VIVUS Announces Grant of Key Patent for MDTS® Delivery System
VIVUS Announces Grant of Key Patent for MDTS® Delivery System
Mar 01, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- VIVUS, Inc. (Nasdaq: VVUS), a leading specialty pharmaceutical company focused on the development and commercialization of novel products to restore sexual function in women and men, today announced that an additional patent relating to the Metered Dose Transdermal Spray (MDTS®) has been granted by the U.S. Patent and Trademark Office to Acrux (ASX: ACR). This patent expires July 31, 2022.
The patent, number 6,978,945, provides protection for the MDTS applicator, which is currently used in two of VIVUS's women's health products under clinical development: Testosterone MDTS® for the treatment of decreased libido; and Evamist for the treatment of menopausal symptoms. VIVUS licensed the U.S. rights to these products from Acrux in 2004. The pivotal Phase 3 trial of Evamist is nearing completion.
"This new patent gives additional protection for Evamist and our testosterone spray," commented Peter Tam, senior vice president of product and corporate development. "In this increasingly competitive market, a strong proprietary position is critical to commercial success. This patent along with other issued patents for MDTS technology will, in our view, prevent other competitive estrogen and testosterone transdermal sprays from entering the market through the life of these patents."
The claims of U.S. Patent number 6,978,945 describe a hand-held device for dispensing and applying a substance to the skin utilizing a capsule and actuator to deliver a metered quantity of product.
About VIVUS
VIVUS, Inc. is a pioneer in the research and development of proprietary products to restore sexual function for women and men. VIVUS's current product pipeline includes four investigational products in late stage clinical development. For women, VIVUS has initiated a Phase 3 program for Evamist for the treatment of vasomotor symptoms associated with menopause and a Phase 2B program with ALISTA for female sexual arousal disorder. Additionally, the company has completed Phase 2 development of Testosterone MDTS® for the treatment of hypoactive sexual desire disorder (HSDD). The MDTS system is a patented new-generation, transdermal drug delivery technology that delivers drugs directly through the skin. For men, VIVUS has completed Phase 2 development of avanafil for erectile dysfunction. The company currently markets MUSE® (alprostadil) suppository for the treatment of erectile dysfunction in the U.S. and internationally through distributors. For more information on clinical trials and products, please visit the company's web site at www.vivus.com.
About Acrux
Acrux is a specialty pharmaceutical company, developing and
commercializing a range of patented, patient-preferred healthcare products for
global markets, using its innovative technology to administer drugs through
the skin. Acrux's product pipeline includes treatments of hormonal
deficiencies, pain, central nervous system disorders and a contraceptive.
Acrux has licensed USA rights for Evamist and Testosterone MDTS to VIVUS and
AUS/NZ distribution rights for Testosterone MDTS and Fentanyl MDTS to CSL
Limited. Acrux has also licensed its technology to Eli Lilly for veterinary
healthcare products. For more information on clinical trials and products,
please visit the company's web site at www.acrux.com.au.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2004 and periodic reports filed with the Securities and Exchange Commission.
SOURCE VIVUS, Inc.
Stephanie Diaz & Tim Brons of Vida Communication, +1-415-675-7400, for VIVUS, Inc.; or Timothy E. Morris, Chief Financial Officer of VIVUS, Inc., +1-650-934-5200