Key Developments For Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc. (ALXN.O) (Consolidated Issue listed on NASDAQ Global Market)
Alexion Pharmaceuticals, Inc. Raises FY 2009 Guidance
Alexion Pharmaceuticals, Inc. revised upward its previously announced guidance for worldwide Soliris net product sales, from a previous range of $368-$378 million, now to a higher range of $383-$385 million for the fiscal 2009. The Company expects to achieve these results despite an anticipated negative impact of approximately $3 million on fourth quarter of 2009 revenues compared to third quarter of 2009, resulting from lower Euro hedging rates previously set at lower levels. Fiscal 2009 financial guidance for non-GAAP diluted earnings per share (EPS) is being revised upward, from the previously announced range of $1.01-$1.06, to a higher range of $1.15-$1.18. According to Reuters Estimates, analysts were expecting the Company to report $377 million and EPS of $0.77 for the same period.
European Commission And U.S. FDA Grant Alexion Pharmaceuticals, Inc.'s Soliris (eculizumab) Orphan Drug Designation For Treatment Of Atypical Hemolytic Uremic Syndrome (aHUS)
Alexion Pharmaceuticals, Inc. announced that Soliris (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS). AHUS is an ultra-rare, inherited, and life-threatening complement-inhibitor deficiency disease that often progresses to end-stage kidney disease or failure. The U.S. Food and Drug Administration granted orphan drug designation to Soliris for the same indication in May 2009. Soliris is not approved for the treatment of patients with aHUS. Alexion is currently enrolling patients at the initial sites in four clinical studies of Soliris as an investigational treatment for adolescent and adult patients with aHUS. Clinical studies are also currently being planned to investigate the use of Soliris as a treatment for children with aHUS. If Soliris is approved for the treatment of patients with aHUS in Europe or the U.S., orphan-drug status would entitle Alexion to 10 years of market exclusivity in Europe and seven years of market exclusivity in the U.S. for this use of Soliris.
Alexion Pharmaceuticals, Inc.'s Alexion Pharma Canada Announces Soliris (Eculizumab)
Alexion Pharma Canada, a newly incorporated division of Alexion Pharmaceuticals, Inc. announced the availability in Canada of Soliris (eculizumab) for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), an ultra-rare, progressive and life-threatening blood disease characterized by chronic haemolysis, or red blood cell destruction.
Alexion Pharmaceuticals, Inc. Raises FY 2009 Guidance
Alexion Pharmaceuticals, Inc. announced that it has revised upward its previously announced guidance for fiscal 2009 sales, from a previous range of $360-$375 million now to a higher range of $368-$378 million. Alexion Pharmaceuticals, Inc. also revised upward its earnings per share (EPS) guidance from the previous range of $1.00-$1.05 for non-GAAP diluted earnings per share now to a higher range of $1.01-$1.06. According to Reuters Estimates, analysts are expecting the Company to report EPS of $0.76 on revenues of $371 million for the same period.
Alexion Pharmaceuticals, Inc.'s Soliris Reduces Hemolysis In Never-Transfused Patients With PNH
Alexion Pharmaceuticals, Inc. announced that the clinical investigators observed that Soliris (eculizumab), a terminal complement inhibitor developed by the Company, reduced hemolysis (red blood cell destruction) and improved symptoms in nine patients with paroxysmal nocturnal hemoglobinuria (PNH) who had received no blood transfusions prior to initiating Soliris therapy. In a separate study of 11 patients with PNH, researchers observed sustained platelet recovery with Soliris treatment in a subset of seven patients with thrombocytopenia (reduced platelet levels), indicating a likely reversal of platelet consumption with Soliris in these thrombocytopenic PNH patients.
