By Val Brickates Kennedy
Drug stocks gained in early action Monday as shares of Icagen
Inc. rallied on news that the FDA was allowing the company to
proceed with development of its new therapy for epilepsy.
The NYSE Arca Pharmaceutical Index (DRG) inched up 0.3% to
279.55 and the NYSE Arca Biotechnology Index (BTK) advanced 0.5% to
874.18.
Shares of Icagen (ICGN) shot up almost 50% to 94 cents a
share.
The biotech group said the Food and Drug Administration has
lifted a temporary hold on clinical study of its compound
ICA-105665 in the treatment of epilepsy. The agency had placed the
hold in March over concerns about certain data compiled from animal
studies.
Icagen added that it now plans to initiate a proof-of-concept
study testing the drug in the treatment of photosensitive epilepsy.
The company expects the study to be completed by mid-2010. Icagen
is also testing the compound for the treatment of pain.
In June, Icagen said that it had retained J.P. Morgan to help it
explore various strategic options, including a possible sale of the
company.
Shares of Genzyme Corp. (GENZ) slipped 2% to $51.01.
On Friday, Genzyme shares fell about 7% after the biotechnology
group said the Food and Drug Administration is planning to
re-inspect its main U.S. plant to ensure it complies with a warning
letter the agency issued in February.
The facility is used to make two of Genzyme's best-selling
medications, Cerezyme and Fabrazyme. Genzyme had also been seeking
FDA approval to make a version of its product Myozyme at the
facility. The company specializes in biologic drugs to treat rare
genetic disorders.
Genzyme shut down production of Cerezyme, which is used to treat
Gaucher disease, in June, after a contaminating virus was found in
one of the plant's bioreactors. While production resumed in late
July, shortages of the product have caused concern in the medical
community.
In addition, on Monday, Shire PLC (SHPGY) reported the Food and
Drug Administration has agreed to allow doctors to use its
experimental treatment for Gaucher, called velavelaglucerase alfa,
during the shortage, even though it is not yet approved. The
product is currently in Phase III testing.
A third company, Israel's Protalix BioTherapeutics (PLX), also
has a Gaucher treatment in Phase III testing. Protalix has likewise
been in contact with the FDA about making its therapy available to
doctors during the Cerezyme shortage.
Shares of Protalix were up 4% at $7.20.
-Val Brickates Kennedy; 415-439-6400;
AskNewswires@dowjones.com