Starpharma today announced that it has received final written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel^® for the treatment of bacterial vaginosis (BV) under the FDA’s Special Protocol Assessment (SPA) scheme.

The SPA is a binding declaration from the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned studies are acceptable to support regulatory approval of the product.

In this issue:

› Starpharma raises $35m to advance pipeline

› Starpharma signs with Ansell for condom coating

› Putting a stop to stubborn BV: The VivaGel^© solution

› Clinical trials for VivaGel^© gather pace

› M&G invests $20 million

› Dendrimers through the eyes of Professor Donald Tomalia

Download: Shareholder Update: December 2011 (pdf file, 628kb)

Starpharma today announced the advancement of its drug delivery collaboration with US pharmaceutical corporation Eli Lilly and Company.

Starpharma  today announced that its Share Purchase Plan (SPP) which closed on Wednesday 7 December 2011, is oversubscribed by more than 400%.  The SPP was capped at $3 million, and shareholders have subscribed a total in excess of $12 million.

Herald Sun Journalist John Beveridge takes a close look at why M&G made a significant investment in Starpharma and what it could mean for other buyers: ‘If you see a clever investor grabbing a stake in a company, there is no problem piggy-backing on their research and following them on board.’

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Australian Financial Review Journalist Brendon Lau investigates the activity of fund managers across a number of key stocks: Emerging biotech Starpharma Holdings has also found itself in demand by institutional investors in the wake of its recent capital raising.

The stock could re-rate, just as Mesoblast did, because M&G – one of the largest UK investment funds that is owned by Prudential Group – bought a 6.7 per cent stake in Starpharma.

M&G also became a major shareholder in Mesoblast in December last year and the stock has rallied around 80 per cent since.

Wall Street Journal Reporter Gillian Tan investigates M&G’s stake in Starpharma: ‘M&G emerged with a 6.7 per cent stake in the company after participating in Starpharma’s $32m oversubscribed institutional placement which raised funds to –among other things — accelerate the commercialisation of its VivaGel product which will include a New Drug Application filing with the United States’ Food and Drug Administration.’

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M&G has today lodged a substantial shareholder notice with the ASX advising a 6.7% shareholding in Starpharma following their investment of AUD$20 million in the Share Placement announced last week.

Starpharma today announced that the Phase 3 clinical trial program for VivaGel^® bacterial vaginosis (BV) treatment has now also been agreed with the European Medicines Agency (EMA).

Australian Financial Review Journalist Claire Stewart investigates Starpharma’s continued resilience in a difficult market, noting the significance of its $32m capital raising at market price: As market volatility shakes investors’ confidence, the share prices of many research and development-focused companies are suffering as a result of increasing concerns about capital availability and funding issues.

But for Starpharma, a $260 million pharmaceutical company that develops polymer – or dendrimer – nanotechnology, equity has not been an issue.

This week it raised $32 million through a share placement to institutional investors and it will launch a retail share purchase plan to raise an additional $3 million, opening on November 23.