14 January 2003 22:18 [Source: ICIS news]
HOUSTON (CNI)--Shares of biopharmaceuticals developer Genzyme General rose 5% or $1.64 to $33.32 Tuesday on positive news from a US Food and Drug Administration (FDA) advisory committee concerning the company's biologics license application for genetic disorder disease drug Fabrazyme.
Although the FDA advisory committee did note vote on whether to approve Fabrazyme - which Genzyme seeks to market for the treatment of Fabry disease, a rare and potentially fatal genetic disorder - it responded to safety questions posed by the FDA.
Genzyme said the panel affirmed that the primary endpoint studied in the Phase III clinical trial of Fabrazyme "is an appropriate surrogate marker for purposes of accelerated approval."
The FDA will now evaluate the committee's input; formal FDA action on Fabrazyme is expected by April.
Richard Moscicki, Genzyme's senior vice president for medical, clinical and regulatory affairs, said the company was "very encouraged" by the panel's actions.
He added: "We agree with the FDA and the committee on the importance of our ongoing Phase IV study, and we are committed to continue our Phase IV efforts. We are confident that the valuable input of the committee will enable us to move forward."
According to an analysis by the New York City brokerage house SalomonSmithBarney, 2003 sales of Fabrazyme could top $50m (Euro47.2m) if the drug is approved.
Said the brokerage firm in a research report: "We continue to believe Fabrazyme is in an advantageous regulatory position and is likely to become the orphan drug of choice."
Genzyme General of Cambridge, Massachusetts develops and markets therapeutic products and diagnostic products and services.
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