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AstraZeneca buys FDA priority review voucher from Sobi

Picks up coveted voucher for $95m

AZ


AstraZeneca has paid Swedish biopharma company Sobi $95m in cash for an FDA priority review voucher (PRV), which could help cut four months off the FDA review process. 

The FDA’s PRV is used as an incentive for companies to invest in orphan drugs, by promising a cost reduction for the application fee for future products and a fast-tracked review period. Sobi gained the PRV during the acquisition of Novimmune’s Gamifant (emapalumab) related business earlier this year.

A PRV reduces the target review time of the drug application from ten to six months, and the value of gaining an earlier launch on the US market could be worth hundreds of millions for the most promising drugs.

AZ has not yet said how it will use the PRV, but the company could gain competitive benefits in the market it chooses to apply the voucher to. One likely area is oncology - AZ  has various phase 3 trials of its anti-PD-L1 monoclonal antibody Imfinzi, its PARP inhibitor Lynparza and its BTK inhibitor Calquence currently in the pipeline.

Jose Baselga

José Baselga, head of oncology research and development, AZ

In its second quarter earnings call,  head of oncology R&D José Baselga confirmed the second half of the year will be very busy for AZ's oncology business.

The PRV is a useful tool to have in its arsenal for this therapy area. However the company suffered a setback yesterday when it announced another failure of Imfinzi in combination with tremelimumab in first-line non-small cell lung cancer.

The $95m price tag AZ  represents a price towards the lower end of prices PRVs have fetched. Earlier this year, Novo Nordisk used a PRV to hasten the approval of the new oral formulation of diabetes therapy Ozempic. Novartis also used one to speed up the regulatory process of its MS drug Mayzent and quickly won approval for the drug.

Last June, Alexion used its own PRV for its rare blood disorder therapy ravulizumab, a follow-up to Soliris which is already approved in the same indication. The high point of prices paid for a PRV was AbbVie's outlay of $350m in 2015, but have declined since then.

Article by
Lucy Parsons

21st August 2019

From: Sales

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