CHESHIRE, Conn., May 28, 2009 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that researchers are scheduled to present early clinical and laboratory data on the potential role of terminal complement inhibition with Soliris(R) (eculizumab) for the treatment of a subset of kidney transplant patients who are at high risk for antibody-mediated rejection (AMR) of their grafts. These data will be included in three oral sessions and one poster presentation at the American Transplant Congress being held May 30 to June 2, 2009 at the Hynes Convention Center in Boston. This research includes interim results from an investigator-initiated study of Soliris(R) for the prevention of AMR in this sub-population of kidney transplant patients.
Abstracts listed below can be accessed at: http://www.abstracts2view.com/atc/sessionindex.php.
|Abstract #178 will be presented during an oral session (Concurrent Session 25) on Sun., May 31 at 4:48 p.m.:|
- "Prevention of Acute Humoral Rejection with C5 Inhibition," Dr. Mark D. Stegall, et al.
|Abstract #393 will be presented during a plenary session (Plenary Session III) on Tues., June 2 at 9:45 a.m.:|
- "Prevention of Endothelial Activation with C5 Inhibition in Positive-Crossmatch Kidney Transplants (+XMKTx)," Dr. Lynn D. Cornell, et al.
|Abstract #62 will be presented during an oral session (Concurrent Session 9) on Sun., May 31 at 2:15 p.m.:|
- "Anti-C5 mAb Plus Low Dose CTLA4 Ig Inhibit Alloreactive T Cells and Prolong Heart Graft Survival in Mice," Dr. Staci A. Leisman, et al.
|Abstract #755 will be presented during a poster session (Kidney Immunosupression: Novel Agents) on Sat., May 30 from 5:30 - 7:00 p.m.:|
- "Complement C5 Inhibitor - Is It Useful in Antibody-Mediated Rejection?" Rizwan Hamer, et al.
Soliris has been approved by the U.S. Food and Drug Administration (March 2007), the European Commission (June 2007), Health Canada (January 2009) and Australia's Therapeutic Goods Administration (February 2009) as the first treatment for all patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder defined by hemolysis, or the destruction of red blood cells. All four jurisdictions reviewed and approved their respective marketing applications for Soliris under their priority review or accelerated assessment procedures, and all four have designated Soliris as an orphan drug. Soliris is not approved for the treatment of transplant rejection. More information on Soliris is available at www.soliris.net.
Important Safety Information
Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection. Prior to beginning Soliris therapy, all patients and their prescribing physicians are encouraged to enroll in the PNH Registry, which is part of a special risk-management program that involves initial and continuing education and long-term monitoring for detection of new safety findings.
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris is Alexion's first marketed product, approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at www.alexionpharma.com.
SOURCE: Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Sr. Director, Corporate Communications
Makovsky & Company
Kristie Kuhl, 212-508-9642
Rhonda Chiger, 917-322-2569
Copyright Business Wire 2009