Select a Country Investors News Media Gallery Contact About Alexion Patient Focus Products Research and Development Careers Home » About Alexion » Milestones Milestones Alexion Timeline: A Commitment to Breakthrough Innovation The years since Alexion was established in 1992 have been extraordinary. We have grown from a tiny biotech startup 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. 1992 Alexion is founded in New Haven, CT, USA 1993 C5 complement inhibitor development program commences 1994 First pilot manufacturing facility is established in New Haven, CT, USA 1996 Initial public offering on NASDAQ under ticker symbol ALXN 1998 First in-human clinical trial of eculizumab begins 2000 Corporate headquarters relocates to Cheshire, CT, USA 2002 Pilot study with eculizumab commences in Leeds, England in paroxysmal nocturnal hemoglobinuria (PNH) 2004 New England Journal of Medicine publishes positive results from the pilot study with eculizumab in 11 patients with PNH First pivotal Phase 3 study of eculizumab commences in patients with PNH (TRIUMPH) 2005 Alexion Europe SAS is established in Paris, France Second pivotal Phase 3 study of eculizumab in patients with PNH begins (SHEPHERD) 2006 Alexion acquires a biomanufacturing facility in Smithfield, RI, USA, in anticipation of commercial-scale production of eculizumab 2006 New England Journal of Medicine publishes clinical data from the TRIUMPH PNH study 2007 Soliris® receives approval from the FDA and European Medicines Agency (EMA) as the first and only treatment for patients with PNH 2008 Soliris is first used as a treatment for patients with atypical hemolytic uremic syndrome (aHUS) in France and Germany Soliris receives the Prix Galien USA Award for Best Biotechnology Product with Broad Implications for Future Biomedical Research 2009 Soliris receives the Prix Galien France Award for Drugs for Rare Diseases Alexion’s Rhode Island manufacturing facility receives EU approval to supply Soliris 2010 Alexion’s Rhode Island manufacturing facility receives FDA approval to supply Soliris 2011 Alexion responds to a historic public health crisis in Germany and provides Soliris® without charge to hundreds of patients with life-threatening Shiga toxin E-coli-related hemolytic uremic syndrome (STEC-HUS) Soliris is approved by the FDA and the EMA as the first and only treatment for adult and pediatric patients with aHUS 2012 Alexion acquires asfotase alfa, the first potential treatment for patients with hypophosphatasia (HPP) New England Journal of Medicine publishes data from Phase 2 study of asfotase alfa in life-threatening HPP Alexion is added to the S&P 500 Index of leading global companies Alexion announces relocation of its US headquarters to New Haven, CT, USA, in 2015 2013 Asfotase alfa receives Breakthrough Therapy Designation from the FDA for the treatment of HPP Soliris is approved as a treatment for patients with aHUS in Japan Soliris receives orphan drug designation for the treatment of neuromyelitis optica (NMO) from the FDA and EMA cPMP (ALXN1101) receives Breakthrough Therapy Designation from the FDA for the treatment of molybdenum cofactor decifiency (MoCD) Type A 2014 Alexion announces a significant expansion of its drug discovery capabilities with a broad and long-term strategic agreement with Moderna Therapeutics for Alexion to develop messenger RNA (mRNA) Therapeutics™ for rare diseases Soliris receives orphan drug designation from the FDA for prevention of delayed graft function (DGF) in renal transplant patients, and from the EMA for the prevention of DGF after solid organ transplantation Alexion initiates multinational registration trials of eculizumab as a potential treatment for patients with NMO and refractory generalized myasthenia gravis (MG) Soliris receives orphan drug designation for the treatment of MG from the FDA and EMA Leadership Global Presence Partnering Milestones In Our Communities Awards & Recognition © 2014 Alexion Legal|Privacy Policy|Terms of Use|Site Map Please see Full Prescribing Information and Important Safety Information for Soliris® (eculizumab). This website is intended only for residents of the United States.