VIVUS PIPELINE INFORMATION 1/24/2001
Female Sexual Dysfunction (FSD)
The recognition of FSD as an emerging market presents a medical and marketing opportunity in which VIVUS intends to be a major player.A s previously reported, during the fourth quarter the Company initiated its first clinical trial with ALISTA, a proprietary formulation of alprostadil applied locally to the female genitalia. The purpose of this trial was to evaluate the safety of and local
tolerance to ALISTA.
Enrollment has begun in a multi-center Phase II clinical trial, which is designed to assess the safety and efficacy of ALISTA in women with a primary diagnosis of Female Sexual Arousal Disorder, one of four clinical subcategories of FSD. Results from this second study will help in the design of future trials.
The Company believes it enjoys a strong, proprietary position in the treatment of FSD, including multiple issued and pending patents.
Erectile Dysfunction (ED)
As announced in January 2001, the Company is pursuing approval of its second-generation transurethral drug for the treatment of ED,ALIBRA, through discussions with the U.S. Food and Drug Administration and with the European Agency for the Evaluation of Medicinal Products.
ALIBRA consists of alprostadil, the active ingredient in MUSE, and prazosin. The goal of the program is to develop ALIBRA for at-home use without the need for titration in the physician's office.
The Company is also evaluating potential products as a
third-generation transurethral formulation, and believes there continues to be a need for safe, effective products that can be used by patients who fail oral therapies or who, for various reasons, are not candidates for oral therapies.
Premature Ejaculation (PE)
Premature ejaculation is reported to be the most common cause ofsexual dysfunction in men. As with other types of sexual disorders, PE can cause significant psychological effects and can be disruptive to interpersonal relationships.VIVUS conducted a proof-of-concept study with an on-demand, oral drug during 2000. In that study, the latency period for ejaculation was increased subsequent to treatment with the VIVUS compound. The Company will be initiating a Phase II study later this year with its
novel oral formulation for this product.
Investor Information
VIVUS, Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE (alprostadil) and ACTIS(R) (recently cleared for OTC
marketing), two innovations in the treatment of erectile dysfunction,and has partnered with Abbott Laboratories (NYSE: ABT) for theinternational marketing and distribution of its male transurethral ED products. In Canada, VIVUS is partnered exclusively with Paladin Labs, Inc. (TSE: PLB) to market and distribute MUSE. VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA,
during the fourth quarter of 2000.
Contact:
VIVUS, Inc.
Dick Walliser, 650/934-5264
ir@vivus.com
www.vivus.com
or
Lippert/Heilshorn & Associates, Inc.
Investor Contacts:
Bruce Voss
bruce@lhai.com
Bonnie Feldman
bonnie@lhai.com
310/575-4848
or
Media Contacts:
Pamela Rigler
pamela@lhai.com
Carrie Kocik
carrie@lhai.com
212/838-3777
www.lhai.com
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Interesting article regarding FSD: Vivus well represented.
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