VIRALEZE™ launches in Europe

May 6th, 2021

Starpharma today announced that VIRALEZE^™ antiviral nasal spray is now available for purchase by consumers in Europe via Starpharma’s www.viraleze.co webstore.

Quarterly Cashflow and Activities Report

Apr 27th, 2021

Melbourne, Australia; 27 April 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2021.

Starpharma’s cash balance as at 31 March 2021 was $64.3 million.

Net operating cash outflows for the quarter were $5.8 million, including significant investment in DEP^®/VIRALEZE™ clinical trials and product manufacture of VIRALEZE™, and launch-related items, e.g., EU taxation costs (expected to be refundable). Expenditure during the quarter also includes costs associated with VIRALEZE™ registration, further antiviral testing and the small safety study undertaken to support commercialisation activities, as well as expenditure on Starpharma’s three phase 2 clinical programs – for DEP^® docetaxel, DEP^® cabazitaxel and DEP^® irinotecan. 

Key recent activities and events:

• Starpharma announced a new Research Agreement with leading global pharma company Merck utilising Starpharma’s proprietary DEP^® technology for dendrimer-based ADCs. Starpharma’s DEP^® partner, Merck, is ranked 4th globally by total sales revenue and is a recognised leader in oncology.
• AstraZeneca advised a significant expansion of its clinical program for DEP^® AZD0466, to include a multi-centre global phase 1 study with a focus on haematological tumours. The clinical expansion facilitates patient recruitment and is aimed at rapid development and approval of AZD0466.
• On 25 March Starpharma signed an exclusive commercial arrangement for VIRALEZE™ with LloydsPharmacy/McKesson UK, one of the largest pharmacy groups in the UK with around 1,400 LloydsPharmacy stores across the UK and servicing a further 14,000 independent UK pharmacies.
• On 29 March, VIRALEZE™ was launched in the UK by LloydsPharmacy, initially online and in its first week was the fastest selling product on record on LloydsPharmacy.com. Whilst it is not expected that this rate of sales will necessarily be maintained, both Starpharma and LloydsPharmacy have been very pleased with the launch of the product. VIRALEZE™ has been well received by UK consumers, and the product is now also available at LloydsPharmacy outlets in-store.
• To date, Starpharma has invoiced LloydsPharmacy $1.2 million, for the launch supply of VIRALEZE™ in the UK, with further orders to be filled between now and the end of FY21.
• Starpharma has been progressing arrangements to facilitate the launch of VIRALEZE™ in other parts of Europe in the coming weeks via viraleze.co, as well as commercial discussions with pharmacy groups.
• As outbreaks of COVID-19 continue around the world, commercial interest in VIRALEZE™ remains strong and discussions for distribution of the product in a number of markets actively continue in parallel. Starpharma is also engaged in discussions with organisations, including various sporting teams which have expressed interest in the product.
• Starpharma is leveraging the European registration of VIRALEZE™ to expedite further marketing approvals for the product as soon as practicable in other countries, including Australia.
• Dosing was completed in the VIRALEZE™ double-blinded, placebo-controlled safety study, which was undertaken to support commercialisation activities. The study involved 40 healthy volunteers, using VIRALEZE™ or placebo 4 times a day for 14 consecutive days. All participants have now completed the study. Whilst the data is not yet unblinded, both VIRALEZE™ and the placebo nasal spray were extremely well tolerated by all participants.
• Further antiviral testing of SPL7013 (VIRALEZE™ active) at the Scripps Research Institute has confirmed it is active in two additional pandemic coronaviruses - severe acute respiratory syndrome coronavirus (SARS-CoV) or “SARS” and Middle East respiratory syndrome coronavirus (MERS‑CoV) or “MERS”. SPL7013’s broad-spectrum antiviral activity is a compelling feature for the role of VIRALEZE™ today and further testing is underway in multiple COVID strains.
• DEP^® irinotecan phase 2 trial continues to progress well, with more than 40 patients now recruited. Encouraging efficacy signals observed include prolonged stable disease, impressive tumour shrinkage and reductions in tumour marker levels for a number of tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. A patient with heavily pre-treated metastatic ovarian cancer experienced a 98% reduction of tumour marker (CA-125) following 7 cycles of DEP^® irinotecan, and follow up scans showed a complete disappearance of her ovarian target tumour.
• DEP^® docetaxel clinical trials continue to progress well, with more than 40 patients now recruited and encouraging efficacy signals observed, including prolonged stable disease and tumour shrinkage in patients with pancreatic, oesophageal, and gastric cancer. These impressive tumour responses include stable disease for up to 40 weeks and significant tumour shrinkage in a heavily pre-treated oesophageal cancer patient, maintained for more than 28 weeks. In addition to the monotherapy of DEP^® docetaxel, Starpharma is also recruiting into a study combining DEP^® docetaxel with gemcitabine. This study follows compelling data for this combination in pre-clinical human pancreatic cancer models.
• DEP^® cabazitaxel phase 2 trial continues to progress well, with more than 35 patients now recruited. Encouraging efficacy signals have been observed, including stable disease, significant target tumour shrinkage and substantial tumour marker reductions (e.g., PSA), in cancers including prostate, ovarian, lung, gastro-oesophageal, head and neck and other cancers. These impressive tumour responses include significant tumour shrinkage including in prostate and ovarian cancer, in patients who have failed multiple other lines of cancer treatment.
• Starpharma’s second radiopharmaceutical candidate, DEP^® HER2-lutetium outperformed in human breast cancer model - achieving complete tumour regression, outperforming Herceptin^® (trastuzumab) labelled with lutetium, in a human breast cancer model (BT474).
• Further DEP^® candidates are being progressed toward the clinic, including DEP^®
• Starpharma is engaged in active discussions with further partners in relation to DEP^® The Company’s disclosed/undisclosed partnered programs continued to progress, including with AstraZeneca, Merck and Chase Sun. Following the Merck ADC partnership, Starpharma has also initiated a number of new ADC discussions.
• Mundipharma has continued its rollout of VivaGel^® BV with the launch of Betadine™ BV Gel in South Africa in March 2021. The Starpharma and Mundipharma teams continue to work together on expanding the breadth of regulatory submissions for VivaGel^® BV, which has now been approved in more than 45 countries. Further regulatory submissions are underway to support additional launches of VivaGel^® BV in Mundipharma’s territories.

