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ulcerative colitis in certain European Union ("EU") countries during
2008 and 2009;
- FIRAZYR(R) (icatibant) which was launched in Germany and the UK in Q3,
following the receipt of marketing authorization from the European
Commission. Launches will continue across Europe as reimbursement
negotiations proceed. FIRAZYR has orphan designation and is the first
hereditary angiodema ("HAE") product to receive approval throughout the
European Union;
- INTUNIV(TM) (guanfacine) for use in children and adolescents
in the US in 2009;
- FOSRENOL(R) (lanthanum carbonate) in the pre-dialysis Chronic Kidney
Disease ("CKD") market in the US in 2009 subject to ongoing discussions
with the FDA regarding regulatory pathway for approval;
- DAYTRANA(R) (methylphenidate transdermal system) for use in
children in the EU in 2009 and adolescents in the US in 2010; and
- Velaglucerase alfa for the treatment of Gaucher disease in
the US and the EU in 2010.
Update on Current Portfolio
VYVANSE(R) (lisdexamfetamine dimesylate) - Attention Deficit and
Hyperactivity Disorder ("ADHD")
- The launch of VYVANSE for adult ADHD in June 2008 has helped to make
VYVANSE the third highest prescribed ADHD product in the US. For the
nine months to September 30, 2008 VYVANSE net sales totaled $215.6
million.
- On July 2, 2008 Shire shipped to wholesalers stocks of three additional
dosage strengths (20mg, 40mg and 60mg) for VYVANSE representing product
sales of approximately $24 million. These net product sales have been
recognized into revenue in Q3 2008.
FOSRENOL(R) -Hyperphosphatemia
- FOSRENOL was approved in Japan in October 2008. Shire's out-licensee,
Bayer Yakuhin Limited, is now progressing pricing and reimbursement
negotiations in that ma
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