Beur schreef op 17 juni 2020 18:39:
Geen geweldige resultaten voor Sanofi's Pompe study.
Amicus shares surge as Sanofi struggles to raise a cheer for mixed pivotal data for a PhIII contender — and analysts blow a raspberrySanofi took extra time on Tuesday to offer an upbeat assessment of its top-line results for a pivotal study of a new ERT for late-onset Pompe disease. But with Amicus breathing down its neck with a Phase III rival of its own, the pharma giant was treated to some unwelcome reviews from a slate of analysts covering the matchup.
“Meh,” summed up Cowen’s Ritu Baral in the headline, which helps explain why Amicus’ stock shot up 17%.
The (Sanofi) trial met its reported primary endpt of non-inferiority of neo-GAA (avalglucosidase alfa) to Lumizyme, but not superiority. We see the data as a positive for FOLD, with a long-standing competitive overhang to the AT-GAA opportunity in Pompe now removed. Neo-GAA seems approvable, but a label limited to ERT-naive pts leaves upside for FOLD.
Joseph Schwartz at SVB Leerink penned his own downbeat assessment:
Today’s announcement was in line with our expectations that NeoGAA’s Ph.3 data would be underwhelming, and we continue to see FOLD’s AT-GAA (enzyme replacement therapy (ERT)-chaperone combination) as likely the best-in-class next-generation ERT for Pompe patients. After today’s mediocre NeoGAA results, the fear that SNY as the incumbent would have strong Ph.3 data is now removed….
Paul Hudson
One of the reasons for the tilt to Amicus was a cross-trial comparison, always a quick stimulant for debate, in which analysts scored Sanofi’s positive data against the open label experience reported by the little rival. It didn’t help that Sanofi also reported a drop in efficacy from mid-stage results.
Here’s Schwartz again:
SNY’s placebo corrected FVC benefit of 2.43% (2.89-0.46) is less than FOLD’s open label experience of 4.46%. Meanwhile, SNY’s placebo corrected 6MW of 30M (32.2-2.2) in the treatment naïve patients is less than FOLD’s open label experience of 42.2M. In addition, SNY’s open label 6MW benefit of 23M for ERT-switch patients at 97 weeks is less than FOLD’s 36M benefit at 24 months. The 2.4% FVC benefit demonstrated in SNY’s Ph.3 is also less than the 4.6% that was reported in SNY’s Phase 2 trial.
Mediocre data in a competitive field don’t inspire much confidence by way of peak sales potential. Says Scala: “We estimate avalglucosidase sales of €100MM in 2025 and Lumizyme sales of €1.25B.”
None of that is good news for John Reed and the R&D team at Sanofi, who CEO Paul Hudson is looking to in order to provide blockbuster new products.