Dr Jackie Fairley, Starpharma CEO, commented: “It has been an important quarter for Starpharma, with multiple value-adding milestones achieved in the DEP^® portfolio, in addition to the commercialisation and launch of VIRALEZE™. Starpharma signed with leading global pharma company Merck, in the cutting-edge area of ADCs. We were also delighted that AstraZeneca is significantly expanding its clinical program for AZD0466 globally to support rapid development and approval of this product”.

Dr Fairley added, “Alongside these partnered DEP^® programs, we also progressed our internal DEP^® assets, including our three clinical stage assets which continued to recruit further patients and report impressive tumour responses, in heavily pre-treated patients who have limited options”.

“Starpharma was excited to launch VIRALEZE™ in the UK in March, ahead of our original schedule. We were pleased to partner with Lloyds/McKesson to bring this important product to consumers in the UK. We are rapidly advancing the launch of VIRALEZE™ in other parts of Europe and look forward to pursuing registrations in further countries and regions”.  

The closing cash balance as at 31 March 2021 was $64.3 million. Net operating cash outflows of $5.8 million for the quarter includes significant investment in R&D ($4.3 million) and product manufacturing and operating expenses, this reflects investment in multiple phase 2 DEP^® clinical programs and manufacture of VIRALEZE™. Receipts from customers and grants in the quarter totalled $0.6 million. Staffing levels remained stable with quarterly staff costs of $1.6 million, including non-executive and executive directors’ fees of $233,000.

Download ASX Announcement: Quarterly Cashflow and Activity Report (pdf, 428kb)

VIRALEZE™ now launched by LloydsPharmacy in the UK

Mar 30th, 2021

Starpharma today confirms that Starpharma’s VIRALEZE™ antiviral nasal spray has launched in the UK by LloydsPharmacy, as announced on 25 March 2021.

VIRALEZE™ to be launched with LloydsPharmacy in the UK

Mar 25th, 2021

Starpharma today announced it has signed a sales and distribution agreement for VIRALEZE™ antiviral nasal spray with LloydsPharmacy and the McKesson group in the UK. LloydsPharmacy/McKesson is one of the largest pharmacy groups in the UK and is also a major wholesaler in the UK.

Annual report and full year financial results

Aug 27th, 2020

Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2020.

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.

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.

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)

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.

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.

VivaGel® BV - Product Information and Independent Market Research

Apr 30th, 2018

VivaGel® BV - Product Information and Independent Market Research

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).

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).

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.

