- Regeneron and its pharma partner Sanofi on Wednesday won a temporary reprieve from the court-ordered injunction on sales of the high cholesterol drug Praluent (alirocumab) in the U.S., which had been set to take effect on Feb. 21.
- Praluent will now remain on the market throughout Sanofi and Regeneron's appeal of the district court ruling on the patent dispute with PCSK9 rival Amgen. Federal judge Sue Robinson had surprised many by granting Amgen's request for a permanent injunction on Praluent early last month.
- The positive news helped to lift Regeneron in Thursday trading despite the release of 2017 guidance forecasting slowing growth for sales of Regeneron's flagship eye drug Eylea (aflibercept).
Eylea, approved for diabetic macular edema and diabetic retinopathy, makes up the lion's share of Regeneron's revenues. Last year, the drug pulled in $3.3 billion in sales, up 24% from 2015 and accounting for nearly 70% of the New York biotech's total revenues.
While company CEO Len Schleifer emphasized that Eylea still has room to grow, its clear from the 2017 guidance that the torrid sales growth seen to date will slow. For the year, Regeneron is forecasting single digit percentage growth over 2016 sales, although it did not give further specificity on where in that range Eylea is likely to land.
Schleifer also said that this would be the final year Regeneron plans to give specific guidance on Eylea sales, as the company begins to fill out its portfolio of marketed drugs and lessen its reliance on a single revenue stream.
Headlining that pipeline are Dupixent (dupilumab) and Kevzara (sarilumab), both of which are in collaboration with Sanofi. The companies expect to win approval for Dupixent in moderate-to-severe atopic dermatitis by the end of March. Schleifer indicated field staff are fully trained in anticipation of launch.
Regeneron has high expectations for Dupixent, believing the IL-4/IL-13 inhibitor can forge a lucrative new market from a patient population underserved by topical treatments and corticosteroids. Evaluate Pharma predicts the drug could eventually command sales of over $4.5 billion by 2022 (which would accrue to both Sanofi and Regeneron).
Kevzara, after being dealt an embarrassing rejection by the FDA for manufacturing-related issues at a Sanofi plant, is back on track and a resubmission of an application for approval should be completed by the end of the first quarter.
Regeneron indicated a successful resubmission would likely receive a target action date in the second quarter with a two-month review cycle.
Schleifer, while recognizing the continued importance of Eylea, stressed that Regeneron was doing all it can to make its late-stage pipeline a commercial success.
The temporary stay of the injunction on Praluent should also give Regeneron and Sanofi a boost, even if the eventual outcome of the litigation is unclear at this point. Regeneron, for example, has baked in a full year of Praluent sales into its 2017 guidance. Without a stay during the appeal, that might have had to be revisited.