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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of report (date of earliest event reported): JUNE 30, 2003
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VIVUS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
COMMISSION FILE NUMBER: 0-23490
DELAWARE 94-3136179
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NUMBER)
1172 CASTRO STREET
MOUNTAIN VIEW, CA 94040
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)
(650) 934-5200
(REGISTRANT'S TELEPHONE NUMBER,
INCLUDING AREA CODE)
N/A
(FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR,
IF CHANGED SINCE LAST REPORT)
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ITEM 5. OTHER EVENTS.
On June 30, 2003, the Registrant issued a press release announcing that
data from its proof-of-concept trial to evaluate the effects of
phosphodiesterase type 5 inhibitors in men with premature ejaculation did not
demonstrate an increase in the time to ejaculation. The press release is
attached as exhibit 99.1 to the Current Report of Form 8-K.
EXHIBIT
NUMBER DESCRIPTION
99.1 Press Release dated June 30, 2003 announcing that data from its
proof-of-concept trial to evaluate the effects of phosphodiesterase
type 5 inhibitors in men with premature ejaculation did not
demonstrate an increase in the time to ejaculation.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Date: June 30, 2003 VIVUS, Inc.
/s/ Richard Walliser
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Richard Walliser
Vice President and Chief Financial Officer
/s/ Leland F. Wilson
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Leland F. Wilson
President and Chief Executive Officer
VIVUS, INC.
INDEX TO EXHIBITS The
following exhibits are filed herewith:
EXHIBIT DESCRIPTION
99.1 Press Release dated June 30, 2003 announcing that data from its
proof-of-concept trial to evaluate the effects of phosphodiesterase
type 5 inhibitors in men with premature ejaculation did not
demonstrate an increase in the time to ejaculation.
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EXHIBIT 99.1
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(COMPANY LOGO)
COMPANY CONTACT: INVESTOR CONTACTS:
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VIVUS, Inc. Lippert/Heilshorn & Associates, Inc.
Richard Walliser Bruce Voss (bvoss@lhai.com)
(650) 934-5200 (310) 691-7100
ir@vivus.com Jody Cain (jcain@ihai.com)
www.lhai.com
Media Contact
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IRG
Janet Vasquez
(theproteam@aol.com)
(212) 825-3512
FOR IMMEDIATE RELEASE
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VIVUS REPORTS DATA FROM PREMATURE EJACULATION PROOF-OF-CONCEPT TRIAL
MOUNTAIN VIEW, Calif. (June 30, 2003)-VIVUS, Inc. (Nasdaq NM: VVUS), a
pharmaceutical company developing innovative products to improve quality of
life, today announced that data from its proof-of-concept trial to evaluate the
effects of phosphodiesterase type 5 (PDE 5) inhibitors in men with premature
ejaculation (PE) did not demonstrate an increase in the time to ejaculation. The
trial evaluated the Company's VI-0162 (TA-1790); Viagra(R) (sildenafil),
manufactured by Pfizer (NYSE:PFE); as well as placebo. Previous studies had
suggested that inhibition of PDE5 was associated with increased time to
ejaculation in men with PE.
"While in this study PDE5 inhibitors did not demonstrate a significant
improvement in ejaculatory latency, we have previously shown in a well
controlled clinical trial that VIVUS' VI-0134, an oral, on-demand psychotropic
compound, was able to significantly increase the ejaculatory latency period in
men with PE," commented Dr. John Dietrich, Vice President of Research and
Development at VIVUS. "TA-1790 has been shown to have important advantages over
other PDE5 inhibitors for the treatment of erectile dysfunction (ED) and,
therefore, our development plans with this product in ED remain unchanged and on
schedule."
Additional analysis of the VI-0162 study and plans to bring forward a product
for PE will be discussed during the Company's quarterly conference call
scheduled for July 16, 2003.
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).
VIVUS 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
Meda AB (Stockholm: MEDAa.ST) 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. For more
information, please visit the Company's Web site at: www.vivus.com.
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 future clinical studies discussed in this
news release will be successful or 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.