We have also developed a promising pipeline with encouraging recent news. With the receipt of a Complete Response Letter from the US Food and Drug Administration ("FDA") for INTUNIV, we are confident that we will quickly come to agreement on the final wording of the product label and will launch in the fourth quarter of 2009 as planned. We are also initiating Phase 2 pilot clinical trials to assess the efficacy and safety of VYVANSE in non ADHD ("Attention Deficit Hyperactivity Disorder") indications. Our HGT pipeline has been strengthened by positive results from our trial of velaglucerase in naÃ¯ve Gaucher patients. A treatment protocol for early access has been approved by the FDA and the agency has approved Fast Track designation for the product. Rolling review of the New Drug Application ("NDA") has started.
Our core portfolio has made good progress in the quarter. We are pleased with the performance of VYVANSE as it has retained market share during the historically quieter summer vacation season in contrast to other branded ADHD treatments that have lost market share. We are anticipating the benefits of the back to school season for VYVANSE and are looking forward to increased sales momentum from our co-promote agreement with GSK for adult ADHD. We are also expecting further positive newsflow from our pipeline during the second half of this year.
Supported by pro-active cost management, our business is well placed to deliver on our unchanged guidance framework for 2009 and looking ahead we reiterate our aspiration of growing sales in the mid-teens range on average between 2009 and 2015."
Second Quarter 2009 Unaudited Results
|SOURCE Shire Plc|
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