Alexion has grown rapidly to become a leading global biopharmaceutical company dedicated
to improving the lives of people facing rare, serious and life-threatening diseases.
The following timeline charts the evolution of the company and the milestones that
have marked its growth.
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2012
Alexion acquires Enobia Pharma Corp and gains full worldwide development and commercial rights to asfotase alfa, an innovative, first-in-class targeted enzyme-replacement therapy in Phase 2 clinical trials for patients with hypophosphatasia (HPP), an ultra-rare, life-threatening, genetic metabolic disease.
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2011
The European Commission extends the therapeutic indication for Soliris® (eculizumab) to include the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS).
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The U.S. FDA approves Soliris® (eculizumab) for pediatric and adult patients with
aHUS.
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The European Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending that the therapeutic indication for Soliris be extended to include the treatment of pediatric and adult patients with aHUS.
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Alexion acquires Taligen Therapeutics and creates the Alexion Translational Medicine Group
to accelerate development of an expanded portfolio, including innovative complement inhibitors.
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Alexion acquires investigational cPMP replacement therapy from Orphatec Pharmaceuticals for infants
suffering from molybdenum cofactor deficiency (MoCD) Type A, a catastrophic, ultra-rare genetic neurologic disorder.
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2010
Soliris receives marketing approval in Japan for the treatment of patients with PNH.
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Investigators present positive interim data from an investigator-initiated trial with eculizumab in patients at
elevated risk for acute humoral rejection (AHR) at the American Transplant Congress.
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Australian government makes landmark decision concluding that Soliris treatment substantially extends the lives of patients with PNH.
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Independent European investigators present data at the annual meeting of the American Society of Hematology showing that Soliris-treated
PNH patients had survival rates similar to an age- and gender-matched population of normal individuals.
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Alexion receives FDA approval of its Rhode Island manufacturing facility for Soliris supply, providing a second source
for commercial and clinical needs.
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2009
Alexion receives the Prix Galien France award, one of the nation's highest honors,
for the Most Innovative Drug for Rare Diseases for Soliris® (eculizumab).
This award, given by an elite committee of scientific, academic and medical leaders
in France, recognizes the innovative technology and positive impact of Soliris.
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Australia's Therapeutic Goods Administration approves the use of Soliris to treat
all patients with PNH. Soliris is the first drug approved in Australia for the treatment
of patients with PNH.
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Health Canada, the Canadian national healthcare regulatory agency, approves Soliris
for the treatment of PNH in all patients of the disease.
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Soliris® is designated as an orphan drug by the Ministry
of Health, Labour and Welfare of Japan. Alexion follows this designation by submitting
a New Drug Application for Soliris, in anticipation of the drug's commercial launch
in the country in 2010.
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2008
Alexion is honored with the Prix Galien USA Award for Best Biotechnology Agent for
Soliris. This prestigious award, selected by a committee which includes seven recipients
of the Nobel Prize, recognizes the development of innovative medicines that improve
the human condition.
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2007
The U.S. FDA approves Soliris as the first treatment for patients with PNH.
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The European Commission (EC) approves Soliris for the treatment of patients with
PNH in 29 countries, making it the first drug to be approved both under Priority
Review by the FDA and through the Accelerated Assessment procedure of the EC.
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An analysis of clinical studies published in Blood, the journal of the American
Society of Hematology, demonstrates that PNH patients treated with Soliris experienced
a dramatic reduction in blood clots during clinical trials.
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Alexion receives the Award of Excellence from Connecticut United for Research Excellence
(CURE), an association of more than 100 bioscience organizations.
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Alexion is honored with the Corporate Leadership Award of the National Organization
for Rare Disorders due to pioneering work conducted to bring Soliris to patients
with PNH.
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2006
Results of the
Phase III TRIUMPH Study published in the New England Journal of Medicine demonstrate
that Soliris significantly reduces the symptoms of PNH.
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2005
Alexion Europe SAS, a wholly owned subsidiary, is formed to serve as the company's
initial European headquarters.
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2004
Data published in theNew England Journal of Medicine detail the effect of Soliris on hemolysis and other patient morbidities in patients with paroxysmal nocturnal hemoglobinuria (PNH).
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1996
Alexion becomes a publicly traded company and is listed on NASDAQ under the symbol
ALXN.
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1992
Alexion was established in New Haven, Connecticut, by Dr. Leonard Bell, a practicing
physician, researcher and Assistant Professor of Medicine and Pathology at Yale
University.