A Commitment to Breakthrough Innovation
The years since Alexion was established in 1992 have been extraordinary. We have grown from a tiny biotech start-up to become a leading global biopharmaceutical company focused on the niche area of developing life-transforming therapies for patients with severe and life-threatening rare diseases.
Here are some of the milestones that have marked our growth.
Alexion founded in New Haven, CT, USA
C5 complement inhibitor development program commences
First in-human clinical trial of eculizumab begins
Pilot study with eculizumab in paroxysmal nocturnal haemoglobinuria (PNH) commenced in Leeds, England
Positive results from the pilot study with eculizumab in 11 patients with PNH published in the New England Journal of Medicine
First pivotal Phase 3 study of eculizumab commenced in patients with PNH (TRIUMPH)
Alexion Europe SAS established in Paris, France Second pivotal Phase 3 study of eculizumab in patients with PNH (SHEPHERD) begins
Soliris® approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the treatment of patients with PNH
Soliris first used on an investigational basis for patients with atypical haemolytic uremic syndrome (aHUS) in Germany and France Soliris awarded Prix Galien USA Award for Best Biotechnology Product with Broad Implications for Future Biomedical Research
Soliris awarded the Prix Galien France Award for Drugs for Rare Diseases Alexion’s Rhode Island manufacturing facility receives EU approval to supply Soliris
Alexion responds to an outbreak of life-threatening Shiga toxin E-coli-related haemolytic uremic syndrome (STEC-HUS) in Germany by providing Soliris to the German government at their request Soliris approved by the European Medicines Agency and FDA for the treatment of adult and paediatric patients with aHUS
EMA extends approval of Soliris to paediatric patients with PNH Soliris receives orphan drug designation (ODD) from EMA for the treatment of neuromyelitis optica (NMO) Soliris also receives orphan drug designation from the US FDA for the treatment of NMO FDA grants Breakthrough Therapy Designations to two investigational therapies in Alexion’s pipeline: asfotase alfa for the treatment of hypophosphatasia (HPP) and cPMP replacement therapy (ALXN 1101) for the treatment of patients with Molybdenum Cofactor Deficiency (MoCD) Type A
Alexion expands its drug-discovery capabilities with a long-term strategic agreement with Moderna Therapeutics to develop messenger RNA (mRNA) Therapeutics™ for rare diseasesSoliris receives ODD from the FDA for prevention of delayed graft function (DGF) in renal transplant patients, as well as ODD from the EMA for prevention of DGF after solid organ transplantation; Soliris also receives ODD from the FDA and EMA for treatment of refractory myasthenia gravis (MG)Alexion initiates multinational registration trials of eculizumab as a potential treatment for patients with NMO, MG and DGFAlexion's Board of Directors appoints Leonard Bell, M.D., as Chairman of the Board
Alexion acquires Synageva BioPharma, strengthening its pipeline and establishing a metabolic franchise with the addition of Kanuma® (sebelipase alfa) Strensiq® (asfotase alfa) is approved as a treatment for patients with HPP in the U.S., EU, Japan and Canada Kanuma is approved as a treatment for patients with lysosomal acid lipase deficiency (LAL-D) in the U.S. and EU Alexion establishes a new Global Supply Chain and Operations headquarters at College Park in Blanchardstown, Dublin Alexion relocates its EMEA headquarters to Zürich, Switzerland
Kanuma® (sebelipase alfa) receives 2016 German Prix Galien Award in the Orphan Product category Alexion receives orphan drug designation (ODD) for ALXN1007 for the treatment of graft-versus-host disease (GVHD) in the U.S. and the EU Alexion receives ODD for ALXN1210 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the EU Kanuma is approved as a treatment for patients with lysosomal acid lipase deficiency (LAL-D) in Japan Alexion moves into its new global corporate headquarters in New Haven, Connecticut, U.S.