Genelabs and Watson Report on FDA Advisory Committee Meeting for Aslera(TM) New Drug Application for Lupus

Apr 19, 2001, 01:00 ET from Watson Pharmaceuticals, Inc.

    REDWOOD CITY, Calif. and CORONA, Calif., April 19 /PRNewswire/ --
 Genelabs Technologies, Inc. (Nasdaq:   GNLB) and Watson Pharmaceuticals, Inc.
 (NYSE:   WPI) reported that the U.S. Food and Drug Administration's (FDA)
 Arthritis Advisory Committee met today to review Aslera(TM) (prasterone) for
 the treatment of patients with mild to moderate systemic lupus erythematosus
 (SLE or lupus).  The committee was not asked by the FDA to vote on whether to
 recommend approval of Aslera(TM) for the treatment of SLE.  The FDA seeks
 expert advice from advisory committees as part of its review of a New Drug
 Application (NDA).  However, the final decision regarding the approval of an
 NDA is made by the FDA.
     Irene Chow, Ph.D., Chairman and Chief Executive Officer of Genelabs,
 commented:  "We are very pleased with the positive feedback provided by
 advisory committee members at the meeting regarding our NDA for Aslera(TM).
 We intend to work with the FDA to facilitate its completion of the review of
 Aslera(TM) for the treatment of SLE."
     Aslera(TM) was developed by Genelabs and has been exclusively licensed to
 Watson in North America.  The NDA for Aslera(TM) was submitted to the FDA in
 September 2000 and granted priority review designation by the FDA in
 October 2000.  Priority review designation generally provides for a six-month
 review period by the FDA and is granted to potential new drugs that are
 intended to treat a serious or life-threatening condition for which there is
 no adequate therapy currently available.  In March 2001, Genelabs agreed with
 the FDA to extend the review period until no later than June 26, 2001, to
 allow the FDA to complete its review.
     Allen Chao, Ph.D., Watson's Chairman and Chief Executive Officer, said,
 "We intend to continue to work closely with Genelabs and support its efforts
 toward approval of Aslera(TM)."
     SLE is an autoimmune disease that can cause the patient's immune system to
 attack its own tissue, leading to inflammation, severe fatigue, arthritis
 pain, tissue injury and major organ damage.  Current SLE treatment primarily
 relies on the chronic use of corticosteroids, such as prednisone, that can
 have many adverse consequences for a patient's health and quality of life.
 Genelabs is seeking approval of Aslera(TM) as a first line therapy for women
 with mild to moderate systemic lupus erythematosus to improve disease activity
 and its symptoms, and also to reduce corticosteroid requirements.
     Genelabs Technologies, Inc., is a biopharmaceutical company engaged in the
 discovery and development of a new class of pharmaceutical products that
 target DNA.  By acting directly on the genetic material, Genelabs' technology
 can be applicable to a wide range of therapeutic applications, including
 diseases such as cancer and autoimmune disorders and infectious diseases
 caused by fungi, bacteria, parasites and viruses.  Apart from its research,
 Genelabs has a near-term product opportunity in Aslera(TM) for systemic lupus
 erythematosus, which was developed under a license from Stanford University.
     Watson Pharmaceuticals, Inc., headquartered in Corona, California, is
 engaged in the development, manufacture and sale of proprietary and off-patent
 pharmaceutical products.  Watson pursues a strategy of generating revenue
 through established proprietary and off-patent businesses, capitalizing on its
 proven ability to support the development and commercialization of a broad
 range of proprietary and off-patent pharmaceutical products.
     This and past press releases of Genelabs Technologies, Inc. are available
 at Genelabs' web site at www.genelabs.com.  In addition, press releases are
 available through PR Newswire's Company On-Call fax service at 800-758-5804,
 extension 115419 and at www.prnewswire.com.
     This and past press releases of Watson Pharmaceuticals, Inc. are available
 at Watson's web site at www.watsonpharm.com.  In addition, press releases are
 available through PR Newswire's Company On-Call fax service at 800-758-5804,
 extension 112856, and at www.prnewswire.com.
     This press release contains certain statements of a forward-looking nature
 relating to future events or future business performance.  Any such statements
 that refer to Watson's or Genelabs' estimated or anticipated future results,
 product development efforts or performance, the prospects and proposed
 timeframe for product approval or market launch, if approved, or other
 non-historical facts are forward-looking and reflect respectively Watson's and
 Genelabs' current perspective of existing trends and information.  Watson and
 Genelabs each disclaim any intent or obligation to update these
 forward-looking statements.  These forward-looking statements involve risks
 and uncertainties that cannot be predicted or quantified and, consequently,
 actual results may differ materially from those expressed or implied by such
 statements.  Such risks and uncertainties include, among others, the
 difficulty of predicting the timing or outcome of product development efforts
 and FDA or other regulatory agency approval or actions (including prospects or
 timing of product approval or market launch, if approved, of Aslera(TM),
 market acceptance of products and the impact of competitive products and
 pricing, the availability on commercially reasonable terms of third party
 sourced products, dependence on sole source suppliers and risks associated
 with production interruptions or shipment delays at such suppliers, successful
 compliance with extensive, costly, complex and evolving governmental
 regulations and restrictions, exposure to product liability and other lawsuits
 and contingencies, and other risks and detailed in the relevant party's most
 recent filings with the Securities and Exchange Commission.
 
