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Quarterly Cashflow and Activity Report

Apr 7th, 2020

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2020.

Starpharma’s cash balance as at 31 March 2020 was $36.1 million, an increase of $0.2 million compared to the previous quarter’s cash balance. Net operating cash outflows for the quarter were $0.9 million, or $6.0 million for the nine months to 31 March 2020. Starpharma’s strong cash reserves and clean balance sheet places the Company in a strong position to continue to progress its commercial and R&D activities in the current uncertain global environment of the COVID-19 pandemic.

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COVID-19 measures

Mar 30th, 2020

Starpharma continues to closely monitor the COVID-19 pandemic and its impact.

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Okamoto licenses VivaGel® antiviral condom in Asian countries

Mar 4th, 2020

Starpharma today announced that following the successful launch of the VivaGel® antiviral condom by Okamoto Industries, Inc. (TYO: 5122:JP; Okamoto) in Japan, Okamoto has sought an expansion to its licence territory for the VivaGel® condom. As a result, Starpharma has granted Okamoto marketing rights to a further 11 countries in Asia which include South Korea, Indonesia, Malaysia, Thailand, Singapore and the non-government China market.

 

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Starpharma appoints David McIntyre and Appendix 3X

Mar 2nd, 2020

Starpharma today announced that Mr David McIntyre has commenced as an independent non-executive director of Starpharma, effective 1 March. Mr McIntyre’s appointment follows a comprehensive Board renewal and search process. As advised at the Company’s last AGM, Mr Richard Hazleton will be retiring at the 2020 AGM in November, having served 13 years on the Company’s Board. The timing of Mr McIntyre’s appointment enables a smooth transition and handover between directors.

 

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Interim Report and Half-Year Financial Results

Feb 24th, 2020

Starpharma today released its interim report and financial results for the half-year ended 31 December 2019.

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VivaGel BV launched in Asia

Feb 13th, 2020

Starpharma today announced that VivaGel® BV has been launched in Asia under the brand name BETADINETM BV Gel. The product has initially been launched in South East Asia, with further roll-out in additional Asian countries, as regulatory approvals are granted.  

BETADINETM BV Gel will be available over-the-counter (OTC), without the need to see a doctor or obtain a prescription. Asia is the third region to launch VivaGel® BV and represents a large commercial opportunity with access to more than 1.5 billion women.

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David McIntyre appointed as non-executive director

Feb 12th, 2020

The Board of Starpharma is pleased to announce the appointment of Mr David McIntyre as an independent non-executive director, effective 1 March 2020.

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Starpharma receives US$3M milestone from AstraZeneca

Feb 11th, 2020

Starpharma today announced it has received US$3 million (A$4.5 million) from AstraZeneca following the successful dosing of the first patient in the phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) in December.

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Shareholder Update January 2020

Jan 30th, 2020

In this issue: 

>> VivaGel® BV launched in the UK

>> AstraZeneca first DEP® product enters the clinic; triggers US$3M milestone

>> DEP® cabazitaxel trial moves into phase 2 on positive results

>> Fleurstat BVgel marketing campaign; New Zealand launch planned

>> Dual strategy to achieve approval of the NDA in the US

>> Okamoto joins forces with Japanese government for STI prevention campaign

>> VivaGel® condom receives regulatory approval in Europe

>> DEP® docetaxel & DEP® cabazitaxel clinical trial case studies

>> DEP® irinotecan phase 1/2 trial

>> New candidate - DEP® gemcitabine

>> GMP DEP® facility licence

>> DEP® combinations add further value

>> Outlook, recent news & events

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Quarterly Cashflow Report

Jan 29th, 2020

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2019.

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Commencement of phase 1 trial for AZD0466 utilising DEP®

Dec 30th, 2019

Starpharma today announced that AstraZeneca (LSE/STO/NYSE: AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) and the first patient has been successfully dosed. The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.

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Starpharma receives $4.9M R&D tax incentive refund

Dec 16th, 2019

Starpharma today announced that it has received a $4.9M R&D tax incentive refund which relates to the costs of research and development during the 2019 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including DEP® and VivaGel®.

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DEP® cabazitaxel progresses to phase 2 on positive results

Dec 10th, 2019

Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® cabazitaxel. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m2. The trial will now transition seamlessly into phase 2, with two new sites initiated and recruitment activities already underway.

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AGM Chairman’s address and CEO’s presentation

Nov 21st, 2019

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 4.00pm today.

 

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VivaGel® condom receives regulatory approval in Europe

Nov 20th, 2019

Starpharma today announced that it has been granted marketing approval for the VivaGel® condom in Europe.  

