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Details:
The assets acquired include Zosano’s proprietary microneedle array patch (MAP) intradermal drug delivery system, intended for the epidermal delivery of M207 (zolmitriptan) for the treatment of migraine attacks in adults.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: M207
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Emergex Vaccines Holding
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 18, 2023
Details:
The MAP technology developed by Zosano is an exceptional strategic fit that complements our CD8+ T cell Adaptive Vaccine platform and intend to develop the MAP technology acquired from Zosano for delivery of vaccines.
Lead Product(s): CD8+ T-cell Adaptive Vaccine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Vaccine
Partner/Sponsor/Collaborator: Emergex Vaccines Holding
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 12, 2022
Details:
Company has received feedback from the U.S. Food and Drug Administration Division of Neurology II (the “Division”) on the protocol for the pharmacokinetic study required to support the resubmission of the Qtrypta™ NDA.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
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 April 26, 2021
Details:
Company has received the official Type A meeting minutes from the U.S. FDA Division of Neurology II regarding the requirements for resubmission of the Qtrypta™ New Drug Application following the Complete Response Letter received on October 20, 2020.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
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 February 22, 2021
Details:
The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies and recommended the company to conduct a repeat bioequivalence study between three of the lots used during development.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
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 October 21, 2020
Details:
The DRL described two concerns regarding clinical pharmacology section of the NDA; (i) regarding unexpected high plasma concentrations of zolmitriptan observed from two pharmacokinetic studies; (ii) the FDA raised questions regarding differences in zolmitriptan exposures.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
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 September 30, 2020
Details:
Zosano and EVERSANA will utilize EVERSANA’s commercial execution expertise for marketing, market access, distribution, sales force deployment, reimbursement, and patient adherence support services. EVERSANA to commercialize and distribute Qtrypta™ in the United States.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
Highest Development Status: Phase IIIProduct Type: Small molecule
Recipient: Eversana
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 06, 2020
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