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REDWOOD CITY, Calif., June 20 /PRNewswire-FirstCall/
-- Genelabs Technologies, Inc. (Nasdaq: GNLB) announced today that
the European Agency for Evaluation of Medicinal Products (EMEA)
has advised Genelabs that Aslera(TM) qualifies for Part B status.
This status enables Genelabs to file a Marketing Authorization Application
(MAA) under the EMEA's centralized procedure. The centralized procedure
allows companies to submit one MAA for simultaneous consideration
in all European Union countries and provides for a single review
and decision regarding the MAA. Genelabs sought to qualify Aslera
for Part B status on the basis of its potential as a new treatment
for an indication that is of significant therapeutic interest in
the opinion of the EMEA. Genelabs is seeking approval of Aslera
for women with systemic lupus erythematosus.
Irene A. Chow, Ph.D., chairman and chief executive
officer, stated, "I am pleased that the EMEA has agreed that Aslera
qualifies for Part B status, which will allow us to submit one application
in the European Union for review under the centralized procedure.
We are preparing our MAA and plan to submit it as soon as possible.
In addition, we are working actively with the U.S. Food and Drug
Administration, and expect to receive a new action on our New Drug
Application in the United States no later than the end of August."
Genelabs Technologies, Inc. is a biopharmaceutical
company pioneering the discovery and development of novel pharmaceutical
products to improve human health. We have built drug discovery and
clinical development capabilities that can support various research
and development projects, while concentrating these capabilities
on two core programs: developing a late-stage product for lupus
and discovering novel drug candidates targeting DNA. Our research
efforts are currently directed toward anti-microbial drug discovery
and we have synthesized many lead compounds targeting DNA in bacteria,
fungi and viruses. Our clinical development efforts are concentrated
on Aslera(TM) for systemic lupus erythematosus.
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