Starpharma closer to VivaGel approval in Europe and US
The terms of Starpharma's (ASX:SPL) phase III trial for its VivaGel bacterial vaginosis treatment have now been endorsed by both the European EMA and the US FDA.
Dylan Bushell-Embling (Australian Life Scientist)23 November, 2011 12:15Comments
Starpharma (ASX:SPL) has gained the support of the European Medicines Agency for its phase III trials for its VivaGel bacterial vaginosis treatment.
The EMA has accepted the terms of Starpharma's proposed phase III trial of the VivaGel treatment, indicating that positive results would lead to the product being cleared for sale in the major market.
The US FDA agreed to the clinical trial program in October indicating that, pending successful trial results, VivaGel is on the road to approval in the world's two biggest pharmaceutical markets.
Melbourne-headquartered Starpharma plans to conduct two sets of placebo-controlled phase III trials in parallel from early next year. Around 220 patients will be involved, with the primary goal being clinical cure of bacterial vaginosis symptoms.
The company secured funding for the trials through an oversubscribed $32 million institutional placement, which closed last week. Around $16 million of this will be put towards the trials.
Starpharma CEO Jackie Fairley said that in light of the capital raising, the company plans to add more trial sites than originally planned. After the phase III trials are completed, the company plans to seek partners for the product.
The company already has a prospective agreement with Ansell to develop a VivaGel-coated condom, to take advantage of another potential use for the vaginal microbicide as an inhibitor of the transmission of STIs including HIV and genital herpes
The condom product is expected to launch within 18 months. Startpharma has advised it expects royalties from this product to be worth over $100 million. The company has a similar agreement with Okamoto.
Starpharma (ASX:SPL) shares rose 1.77% on Tuesday to $1.150, in high-volume trading relative to recent weeks.
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