Calliditas signs up Stada in Europe

Calliditas was known to be searching for a European partner for its rare kidney disease project Nefecon, but a couple of things about today’s deal with Stada are surprising. First, at just €20m ($24m) up front, Calliditas has arguably let rights go cheaply, with payback dependent on commercial success, since Stada is on the hook for royalties in the low twenties to low thirties. Second, Stada seems a strange choice of partner, being best known for generics, though it does have a biosimilar version of epoeitin alfa for chronic anaemia of kidney disease, and claims to be focused on building a nephrology business. So perhaps Nefecon, a gut-targeted formulation of the steroid budesonide, could be a good fit. If approved, the project will be the first therapy for immunoglobulin A nephropathy: an EU launch is expected next year but the US is the big test, where Nefecon has a Pdufa date of September 15 and where Calliditas is planning a solo launch. The group will need around 40 reps to target 3,700 nephrologists, its chief executive, Renée Aguiar-Lucander, recently told Evaluate Vantage. Evaluate Pharma’s sellside consensus puts Nefecon’s 2026 sales at $829m, with $664m coming from the US.

Selected projects in mid to late-stage development for IgA nephropathy
Project Company Description Note
Nefecon Calliditas Therapeutics Oral formulation of the steroid budesonide Pdufa date Sep 15, 2021
Phase 3
Iptacopan/LNP023 Novartis Oral complement factor B inhibitor Positive ph2 data just reported, ph3 under way
Sparsentan Travere Therapeutics (previously known as Retrophin) Endothelin type A & angiotensin II type 1 inhibitor Pivotal Protect data due Aug 2021
Narsoplimab/OMS721 Omeros Anti-MASP2 antibody Artemis-IGAN recruiting
Phase 2
Bardoxolone methyl Reata Pharmaceuticals Nrf2 stimulant Reported data from Phoenix trial in 2019
IONIS-FB-LRX Ionis/Roche Complement factor B antisense Ph2 completed Jan 2021
Atacicept Vera Therapeutics     Recombinant fusion protein binding to Blys and April Ph2b Origin recruiting; licensed from Merck KGaA
VIS649 Otsuka Anti-April antibody Ph2 recruiting
Cemdisiran Alnylam Pharmaceuticals Anti-complement C5 RNAi Ph2 recruiting
Source: Evaluate Pharma &

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