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Write your reply hereSPL7013 shows significant activity against SARS-CoV-2
(coronavirus)
• Starpharma’s antiviral dendrimer, SPL7013, has been shown to have significant
activity against SARS-CoV-21 (coronavirus), which causes COVID-19
• SPL7013 is the active component in Starpharma’s range of marketed VivaGel®
products2 (VivaGel® BV and the VivaGel® condom), already sold in Australia, UK,
Europe, Canada, Japan and South East Asia
• Given that products containing SPL7013 are already approved in the above
markets, the existing preclinical and clinical data on file creates the opportunity to
fast-track the development and commercialisation of SPL7013-based product(s)
for COVID-19
Melbourne, Australia; 15 April 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today
announced that its proprietary VivaGel® active, astodrimer sodium (SPL7013), has been
shown in laboratory studies to have significant antiviral activity against the coronavirus that
causes COVID-19 (coronavirus disease). SPL7013 inhibited the infection of cells with the
SARS-CoV-2 virus and the finding was validated by replicate testing against a positive
control compound, remdesivir (Gilead), which is considered a leading candidate for the
treatment of COVID-19. The finding was also significant given that SPL7013 was reported to
be the best performing test compound against SARS-CoV-2 in the laboratory’s assay to
date. With these positive results, Starpharma is evaluating product concepts and formulation
options for SPL7013, which may have potential applications in the prevention and
management of COVID-19.
Given SPL7013 is already approved as the active component of two marketed VivaGel®
products (VivaGel® BV and the VivaGel® condom) and these products have regulatory
approval in Europe, Canada, Japan, Australia and South East Asia, Starpharma anticipates
it should be possible to fast-track certain aspects of the development path for products
targeted at COVID-19. The Company will now commence additional short-term preclinical
studies, and in parallel, will confirm the pathway with regulatory authorities. A new patent
has also been filed following receipt of these coronavirus results. Starpharma retains rights
to COVID-19 related products resulting from these findings and as such they would be the
subject of new commercial licences and would not impact existing VivaGel® licences.
The SARS-CoV-2 antiviral testing of SPL7013 was conducted under contract by Melbournebased 360Biolabs, which has developed SARS-CoV-2 assays to support antiviral discovery
and development. SPL7013 is one of the first agents tested by 360Biolabs to demonstrate
significant SARS-CoV-2 activity.
The VivaGel® active (SPL7013) has previously been shown to have potent antiviral activity
against a wide range of viruses, including HIV, herpes simplex, hepatitis B, HPV, Zika virus
and adenovirus. SPL7013 inactivates viruses by blocking the interaction between viral
surface proteins and the human cell receptor proteins. As for other viruses inhibited by
SPL7013, SARS-CoV-2 infects human cells by using the characteristic viral surface proteins,
or “spikes”, to attach to receptor proteins on the surface of human cells.
Dr Jackie Fairley, Starpharma CEO, commented: “Following the emergence of the
coronavirus pandemic in February, Starpharma instigated testing of SPL7013 via a specialist
1 Severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, is the virus that causes COVID-19.
2
VivaGel BV® is marketed by Mundipharma as Betafem® BV Gel (UK), Betadine BV™ (Europe), Betadine™ BV Gel (Asia) and by Aspen
Pharmacare as Fleurstat BVgel (Australia and New Zealand). The VivaGel® condom was launched by Okamoto as VivaGel® Zero Zero Three
(003) (Japan) and by LifeStyles under the Dual Protect® brand and is pending launch by LifeStyles under the Absolute™ Dual Protection brand
in Europe.
2
antiviral testing laboratory in Melbourne. We are very pleased to find that the compound is
highly active against the coronavirus that causes COVID-19 and we are now exploring a
number of product opportunities, including a potential preventative application to reduce the
risk of infection. Such a product could provide additional personal protection including for
those in the frontline of this crisis, such as doctors, nurses and other essential workers, and
is in keeping with Starpharma’s strategy to expand commercial applications of our
dendrimers. We are very pleased to be in a position to potentially help with the effort in
overcoming the current global COVID-19 pandemic.”
About 360biolabs
360biolabs (www.360biolabs.com), is a commercially-focused, ISO-accredited laboratory
that offers specialised clinical virology testing, and which has access to specialist Physical
Containment (PC) 3 biological facilities. Starpharma thanks Melbourne Health, the Doherty
Institute and VIDRL (Victorian Infectious Diseases Reference Laboratory) for providing a
sample of SARS-CoV-2 to 360biolabs to facilitate testing.
About VivaGel® active (SPL7013)
SPL7013 is one of Starpharma’s proprietary dendrimers that is already a component of two
approved products, VivaGel® BV for bacterial vaginosis and the VivaGel® antiviral condom.
These products are approved and marketed in a range of regions/ countries including the
UK, Europe, Japan, South East Asia, Canada, Australia and New Zealand.
About Starpharma
Starpharma Holdings Limited (ASX: SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the
development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure
and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: VivaGel® portfolio and DEP® drug delivery
with the Company developing several products internally and others via commercial partnerships.
VivaGel®: Starpharma’s women’s health product - VivaGel® BV is based on SPL7013, astodrimer sodium, a proprietary dendrimer. VivaGel® BV
for bacterial vaginosis (BV), is available for sale under the brand names Betafem® BV Gel (UK), Betadine BVTM (Europe), BetadineTM BV Gel
(Asia) and Fleurstat BVgel (Australia and New Zealand) and a new drug application has been submitted to the US FDA. Starpharma has licensed
the sales and marketing of VivaGel® BV to ITF Pharma for the US; Mundipharma for Europe, Russia, CIS, Asia, the Middle East, Africa and Latin
America; and to Aspen Pharmacare for Australia and New Zealand. Starpharma also has licence agreements to market the VivaGel® condom (an
antiviral condom which includes VivaGel® in the lubricant) in several regions, including Australia, Europe, Canada, China and Japan (Okamoto).
The VivaGel® condom has been launched in Japan under Okamoto’s 003 brand, and in Australia and Canada under the LifeStyles Dual Protect®
brand. The VivaGel® condom is approved in Europe.
DEP® - Dendrimer Enhanced Product®: Starpharma’s DEP® drug delivery platform has demonstrated reproducible preclinical benefits across
multiple internal and partnered DEP® programs, including improved efficacy, safety and survival. Starpharma has three internal DEP® products –
DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan - in clinical development in patients with solid tumours. Starpharma’s partnered DEP®
programs include a multiproduct DEP® licence with AstraZeneca, which involves the development and commercialisation of two novel oncology
compounds, with potential to add more. In June 2019 Starpharma signed a Development and Option agreement with AstraZeneca for a DEP®
version of one of AstraZeneca’s major marketed oncology medicines.
Starpharma.com | Twitter | LinkedIn
Media:
WE Communications
Rebecca Wilson
Mob: +61 417 382 391
[email protected]
Arthur Chan
+61 2 9237 2805
[email protected]
Starpharma Holdings Limited
Dr Jackie Fairley, Chief Executive Officer
Nigel Baade, CFO and Company Secretary
+61 3 8532 2704
[email protected]
4-6 Southampton Crescent
Abbotsford Vic 3067
Disclosure
This ASX Announcement was
authorised for release by the
Chairman, Mr Rob Thomas.
3
Forward Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such
as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could
provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing
approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that
may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no
assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding any one or more product candidates nor can
there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In
particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected
trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to
obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and
additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more
of these risks or uncertainties materialize, or s