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Alexion Pharmaceuticals, Inc. history, profile and corporate video

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company, engages in the innovation, development, and commercialization of life-transforming therapeutic products for treating patients with severe and ultra-rare disorders. It focuses on developing products for the treatment of diseases in the areas of hematology, nephrology, neurology, metabolic disorders, oncology, and ophthalmology. The company offers Soliris (eculizumab), a therapeutic product for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), a blood disorder; and atypical hemolytic uremic syndrome (aHUS), an ultra-rare and life-threatening genetic disease. It also conducts Phase IV clinical trails on Soliris for its usage for the treatment of PNH registry, and aHUS for pediatric and adult. The company conducts various Phase II clinical trail programs on Soliris for its usage for the treatment of cold agglutinin disease; hemolytic uremic syndrome; dense deposit disease; presensitized renal transplant; ABO incompatible renal transplant; myasthenia gravis; neuromyelitis optica; and dry age-related macular degeneration. It serves specialty distributors and specialty pharmacies, which supply physician office clinics, hospital outpatient clinics, infusion clinics, or home health care providers; government agencies; and hospitals, hospital buying groups, pharmacies, other healthcare providers, and distributors. Alexion Pharmaceuticals was founded by Joseph A. Madri, David W. Keiser, Stephen P. Squinto and Leonard Bell in January 1992 and is headquartered in Cheshire, CT.

“Alexion Pharmaceuticals History

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 founded in New Haven, CT, USA.

1993 – C5 complement inhibitor development program commences.

1994 – First pilot manufacturing facility 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 relocated to Cheshire, CT, USA.

2002 – Pilot study with eculizumab commenced in Leeds, England in paroxysmal nocturnal hemoglobinuria (PNH).

2004 – 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).

2005 – Alexion Europe SAS established in Paris, FranceSecond pivotal Phase 3 study of eculizumab in patients with PNH (SHEPHERD) begins.

2006 – Biomanufacturing facility in Smithfield, RI, USA, acquired in anticipation of commercial-scale production of eculizumab.

2006 – Clinical data from the TRIUMPH PNH study published in the New England Journal of Medicine.

2007 – Soliris® approved by the FDA and European Medicines Agency as the first and only treatment for patients with PNH.

2008 – Soliris first as a treatment for patients with atypical hemolytic uremic syndrome (aHUS) in France and GermanySoliris awarded Prix Galien USA Award for Best Biotechnology Product with Broad Implications for Future Biomedical Research.

2009 – Soliris awarded the Prix Galien France Award for Drugs for Rare DiseasesAlexion’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 approved by the FDA and the European Medicines Agency 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)Data from Phase 2 study of asfotase alfa in life-threatening HPP published in the New England Journal of MedicineAlexion added to the S&P 500 Index of leading global companiesAlexion announces relocation of its US headquarters to New Haven, CT, USA, in 2015.

2013 – Asfotase alfa receives Breakthrough Therapy Designation for the treatment of HPPSoliris approved as a treatment for patients with aHUS in JapanSoliris receives orphan drug designation for the treatment of neuromyelitis optica (NMO) from the FDA; Soliris also receives a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the EMA for the treatment of NMO.”

*Information from Forbes.com and Alexionpharm.com

**Video published on YouTube by “BusinessinCT