AUSTRALIA – A pharmaceutical company out of Melbourne has designed a gel, much like spermicide, that has been found to be 99.9 percent effective at deactivating HIV, herpes, bacterial vaginosis and HPV. This gel will soon be added to Australian condoms, available for purchase throughout the country.
VivaGel is the brainchild of Starpharma, an Australian Biotech firm. The active ingredient is astodrimer sodium, designed specifically with HIV and HSV antiviral activity and human safety in mind. The designed condom contains .5 percent of the non-antibiotic, antimicrobial drug.
It was released on July 21, at the 20th International AIDS Conference, that Australia's Therapeutic Goods Administration, much like the U.S. FDA, has approved the use of VivaGel condoms. This paves the way for them to go on sale within months in a new line of Ansell condoms, the makers of Lifestyles, in the down under country.
"With the launch of LifeStyles Dual Protect expected in the near future, certification by TGA marks another major milestone for the VivaGel condom and our partnership with Ansell, one of the world's leading condom companies and healthcare innovators," Starpharma Chief Executive Officer, Dr Jackie Fairley said.
The global branded condom market is estimated to be worth approximately $1.1 billion. Ansel's share of the condom market is round 70 percent, according to businesswire.com.
"Our partnership with Starpharma is a great example of two highly innovative Australian businesses working together to bring to market a ground-breaking new sexual health product. New product development is central to Ansell's business strategy and this highly innovative product is exciting for both companies," Ansell President & General Manager, Sexual Wellness Global Business Unit, Peter Carroll, said.
In the United States, VivaGel was granted Special Protocol Assessment agreement on July 14 from the FDA on the design and planned analyses of the phase 3 clinical studies of the VivaGel bacterial vaginosis (BV) product for the prevention of recurrent bacterial vaginosis. The SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product. The first step for the FDA is to verify that the gel is safe for vaginal application. Starpharma will commence two pivotal phase 3 clinical trials of VivaGel for the prevention of recurrent BV at sites in North America, Europe and Asia. Approximately 600 women will be recruited into each trial.
No current plans have been made to create a stand alone product, sold in gel, but the company is not ruling that out for the future, Fairley noted. Currently marketing and selling approval has been granted in Japan, the world's second largest condom market.
An unrelated company to Starpharma called Optimally Holding Co., Ltd. is marketing a product called "VIVAgel." But this product with a seemingly similar name does not contain the active ingredient in the VivaGel trials and product and is a fraudulent site.