Shareholder Update January 2019

Jan 17th, 2019

In this issue: 

>> FDA requests further data for VivaGel® BV approval in the US

>> Launch of VivaGel® BV in multiple territories

>> VivaGel® BV licensed to ITF Pharma in the US

>> VivaGel® condom approved in Japan

>> Clinical trials for internal DEP® products progressing well

>> Patent published for AstraZeneca-DEP® drugs: DEP® Bcl2/xL inhibitors show compelling efficacy & synergy in combination

>> DEP® docetaxel & DEP® cabazitaxel outperformed both gemcitabine & Abraxane®

>> SPL7013 eye drops for viral conjunctivitis

>> Partnering activities 

>> Macquarie initiates coverage of Starpharma

>> Outlook

 Download: Shareholder Update January 2019 (pdf file, 557kb)

 

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VivaGel® condom receives final regulatory approval in Japan

Jan 2nd, 2019

Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel® condom.

 

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US FDA requests further data for VivaGel® BV approval

Dec 27th, 2018

Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).

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US VivaGel® BV licensed for A$142M milestones, plus royalties

Dec 20th, 2018

Melbourne, Australia: Starpharma and ITF Pharma today announced they have signed a licence for the sales and marketing rights to VivaGel® BV in the United States. Starpharma will be eligible to receive up to US$101M (A$142M) in regulatory approval and commercialisation milestones in addition to attractive tiered royalties on sales.

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US patent granted for SPL7013 eye drops for conjunctivitis

Dec 12th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US Patent and Trademark Office has granted a patent for SPL7013 ophthalmic drops for viral conjunctivitis. The patent has been granted with broad claims for treating and preventing microbial infections of the eye, including adenoviral conjunctivitis, bacterial conjunctivitis and other eye infections. The patent term is to 2033.

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AGM - Chairman address and CEO presentation

Nov 29th, 2018

Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 3.00pm today.

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DEP® docetaxel and DEP® cabazitaxel outperform in human pancreatic cancer model

Nov 16th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP® docetaxel and DEP® cabazitaxel products, which are both currently in the clinic, showed significant efficacy and safety benefits over gemcitabine (Gemzar®) alone, Abraxane® (Nab-paclitaxel) alone and in combination, in a human pancreatic cancer model. These impressive efficacy results were despite the fact that these standard pancreatic cancer treatments, gemcitabine and/or Abraxane® showed limited activity in this model.

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Quarterly Cashflow Report

Oct 26th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2018

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Starpharma Investor Presentation for Citi Conference

Oct 17th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) will today participate in Citi's 10th Annual Australian and New Zealand Investment Conference in Sydney.

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DEP® irinotecan outperforms in pancreatic cancer model

Sep 5th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP® irinotecan development candidate showed significant efficacy and safety benefits over standard irinotecan in combination with 5-FU in a mouse xenograft model of human pancreatic cancer (Figure 1 and 2). The human pancreatic tumour model used in this study virtually did not respond to the traditional irinotecan regimen (irinotecan + 5-FU), whereas complete tumour regression and 100% survival was achieved using Starpharma’s DEP® irinotecan.

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AstraZeneca’s DEP Bcl2/xL inhibitors show compelling efficacy and synergy in combination

Aug 31st, 2018

Melbourne, Australia; Starpharma today announced AstraZeneca’s first patent application on DEP® Bcl2/xL conjugates has been published by the World Intellectual Property Organisation. These DEP® Bcl2/xL conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitor for treating various cancers, including leukemias.

The published patent application shows compelling efficacy data on DEP® Bcl2/xL conjugates, both alone and in combination with other leading current anti-cancer treatments, in various preclinical human tumour models.

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Motley Fool ‘Extreme Opportunities’ Advisor Dr Anirban Mahanti covers Starpharma’s 2018 Financial Year Results

Aug 22nd, 2018

Dr Anirban Mahanti, Advisor at Motley Fool writes that FY18 was a “hugely transformative year for Starpharma”, noting the Company’s key milestones including its “smart licensing agreements” and “potentially game-changing pipeline of drugs”. Originally published on Motley Fool and republished with permission. Read the full article here

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Annual report and full year financial results

Aug 21st, 2018

Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2018.

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Quarterly Cashflow Report

Jul 17th, 2018

Melbourne, Australia; Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2018.

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Starpharma CEO Dr Jackie Fairley interviewed by Alan Kohler for The Constant Investor

Jul 16th, 2018

Starpharma CEO Dr Jackie Fairley speaks with Alan Kohler on online investor publication The Constant Investor, where she discussed the company’s dendrimer platform technology. To listen to fully interview, click here. (Note: paywall) Read More

VivaGel® BV NDA advances to next stage of FDA review

Jul 9th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US FDA has completed its filing review of the VivaGel® BV New Drug Application (NDA), with no issues identified, and confirmed its progress to the next stage.

