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Cinryze® (C1 Esterase Inhibitor [Human]) Data Presented at 2010 International Scientific Conference of the World Allergy Organization (WAO)
Date:12/6/2010

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Forward Looking Statements

Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events. There can be no assurance that that the data presented during the 2010 International Scientific Conference of the World Allergy Association (WAO) regarding Cinryze is predictive of how Cinryze will perform in commercial usage.  Cinryze is currently available only in the United States.  Cinryze is not approved in the U.S. for acute treatment of attacks nor has the safety and effectiveness of Cinryze been established in pediatric patients with HAE. We cannot assure that current or future studies with Cinryze in the patient populations described in the WAO presentations may demonstrate the safety and efficacy profile of Cinryze. The EMA may view the data regarding the use of Cinryze for acute treatment and / or prevention of HAE we have submitted in the MAA as insufficient or inconclusive, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, deny the approval of Cinryze for acute treatment and / or prevention of HAE or approve a competing product which has been granted orphan drug designation thereby preventing Cinryze from reaching the European market.  For example, in June 2009, the U.S. FDA issued a complete response letter and requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the sBLA for acute treatment of HAE lacked robustness. These factors, and other factors, including, but not limited
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