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By Eric Jones
Of DOW JONES NEWSWIRES
LONDON -(Dow Jones)- Biopharmaceutical company Shire PLC (SHP.LN) said Thursday it has received Fast Track designation from the U.S. Food and Drug Administration for its drug velaglucerase alfa, an enzyme replacement therapy that targets 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.
On July 6, the FDA asked that Shire file a treatment protocol for velaglucerase alfa, which if accepted would allow physicians to treat patients suffering from Gaucher - a genetic disease in which a fatty substance accumulates in cells and certain organs - with the drug before it was commercially available.
Shire said it would initially provide the drug free of charge to speed up access for patients.
The total diagnosed population of Gaucher Disease patients is around 7,000 worldwide, but it's thought that between 10,000 and 15,000 people have the disease.
The request came after production of Genzyme Corporation's (GENZ) Cerezyme, the only other treatment for Gaucher I disease, was halted due to manufacturing problems. Genzyme said production would be resumed later this month.
At that time, Israel's Protalix BioTherapeutics Inc. (PLX) was also approached by the FDA for a treatment protocol.
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. He noted that Genzyme's Cerezyme achieve revenues of $1.2 billion in 2008. Batstone-Carr has a hold rating on Shire stock.
Velaglucerase alfa is made with Shire's proprietary technology, and the enzyme produced has the exact human amino acid sequence.
Shire shares opened lower but by 0840 GMT had rebounded, to 837 pence, up 4p or 0.5% on the day. They have risen 12% in the past year, giving the company a market capitalization of GBP4.66 billion.
Company Web site: www.shire.com
-By Eric Jones, Dow Jones Newswires; 44-207-842-9295; eric.jones@dowjones.com