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Starpharma CEO Dr Jackie Fairley interviewed by Alan Kohler on Talking Business

Jul 1st, 2018

Starpharma CEO Dr Jackie Fairley speaks with Alan Kohler about how the company has taken VivaGel® BV from discovery to market and developed commercial products with its proprietary dendrimer technology platform.

To listen to the podcast, click here.

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Starpharma CEO Jackie Fairley featured on Qantas’ inflight magazine Travel Insider

Jul 1st, 2018

Starpharma CEO Dr Jackie Fairley was featured in Qantas’ inflight magazine. To read the article, click here.

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Starpharma licenses VivaGel® BV to Mundipharma for Europe

Jun 27th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a licence agreement for the sales and marketing rights to VivaGel®BV for 43 countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the balance of countries in Latin America. This deal builds on the VivaGel® BV licence signed with Mundipharma in May 2018 for Asia, the Middle East, Africa and parts of Latin America. 

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Mundipharma licenses Starpharma’s VivaGel® BV

May 3rd, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a multi-region licence for the sales and marketing rights to VivaGel® BV in Asia (including China, Japan and Korea), the Middle East, Africa and the majority of Latin America.

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Quarterly Cashflow Report

Apr 30th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2018.

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Starpharma completes US New Drug Application for VivaGel® BV

Apr 30th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its rolling new drug application (NDA) for VivaGel® BV including two indications, for the treatment of bacterial vaginosis (BV) and prevention of BV, has been completed, and the final module of the NDA will be submitted to the US Food and Drug Administration (FDA) on Monday 30 April 2018 (US time).

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VivaGel® BV - Product Information and Independent Market Research

Apr 30th, 2018

VivaGel® BV - Product Information and Independent Market Research

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Starpharma to present at OTCQX Virtual Investor Conference

Apr 11th, 2018

Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that as part of its OTCQX investor communications, a pre-recorded presentation by Chief Executive Officer Dr Jackie Fairley will be broadcast at VirtualInvestorConferences.com on Thursday 12 April 2018 at 10:30am (US ET time).

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Starpharma on CommSec’s The Executive Series

Mar 14th, 2018

Starpharma CEO Dr Jackie Fairley speaks with CommSec’s Tom Piotrowski about the Company’s performance since March 2017, its partnership with AstraZeneca and upcoming milestones.

To view the video, click here

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Starpharma CEO Dr Jackie Fairley on Channel 9’s The Today Show for International Women’s Day

Mar 8th, 2018

As part of International Women’s Day, Starpharma CEO Dr Jackie Fairley appeared with the Federal Minister for Women Kelly O’Dwyer and Today Show presenter Georgie Gardiner to discuss women in the workforce and gender equality.

To view the video, click here.

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Starpharma Interim Report and Half-Year Financial Results

Feb 26th, 2018

Starpharma today released its interim report and financial results for the half-year ended 31 December 2017.

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Starpharma receives $3.7M R&D tax incentive refund

Feb 22nd, 2018

Starpharma today announced that it has received a $3.7M R&D tax incentive refund associated with FY17 expenditures. The refund relates to eligible R&D expenditure across Starpharma’s portfolio, including VivaGel® and DEP® programs.

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Shareholder Update February 2018

Feb 19th, 2018

In this issue: 

>> New sites open for the DEP® docetaxel phase 2 trial

>> DEP® cabazitaxel phase 1 / 2 trial commences

>> VivaGel® BV NDA submission lodged under Fast Track program

>> VivaGel® BV approved by TGA

>> DEP® irinotecan progressing towards the clinic

>> AstraZeneca-Starpharma collaboration

>> Extensive global licensing negotiations for VivaGel® BV

>> Positive market research findings for VivaGel® BV 

>> Q2 Cashflow Report at 31 December 2017

>> OTCQX market recognition

>> Starpharma News & Events

>> Outlook

 Download: Shareholder Update February 2018 (pdf file, 1.5mb)

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Starpharma announces DEP cabazitaxel Phase 1/2 Trial

Jan 31st, 2018

Morningstar reported on Starpharma's announcement regarding the commencement of its phase 1/2 clinical trial for DEP cabazitaxel having received regulatory and ethics approvals. 

Go to article (external link)

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Starpharma to commence DEP® cabazitaxel phase 1/2 trial

Jan 31st, 2018

Starpharma today announced that it has received regulatory and ethics approvals to commence its phase 1/2 clinical trial for DEP® cabazitaxel. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® cabazitaxel, to define a recommended phase 2 dose (RP2D), and then to determine anti-tumour efficacy of the product in select tumour types.

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Appendix 4C - Quarterly Cashflow Report

Jan 25th, 2018

Starpharma (ASX: SPL, OTCQX: SPHRY) released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2017.

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AstraZeneca plans to make better use of Australia’s innovation

Jan 23rd, 2018

The Australian highlighted Starpharma’s partnership with global pharmaceutical company AstraZeneca, noting the application of Starpharma’s DEP® technology platform helps make cancer drugs more effective, more patient-friendly and less toxic.
Go to the article (external link)

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VivaGel® BV treatment clinical submission under rolling submission

Dec 21st, 2017

Melbourne, Australia; 21 December 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has completed the VivaGel® BV treatment clinical section of the NDA clinical module, which will be submitted to the FDA under Starpharma’s rolling submission on Friday 22 December 2017 (US time). 

