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Expansion in Massachusetts
- Shire Human Genetic Therapies ("HGT") announced on February 14, 2008, that the Company will invest approximately $400 million over four years through 2011 to expand its Lexington, Massachusetts campus, making Lexington the global centre for HGTs research, development, and production. This will result in the creation of an estimated 680 additional full-time jobs over the next eight years, doubling the existing full time workforce.
Recent developments
VYVANSE approved to treat ADHD in adults
- On April 23, 2008 Shire announced that the 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 acquires clinical candidate, arylsulfatase-A, for Metachromatic Leukodystrophy
- On April 24, 2008 Shire announced that it acquired from Zymenex A/S ("Zymenex") the global rights to the clinical candidate arylsulfatase-A ("ASA"), currently known as METAZYM(TM), being investigated for the treatment of Metachromatic Leukodystrophy ("MLD"). MLD is caused by a deficiency in the enzyme ASA which causes an excess concentration of sufatide in cells and an ensuing breakdown of myelin. There are approximately 2,000 MLD patients in developed world markets.
- The newly acquired ASA product has completed a Phase 1b clinical
trial in 12 MLD patients in Europe and an extension to this study is
ongoing. The product has received US FDA approval for its IND application
to initiate a Phase 2 clinical trial and has been granted Orphan Drug
designation in the US and in the EU. Shire will make a payment of US$135
million to Zymenex (which will be substantially expensed to Research &
Development ("R&D")) for the acquisition of global rights to the product
upon completion of the transaction, whi
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