Shire General Discussion

17th Jul '09 by Betasurfer

1 comment 2356 reads

A thread for general discussion of the company and developments that affect it. See the Shire Wiki for further information on Shire but, in summary:

Founded by Harry Stratford in 1986, Shire is a leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.
Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
The Company focuses its drug research and development on Attention Deficit Hyperactivity Disorder (ADHD) through three of its currently leading medications (Adderall/Adderall XR, Daytrana, and the newly developed Vyvanse). However the Company also works on gastrointestinal (GI) treatments, human genetic therapies (HGT) and renal diseases.
In 2007 it acquired New River Pharmaceuticals Inc, a leading US drug maker, for $2.3bn

See here for an interview with Angus Russell of Shire re: the problems of Big Pharma.

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Betasurfer

17th Jul '09

US regulators said they would fast-track the approval of velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease. Fast track designation is used to speed through to market drugs which are needed to treat a serious disease or unmet medical need. Gaucher is a rare genetic disease, affecting about 10,000 people worldwide, that causes a fat to accumulate in cells and certain organs because of deficient enzymes.
Shire is completing a phase III clinical program that includes three phase III controlled studies involving over 100 patients at 24 sites in 10 countries around the world.
Velaglucerase was initially forecast to launch in the second half of 2010 but analysts estimate that the review process could now take six months rather than the normal 10 to12.
Charles Stanley analyst Jeremy Batstone-Carr said the news "represents a golden opportunity" for Shire to take market share from Genzyme, but added that Shire is unlikely to capture all of Genzyme's market. About 10,000 Gaucher’s patients take Genzyme’s Cerezyme, a drug with annual sales of $1.2bn.

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