Celgene submits EU marketing pitch for luspatercept; Bausch Health wins FDA approval for topical psoriasis treatment
→ Celgene and partner Acceleron have submitted an EU marketing application for their their red blood cell boosting drug luspatercept weeks after submitting an FDA marketing application for the biologic. For the big biotech $CELG, tarnished by a poor performance under CEO Mark Alles — the drug is one of the top five in its pipeline, critical for the mighty $74 billion Bristol-Myers Squibb $BMY takeover.
→ The FDA has approved a topical plaque psoriasis treatment called Duobrii, days after approving AbbVie’s biologic Skyrizi. The lotion — which comprises halobetasol propionate and tazarotene — is made by Bausch Health $BHC (formerly Valeant) and its dermatology business, Ortho Dermatologics and will launch in June. Duobrii is priced at $825 for a supply of a 100-gram tube, which is more than 50% cheaper than other branded topical combination products, its makers said on Thursday.
Duobrii should be able to take substantial market share from biologic therapies for psoriasis, given its favorable efficacy profile and potentially advantageous safety, since the drug is approved for use over a continuous basis for up to 52 weeks versus existing acute use therapeutic solutions that can only be applied for up to two weeks, H.C. Wainwright analysts wrote in a note. “From our vantage point, Duobrii should be positioned to take market share from existing topical products as well as biologics like Taltz and Cosentyx, while selectively allowing Siliq to eke out a niche due to its favorable pricing.”
→ Stanford spinoff Forty Seven is adding a third clinical trial to its collaboration with Roche’s Genentech. The aim is to study how well its experimental antibody 5F9 in combination with Genentech’s anti-CD20 antibody Rituxan and anti-PDL1 Tecentriq, does in patients with diffuse large B-cell lymphoma, an aggressive form of non-Hodgkin’s lymphoma. Previously, Forty Seven’s agreement consisted of only two clinical trials which tested a combination of 5F9 and Tecentriq in patients with acute myeloid leukemia and urothelial cancer.