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starpharma holdings ltd (SPL) Snapshot

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starpharma holdings ltd (SPL) Details

Starpharma Holdings Limited researches, develops, and commercializes dendrimer products for pharmaceutical, life-science, and other applications primarily in Australia. The company focuses on the development of VivaGel, a microbicidal agent in Phase III clinical trials for the management and prevention of bacterial vaginosis, and as a condom coating for prevention of sexual transmitted infections. It also develops dendrimer-enhanced, or DEP versions of existing drugs, including DEP docetaxel in Phase I clinical trial for breast, prostate, lung, and ovarian tumor; and agrochemicals. Starpharma Holdings Limited was founded in 1996 and is headquartered in Melbourne, Australia.

Founded in 1996

starpharma holdings ltd (SPL) Top Compensated Officers

Chief Executive Officer and Executive Directo...
Total Annual Compensation: A$603.6K
Chief Financial Officer and Company Secretary
Total Annual Compensation: A$222.6K
Vice President of Development & Regulatory Af...
Total Annual Compensation: A$237.2K
Vice President of Business Development
Total Annual Compensation: A$237.1K
Vice President of Research
Total Annual Compensation: A$236.8K
Compensation as of Fiscal Year 2014.

starpharma holdings ltd (SPL) Key Developments

Starpharma Holdings Limited Announces Unaudited Consolidated Earnings Results for the Year Ended June 30, 2014

Starpharma Holdings Limited announced unaudited consolidated earnings results for the year ended June 30, 2014. For the year, the company reported revenue from continuing operations of $1,246,000 compared to $2,429,000 a year ago. Loss before income tax was $14,635,000 compared to $5,229,000 a year ago. Loss from continuing operations attributable to members of the company was $14,635,000 or $0.05 per basic and diluted share compared to $5,229,000 or $0.02 per basic and diluted share a year ago. Net cash outflows from operating activities were $9,813,000 compared to $9,795,000 a year ago. Payments for property, plant and equipment were $251,000 compared to $156,000 a year ago.

FDA Grants SPA Agreement for Phase 3 Recurrent BV Trial to Starpharma Holdings Limited

Starpharma Holdings Limited announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel bacterial vaginosis (BV) product for the prevention of recurrent BV. The favourable SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product. The granting of SPA agreement by the FDA follows the earlier agreement of the European Medicines Agency (EMA) on the design of the phase 3 studies. Starpharma will now commence its two pivotal phase 3 clinical trials of VivaGel for the prevention of recurrent BV at sites in North America, Europe and Asia. The two phase 3, double-blind, randomised, placebo-controlled trials will be identical in design and will compare the rate of BV recurrence in women using VivaGel to the rate of recurrence in women using a placebo gel during a 16 week treatment period. Approximately 600 women will be recruited into each study. This significantly reduces overall development risk for VivaGel. SPA agreement from the FDA is protected by US law and gives Starpharma certainty and confidence that the studies will support a regulatory submission for the approval of VivaGel for the prevention of recurrent BV in the US. VivaGel (SPL7013, astodrimer sodium) is a non-antibiotic agent formulated as a vaginally applied gel for prevention of BV recurrence.

Starpharma Holdings Limited Presents at 2014 Bioshares Biotech Summit, Jul-19-2014 07:30 AM

Starpharma Holdings Limited Presents at 2014 Bioshares Biotech Summit, Jul-19-2014 07:30 AM. Venue: Rydges Lakeland Resort, Queenstown, New Zealand. Speakers: Jacinth K. Fairley, Chief Executive Officer and Executive Director.


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