 

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UK launch of VivaGel® BV

Nov 13th, 2019

Starpharma today announced that VivaGel® BV has been launched in the UK under the brand Betafem® BV Gel. This launch follows the first European launches in June 2019, including in Germany and other countries.

 

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DEP® gemcitabine outperforms Gemzar® in human pancreatic cancer model

Oct 31st, 2019

Starpharma today announced results for its next internal development candidate, DEP® gemcitabine.

 

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Quarterly Cashflow Report

Oct 30th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2019.

Starpharma’s cash balance as at 30 September 2019 was $36.8 million, with net operating cash outflows for the quarter of $4.6 million. The cash balance does not include the anticipated $4.9 million R&D tax incentive which is expected to be received during the December quarter.

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Starpharma to present at US Drug Delivery Conference

Oct 8th, 2019

Starpharma today announced that it has been invited once more to present at the 9th Annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, USA, on 7-8 October.

The PODD conference showcases the latest advances in drug delivery and provides networking opportunities with senior scientific and commercial executives from many of the major international pharmaceutical companies. This year’s PODD conference will be chaired by AstraZeneca’s Head of Drug Delivery, Dr Shawn Davis.

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FDA Authorisation of First-in-Human Clinical Trial with AstraZeneca’s DEP® product AZD0466

Sep 26th, 2019

Starpharma today announced that that the U.S. Food and Drug Administration (FDA) has authorised the use of AstraZeneca’s DEP® Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug (IND) application. This is the first DEP® candidate to reach this milestone from Starpharma’s multiproduct license with AstraZeneca.

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DEP® irinotecan synergistic with Lynparza® in refractory human colon cancer model

Sep 12th, 2019

Starpharma today announced that its patented clinical stage nanoparticle formulation, DEP® irinotecan, showed significantly enhanced efficacy benefits over standard irinotecan (Camptosar®) and olaparib (Lynparza®) alone and in combination, in an irinotecan-refractory HT-29 human colon cancer xenograft model.

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VivaGel® BV regulatory approvals continue in Asia

Sep 3rd, 2019

Starpharma today announced that it has received a further regulatory approval in an Asian country for VivaGel® BV. This approval follows multiple country approvals in the region as previously announced on 15 August 2019. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.

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Positive results with Targeted DEP® using antibody fragment in human ovarian cancer model

Aug 29th, 2019

Starpharma today announced that treatment with a novel HER-2 Targeted DEP® conjugate from its internal Targeted DEP® program resulted in tumour regression and 100% survival in a preclinical human ovarian cancer model. 

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Annual report and full year financial results

Aug 28th, 2019

Starpharma today released its annual report and financial results for the year ended 30 June 2019.

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Promising efficacy signals observed in ongoing DEP® trials, including DEP® cabazitaxel escalation phase

Aug 28th, 2019

Starpharma today announced that promising efficacy signals have been observed in its ongoing clinical trials for both DEP® cabazitaxel and DEP® docetaxel.  

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First Asian Regulatory Approvals Received for VivaGel® BV

Aug 15th, 2019

Starpharma today announced that it has received the first regulatory approvals in South East Asia for VivaGel® BV. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.

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Starpharma commences phase 1/2 DEP® irinotecan trial

Aug 8th, 2019

Starpharma today announced that it has received the necessary regulatory and ethics approvals and will  commence its phase 1/2 clinical trial for DEP® irinotecan. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® irinotecan to define a recommended phase 2 dose (RP2D), and to determine anti-tumour efficacy of the product in select tumour types. DEP® irinotecan is the third DEP® product to enter the clinic from Starpharma’s internal portfolio with a fourth, partnered DEP® candidate, AZD0466, also set to enter the clinic later this year.

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Quarterly Cashflow Report

Jul 16th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2019.

 

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Shareholder Update July 2019

Jul 1st, 2019

In this issue: 

>> VivaGel® BV launched in Europe & Australia; US regulatory progress

>> VivaGel condom launched in Japan by Okamoto

>> DEP® docetaxel & DEP® cabazitaxel clinical trial update; DEP® irinotecan trial start & new data

>> Starpharma signs second commercial oncology agreement with AstraZeneca

>> AstraZeneca highlights AZD0466 at 2019 ASCO meeting & upcoming US FDA IND 

>> Patent published for AstraZeneca Bcl2/xL DEP conjugates

>> DEP® radiotherapeutics

>> Outlook, recent news & events

 

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VivaGel® BV launched in Europe

Jun 27th, 2019

Starpharma today announced that VivaGel® BV has been launched in Europe under the brand name Betadine BVTM. The product has been launched in several countries in Europe, including Germany, with further roll-out in additional European countries during the year.

