UPDATE 2-Shire's new Gaucher drug moves closer to market

Mon Aug 3, 2009 3:46am EDT

* Positive Phase III results for velaglucerase alfa

* Shire begins rolling submission to FDA

* Shares up 1.2 percent

(Adds sales forecasts, analyst comments, shares

By Ben Hirschler

LONDON, Aug 3 (Reuters) - Shire Plc's (SHP.L) new Gaucher disease drug velaglucerase alfa moved closer to market on Monday, following positive Phase III trial results and the start of a rolling submission to U.S. regulators.

Britain's third-biggest drugmaker said the first of three Phase III studies of velaglucerase alfa had produced positive clinical results and the FDA had accepted its treatment protocol for the enzyme replacement therapy.

The U.S. Food and Drug Administration said last month it was moving to speed up access to experimental drugs for Gaucher disease to help offset likely shortages of Cerezyme, the top-selling drug made by Genzyme Corp GENZ.O, which has suffered manufacturing problems. [ID:nN31431444]

Patients with Gaucher are deficient in an enzyme that breaks down a certain type of fat molecule. Fatty cells accumulate in different parts of the body, including the spleen, liver and bone marrow.

Shire plans to provide the drug initially free of charge in order to provide access to patients as quickly as possible.

Jefferies analyst Peter Welford said the short-term financial benefit to Shire was likely to be minimal but the upside lay in physicians gaining experience with the drug.

Savvas Neophytou at brokerage Panmure Gordon noted Cerezyme achieved sales of $1.2 billion in 2008 and if Shire could generate $500 million in 2010 this would translate into a near 15 percent upgrade to forecasts.

Shire shares gained 1.2 percent to 899 pence by 0730 GMT.

U.S. biotech group Protalix BioTherapeutics Inc (PLX.A) is also developing a new Gaucher drug. (Editing by Simon Jessop and David Holmes)

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