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Australian company Starpharma Holdings Ltd. received Fast Track status from the U.S. Food and Drug Administration in 2006 – and received more than $20 million from the U.S. National Institutes of Health – for clinical trials to study the product's use in preventing the spread of HIV, HSV-2 (genital herpes) and other sexually transmitted infection. The company is also studying the product's potential uses against human papillomavirus (HPV) and bacterial vaginosis, as well as its potential as a contraceptive.
The company's first priority from a commercial standpoint: Approval for use against genital herpes. Starpharma estimates that approximately 45 million Americans (26% of women and 18% of men) are infected with HSV-2, the causative agent of genital herpes. There is no cure for HSV-2, so a product that prevents its spread could be extremely lucrative.
“Commercially it’s actually the herpes market which we think is a more important market” than that for HIV, [Chief Executive Officer Jackie Fairley] said May 27. “Because herpes is such a massive problem, particularly in the U.S., we think that the herpes opportunity alone is more than attractive enough.”
The product is expected to be available as a single-use gel applicator (see image above), and as a condom coating. The company has already struck a royalties deal with SSL International (makers of Durex condoms) to bring the product to market.
Starpharma has identified several potential line extensions for the gel. These include both the combination gel mentioned above and condom coatings. The commonly used coating on premium condoms is Nonoxynol 9 (N-9), which has spermicidal properties. However, because of its detergent nature, N-9 has been shown to increase the risk of infection with HIV and other viruses such as HSV-2. Starpharma has signed agreements with two leading condom companies to develop VivaGel® as a condom coating. For regulatory reasons, the approval process for VivaGel® in this application may offer a faster route to market than the stand-alone gel.
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Comments
Wow, I hope it works, and especially if it works for more than one of those STIs. Could be HUGE for condom use – and Durex – if it does.
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