Starpharma signs license for VivaGel® Condom in Iran

Nov 28th, 2016

Starpharma Holdings Ltd today announced the signing of a License and Supply Agreement with Koushan Pharmed for the sales and marketing rights to the VivaGel® condom in Iran.

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Starpharma to present at Bio-Europe conference

Nov 8th, 2016

Starpharma will be presenting at the Bio-Europe® conference held in Cologne, Germany this week. At the conference Starpharma will also be conducting licensing discussions for DEP™ and VivaGel® with pharmaceutical companies.

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Appendix 4C - Quarterly Cashflow Report

Oct 28th, 2016

Starpharma released its Appendix 4C – Quarterly Cashflow report for the period ended 30 September 2016.

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Additional Priostar® Glyphosate Patent Allowed in US

Oct 28th, 2016

Starpharma Holdings Ltd announced the allowance of a patent by the US Patent Office for a Priostar® glyphosate formulation.

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Starpharma to present at US Drug Delivery Conference

Oct 26th, 2016

Starpharma will be presenting its DEP™ platform at the 6th Annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, USA, on 27-28 October.

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Starpharma to present at ASX Spotlight in Asia

Oct 25th, 2016

Starpharma presents to more than 300 sophisticated and institutional investors as part of the ASX Spotlight Conference in Hong Kong and Singapore.

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Enrolment complete for Phase 3 VivaGel® BV-R program

Oct 13th, 2016

Starpharma Holdings Ltd today announced completion of patient enrolment for its pivotal phase 3 trials evaluating the efficacy and safety of VivaGel® BV for prevention of recurrent bacterial vaginosis (BV). 

 

·         100% enrolment for phase 3 trials of VivaGel® BV for prevention of recurrence

·         Trial completion expected Q1 CY2017

·         Favourable revision to FDA guidance for BV treatment product opportunity

Melbourne, Australia; 13 October 2016: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced completion of patient enrolment for its pivotal phase 3 trials evaluating the efficacy and safety of VivaGel® BV for prevention of recurrent bacterial vaginosis (BV). Trial completion is expected in the first quarter of calendar 2017, with topline results available early-to-mid second quarter of calendar 2017.

 

The two phase 3 trials are being conducted according to the requirements of the US Food and Drug Administration (FDA) and the European authorities to support global marketing applications for VivaGel® BV for the prevention of recurrent BV. Starpharma also secured the binding agreement of FDA on the trial design including the primary endpoint, by way of a Special Protocol Assessment (SPA). The SPA minimises regulatory risk associated with acceptance of the trial data to support marketing approval. The studies are being conducted across multiple sites in the US, Canada, Mexico, Europe and Asia.

 

The two double-blind, randomised, placebo-controlled trials are identical in design. The primary endpoint of the studies is recurrence of BV during the 16-week treatment period. The primary objective of the study is to demonstrate that the rate of BV recurrence in women using VivaGel® BV is lower than the rate of BV recurrence in women using a placebo gel during the 16-week treatment period. After the treatment period, there is a 12-week follow-up period off treatment which will assess secondary endpoints including safety.

 

Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “We are delighted to have achieved full enrolment of our pivotal phase 3 trials for this indication and look forward to trial completion early next year.

 

“There are no approved products for this indication, so we have an opportunity to be first in class with VivaGel® BV for the prevention of BV recurrence. This important differentiating factor is a significant commercial advantage recognised by potential partners. There is significant unmet medical need for this chronic condition, where the global market is estimated to be worth around $1 billion annually.

 

Starpharma has already developed VivaGel® BV for bacterial vaginosis treatment separate to the prevention of recurrence indication. VivaGel® BV is approved in Europe for the treatment of BV, including relief of symptoms, and is well advanced in regulatory review in other markets, with launch planned in coming months.

 

Significantly, in a related development, the FDA recently issued a new draft clinical guidance for the development of products for BV treatment. This new guidance recommends the assessment of the primary endpoint for efficacy in treatment studies be soon after cessation of treatment (End of Treatment: day 7-14 post randomisation), and not 2‑3 weeks after treatment is ceased, which was the required timing previously. This development is particularly important as the new FDA revised End of Treatment time point is consistent with Starpharma’s 2012 phase 3 results for VivaGel® BV for treatment of BV, which showed, in both studies, highly statistically significant Clinical Cure of BV at the End of Treatment time point.

 

Starpharma has licensed VivaGel® BV to Aspen Pharmacare for Australia and New Zealand and has advanced negotiations underway with a number of parties for other regions, including Europe. Naturally, the shift in FDA requirements has positive implications in terms of partnering for VivaGel® BV - for both the treatment and the prevention of recurrent BV product opportunities.

 

The FDA draft guidance is available:  
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510948.pdf.

 

About VivaGel® BV

VivaGel® (SPL7013, astodrimer sodium) is a non-antibiotic agent formulated as a vaginally applied gel (VivaGel® BV) for treatment of BV and prevention of BV recurrence. VivaGel® BV has been approved in Europe as a topical treatment for the rapid relief of BV, including symptoms of unpleasant vaginal odour and discharge.

 

About Bacterial Vaginosis (BV)

Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age, and affects around 30% of women in the US. It is a highly recurrent condition with 50-60% of sufferers having it recurrently. BV is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman's vagina). Smoking, the use of some hygiene products and several other risk factors are linked to a higher risk of developing BV. The global market value for the prevention of recurrent BV is estimated to be more than US$1 billion.

 

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VivaGel® condom receives regulatory approval in Canada

Sep 13th, 2016

Starpharma today announced it had been granted a medical device license for the VivaGel® condom by the Canadian regulatory authority, Health Canada.

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Highlights of FY2016 Presentation: FNN Interview

Aug 30th, 2016

Starpharma advises a brief audio interview and presentation with Chief Executive Officer Dr Jackie Fairley will be broadcast today by the Finance News Network.

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Annual Report and full year financial results

Aug 29th, 2016

Starpharma released its annual report and financial results for the year ended 30 June 2016.

 Financial Results

  • Net cash burn (cash outflows before new capital) $17.5M
  • Cash position at end of the year $46.0M
  • Net proceeds of $32.6M from equity placement and share purchase plan
  • Total revenue and other income $4.6M including the first US$2M DEP™ milestone from AstraZeneca
  • Reported loss $22.7M
  • Receipt of $3.4M R&D tax incentive
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The Australian: Starpharma perks up on China condom deal

Aug 1st, 2016

The Australian’s David Rogers reports that Starpharma has signed “an exclusive license and supply agreement with Shenyang SKY and Land Latex Co for the manufacture and sale of VivaGel condoms to the Government segment of the Chinese condom market”.

Go to the article (external link)

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Starpharma initiates new DEP™ drug delivery program with AstraZeneca

Jul 28th, 2016

Melbourne, Australia; 28 July 2016: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced the initiation a new DEP™ drug delivery program with AstraZeneca. The new agreement will see the application of Starpharma’s DEP™ platform to a further compound from AstraZeneca’s portfolio. 

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