Alexion Pharmaceuticals Inc. Reports Phase III Preliminary Results For APEX-AMI Study; Drug Fails In Another Trial
Pexelizumab, a terminal complement inhibitor, is a monoclonal antibody fragment that inhibits complement-mediated tissue damage. The Phase III trial titled "A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- Controlled Study of Pexelixumab in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention" (APEX-AMI), included approximately 5,700 patients, and compared the safety and efficacy of pexelizumab against that of placebo in reducing death in patients experiencing a heart attack who are treated with PCI. Alexion expects that the trial results will be presented at an upcoming scientific meeting. The trial was conducted at more than 300 U.S. and international study sites.
"The APEX-AMI trial is one of the largest PCI in AMI trials ever conducted and we thank each of the investigators and patients who enable us to pursue this research," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "We look forward to completing an analysis of the data and obtaining a more in-depth understanding of these results. As previously stated, we remain focused on our lead product Soliris(TM) (eculizumab) and moving that important therapy toward commercialization for patients suffering from the orphan blood disorder Paroxysmal Nocturnal Hemoglobinuria."
Alexion remains on track to complete and submit its Biologics License Application (BLA) for its lead drug candidate Soliris(TM) (eculizumab) in the orphan blood disorder Paroxysmal Nocturnal Hemoglobinuria (PNH) during the second half of this year.
Alexion expects to discuss its pexelizumab partnership with P&G following complete analysis of the APEX-AMI data.
About Alexion
Alexion Pharmaceuticals is a biotechnology 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 and development of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic diseases, cancer, and autoimmune disorders. Alexion's two lead product candidates, Soliris(TM) (eculizumab) and pexelizumab, are currently undergoing evaluation in several clinical development programs, including two Phase III trials of Soliris(TM) (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Under the Special Protocol Assessment (SPA) process, the FDA has agreed to the design of protocols for the two trials of Soliris(TM) (eculizumab) in PNH patients that could, if successful, serve as the primary basis of review for approval of a licensing application for eculizumab in the PNH indication. Results from the PRIMO-CABG2 trial of pexelizumab in coronary artery bypass graft (CABG) surgery patients indicate that the trial is unlikely to be sufficient for filing for licensing approval of pexelizumab in the CABG indication. The APEX- AMI trial of pexelizumab in acute myocardial infarction patients was conducted pursuant to a protocol approved under the SPA process; however, that trial has ended prior to enrolling the anticipated number of patients. Results from the APEX-AMI trial indicate that the trial is unlikely to be sufficient for filing for licensing approval of pexelizumab in the acute myocardial infarction indication. The pexelizumab trials were conducted in collaboration with Procter and Gamble Pharmaceuticals. Alexion is engaged in discovering and developing a pipeline of additional antibody therapeutics targeting severe unmet medical needs, through its wholly owned subsidiary, Alexion Antibody Technologies, Inc. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: http://www.alexionpharm.com.
This news release contains forward-looking statements, including statements related to characterization of clinical trial results, timing of announcement of clinical trial results, commercial potential of Alexion's drug candidates, the progression of Alexion's drug candidates towards commercial sales and timing for submission of, and decisions with respect to, marketing applications for Soliris(TM)(eculizumab). Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including delays in completion of ongoing clinical trials, delays in completion of analysis of clinical trial results, timing and evaluation by regulatory agencies of the results of these and other clinical trials, the results of pre-clinical or clinical studies (including termination or delay in clinical programs), the need for additional research and testing, decision of the FDA or other regulatory authorities not to approve (or to materially limit) marketing of one or both of Alexion's two drug candidates, delays in arranging satisfactory manufacturing capability, inability to acquire funding on timely and satisfactory terms, delays in developing or adverse changes in commercial relationships, the possibility that results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, dependence on Procter & Gamble Pharmaceuticals for development and commercialization of pexelizumab, the risk that third parties won't agree to license any necessary intellectual property to us on reasonable terms, and a variety of other risks set forth from time to time in Alexion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Transition Report on Form 10-K/T for the five-month transition period ended December 31, 2005 and in our other filings with the Securities and Exchange Commission. P&GP retains the development rights and the termination rights discussed in Alexion's Form 10-K/T referred to above. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.
Alexion Pharmaceuticals, Inc. Leonard Bell, M.D. Chief Executive Officer (203) 272-2596 Rx Communications Patricia Garrison (Scientific Media) (917) 322-2567 Rhonda Chiger (Investors) (917) 322-2569 Noonan/Russo Matt Haines (Business and Financial Media) (212) 845-4235
Source: Alexion Pharmaceuticals, Inc.