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Details:
Pfizer has given Royalty Pharma an accelerated milestone payment following the US approval of its migraine nasal spray, Zavzpret (zavegepant). Zavzpret was approved by the U.S. FDA, which provides another important new treatment option for migraine patients.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: Zavzpret
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $475.0 million Upfront Cash: Undisclosed
Deal Type: Agreement March 15, 2023
Details:
Zavzpret (zavegepant) is a calcitonin gene-related peptide receptor antagonist. CGRP antagonists have been shown pain relief during migraine induced headaches.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: Zavzpret
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Details:
Complete data from the Phase 3 BHV3500 (zavegepant) nasal spray study highlight its ultra-rapid pain relief in as little as 15 minutes that lasts through 48 hours after a single dose.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: BHV-3500
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
In the pivotal studies, BHV3500 (zavegepant) was statistically superior to placebo on the coprimary regulatory endpoints of superiority to placebo at 2 hours for pain freedom and freedom from the migraine-associated most bothersome.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: BHV-3500
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Biohaven plans to file a NDA for BHV-3500 (zavegepant) with the USFDA in 1Q2022,showed ultra-rapid pain relief at the earliest measured time point of 15 minutes and sustained efficacy through 48 hours after a single intranasal dose.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: BHV-3500
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
Zavegepant is a high affinity, selective and structurally unique, third generation, CGRP receptor antagonist in development for both migraine and non-migraine CGRP-mediated diseases.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: BHV-3500
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2021
Details:
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist in development for both migraine and non-migraine indications including COVID-19 associated lung inflammation.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: BHV-3500
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
Funding will advance the Biohaven's CGRP receptor antagonist program through the development of zavegepant (vazegepant). The zavegepant program encompasses intranasal zavegepant as well as oral zavegepant for migraine prevention and non-migraine indications.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: BHV-3500
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $450.0 million Upfront Cash: Undisclosed
Deal Type: Funding August 07, 2020
Details:
Biohaven plans to study intranasal vazegepant, a high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease.
Lead Product(s): Zavegepant
Therapeutic Area: Infections and Infectious Diseases Product Name: BHV-3500
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2020
Details:
The Company addressed all issues raised by the FDA and will advance the 10 mg dose of intranasal vazegepant into a double-blind, placebo-controlled Phase 3 clinical trial.
Lead Product(s): Zavegepant
Therapeutic Area: Neurology Product Name: BHV-3500
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2020
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