On 22 May, Sanofi acquired a so-called priority review voucher (PRV) from the US biotech Retrophin for 245 mUSD. Since then, it has been speculated that Sanofi will use the PRV to expedite the FDA review of its insulin-GLP-1 combination Lixilan to get to the US market ahead of Novo Nordisk?s Xultophy®.
PRV: An incentive to develop drugs for tropical and rare paediatric diseases
In 2007, the FDA introduced priority review vouchers as an incentive for companies to invest in the development of new drugs and vaccines for neglected tropical diseases. In 2012, the voucher programme was extended to rare paediatric diseases, but only on a trial basis. One year after the third paediatric PRV is awarded, no other paediatric PRVs may be awarded. PRVs are awarded to a sponsor by the FDA upon approval of drug or vaccine that meets at least four criteria. It must (1) treat a neglected tropical or rare paediatric disease as defined by the FDA, (2) be a new drug application (NDA or BLA), (3) be a new chemical entity (NCE) or new molecular entity (NME), and (4) offer major advances in treatment, or provide treatment where no adequate therapy exists, thus earning priority review on its own merit. Once awarded, PRVs can be used to obtain an expedited priority review for a product of choice or they can be sold to a third party.
Six vouchers have been awarded to date, three sold, two used
Since the introduction of PRVs, six vouchers have been awarded; three in each category. Of the six vouchers, one has been used by its original awardee, Novartis, while three other PRVs have been sold, one of which has been used. Since the sale of the first PRV for 65 mUSD, the acquisition price has almost doubled for each subsequent sale. Given that paediatric vouchers now only can be awarded until March 2016 after the third voucher was awarded earlier this year, the price of vouchers is expected to remain high.
Sanofi?s first use of a PRV appears to have been successful
In July 2014, Sanofi and its partner Regeneron acquired a paediatric PRV from Biomarin for 65 mUSD. The PRV was subsequently used for the PCSK9 inhibitor Praluent (alirocumab) BLA to obtain expedited priority review and earlier PDUFA action date than Amgen?s PCSK9 inhibitor Repatha (evolocumab). Both Praluent and Repatha were recently recommended for approval by an FDA advisory committee.
Will Sanofi use its newly acquired voucher for Lixilan?
The best use for a PRV is for a compound that represents a sizeable opportunity and where an expedited access to market would bring it in front of close competition. With that in mind, the most relevant candidate for use of the PRV in Sanofi?s late-stage portfolio appears to be either the anti-IL4 receptor antibody dupilumab or the insulin-GLP-1 combination Lixilan (lixisenatide+Lantus). Dupilumab already has been designated a so-called breakthrough therapy by the FDA allowing for expedited development and approval. Further, dupilumab is partnered with Regeneron but only Sanofi acquired the PRV. According to investment analysts, this makes Lixilan a more likely candidate for use of the newly acquired PRV.
With priority review, Lixilan could enter the US market as early as mid 2016
With phase 3 trials completing mid 2015, Sanofi has communicated plans to submit Lixilan for FDA review in late 2015. With priority review, this would allow for approval mid 2016, shortly after the expected US approval of Lyxumia (lixisenatide); a prerequisite for Lixilan approval. Further, a mid 2016 approval also coincides with the end of the glargine 30-month stay, where Eli Lilly could launch its biosimilar glargine product, Basaglar, in the US. It should be noted, however, that final FDA approval of Basaglar, and subsequent launch, may occur already in Q1 2016 pending the outcome of the ongoing law suit scheduled to begin in court in September 2015. Finally, a mid 2016 approval of Lixilan would likely be earlier than US approval of Xultophy® unless Novo Nordisk submits within the next months.
Lixilan as protection of Sanofi?s 7 bUSD basal insulin franchise
At first glance, paying 245 mUSD to reduce the FDA review time by 4 months for Lixilan, a compound with projected US sales in 2020 of around 400 mUSD, would seem excessive. However, with the mixed start of Toujeo in the US due to a largely undifferentiated label compared to Lantus, Sanofi increasingly sees Lixilan as key to protect its 7 bUSD basal insulin franchise against competition from biosimilar glargine and Tresiba®. The company is pursuing a dual positioning for Lixilan, as both first injectable and basal optimisation. Hence, while Lixilan is not expected to be able to match Xultophy®, it could still have a competitive profile versus Tresiba® as a starter insulin, and perhaps even as an alternative to Victoza® as first injectable in some patients.
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