nigel, maybe it is once again time to revive the gnlb thread?
siliconinvestor.com
REDWOOD CITY, Calif., May 29, 2002 /PRNewswire-FirstCall from COMTEX/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB chart, msgs) stated today that the company currently expects a new U.S. Food and Drug Administration (FDA) action on its New Drug Application (NDA) for Aslera(TM) (GL701) no later than the end of August 2002. As part of Genelabs' on-going discussions with the FDA, the company has submitted additional clinical data and analyses to the agency. Genelabs recently learned that these submissions have been classified as a proposed treatment of women with systemic lupus erythematosus to limit bone loss while on low-dose glucocorticoids.
Irene A. Chow, Ph.D., chairman and chief executive officer, stated, "In working with the FDA toward Genelabs' goal of approval of the Aslera NDA, one of our meetings with the agency occurred in December 2001. The FDA sent us a letter in January 2002 suggesting that we submit additional clinical data and analyses. Over the course of the past several months, as we have continued to work with the FDA, we have submitted additional information to the agency, including information submitted in February 2002 in response to the January letter. While it is not possible to predict the outcome of our current discussions with the FDA on the approvability of the Aslera NDA, I am pleased Genelabs is now able to provide guidance regarding a timeframe for the agency's next action."
Genelabs submitted an NDA for Aslera in September 2000 and received a not-approvable letter in June 2001. Since that time, the company has been actively working with the agency toward resolution of the deficiencies identified by the FDA in the not-approvable letter. Aslera is being developed by Genelabs and is exclusively licensed to Watson Pharmaceuticals, Inc. in North America.
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 which we have an exclusive license from Stanford University. |
