Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidanc...(s decided to stop thecommercialization o...)
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Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidance Upgrade.
Date:7/31/2008
s decided to stop the commercialization of DYNEPO. Changes in the external environment including the launch of several bio-similars at lower prices have proved challenging for DYNEPO, a gene-activated erythropoietin indicated for use in treating anemia associated with kidney disease, making it an uneconomic product for Shire. Product sales will wind down over the second half of 2008 as all patients are transferred off DYNEPO by the end of the year.
Shire has recorded charges of $150.3 million in the quarter ended June 30, 2008 to cover intangible asset impairment, inventory write-down and other exit costs. The cash effect of these exit costs is approximately $20 million.
Product Highlights
New Product Launches - subject to obtaining relevant
regulatory/governmental approvals, product launches planned over the next
two years include:
- MEZAVANT(R) (mesalazine) in certain EU countries during
2008;
- 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;
- DAYTRANA(TM) (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.
VYVANSE(TM) (lisdexamfetamine dimesylate) - Attention Deficit and
Hyperactivity Disorder ("ADHD")
- On April 23, 2008 Shire announced that the Food and Drug Administration
("FDA") had approved the adult indication for VYVANSE, making it the
first and only once-daily prodrug stimulant approved to treat adults
with ADHD. Shire launched VYVANSE for adult ADHD in June 2008.
- On May 8, 2008 Shire announced the results of a Phase 3 pivotal study
in which VYVANSE demonstrated significant improvements in ADHD
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| SOURCE Shire Ltd Copyright©2008 PR Newswire. All rights reserved |
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