Soliris

Alexion Pharmaceuticals and PDL BioPharma Resolve Patent Dispute

...ortfolio, thus permitting Alexion to commercialize soliris for all indications under the Queen patents. In c...exion to PDL under the Queen patents in respect of soliris sales for any indication. As part of the settleme...ed that the Queen patent claims are valid and that soliris employs technology covered under the Queen patents...

David W. Keiser to Retire as President of Alexion

...rnational organization that is now able to deliver soliris to a growing number of patients in a growing numbe...arketing approval for the Company's first product, soliris for all patients with PNH. In June 2007, the European Commission granted marketing approval for soliris in the European Union for all patients with PNH. T...

Researchers to Present Additional Data on Soliris(R) (eculizumab) for the Treatment of PNH at the ASH Annual Meeting

...awal," Dr Valerie Chatelet et al. About Soliris soliris is the first product approved for the treatment of...s this hemolysis. Important Safety Information soliris is generally well tolerated. The most frequent adv...back pain and nausea. The U.S. product label for soliris also includes a boxed warning: "Soliris increases ...

Alexion Pharmaceuticals Chooses Blue Mountain Regulatory Asset Manager(R) for Best-in-class Calibration Management Integrated with SAP(R)

.... at 800-982-2388, +1-814-234-2417 or ram@coolblue.com . SAP is the registered trademarks(s) of SAP AG in Germany and in several other countries. soliris is the registered trademark of Alexion Pharmaceuticals, Inc. Blue Mountain Regulatory Asset Manager is the registered trademark of Blue Mountain Qua...

FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder

... Food and Drug Administration (FDA) today approved soliris (eculizumab), the first product for the treatment ...r that can lead to disability and premature death. soliris is classified as an Orphan Drug and is a new molec...lood cells, the most common characteristic of PNH. soliris acts to block the complement system activity, incl...

Soliris in Medical Technology

Alexion Reports Positive Results from AEGIS Registration Study of Soliris in Japanese Patients With PNH

CHESHIRE, Conn., Dec. 8 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN ) today reported positive results from AEGIS, an open-label registration study examining Soliris(R) (eculizumab) treatment of Japanese patients with paroxysmal nocturnal hemoglobinuria (PNH). The pre-sp...

Studies Show Efficacy and Safety of Alexion's Soliris in Broad Population of PNH Patients

- Data presented at 12th Congress of European Hematology - CHESHIRE, Conn., June 11, 2007 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. today announced results from three analyses of Phase III studies examining Soliris(TM) (eculizumab) for the treatment of paroxysmal nocturnal hemoglobin...

First Clinical Experience With Soliris(R) in Treating Patients With Two Rare Complement-Mediated Diseases Presented at ASH Annual Meeting

...ans reported on the first clinical experience with soliris in patients with atypical Hemolytic Uremic Syndrom...and poor quality of life. In one patient with CAD, soliris treatment was associated with reduced hemolysis, a...of eculizumab in patients with CAD." About soliris ...

Alexion Secures U.S. Patent for ALXN6000, a First-In-Class Anti-CD200 Monoclonal Antibody

...sease. In June 2007, the European Commission granted marketing approval for soliris in the European Union for all patients with PNH. Alexion is evaluating other potential indications for soliris as well as other formulations of eculizumab for additional clinical indicat...

Soliris(R) Improved Fatigue Independent of Changes in Anemia in Patients with PNH by Controlling Hemolysis

...s approved in the U.S. and European Union in 2007; soliris is indicated in the U.S. for the treatment of pati...ar to those experienced by anemic cancer patients. soliris has been shown to reduce substantially the frequen...dditional insight into the mechanism through which soliris positively impacts PNH-related fatigue. While trea...

Alexion Completes Enrollment in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan

... of 29 patients. The patients will be treated with soliris at clinical sites throughout Japan for 12 weeks. ...aseline. The study will also measure the effect of soliris on other clinical manifestations of PNH, including...tudy, one of Alexion's previous Phase 3 studies of soliris as a treatment for PNH. SHEPHERD examined the safe...

Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan

...aseline. The study will also measure the effect of soliris on other clinical manifestations of PNH, including...ed in one of Alexion's previous Phase 3 studies of soliris as a treatment for PNH, the SHEPHERD study. SHEPHE... SHEPHERD study and the TRIUMPH Phase 3 study, (2) soliris was approved as the first treatment for patients w...

PNH Patients With Lower Levels of Hemolysis, Mild Anemia and Minimal Transfusion Support Have Significant Disease Burden; Soliris(R) Therapy Provided Clinical Improvements in PNH Patients Regardless of Disease Severity

...ment with Eculizumab Therapy." In the study, (1) soliris was associated with significant long-term clinical... group, regardless of disease severity, long- term soliris treatment provides important clinical improvements... today provide further evidence for the utility of soliris therapy in patients with diverse manifestations of...

Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patients With PNH

... Study Shows that Long-Term soliris Therapy Continued to Be Associated with Reduction...studies, the long-term reduction in hemolysis with soliris therapy was associated with sustained reduction in... the destruction of red blood cells, or hemolysis. soliris is a complement inhibitor indicated for the treatm...

Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients

... the destruction of red blood cells, or hemolysis. soliris is indicated for the treatment of patients with PN..., studied in the non-placebo controlled open-label soliris Phase III SHEPHERD trial. The primary efficacy end...blood cell destruction. Every patient treated with soliris had a substantial reduction in hemolysis as measur...

Soliris in Biological Technology

Soliris(R) Reduced Measures of Thrombosis and Inflammation, and Decreased Indicators of Pulmonary Hypertension, in Studies of Patients with PNH

...ents with PNH. A separate study found that soliris was observed to reduce indicators of pulmonary art...oliris (1) compared to the period of time prior to soliris treatment. To better understand the mechanism for ... blood markers in order to determine the effect of soliris on markers of thrombin generation and inflammation...

Alexion Reports Third Quarter 2008 Results

...rtain government payors during Q3 to reimburse for soliris shipments that occurred in previous quarters. --...nsisted of $71.2 million of net product sales from soliris shipments during Q3, plus recognition of $5.3 mill...of certain government payors to reimburse for past soliris shipments. The $71.2 million in sales from shipmen...

Alexion's Soliris(R) Receives 2008 Prix Galien USA Award for Best Biotechnology Product

...omplishment in Complement Inhibition and Impact of soliris on Patients Living with PNH CHESHIRE, Conn., Sep...ebilitating and life-threatening blood disorder. soliris is a first-in-class complement inhibitor that sele...e that every patient with PNH who can benefit from soliris will have access to Soliris. We are building on th...

Alexion Reports First Quarter 2008 Results

...evelopment, including Soliris registration and the soliris extension study. Non-GAAP selling, general, and ad...penses associated with drug development, including soliris registration and the Soliris extension study. SG&A...cility for working capital purposes. "Demand for soliris increased significantly in both the United States ...

Alexion Reports Fourth Quarter and Full Year 2007 Results

... Total 2007 revenues were $72.0 million, including soliris net product sales of $66.4 million, representing the first nine months of soliris commercial availability. * 2007 GAAP net loss...irely of Soliris(R) net product sales, compared to soliris net product sales of $21.8 million in the third qu...

Alexion Acquires All Rights to OMRF Patents Related to Soliris(R)

...r amounts, including royalties, will be owed to OMRF in respect of sales of soliris or other use of the OMRF patents. Accordingly, the previously announced cla...autoimmune disorders. Alexion is evaluating other potential indications for soliris as well as other formulations of eculizumab for additional clinical indicat...

PNH Patients Treated with Soliris(TM) Experienced Dramatic Reduction in Blood Clots During Clinical Trials

... at Leeds, Leeds, UK. "In several clinical trials, soliris reduced hemolysis in all PNH patients and signific... life. The comprehensive analyses demonstrate that soliris substantially reduced the risk of thrombosis in a ...ensure that every PNH patient who can benefit from soliris will have access to it." "Many PNH patients face ...