Vivus, Inc.: VVUS (NASDAQ)
VIVUS Awarded Patent for the Use of Phosphodiesterase Inhibitors
to Treat Premature Ejaculation
MOUNTAIN VIEW, Calif.--June 11, 2002--VIVUS, Inc.
(Nasdaq NM:VVUS), a developer of innovative pharmaceutical products
to improve quality of life, has been awarded Patent No. 6,403,597
entitled, "Administration of Phosphodiesterase Inhibitors for the
Treatment of Premature Ejaculation," by the U.S. Patent & Trademark
Office.
"The use of phosphodiesterase (PDE5) inhibitors to treat premature
ejaculation (PE) has the potential to become an important medical
advance," said Dr. John Dietrich, Vice President of Research and
Development at VIVUS. "PDE5 inhibitor therapy may ultimately become an
on-demand treatment that delays ejaculation in these patients while
improving their erectile function," added Dr. Dietrich.
In preliminary studies(1,2), PDE5 inhibitor therapy was shown to
be significantly more effective in delaying ejaculation in men with PE
than anti-depressant therapy which is currently being used by
physicians off-label to treat PE. In addition, PDE5 inhibitor therapy
appears to be better tolerated and importantly patients reported a
much higher level of sexual satisfaction while receiving the PDE5
inhibitor therapy.
"While VIVUS is currently developing TA-1790, a novel oral PDE5
inhibitor, for the treatment of ED, we are assessing all opportunities
including working with other companies with PDE5 inhibitors in order
to maximize the value of this intellectual property," said Leland F.
Wilson, President and CEO at VIVUS. "We will also continue to develop
VI-0134, our existing compound in development for PE, until
comparative trials have been completed," added Mr. Wilson.
"The market potential for an effective product to treat PE is
substantial," commented Mr. Wilson. In a national scientific survey,
28.5% of men aged 18-59 reported experiencing PE over a period of at
least several months. By comparison, in the same group of respondents
only 10.4% reported experiencing difficulty in achieving and
maintaining an erection(3). Today, there is no approved medical
therapy for the treatment of PE, even though some experts believe PE
patients constitute the largest subset of patients with sexual
dysfunction.
VIVUS, Inc. is a pharmaceutical company engaged in the development
of innovative therapies for the treatment of quality-of-life disorders
in men and women, with a focus on sexual dysfunction. Current
development programs target Female Sexual Dysfunction (FSD), Erectile
Dysfunction (ED) and Premature Ejaculation (PE). The Company developed
and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R), two
innovations in the treatment of erectile dysfunction, and has
partnered with Abbott Laboratories (NYSE:ABT) for the international
marketing and distribution of its male transurethral ED products. In
Canada, VIVUS has partnered exclusively with Paladin Labs (TSE:PLB) to
market and distribute MUSE.
References:
-- 1. Abdel-Hamid. Assessment of as needed use of pharmacotherapy
and the pause-squeeze technique in premature ejaculation.
International Journal of Impotence Research. 2001;13:41-45.
-- 2. Chen, J. Role of Sildenafil in the Treatment of Premature
Ejaculation. International Journal of Impotence Research.
2001;13-4:S48- #133
-- 3. Laumann, E., et al., in The Social Organization of
Sexuality: Sexual Practices in the United States. 1994, The
University of Chicago Press: Chicago IL.
This news release contains forward-looking statements about the
potential commercialization of products in treating male sexual
dysfunction and reflects management's current beliefs. However, as
with any pharmaceutical under development, there are significant risks
in development, regulatory approval and commercialization of new
products. There are no guarantees that any product will receive
regulatory approval for any indication. Further, even if the Company
were to receive regulatory approval for a product, there could be no
assurance that such a product would prove to be commercially
successful. Please see the Company's filings with the Securities and
Exchange Commission including, without limitation, the Company's Form
10-K and Forms 10-Q, which identify these and other risks and
uncertainties that may cause actual results or events to differ
materially from those described in this news release.
# # #
CONTACT: VIVUS, Inc.
Richard Walliser, 650/934-5200
ir@vivus.com, www.vivus.com
or
VIVUS Media Contact --
Lisa Lindberg, 212/825-3210, theproteam@aol.com
or
Investor Relations --
Lippert/Heilshorn & Associates, Inc.
Bruce Voss/Jody Cain, 310/691-7100
bvoss@lhai.com / jcain@lhai.com |
