COMUNICADO: Alexion's Soliris(TM) Granted Marketing Approval in Europe for Treatment of All Patients With PNH (y 2)

Actualizado 22/06/2007 14:39:18 CET

This news release contains forward-looking statements, including statements related to potential benefits and commercial potential for Soliris, timing for, and potential regulatory decisions with respect to, the marketing applications for Soliris in Europe, timing of first commercialization in different territories, and interest and excitement about Soliris in the physician community. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including for example, requests by regulatory authorities for additional information or data after their review of our submissions, the need for additional research and testing, decision of regulatory authorities not to approve (or to materially limit) marketing of Soliris in Europe or other territories, delays in arranging satisfactory manufacturing capability and establishing commercial infrastructure, delays in developing or adverse changes in commercial relationships, the possibility that results of clinical trials are not predictive of safety and efficacy results of Soliris in broader patient populations, the risk that third parties won't agree to license any necessary intellectual property to us on reasonable terms, the risk that third party payors will not reimburse for the use of Soliris at acceptable rates or at all, the risk that Soliris will not generate interest among physicians, the risk that estimates regarding the number of PNH patients are inaccurate, the risk that pending litigation may be resolved adversely, 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 Quarterly Report on Form 10-Q for the period ended March 31, 2007 and in our other filings with the Securities and Exchange Commission. 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.

(1) Rother R, Bell L, Hillmen P, Gladwin M. The clinical sequelae of
intravascular hemolysis and extracellular plasma hemoglobin. JAMA
2005; 293:1653-1662.
(2) Parker C, Omine M, Richards S, et al. Diagnosis and management of
paroxysmal nocturnal hemoglobinuria. Blood 2005; 106:3699-3709.
(3) Hill A, Platts PJ, Smith A et al. The incidence and prevalence of
paroxysmal nocturnal hemoglobinuria (PNH) and survival of patients
in Yorkshire [abstract]. Blood. 2006;108(11):290a. Abstract 985.
(4) Socie G, Mary J Yves, de Gramont A, et al. Paroxysmal nocturnal
haemoglobinuria: long-term follow-up and prognostic factors. Lancet
1996; 348:573-577.
(5) Hillmen P. Lewis SM, Bessler M, Luzzatto L, Dacie JV. Naturalhistory
of paroxysmal nocturnal hemoglobinuria. N Engl J Med 1995; 333:1253-
(6) Johnson RJ, Hillmen P. Paroxysmal nocturnal hemoglobinemia: Nature's
gene therapy? J Clin Path: Mol Pathol. 2002;55:145-152.
(7) Wang, et al. Clinical significance of a minor population of
paroxysmal nocturnal hemoglobinuria-type cells in bone marrow
failure syndrome. Blood 2002;100:3897-3902.
(8) Iwanga, et al. Paroxysmal nocturnal haemoglobinuria clones in
patients with myelodysplastic syndromes. Brit J Haem. 1998;102:465
(9) Maciejewski, et al. Relationship between bone marrow failure
syndromes and the presence of glycophosphatidyl inositol-anchored
protein-deficient clones. Brit J Haem. 2001;115:1015-1022.
(10) Hill A, Richards S, Hillmen P. Recent developments in the
understanding and management of paroxysmal nocturnal
haemoglobinuria. British Journal of Haematology 2007; 137:3, 181-

Web site:

Leonard Bell, M.D., Chief Executive Officer of Alexion Pharmaceuticals, Inc., +1-203-272-2596; Media: Stephen Elliott of Surrey House, +44-(0)-1372-460-111; Investors: Rhonda Chiger of Rx Communications Group, LLC, +1-917-322-2569,, for Alexion Pharmaceuticals, Inc.

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