Australian Financial Review Journalist Carrie LaFrenz reports: Emerging biotech Starpharma Holdings has been given the tick of approval from the US Federal and Drug Administration on the design of its Phase 3 clinical studies for its key VivaGel product, taking it one step closer to market.

Starpharma has a number of promising technologies and has caught the attention of some large investors. UK-based M&G Investments took a 6.7 per cent stake following the successful $32 million placement in November.

Australian Life Scientist Journalist Tim Dean notes the significance of Starpharma's written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel^® under the FDA’s Special Protocol Assessment (SPA) scheme: Starpharma has kicked off the year with a tick from the US Food and Drug Administration for its study design for phase III trials of VivaGel under the FDA’s Special Protocol Assessment scheme.

Rebecca Richardson of Finance News Network presents on Starpharma's 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.

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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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