 

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Starpharma presents at Macquarie Emerging Leaders Forum

Jun 20th, 2019

Starpharma has been invited to present at the Macquarie Emerging Leaders Corporate Forum in Melbourne. The Macquarie Emerging Leaders Corporate Forum provides Starpharma with an opportunity to present to more than 100 investors from Melbourne and Sydney.

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US patent granted for DEP Bcl2/xL inhibitor conjugates

Jun 12th, 2019

Starpharma announced the first patent for DEP® Bcl2/xL inhibitor conjugates, developed in collaboration with AstraZeneca, has been granted by the US Patent and Trademark Office. These patented DEP® Bcl2/xL inhibitor conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitors, which are being investigated for treating various cancers, including leukemias.

 

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Okamoto launches VivaGel® condom in Japan

Jun 4th, 2019

Starpharma today announced that the VivaGel® condom has been launched in Japan under Okamoto’s leading and highly successful Zero Zero Three (003) brand. This is the first condom with antiviral coating in Japan and will also carry Starpharma’s VivaGel® brand.

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Starpharma signs second oncology agreement with AstraZeneca

Jun 3rd, 2019

Starpharma today announced a Development and Option Agreement with AstraZeneca (LON: AZN) to progress the development of a Dendrimer Enhanced Product (DEP®) version of an undisclosed AstraZeneca major marketed oncology medicine. This is the second DEP® commercial agreement Starpharma has signed with AstraZeneca, the first agreement being a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a Bcl2/xL inhibitor).

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Starpharma presents at UBS Healthcare Conference

May 29th, 2019

Starpharma has been invited to present today at the UBS Australian Emerging Companies Conference - Healthcare and Biotech – in Sydney. The UBS Healthcare Conference provides Starpharma with an opportunity to present to approximately 100 institutional investors.

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DEP® irinotecan combination outperforms in refractory human colon cancer model

May 24th, 2019

Starpharma today announced that its patented nanoparticle formulation, DEP® irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar®) and cetuximab (Erbitux®), in the irinotecan-refractory HT-29 human colon cancer model.

These impressive results were despite the fact that these standard colorectal cancer (CRC) treatments, Camptosar® and/or Erbitux®, showed limited activity in this preclinical model.

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Regulatory progress for VivaGel BV in the US

May 23rd, 2019

Starpharma has received formal feedback from the recent meeting held with the US FDA in relation to the approval for two related bacterial vaginosis (BV) indications - BV treatment and the prevention of recurrent BV in the United States.

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Starpharma presents at Macquarie Australia Conference

May 1st, 2019

Melbourne, Australia; 1 May 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) has been invited to present today at the Macquarie Australia Conference in Sydney. The Macquarie Australia Conference is a leading investment event in Australia and attracts more than 800 investors from around the world, including Asia, Europe and North America.

 

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Quarterly Cashflow Report

Apr 29th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2019.

 

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First VivaGel BV launch globally in Australia by Aspen

Apr 16th, 2019

Starpharma today announced that VivaGel® BV has been officially launched in Australia by Aspen Pharmacare (Aspen) as Fleurstat BVgel. The product has undergone distribution across Australia and is already available in some pharmacies. It will be progressively rolled-out nationally over the coming weeks. This is the first launch of VivaGel® BV in the world and further launches by Mundipharma are expected in Europe in May/June this year.

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Starpharma meets with US FDA to discuss VivaGel® BV

Apr 11th, 2019

 

Starpharma today announced that a meeting was held with the US FDA overnight as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel® BV in the US. This meeting was attended by senior representatives of Starpharma as well as internationally recognised Key Opinion Leaders in BV, statisticians and the Company’s expert FDA regulatory consultants, which include former senior FDA clinical personnel. 

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Starpharma Investor Presentation to Goldman Sachs Conference

Apr 3rd, 2019

Starpharma will today present to institutional investors at the Goldman Sachs Tenth Annual Emerging Companies Conference in Sydney.

 

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Shareholder Update March 2019

Mar 18th, 2019

In this issue: 

>> Fleurstat BVgel - Australian launch

>> Mundipharma's European launch of VivaGel® BV

>> Mundipharma's international roll-out of VivaGel® BV

>> FDA meeting to discuss VivaGel® BV approval in the US

 Download: Shareholder Update March 2019 (pdf file, 453kb)

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Starpharma receives $4.0M R&D tax incentive refund

Mar 12th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received a $4.0M R&D tax incentive refund which relates to the costs of research and development during the 2018 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including VivaGel® and DEP® programs. This amount was not included in Starpharma’s cash balance reported in the Company’s Interim Report for the half-year ended 31 December 2018.

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Starpharma Interim Report and Half-Year Financial Results

Feb 27th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2018.

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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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