Zosano Pharma Corp. has tapped life-sciences options agency Eversana to assist commercialize and distribute Qtrypta to the US market. The transdermal microneedle product is a candidate for the acute treatment of migrane.
In March 2020, the US Food and Drug Administration (FDA) gave its thumbs up on a New Drug Application for Qtrypta, granting the treatment a Prescription Drug User Fee Act (PDUFA) aim date of October 20 of this yr; if finally accepted, the drug could be the primary microneedle patch product indicated for acute treatment of migraine.
Zosano Pharma president and CEO Steven Lo stated the corporate believes the drug holds important potential for sufferers affected by migraine and appears ahead to the partnership with Eversana.
“This collaboration enables us to access a comprehensive commercial organization without the significant expense and time that would have been required to build our own infrastructure,” Lo stated. “We and Eversana have been working closely to ensure our commercialization strategies are aligned to provide appropriate resources to enable patients to access Qtrypta if approved.”
Eversana reportedly will leverage its industrial execution sources for advertising, market entry, distribution, gross sales pressure deployment, reimbursement, and affected person adherence help providers. The firm plans to utilize its built-in knowledge and analytics platform to research totally built-in knowledge, predict product and affected person wants, and inform industrial actions at launch of Qtrypta, and past.
Jim Lang, Eversana’s CEO, stated the corporate affords “comprehensive commercial services” for pharma corporations like Zosano.
“Our partnership with Zosano puts the patient first by supporting broad market access, efficient distribution and comprehensive patient support services. We will work closely with Zosano on each stage of the product launch and roll-out,” he stated.
According to the phrases of the five-year settlement, the 2 corporations will collaborate on varied actions for the time period, pursuant to an anticipated $250m commercialization funds for Qtrypta. Zosano will keep possession of the Qtrypta New Drug Application, along with all authorized, regulatory, and manufacturing duties for the product.
Additionally, Eversana reportedly will obtain unique proper to conduct agreed commercialization actions and can make the most of its inner gross sales group together with its different industrial capabilities for market entry, advertising, distribution and affected person help providers for Qtrypta. The firm will obtain reimbursement of sure prices and an unspecified low double-digit proportion of product income when Zosano internet gross sales surpass sure prices incurred by the events pursuant to the commercialization funds.