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PRIMO-CABG Investigators PresentPharmacoeconomic Analyses at the Western Thoracic Surgery Association 2005 Meeting
Contacts:
Alexion Pharmaceuticals, Inc.
Leonard Bell, M.D.
Chief Executive Officer
(203) 272-2596
Noonan Russo
Robert Stanislaro (Business & Financial Media)
(212) 845-4268
Rx Communications
Patricia Garrison (Scientific Media)
(917) 322-2567
Rhonda Chiger (Investors)
(917) 322-2569
PRIMO-CABG Investigators PresentPharmacoeconomic Analyses at the Western Thoracic Surgery Association 2005 Meeting
- Results Suggest Intensive Care Unit Time, Hospital Stay and Overall Costs Increased With Heart Attacks Following Coronary Artery Bypass Graft Surgery; Indicating Cost Saving Opportunities for Potential Heart Attack Prevention Therapies -
CHESHIRE, CONN, June 27, 2005 -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that investigators from its Phase III clinical trial with pexelizumab, a C5 complement inhibitor, presented the first pharmacoeconomic analyses from that study concerning the healthcare cost impact of perioperative myocardial infarction (MI), or heart attack, related to coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). The trial, known as PRIMO-CABG, was conducted with Procter & Gamble Pharmaceuticals.
“Myocardial Infarction Following Coronary Artery Bypass Graft Surgery Increases Intensive Care Unit Time, Hospital Stay, and Overall Costs” was presented Saturday, June 25, at the Annual Meeting of the Western Thoracic Surgery Association in Victoria, British Columbia by lead author John Chen, MD, Clinical Professor, Division of Cardiothoracic Surgery, University of Hawaii, Kaiser Permanente Medical Center. The pharmacoeconomic data collection was done as part of the first Phase III PRIMO-CABG trial and the economic analyses was led by Daniel B. Mark MD, MPH, Associate Professor of Medicine, Division of Cardiology, Duke University Medical School and Director, Health Outcomes, Duke Clinical Research Institute.
Heart attacks occurring shortly after heart surgery have been demonstrated to be associated with a significant increase in the risk of post-operative death. However, the impact of a perioperative heart attack on patient care costs has not been thoroughly examined in a clinical study until PRIMO-CABG. Dr. Chen’s paper revealed new information on the pharmacoeconomic impact of perioperative heart attack occurring within four days following CABG surgery, within the setting of the first PRIMO-CABG trial, a multicenter, multinational, double-blind, placebo-controlled randomized clinical study.
The principal findings were as follows:
• Perioperative MI after CABG surgery increased patient care costs through Day 30 and at six months following CABG surgery. The increase in total costs for a perioperative MI patient, as compared to a patient not having a perioperative MI, was $13,460 by 30 days and $15,431 by six months.
• Perioperative MI was associated with significant increases in hospital costs, in-hospital ICU time, length of stay and physician service costs.
• Strategies aimed at reducing the rate of perioperative MI and associated morbidity may be of value in reducing health care costs in patients undergoing CABG procedures.
“Understanding the problem that drives healthcare costs is a good step toward further improving CABG surgery as the gold-standard of coronary artery revascularization for reducing mortality and morbidity of coronary artery disease,” stated Dr. Chen. “These analyses highlight perioperative MI, not only as an important factor for increasing the chance of death after CABG surgery, but also as a significant cost driver.”
Leonard Bell, MD, CEO of Alexion Pharmaceuticals, added, “We are hopeful that the investigational drug, pexelizumab, will not only show morbidity and mortality benefits for patients in our on-going pivotal Phase III PRIMO-CABG2 trial, but also will yield useful pharmacoeconomic information that may prove helpful to the healthcare system in terms of realizing cost benefits.”
Alexion and Procter & Gamble Pharmaceuticals are currently conducting the pivotal Phase III pexelizumab PRIMO-CABG2 trial, which is expected to enroll approximately 4,000 CABG patients.
Alexion (NASDAQ:ALXN) is engaged in the discovery and development of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and cardiovascular disorders, autoimmune diseases and cancer. Alexion's two lead product candidates, pexelizumab and eculizumab, are currently undergoing evaluation in several clinical development programs, including two Phase III trials of eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a Phase III trial of pexelizumab in coronary artery bypass graft (CABG) surgery patients undergoing cardiopulmonary bypass (CPB), and a Phase III trial of pexelizumab in acute myocardial infarction (AMI) patients. The pexelizumab trials are conducted in collaboration with Procter and Gamble Pharmaceuticals. Under the Special Protocol Assessment process, the FDA has agreed to the design of protocols for the Phase III pexelizumab trials that could, if successful, serve as the primary basis of review for approval of licensing applications for the two indications. Also under the Special Protocol Assessment process, the FDA has agreed to the design of protocols for the two trials of 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. Eculizumab is also being studied in rheumatoid arthritis and membranous nephritis. 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 on the World Wide Web at: http://www.alexionpharm.com.
This news release contains forward-looking statements, including, without limitation, statements relating to projected net loss for the Company’s fiscal year ending July 31, 2005 and the timing of completion of enrollment and the randomization phase in certain of the Company’s ongoing Phase III clinical trials. Such statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including the results of pre-clinical or clinical studies (including termination or delay in clinical programs), the need for additional research and testing, 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(P&GP) 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 Annual Report on Form 10-K for the year ended July 31, 2004 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 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.
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