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Starpharma Loses Sheen On VivaGel BV Update

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Shares of Australian biotech company Starpharma Holdings Ltd. (SPHRY.OB) slipped to a new 52-week low on Thursday, following disappointing regulatory news related to VivaGel BV in the U.S.

VivaGel BV is the Company's non-antibiotic, water-based vaginal gel for the treatment of bacterial vaginosis and prevention of recurrent bacterial vaginosis. The product is approved in Europe and Australia.

In the U.S., VivaGel BV was under priority review by the FDA - with a decision initially expected in early January 2019. Now, it looks like the decision may be delayed as the Company, on Thursday, announced that the FDA has sought confirmatory clinical data prior to approving VivaGel BV.

Starpharma has requested a meeting with the FDA as soon as practicable to discuss the data required and is keen to secure approval with minimal delay. No concerns related to the safety, manufacturing or quality of VivaGel BV have been raised by the U.S. regulatory agency.

It was only as recently as last week, that Starpharma licensed the sales and marketing rights of VivaGel BV in the United States to ITF Pharma, a subsidiary of Italfarmaco S.p.A, a privately held European specialty pharmaceutical company, for A$142 million in milestones, plus royalties.

Given the fact that the FDA decision on VivaGel BV may not be favorable even if announced next month, or may be delayed, Starpharma will be discussing with its US partner, ITF Pharma, the next steps, and any potential impact on its US license.

The product is licensed to Mundipharma in Europe, and to Aspen Pharmacare in Australia under the brand name Fleurstat. Initial launches of the product have been planned in multiple Mundipharma regions (including Europe) and Australia during the first half of 2019, noted the Company.

SHPRY.OB closed Thursday's trading at $6.90, down 28.36%. In intraday trading, the stock touched a new 52-week low of $6.76.

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