 

SOURCE Watson Pharmaceuticals, Inc.
    REDWOOD CITY, Calif. and CORONA, Calif., April 19 /PRNewswire/ --
 Genelabs Technologies, Inc. (Nasdaq:   GNLB) and Watson Pharmaceuticals, Inc.
 (NYSE:   WPI) reported that the U.S. Food and Drug Administration's (FDA)
 Arthritis Advisory Committee met today to review Aslera(TM) (prasterone) for
 the treatment of patients with mild to moderate systemic lupus erythematosus
 (SLE or lupus).  The committee was not asked by the FDA to vote on whether to
 recommend approval of Aslera(TM) for the treatment of SLE.  The FDA seeks
 expert advice from advisory committees as part of its review of a New Drug
 Application (NDA).  However, the final decision regarding the approval of an
 NDA is made by the FDA.
     Irene Chow, Ph.D., Chairman and Chief Executive Officer of Genelabs,
 commented:  "We are very pleased with the positive feedback provided by
 advisory committee members at the meeting regarding our NDA for Aslera(TM).
 We intend to work with the FDA to facilitate its completion of the review of
 Aslera(TM) for the treatment of SLE."
     Aslera(TM) was developed by Genelabs and has been exclusively licensed to
 Watson in North America.  The NDA for Aslera(TM) was submitted to the FDA in
 September 2000 and granted priority review designation by the FDA in
 October 2000.  Priority review designation generally provides for a six-month
 review period by the FDA and is granted to potential new drugs that are
 intended to treat a serious or life-threatening condition for which there is
 no adequate therapy currently available.  In March 2001, Genelabs agreed with
 the FDA to extend the review period until no later than June 26, 2001, to
 allow the FDA to complete its review.
     Allen Chao, Ph.D., Watson's Chairman and Chief Executive Officer, said,
 "We intend to continue to work closely with Genelabs and support its efforts
 toward approval of Aslera(TM)."
     SLE is an autoimmune disease that can cause the patient's immune system to
 attack its own tissue, leading to inflammation, severe fatigue, arthritis
 pain, tissue injury and major organ damage.  Current SLE treatment primarily
 relies on the chronic use of corticosteroids, such as prednisone, that can
 have many adverse consequences for a patient's health and quality of life.
 Genelabs is seeking approval of Aslera(TM) as a first line therapy for women
 with mild to moderate systemic lupus erythematosus to improve disease activity
 and its symptoms, and also to reduce corticosteroid requirements.
     Genelabs Technologies, Inc., is a biopharmaceutical company engaged in the
 discovery and development of a new class of pharmaceutical products that
 target DNA.  By acting directly on the genetic material, Genelabs' technology
 can be applicable to a wide range of therapeutic applications, including
 diseases such as cancer and autoimmune disorders and infectious diseases
 caused by fungi, bacteria, parasites and viruses.  Apart from its research,
 Genelabs has a near-term product opportunity in Aslera(TM) for systemic lupus
 erythematosus, which was developed under a license from Stanford University.
     Watson Pharmaceuticals, Inc., headquartered in Corona, California, is
 engaged in the development, manufacture and sale of proprietary and off-patent
 pharmaceutical products.  Watson pursues a strategy of generating revenue
 through established proprietary and off-patent businesses, capitalizing on its
 proven ability to support the development and commercialization of a broad
 range of proprietary and off-patent pharmaceutical products.
     This and past press releases of Genelabs Technologies, Inc. are available
 at Genelabs' web site at www.genelabs.com.  In addition, press releases are
 available through PR Newswire's Company On-Call fax service at 800-758-5804,
 extension 115419 and at www.prnewswire.com.
     This and past press releases of Watson Pharmaceuticals, Inc. are available
 at Watson's web site at www.watsonpharm.com.  In addition, press releases are
 available through PR Newswire's Company On-Call fax service at 800-758-5804,
 extension 112856, and at www.prnewswire.com.
     This press release contains certain statements of a forward-looking nature
 relating to future events or future business performance.  Any such statements
 that refer to Watson's or Genelabs' estimated or anticipated future results,
 product development efforts or performance, the prospects and proposed
 timeframe for product approval or market launch, if approved, or other
 non-historical facts are forward-looking and reflect respectively Watson's and
 Genelabs' current perspective of existing trends and information.  Watson and
 Genelabs each disclaim any intent or obligation to update these
 forward-looking statements.  These forward-looking statements involve risks
 and uncertainties that cannot be predicted or quantified and, consequently,
 actual results may differ materially from those expressed or implied by such
 statements.  Such risks and uncertainties include, among others, the
 difficulty of predicting the timing or outcome of product development efforts
 and FDA or other regulatory agency approval or actions (including prospects or
 timing of product approval or market launch, if approved, of Aslera(TM),
 market acceptance of products and the impact of competitive products and
 pricing, the availability on commercially reasonable terms of third party
 sourced products, dependence on sole source suppliers and risks associated
 with production interruptions or shipment delays at such suppliers, successful
 compliance with extensive, costly, complex and evolving governmental
 regulations and restrictions, exposure to product liability and other lawsuits
 and contingencies, and other risks and detailed in the relevant party's most
 recent filings with the Securities and Exchange Commission.
 
 SOURCE  Watson Pharmaceuticals, Inc.