Sale of Agrochemicals Business Investor Presentation

Jun 14th, 2017

Melbourne, Australia; 14 June 2017: Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), will be holding an investor conference call today at 11am (AEST) to discuss the sale of its Agrochemicals business to Agrium Inc., for $35 million. A presentation featuring further information on the transaction is available.

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

Jul 1st, 2018

To listen to the podcast, click here.

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.

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. 

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AstraZeneca plans to make better use of Australia’s innovation

Jan 23rd, 2018

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.

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Starpharma featured on Sky Business News

Aug 28th, 2017

To watch the interview, click here. 

Starpharma CEO on Finance News Network

Aug 24th, 2017

To watch the interview, click here. 

Seeking Alpha covers Starpharma

Aug 11th, 2017

Starpharma and Monash awarded STEM+ Business fellowships

Aug 10th, 2017

Hope is on the way for one of the world’s most common sexual problems

Aug 9th, 2017

Investor publication Stockhead recently covered Starpharma’s VivaGel® BV Phase 3 announcement for prevention of recurrent bacterial vaginosis (rBV). The publication noted the significant unmet patient need for BV treatments and how VivaGel® BV targets one of the most common vaginal conditions affecting women of childbearing age. 

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Starpharma readies US NDA for VivaGel® on positive results in Phase 3 Bacterial vaginosis

Aug 9th, 2017

Biotech trade publication noted Starpharma expects to file an NDA for VivaGel® BV for prevention of recurrent bacterial vaginosis (rBV) with the US FDA following the positive results of the Phase 3 trials.

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Biotech clinical trials a star performer

Aug 6th, 2017

Herald Sun covered the investor interest in Starpharma following the positive results of the company’s VivaGel® BV Phase 3 clinical trials for the prevention of recurrent bacterial vaginosis (rBV). Starpharma CEO Dr Jackie Fairley noted VivaGel® BV demonstrated sustained benefits for patients three months after their initial treatment, positioning the company to unlock a multi-million dollar global market.

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Starpharma’s sale of its agrochemical business and technology, expands Agrium’s tech base

Jun 23rd, 2017

The sale of Starpharma’s agrochemical business was recently covered in Farm Weekly, highlighting the unique opportunity that Starpharma’s Priostar® dendrimer technology brings to the agrochemical market and the commercial value Agrium saw in the technology. In the article, Starpharma CEO Dr Jackie Fairley details the sale, including the patent transfer, total sale proceeds and the implications for the Company.

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Starpharma featured on Business IQ, Sky Business News

Jun 20th, 2017

Starpharma CEO Dr Jackie Fairley was interviewed on Sky Business News where she spoke to Business IQ host James Daggar-Nickson about dendrimer technologies and how the company develops products for a wide range of applications using the platform technology. Dr Fairley also discussed Australian innovation and the company's recent sale of its agrochemical business to global agricultural product giant Agrium.

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Finance News Network: Starpharma sells Agrochemicals business for $35M

Jun 14th, 2017

Finance News Network noted Starpharma’s transaction to sell Starpharma Agrochemicals to Agrium Inc. for A$35M in cash consideration. The piece added that cash proceeds from the sale will allow Starpharma to focus on its core pharmaceutical development portfolio.

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Starpharma’s sale of its agrochemical business to Agrium for A$35M noted in The Land

Jun 14th, 2017

The sale of Starpharma’s agrochemical business was covered in The Land, with the article highlighting the innovation behind the Priostar® technology and how Agrium saw the acquisition as a strategic fit for their product portfolio. 

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Starpharma featured on Ticky on Sky Business News

Apr 20th, 2017

Starpharma CEO Dr Jackie Fairley was interviewed on Ticky on Sky Business News where she discussed the company's VivaGel® portfolio, its DEP® drug delivery technology and its relationship with global pharmaceutical giant AstraZeneca.

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Melbourne-based company develops world's first anti-viral condom

Apr 12th, 2017

The ABC notes Starpharma as the Melbourne company developed the world’s first anti-viral condom using its VivaGel® active in the condom lubricant. VivaGel® has been shown to inactivate HIV, herpes, human papillomavirus and the Zika virus in laboratory studies.

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Starpharma VivaGel® BV gets FDA fast track

Jan 13th, 2017

The Australian reports that Bell Potter sees further upside for Starpharma, setting its share price target at $1.05, given the company had been granted Qualified Infectious Disease Product (QIDP) and fast track designation for VivaGel® BV by the US Food and Drug Administration.

 Go to the article (external link)