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
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."
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
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
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
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
...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
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
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
In the study, (1) soliris
was associated with significant long-term
clinical... group, regardless of
disease severity, long- term soliris
treatment provides important clinical
today provide further evidence for the utility of soliris
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
associated with sustained reduction in... the destruction of red blood
cells, or hemolysis. soliris
is a complement inhibitor indicated for the
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
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
(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
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
certain government payors to reimburse for past soliris
$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.
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
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
"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
* 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
Leeds, Leeds, UK. "In several clinical trials, soliris
reduced hemolysis in
all PNH patients and signific...
life. The comprehensive analyses demonstrate that soliris
reduced the risk of thrombosis in a ...ensure that every PNH patient who can benefit
will have access to it." "Many PNH patients face ...