Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidanc...(s decided to stop thecommercialization o...)

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

'/>"/>

SOURCE Shire Ltd Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
Related biology technology :

1. Shire Appoints Sylvie Gregoire President of Human Genetic Therapies Business
2. Shires ELAPRASE(R) (idursulfase) Approved in Japan for the Treatment of Hunter Syndrome
3. Shire Divests Non-Core Product Portfolio to Almirall
4. Correction: Shire plc: Third Quarter 2007 results date notification November 1, 2007
5. David Mott Appointed Non Executive Director at Shire
6. Shire plc: Board Changes
7. Alba Therapeutics Corporation and Shire plc Enter Into $325 Million ex-US, ex-Japan Licensing Agreement to Develop and Commercialize AT-1001
8. Shire Expands its Gastrointestinal Portfolio Through In-Licensing Celiac Disease Phase 2 Product From Alba Therapeutics Corporation
9. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
10. Texas Boy Receives Wheelchair From New Hampshire Couples Recently Deceased Granddaughter
11. Shire Engages Palio