Regeneron ($REGN) and Sanofi ($SNY) have snagged a priority review for their potential blockbuster atopic dermatitis drug, dupilumab. Getting the drug on the inside track at the FDA has resulted in a PDUFA date of March 29, setting the partners up to secure a handy head start on other companies going after moderate-to-severe forms of atopic dermatitis.
The granting of priority review status for the IL-4 and IL-13 inhibiting antibody confirms what has been suspected since Regeneron and Sanofi followed up the receipt of breakthrough therapy designation with the delivery of impressive Phase III data. And, while the March 29 PDUFA date means talk of launching the drug early in 2017 may prove optimistic--unless the FDA hustles the filing through--it is still early enough to ensure the partners can gobble up the market before the chasing pack arrives.
Regeneron and Sanofi’s pitch for the moderate-to-severe atopic dermatitis market is underpinned by data from a trio of Phase III trials that were unveiled earlier this year. Those studies showed the antibody outperformed placebo and the standard of care in terms of clearing skin lesions. And, as importantly, the data downplayed concerns about the safety profile of dupilumab. Serious adverse events and infections were more common in the placebo arm than the dupilumab cohort.
With those data in the bank, analysts have tipped dupilumab to generate annual sales of anything from $2.5 billion to $5 billion. The priority review means, unless the FDA finds red flags in its review of the data, Regeneron and Sanofi should begin racking up the first of those sales well before some of its rivals for the moderate-to-severe atopic dermatitis market bag approvals for their products.
Danish drugmaker Leo Pharma bought itself a spot in Regeneron and Sanofi’s wake earlier this year when it paid $115 million upfront and committed to more than $1 billion in milestones for the rights to AstraZeneca’s ($AZN) tralokinumab in dermatology indications. AstraZeneca posted Phase IIb data on the anti-IL-13 monoclonal antibody in the first quarter of 2016, putting Leo some way behind Regeneron and Sanofi.
Galderma Pharma entered the race in July by picking up the rights to an anti-IL-31 receptor A humanized monoclonal antibody from Roche’s ($RHHBY) Chugai Pharmaceutical, but that is also yet to deliver data beyond Phase II. Pfizer ($PFE) spinout Ziarco Pharma has Phase II data on a atopic dermatitis drug, too. But while its oral asset could prove more convenient for patients than the injectable antibodies in development elsewhere, the Phase IIb trial missed its primary endpoint and talk of a Series C round or trade sale are yet to turn to action.