Pfizer has given Royalty Pharma an accelerated $475m milestone payment following the US approval of its migraine nasal spray, Zavzpret (zavegepant).
Royalty Pharma first signed a deal for the programme in 2020, when it offered Biohaven Pharmaceutical $250m in development funding in exchange for milestones and future royalties.
This deal was inherited by Pfizer in October last year when it acquired Biohaven for $11.6bn.
Pablo Legorreta, founder and chief executive officer of Royalty Pharma, said: “We are pleased that Zavzpret was approved by the US Food and Drug Administration (FDA), which provides another important new treatment option for migraine patients.
“Furthermore, this accelerated return on our Zavzpret research and development funding provides additional capital that can be redeployed to create long-term shareholder value.”
In the same 2020 deal, Royalty Pharma also obtained a small percentage of royalties for Biohaven’s migraine drug Nurtec, as well as rights to a series of payments between 2025 and 2030.
The FDA’s decision on Zavzpret, announced by Pfizer, makes Zavzpret the first and only CGRP receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.
The company’s application was supported by phase 3 results showing Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms at two hours post-dose.
The pivotal study also demonstrated pain relief as early as 15 minutes in a pre-specified secondary endpoint versus placebo.
Angela Hwang, chief commercial officer, president, global biopharmaceuticals business, Pfizer, said the approval marked a “significant breakthrough” for patients who prefer alternative options to oral medications.
Nearly 40 million people in the US suffer from migraine, which the World Health Organization classifies as the second leading cause of disability worldwide.
“When a migraine hits, it has a significant negative impact on a person’s daily life,” said Kathleen Mullin, associate medical director at New England Institute for Neurology & Headache. “As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”Πηγή: pmlive.com