Exhibit 99.1
Contact: Matthew M. Loar
Chief Financial Officer
(650) 562-1424
FOR IMMEDIATE RELEASE
GENELABS TECHNOLOGIES AND PATHEON ENTER INTO
COMMERCIAL SUPPLY AGREEMENT FOR PRESTARA(TM)
REDWOOD CITY, Calif. - September 19, 2002 - Genelabs Technologies, Inc.
(Nasdaq:GNLB) announced today that it has signed an agreement with Patheon
Inc. (TSE:PTI) for the commercial supply of Prestara(TM), Genelabs' drug
candidate for systemic lupus erythematosus. Under the agreement, Patheon
will manufacture and supply Prestara capsules for distribution in North
America and Europe. The agreement has an initial term through December 31,
2008, and is renewable for three-year terms thereafter.
"This commercial supply agreement is an important step in our preparation
for the commercialization of Prestara, which, if approved, would be the
first new drug for lupus in over forty years," stated Irene A. Chow, Ph.D.,
chairman and chief executive officer. "In late August we announced our
receipt of an approvable letter from the U.S. Food and Drug Administration
for our Prestara New Drug Application. We entered into a technology
transfer agreement with Patheon in 2001 and began the process of evaluating
and qualifying Patheon as a manufacturing site for Prestara. Genelabs is
enthusiastic about our commercial supply relationship with Patheon, a
leading provider of drug development and manufacturing services."
The agreement allows Genelabs to supply commercial finished product
manufactured by Patheon to its licensees in Europe and North America.
Genelabs currently plans to commercialize Prestara in Europe and Japan
through established pharmaceutical companies, and is in active discussions
regarding licensing rights to Prestara in these territories. Genelabs has
been advised by the European Agency for Evaluation of Medicinal Products
(EMEA) that Prestara qualifies for Part B status, which enables Genelabs to
file one Marketing Authorization Application (MAA) for simultaneous
consideration in all European Union countries, with a single review and
decision regarding the approval of the MAA for Prestara. Genelabs has
exclusively licensed North American rights to Prestara to Watson
Pharmaceuticals, Inc.
Patheon Inc. is a leading independent provider of drug development and
manufacturing services in the rapidly growing pharmaceutical outsourcing
sector. Patheon operates a network of 10 cGMP facilities in North America
and Europe, employing over 2,800 people. The company serves a client base
consisting of pharmaceutical and biotechnology companies, including 15 of
the world's 20 largest pharmaceutical companies.
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Genelabs Technologies and Patheon Enter Into Commercial Supply Agreement
For Prestara(TM)
Page 2
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. We are
concentrating our capabilities on three core programs: developing a
late-stage product for lupus, discovering novel antimicrobial lead
compounds that target DNA, and discovering novel lead compounds that
selectively inhibit replication of the hepatitis C virus (HCV). Through our
drug discovery efforts we have synthesized numerous DNA-binding
antibacterial and antifungal lead compounds, which are currently being
optimized, and are using high-throughput methods for the discovery of novel
lead compounds for HCV. Our clinical development efforts are concentrated
on Prestara(TM) for systemic lupus erythematosus, for which we have
received an approvable letter from the U.S. Food and Drug Administration.
NOTE: This press release contains forward-looking statements, including,
without limitation, the ability of Genelabs to receive approval to market
Prestara(TM) in the United States or other countries, to consummate
corporate partnerships for the marketing of Prestara in Europe and Japan
and to qualify Patheon as a manufacturing site acceptable to U.S. and
European regulatory authorities. These forward-looking statements are based
on Genelabs' current expectations and are subject to uncertainties and
risks that could cause actual results to differ materially from the
statements made. Uncertainties and risks include, without limitation,
whether the results of the company's clinical trials of Prestara(TM) and
other supporting information will be sufficient to support the approval of
Prestara(TM) by the FDA, the European Agency for Evaluation of Medicinal
Products and other regulatory authorities; delays regarding the regulatory
approval process including the timing and scope of approval received, if
any; uncertainties and risks regarding market acceptance of Prestara(TM) as
a treatment for systemic lupus erythematosus (SLE or lupus); the company's
capital requirements and history of operating losses; uncertainties and
risks regarding the company's ability to consummate strategic or corporate
partner transactions on favorable terms or at all; the early stage of
Genelabs' research programs and uncertainties associated with the
optimization of compounds, including whether a compound will advance to
preclinical testing, clinical trials, or ultimately become a product, and
the uncertainty of the timing of any of these; and the validity, scope and
enforceability of patents related to the company's technologies. The active
ingredient in Prestara(TM) is prasterone, the synthetic equivalent of the
androgenic hormone dehydroepiandrosterone (DHEA). Products containing DHEA
are currently being marketed by others as dietary supplements. The company
has not submitted applications for regulatory review of Prestara(TM)
outside the U.S. In addition, neither U.S. nor other regulatory authorities
have made a determination as to the safety or efficacy of Prestara(TM) for
SLE. Please see the information appearing in the company's filings with the
Securities and Exchange Commission, including the most recent Quarterly
Report on Form 10-Q and Annual Report on Form 10-K, under the captions
"Risk Factors," "Business Risks" and "Forward-Looking Statements" for more
discussion regarding these uncertainties and risks and others associated
with the company's research programs, early stage of development and other
risks which may affect the company. Genelabs does not undertake any
obligation to update these forward-looking statements to reflect events or
circumstances after the date of this release.
This and past press releases are available at Genelabs' web site at
www.genelabs.com and at PR Newswire's Company News on Call at
www.prnewswire.com.
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