Key Developments: Alexion Pharmaceuticals Inc (ALXN.O)

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Latest Key Developments (Source: Significant Developments)

Alexion Pharmaceuticals Inc and Cincinnati Children's launch rare disease innovation fund
Monday, 23 Jun 2014 06:30am EDT 

Alexion Pharmaceuticals Inc and Cincinnati Children's Hospital Medical Center:Announced establishment of collaboration and fund for advancement of research in rare disease.Cincinnati Children's is recognized center of excellence in pediatric rare diseases.Alexion is global leader in development and delivery of breakthrough therapies for patients with severe and life-threatening rare diseases.This collaboration leverages collective expertise of leading pediatric hospital with leading biopharmaceutical company.  Full Article

FDA grants Orphan Drug Designation to Alexion Pharmaceuticals Inc 's Soliris (eculizumab)
Tuesday, 17 Jun 2014 06:39am EDT 

Alexion Pharmaceuticals Inc:Says U.S. FDA has granted orphan drug designation (ODD) to Soliris.Soliris (eculizumab) used for treatment of patients with Myasthenia Gravis (MG), a rare, debilitating neurologic disorder caused by uncontrolled complement activation.In patients with MG, uncontrolled complement activation due to antibodies directed at neuromuscular junction can ultimately lead to profound and debilitating weakness of various muscle groups throughout body.Oliris is first-in-class terminal complement inhibitor and is currently approved for treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.  Full Article

Alexion Pharmaceuticals Inc announces FDA approves conversion of Soliris (eculizumab) accelerated approval in aHUS to regular approval for treatment of patients with aHUS
Monday, 5 May 2014 06:30am EDT 

Alexion Pharmaceuticals Inc:FDA has approves company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris (eculizumab) for treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).This update reflects Alexion's fulfillment of post-marketing requirements, including submission of confirmatory data from two additional prospective clinical trials, including one in pediatric patients with aHUS.Revised label specifies important longer-term clinical benefit associated with chronic and sustained Soliris treatment with inclusion of results with two years of ongoing treatment in aHUS patients.Updated label also includes data on use of Soliris treatment prior to use of supportive care with either plasma exchange or plasma in prospective clinical trials.  Full Article

Alexion Pharmaceuticals Inc raises FY 2014 EPS guidance and reiterates FY 2014 revenue guidance
Thursday, 24 Apr 2014 06:30am EDT 

Alexion Pharmaceuticals Inc:Revises upward guidance for FY 2014 non-GAAP earnings per share (EPS) from previous range of $4.37 to $4.47, now to higher range of $4.75 to $4.85 per share.Reiterates FY 2014 revenue guidance of $2.15 bln to $2.17 bln as provided in press release issued on March 10.FY 2014 EPS of $4.48 and revenue of $2.17 bln - Thomson Reuters I/B/E/S.  Full Article

Alexion Pharmaceuticals Inc Initiates Multinational Registration Trials of Eculizumab as potential treatment for patients
Thursday, 24 Apr 2014 06:15am EDT 

Alexion Pharmaceuticals Inc:Initiation of single, multinational, placebo-controlled trial to evaluate safety and efficacy of eculizumab (Soliris) in patients with relapsing neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder.Alexion also initiated a single, multinational, placebo-controlled trial in patients with refractory generalized myasthenia gravis (MG), another rare and debilitating neurologic disorder.Both NMO and MG are disorders caused by uncontrolled complement activation.In patients with NMO, chronic, uncontrolled complement activation results in severe damage to the central nervous system (CNS), predominantly impacting the optic nerve and spinal cord.This devastating disease is characterized by severe weakness, paralysis, respiratory failure, loss of bowel and bladder function, blindness and premature death.Says there are no approved treatments for NMO.In patients with MG, uncontrolled complement activation due to antibodies directed at the neuromuscular junction can ultimately lead to profound and debilitating weakness of various muscle groups throughout the body.Patients with generalized MG develop significant muscle weakness, impairing their ability to walk, speak clearly, swallow and, in some cases, to breathe normally.  Full Article

European Commission grants Orphan Drug Designation to Alexion Pharmaceuticals Inc's Soliris
Wednesday, 23 Apr 2014 06:30am EDT 

Alexion Pharmaceuticals Inc:European Commission has granted orphan drug designation (ODD) to Soliris.Soliris is first-in-class terminal complement inhibitor, for prevention of graft rejection following solid organ transplantation.  Full Article

Alexion Pharmaceuticals Inc raises FY 2014 guidance
Monday, 10 Mar 2014 06:30am EDT 

Alexion Pharmaceuticals Inc:Raises FY 2014 net revenue guidance from the prior range of $2.000 to $2.020 bln to the higher range of $2.150 to $2.170 bln, which includes the $88 million in net product sales related to years prior to 2014 to be recorded in Q1 2014.Raises FY 2014 non-GAAP EPS guidance from the prior range of $3.70 to $3.80 to the higher range of $4.37 to $4.47, which includes 37 cents attributable to net product sales related to years prior to 2014 to be recorded in Q1 2014.FY 2014 revenue of $2.03 bln and EPS of $3.89 - Thomson Reuters I/B/E/S.  Full Article

Alexion Pharmaceuticals Inc announces European Commission grants orphan drug designation to Soliris (Eculizumab) for prevention of Delayed Graft Function after Solid Organ Transplantation
Monday, 24 Feb 2014 06:30am EST 

Alexion Pharmaceuticals Inc:European Commission has granted an orphan drug designation (ODD) to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of delayed graft function (DGF) after solid organ transplantation.DGF is an early and serious complication of organ transplantation that is characterized by the failure of a transplanted organ to function normally immediately following transplantation.Says in patients undergoing kidney transplantation, patients who develop DGF require dialysis in order to survive.Grants orphan medicinal product status to provide incentives to develop medicinal products to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU.  Full Article

Alexion Pharmaceuticals Inc gives FY 2014 outlook above analysts' estimates
Thursday, 30 Jan 2014 06:30am EST 

Alexion Pharmaceuticals Inc:Sees FY 2014 worldwide net product sales to be within a range of $2.00 to $2.02 bln.Sees FY 2014 Non-GAAP earnings per share (EPS) to be $3.70 to $3.80.FY 2014 revenue of $1.96 bln, EPS of $3.46 - Thomson Reuters I/B/E/S.  Full Article

Alexion Pharmaceuticals Inc announces FDA approval of Orphan Drug Designation to Soliris (eculizumab) for Prevention of Delayed Graft Function (DGF) in Renal Transplant Patients
Tuesday, 21 Jan 2014 06:30am EST 

Alexion Pharmaceuticals Inc:Says that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of delayed graft function (DGF) in renal transplant patients.Says DGF is an early and serious complication of organ transplantation that is characterized by the failure of a transplanted organ to function normally immediately following transplantation.Says In patients undergoing a kidney transplant, DGF leads to the patient requiring dialysis in order to survive. 1-3.  Full Article

Alexion Pharma recalls certain lots of intravenous drug Soliris

- Alexion Pharmaceuticals Inc said it is voluntarily recalling certain lots of Soliris, an intravenous drug for two potentially fatal blood disorders that can damage the kidneys, heart and brain.

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