effective than standard treatment with triptans.
The study authors compared outcomes associated with the use of these agents vs triptans in the acute management of migraine headaches using data gained from the Cochrane Register of Controlled Trials, Embase and PubMed.
While triptans were associated with higher ‘pain freedom’, they were also associated with higher risk for adverse events than rimegepant.