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FDA Grants Breakthrough Therapy Designation To CPMP Replacement Therapy For Patients With Molybdenum Cofactor Deficiency (MoCD) Type A

Safe Harbor Statement

This news release contains forward-looking statements, including statements related to potential medical benefits of cPMP/ALXN1101 for molybdenum cofactor deficiency (MoCD) Type A. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including, for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of cPMP/ALXN1101 for MoCD Type A, delays in arranging satisfactory manufacturing capabilities and establishing commercial infrastructure for cPMP/ALXN1101 for MoCD Type A, the possibility that results of clinical trials are not predictive of safety and efficacy results of cPMP/ALXN1101 in broader or different patient populations, the risk that third party payors (including governmental agencies) will not reimburse for the use of cPMP/ALXN1101 (if approved) at acceptable rates or at all, the risk that estimates regarding the number of patients with cPMP/ALXN1101 and observations regarding the natural history of patients with cPMP/ALXN1101 are inaccurate, 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 June 30, 2013. 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.

References

1. Public Law 112-144. U.S. Government Printing Office, July 9, 2012. http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf.

2. Vijayakumar_Pediatric Neurology_45_2011; Per, Brain Dev.2005; Serrano, Pediatr Radiol, 2007

3. Veldman A, Santamaria-Araujo JA, Sollazzo S, et al. Successful treatment of molybdenum cofactor deficiency type A with cPMP. Pediatrics. 2010;125(5):e1249-54.



Copyright Business Wire 2010
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