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Sanofi pays $245m for FDA priority review voucher

PRV reduces review time from ten to six months

sanofiSanofi has bought another voucher that slices four months off the FDA review process, but hasn't yet said how it will be used. 

The French pharma major is paying small US drugmaker Retrophin $245m for the priority review voucher (PRV), awarded as an incentive for carrying out research in rare paediatric disorders, which reduces the review time from ten to six months. 

It is not the first time has shelled out to accelerate development of one of its products, having paid $67.5m to BioMarin last year for a PRV that allowed its cholesterol-lowering drug alirocumab to leapfrog a rival drug from Amgen.

Retrophin itself acquired the voucher earlier this year when it paid $75m to buy a drug for paediatric bile acid disorders called Cholbam (cholic acid) from Asklepion, so the company is making a tidy profit in just a few weeks.

Upon closing of the transaction, Retrophin stands to receive a payment of $150m, followed by two equal instalments of $47.5m in 2016 and 2017. It will use the windfall to fund its rare disease research, said chief executive Stephen Aselage.

Sanofi is keeping its options open when it comes to using the PRV, saying that with 13 compounds in its late-stage pipeline it will deploy it to "help us more quickly deliver a new medicine or treatment to those who need it most."

This is the third time a PRV has changed hands and, with their value escalating each time, the deals clearly illustrate the competitive benefits that can accrue from even a small lead in the marketplace. 

Gilead Sciences bought one from Canada's Knight Therapeutics last year that was awarded by the FDA in return for developing a drug for a neglected tropical disease.

Knight secured the voucher after getting FDA approval for Impavido, a drug to treat leishmaniasis, with Gilead paying $125m. Like Sanofi, Gilead has not disclosed how it plans to make use of the truncated review.

The rising price also reflects the scarcity of the vouchers, which so far are only available for rare paediatric and tropical diseases. 

Under FDA regulations only three paediatric vouchers can be awarded under the current programme unless extended by Congress, and the one issued for Cholbam was the last of these. 

A paediatric PRV awarded to United Therapeutics following FDA approval for its Unituxin (dinutuximab) therapy for neuroblastoma in March remains unused and so may be available for transfer - at a price. 

Article by
Phil Taylor

28th May 2015

From: Sales

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