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AGM Chairman’s address and CEO presentation

Nov 29th, 2017

Chairman’s address and the CEO’s presentation to the 2017 Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY).

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NDA submission for Starpharma’s VivaGel® BV

Nov 21st, 2017

BioSpectrum Asia reported on Starpharma’s NDA submission for VivaGel® BV, noting that Starpharma is one of the few Australian companies to take a locally developed product to this stage.

Go to article

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NDA submission for VivaGel® BV in the US

Nov 21st, 2017

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its US New Drug Application (NDA) submission for VivaGel® BV for both treatment and prevention of BV has been lodged with the FDA through a rolling submission process. 

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Notice of Annual General Meeting/Proxy Form

Oct 27th, 2017

Download ASX Announcement: Notice of Annual General Meeting/Proxy Form (pdf, 643kb) Read More

Appendix 4C – Quarterly Cashflow Report

Oct 26th, 2017

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2017.

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Starpharma receives TGA marketing approval for VivaGel® BV

Oct 25th, 2017

Online financial news portal Finance News Network reported Starpharma received TGA marketing approval for VivaGel® BV, which is expected to be available in pharmacies in the new year under the Fleurstat™ brand.

Go to article

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VivaGel® BV granted marketing approval in Australia

Oct 25th, 2017

Starpharma today announced it has received Australian marketing approval from the Therapeutic Goods Administration (TGA) for VivaGel® BV, which is intended for treatment of bacterial vaginosis (BV).

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Morgans Under the Microscope Interview featuring Dr Jackie Fairley

Oct 23rd, 2017

Morgans Under the Microscope series featured Starpharma's CEO, Dr Jackie Fairley, discussing a number of key milestones that are approaching and the licensing arrangements entered into with AstraZeneca. 

Listen to the podcast (external link). 

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Shareholder Update October 2017

Oct 18th, 2017

In this issue: 

>> DEP® docetaxel achieves positive phase 1 results and commences phase 2

 >> AZ presents first DEP® candidate AZD0466 – a Bcl2/xL inhibitor

>>  Successful VivaGel® BV phase 3 results

>> Update on other internal DEP® candidates

>> Grant awarded to Starpharma-Monash

>> Starpharma and Peter Mac Cancer Centre awarded grant

>> FY17 Financial results; >$60M cash at 30 June

>> Annual Report and Annual General Meeting

>> Starpharma News & Events

 

Download: Shareholder Update October 2017 (pdf file, 1.3mb)

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Starpharma and Peter Mac Cancer Centre awarded DEP® Grant

Oct 9th, 2017

Starpharma and Peter MacCallum Cancer Centre have been awarded a further Federal Government Innovation Connections grant to support innovative research within Starpharma’s DEP® oncology program

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AstraZeneca presents first DEP® candidate as Bcl2/xL inhibitor

Sep 28th, 2017

 Starpharma advises that AstraZeneca has this week presented its first DEP® candidate utilising Starpharma’s DEP® delivery platform,  AZD0466, at the 3rd AstraZeneca-MedImmune-CRUK Cambridge Centre Symposium 2017 in Cambridge, UK.

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Starpharma reports positive phase 1 results

Sep 26th, 2017

Biotech news and industry publication Biotech Dispatch covered the news that Starpharma achieved positive results for its DEP® docetaxel phase 1 clinical trial and will transition immediately into phase 2.

Go to article (external link)

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Starpharma rockets on cancer drug hope

Sep 23rd, 2017

The Herald Sun noted strong investor interest and support for Starpharma regarding its positive phase 1 DEP® docetaxel trial and that no neutropenia was reported in any patients.

Go to article

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DEP® docetaxel positive phase 1 results; phase 2 commences

Sep 22nd, 2017

Starpharma today announced that its phase 1 trial for DEP® docetaxel has achieved the key objective of determining a Recommended Phase 2 Dose (RP2D), with no reports of protocol-defined dose limiting toxicities (DLTs). The trial has now been adapted to transition seamlessly into phase 2, with ethics and regulatory approvals already granted, and recruitment and patient screening activities underway for this next phase.

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Starpharma featured on Sky Business News

Aug 28th, 2017

Starpharma CEO Dr Jackie Fairly was interviewed on Sky Business News’ Ticky following the company’s successful Phase 3 trial results for VivaGel® BV for the treatment of recurrent bacterial vaginosis. Dr Fairley discussed the commercial significance of the announcement and liaising with the US FDA to bring the product to market.

To watch the interview, click here

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Starpharma annual report and full year financial results

Aug 28th, 2017

Melbourne, Australia; 28 August 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its annual report and financial results for the year ended 30 June 2017.


 

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