Just as Hal Barron planned, GSK $GSK has submitted its first regulatory application for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat, in Japan for patients with renal anemia due to chronic kidney disease (CKD). The application is based on positive Phase III data conducted in Japan on anemic patients across the spectrum of CKD from stages 3-5 — which included patients on and not on dialysis, regardless of prior anemia treatment with erythropoiesis-stimulating agents (ESAs). If approved, daprodustat will be exclusively distributed in Japan by Kyowa Kirin Co.
Alexion Pharmaceuticals has inked a deal centered on discovering and developing several RNAi therapies as the Massachusetts-based biotech continues to build out its pipeline.
Former biotech ace Alexion Pharmaceuticals is still shopping to fatten its pipeline as it continues to shake off a sales practices scandal linked to its expensive rare disease drug Soliris that culminated in an executive exodus and top-to-bottom reorganization. On Wednesday, the Boston, MA-based company said it would fork out $22 million upfront to co-develop two preclinical RNAi therapies owned by Dicerna Pharmaceuticals $DRNA.
BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Syntimmune today announced that they have entered into a definitive agreement for Alexion to acquire Syntimmune, a clinical-stage biotechnology company developing antibody therapeutics targeting the neonatal Fc receptor (FcRn). SYNT001 – a humanized monoclonal antibody that inhibits the interaction of FcRn with Immunoglobulin G (IgG) and IgG immune complexes – has the potential to improve treatment in a number of rare IgG-mediated diseases. SYNT001 is currently being evaluated in Phase 1b/2a studies in patients with warm autoimmune hemolytic anemia (WAIHA) and in patients with pemphigus vulgaris (PV) or pemphigus foliaceus (PF) and has demonstrated proof of mechanism showing rapid IgG reduction.