================================================================================
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------------
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
---------------
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)
================================================================================
ITEM 5. OTHER EVENTS.
On June 26, 2003, the Registrant issued a press release announcing that
data on TA-1790, an oral phosphodiesterase type 5 inhibitor for treatment of
erectile dysfunction, will be featured at the Second International Consultation
on Erectile and Sexual Dysfunction in Paris, France on June 29, 2003. 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 26, 2003 announcing that data on TA-1790,
an oral phosphodiesterase type 5 inhibitor for treatment of erectile
dysfunction, will be featured at the Second International
Consultation on Erectile and Sexual Dysfunction in Paris, France on
June 29, 2003.
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
--------------------------------
Richard Walliser
Vice President and Chief Financial Officer
/s/ Leland F. Wilson
--------------------------------
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 26, 2003 announcing that data on TA-1790,
an oral phosphodiesterase type 5 inhibitor for treatment of
erectile dysfunction, will be featured at the Second International
Consultation on Erectile and Sexual Dysfunction in Paris, France
on June 29, 2003.
- ------------
EXHIBIT 99.1
------------
(COMPANY LOGO)
COMPANY CONTACT: INVESTOR CONTACTS:
- ---------------- ------------------
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
- -------------
IRG
Janet Vasquez
(theproteam@aol.com)
(212) 825-3512
FOR IMMEDIATE RELEASE
- ---------------------
VIVUS TO PRESENT NEW TA-1790 DATA AT INTERNATIONAL MEETING ON
SEXUAL DYSFUNCTION
TA-1790 demonstrates faster onset of action than Viagra(R)(sildenafil);
Ideal for spontaneous sexual activity
MOUNTAIN VIEW, Calif. (June 26, 2003) VIVUS, Inc. (Nasdaq NM: VVUS), a
pharmaceutical company developing innovative products to improve quality of
life, today announced that data on TA-1790, its lead oral phosphodiesterase type
5 inhibitor for treatment of erectile dysfunction (ED), will be featured at the
Second International Consultation on Erectile and Sexual Dysfunction in Paris,
France on June 29, 2003.
Ronald Lewis, M.D., one of VIVUS' lead investigators, will present results from
VIVUS' in-clinic RigiScan(R) efficacy trial as well as data from a recently
completed pharmacokinetic (PK) study. Results from the PK study demonstrated
that TA-1790 was rapidly absorbed after ingestion with median peak plasma levels
achieved at 40 minutes (range 20-90 min). For an on-demand erectile dysfunction
(ED) medication, this rate of absorption compares favorably to the median peak
plasma level of Viagra(R), manufactured by Pfizer (NYSE:PFE), of 60 minutes
(range 30-120 min).
The rapid absorption of TA-1790 supports the efficacy data generated in the
in-clinic trial where RigiScan was used to measure penile rigidity in
conjunction with visual sexual stimulation. Results of this study indicated that
the maximum response to TA-1790 was achieved within 20-40 minutes after dosing,
while the maximum response to sildenafil was not observed until the 60-80 or the
100-120 minute time points depending upon the dosage groups. Importantly, 89%
(24/27) of patients on 50 mg TA-1790 achieved >60% penile rigidity in the 20-40
minute time frame as compared to only 46% (12/26) of patients on 50 mg of
sildenafil.
In a recent market research study, speed to onset of effect was a highly
preferred characteristic for an on-demand ED medication. "We are very pleased
that our RigiScan study demonstrated a rapid onset of effect compared to
available treatment. This response is consistent with both pre-clinical studies
and recently completed pharmacokinetic trials, which confirmed TA-1790's rapid
absorption rate," commented Dr. John Dietrich, VIVUS' Vice President of Research
and Development. "We believe that these characteristics are ideal for an
on-demand treatment for ED," added Dr. Dietrich.
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.
###