Genzyme General shares up 5% on positive 'Fabrazyme' news
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.
By: Mike Sheridan
+1 713 525 2653
For the latest chemical news, data and analysis that directly impacts your business sign up for a free trial to ICIS news - the breaking online news service for the global chemical industry.
Get the facts and analysis behind the headlines from our market leading weekly magazine: sign up to a free trial to ICIS Chemical Business.
| ICIS news FREE TRIAL |
| Get access to breaking chemical news as it happens. |
| ICIS Global Petrochemical Index (IPEX) |
| ICIS Global Petrochemical Index (IPEX). Download the free tabular data and a chart of the historical index |
Related Articles
- 02 May 03 17:30 S&P revises Genzyme to 'positive' on strong finances
- 16 Apr 03 16:09 Genzyme General Q1 profit doubles on 30% revenue rise
- 28 Mar 03 11:09 UK's Genzyme to appeal £6.8m OFT fine over 'Cerezyme'
- 15 Jan 03 20:50 TKT stock off 25% on FDA advisory actions on 'Replagal'
- 11 Oct 02 21:19 Transkaryotic Shares Slide on Replagal Delay
- 24 Dec 01 00:00 TKT Prevails in Genzyme Suit
- 29 Oct 01 00:00 Genzyme's Fabry Disease Drug on Track
- 13 Aug 01 00:00 Genzyme, Transkaryotic Square Off In Niche Market for Fabry's Disease
- 26 Dec 00 17:00 Genzyme to provide FDA 'Fabrazyme' data; start new trials
Latest News
- 19 Jun 13 22:12 Biofuels still play key role in midst of shale revolution: exec
- 19 Jun 13 22:10 Shale gas, tight oil to make US short on benzene, long on xylenes
- 19 Jun 13 21:55 Researchers predicting large Gulf of Mexico dead zone
- 19 Jun 13 21:19 Biofuels to nearly double in road transport use by 2030: exec
- 19 Jun 13 21:13 US Fed says economy likely to make gains, but holds rate steady