Latest News

26 October 2016

Starpharma to present at US Drug Delivery Conference

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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25 October 2016

Starpharma to present at ASX Spotlight in Asia

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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13 October 2016

Enrolment complete for Phase 3 VivaGel® BV-R program

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:


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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13 September 2016

VivaGel® condom receives regulatory approval in Canada

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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In the media

1 August 2016

The Australian: Starpharma perks up on China condom deal

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)

17 May 2016

The Conversation: Antiviral condoms will help protect Australian Olympians from STIs – here’s how

The Conversation noted Dual Protect™ anti-viral condoms, which are coated with Starpharma’s VivaGel®, provide an extra level of protection over regular condoms for Australia athletes when they are at the Olympics in Rio. 

Go to the article (external link)

9 March 2016

AAP: Starpharma licenses VivaGel BV in Aust, NZ

"Starpharma is letting Aspen Pharmacare Australia market and distribute its Vivagel BV treatment in Australia and New Zealand for an undisclosed sum. Aspen will market and distribute the treatment for bacterial vaginosis, that's due to be launched in 2016, to clinicians and pharmacies. In return, Starpharma will receive royalties on net sales.

Starpharma still holds the commercialisation rights in the rest of the world."

Go to the article (external link)

17 December 2015

The Age: Starpharma set for condom sales in China

"Starpharma has signed a memorandum of understanding with a Chinese company to make and sell its VivaGel-coated condom in China...The Chinese company is a major supplier of condoms to the Chinese government's Birth Control Department and Disease Prevention Department. The so-called government market in China requires about three billion condoms each year for birth control and disease prevention."

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Shareholder Updates

13 April 2016

Shareholder Update April 2016

In this issue:

> Message from the CEO

> Adama licenses Priostar® for 2,4-D

> DEPTM cabazitaxel shows superior performance

> Starpharma's Targeted DEPTM conjugates - compelling results in an area of high interest

> AstraZeneca selects second DEPTM candidate

> Starpharma long standing collaborator ranked 4th in the world

> Starpharma signs licence with Aspen for commercialisation of VivaGel® BV in Australia and New Zealand

> MOU for VivaGel® condom in China

> Half-year financial results

> Bio-Europe® conference

Download: Shareholder Update April 2016 (pdf file, 1MB)


29 October 2015

Shareholder Update October 2015

In this Issue:

› EU marketing approval granted for VivaGel® BV
› Multi-product DEP® license with AstraZeneca
› VivaGel® BV: Symptomatic Relief and Treatment of BV/Prevention of recurrence
› VivaGel® condom
› Phase 1 DEP® docetaxel trial update                                                                                    

› Agrochemicals
› Starpharma in the News
› Starpharma full year financial results      

› Presentations and conferences

Download: Shareholder Update October 2015 (pdf file, 994kb)

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© Starpharma Holdings Limited 2016