30, 2008. While the FDA
responded on March 14, 2008, indicating that Noven's responses appear to be
satisfactory, the FDA also noted that it will continue its review of
Noven's response. It is expected that the FDA will perform a follow-up
inspection of Noven's manufacturing plant to ensure compliance.
LIALDA(TM)/MEZAVANT(R) - Ulcerative Colitis
- By April 11, 2008 LIALDA had achieved a 9.8% share of the US oral
mesalamine market based on weekly prescription volumes, up from 8.0% at
December 31, 2007.
- Sales for the three months to March 31, 2008 were $27.2 million
(2007: $nil).
- On March 26, 2008 Shire entered a co-promotion agreement with TAP
Pharmaceutical Products Inc. ("TAP") for LIALDA. The three year agreement
will add more than 500 additional sales representatives from TAP to
increase the reach and frequency of sales calls and will cover an
additional 22,000 doctors.
- Shire's share of the US oral mesalamine market from LIALDA and
PENTASA combined increased to 26.1% for the three months to March 31, 2008
(2007: 17.8%).
- The product was launched as MEZAVANT in Canada and Germany this
quarter. On April 1, 2008 the product was launched in Ireland as MEZAVANT
XL. Further launches in the EU are planned in 2008.
FOSRENOL(R) - Hyperphosphatemia
- Sales for the three months to March 31, 2008 were up 59% to $36.2
million (2007: $22.8 million). Following the launch of the product in Spain
and Hong Kong during this quarter, FOSRENOL is now available in 25
countries.
ELAPRASE(R) - Hunter syndrome
- During the three months to March 31, 2008 ELAPRASE was approved for
commercial sale in Russia and Mexico. ELAPRASE was also approved for
commercial sale in South Korea and Australia, where sales and distribution
will be managed by Genzyme Corporation.
- ELAPRASE is now approved in 39 countries worldwide and sales for the
three months to March 31, 2008 were $71.5 million (2007: $26.6 million).
'/>"/>SOURCE Shire plc Copyright©2008 PR Newswire. All rights reserved | |
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.
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