VIRALEZE™ COVID-19 nasal spray to be ready for marketQ1CY21• EU...

VIRALEZE™ COVID-19 nasal spray to be ready for market
Q1CY21
• EU regulatory dossier >90% complete and VIRALEZE™ now on track to be
registered, and ready for market in Q1 CY2021, earlier than previously announced
• Initial launch batches of VIRALEZE™ scheduled for manufacture in January 2021;
Starpharma is also building inventory of components and raw material to support
rapid roll-out
• Launch and marketing preparations well advanced, including discussions with
pharmacy chains, B2B customers, qualitative and quantitative consumer market
research; partnering discussions are continuing in parallel
• VIRALEZE™ clinical study in healthy volunteers to commence in January 2021, for
completion in Q1 CY2021
• SPL7013 has been shown to be virucidal, inactivating more than 99.99% of SARSCoV-2 and Scripps Research Institute mechanistic studies have confirmed potent
inhibition of viral ‘spike protein’ binding (>90%)
• The broad spectrum antiviral activity of VIRALEZE™ is a compelling differentiating
feature and Starpharma is continuing to build additional efficacy data in other
respiratory viruses to further broaden the product claims for VIRALEZE™
Melbourne, Australia; 10 December 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today
announced significant commercial and regulatory progress has been made for VIRALEZE™
nasal spray with the EU regulatory dossier more than 90% complete and VIRALEZE™ now
on track to be registered, and ready for market in Q1 CY2021. This timing is earlier than
previously announced.
VIRALEZE™ will be marketed as an antiviral nasal spray for SARS-CoV-2 (the coronavirus
that causes COVID-19) as well as other important respiratory viruses (influenza and RSV).
VIRALEZE™ is expected to form part of a range of preventative measures such as masks and
other PPE, and is complimentary to COVID-19 vaccines to further reduce risk of infection.
Starpharma’s pre-launch commercialisation activities for VIRALEZE™ are well advanced
with input from Boston Consulting Group (BCG), focussing initially on direct to consumer and
B2B (business-to-business) channels to facilitate the most rapid entry to market. Starpharma
is continuing partnering discussions in parallel. Europe will be the first geographic region for
the VIRALEZE™ launch. Starpharma plans to leverage the European registration to roll-out
VIRALEZE™ into other markets including Australia as quickly as possible.
As part of the go-to-market planning for VIRALEZE™, BCG conducted qualitative and
quantitative consumer research in Europe during November. The research from ~1,500
consumers confirmed that the product proposition for VIRALEZE™ is highly appealing, and
that consumers would use the product in a wide range of settings including in crowded areas
such as shopping centres, elevators, workplaces and public transport.
2
The research showed a high number of respondents (~60%) liked VIRALEZE™ and that this
translated to very high purchase intent – higher than 80% in millennials, with the following
features of VIRALEZE™ driving strong purchase intent:
• Broad spectrum antiviral activity (COVID-19, influenza, RSV, and further viral testing
ongoing)
• Inactivates >99.99% of SARS-CoV-2 (the coronavirus that causes COVID-19) – with
testing completed in strains from multiple geographies
• Preventative spray (VIRALEZE™ inactivates virus before, and after, exposure to
cells)
• Handy and convenient product (easy to use and does not need refrigeration or
special handling, to be available OTC)
Starpharma’s launch preparations are well advanced with initial launch batches of
VIRALEZE™ scheduled for January 2021 and the Company is also building stocks of raw
material and components. Starpharma’s internationally accredited manufacturer already
supplies marketed VivaGel® products and has expertise in nasal sprays.
Starpharma is leveraging the extensive data already available for the active (SPL7013) in
VIRALEZE™. VIRALEZE™ will be approved via the CE mark route. The Company is also
conducting a clinical study in healthy volunteers to be completed in Q1 CY21 to support
commercialisation activities for VIRALEZE™, noting that this study is not a requirement for
registration.
Dr Jackie Fairley, CEO of Starpharma commented: “We know from the positive market
research that VIRALEZE™ has the ability to restore confidence and encourage people to
resume everyday professional and recreational activities. Our market research also shows
that the compelling features and convenience of VIRALEZE™ are highly appealing to
consumers”.
“The distribution challenges of COVID-19 vaccines are well documented including the timing
of wide-spread availability and adoption. Even after a vaccine becomes widely available,
social distancing, PPE and other measures will continue to be important and VIRALEZE™
complements other prevention strategies, including vaccines. In November, the World Health
Organisation stated that someone died every 17 seconds from COVID-19 in Europe1
. It is
with the greatest urgency that Starpharma is working to make this product ready for market
as quickly as possible in 1Q CY2021”.
Further validation of the product in the form of antiviral mechanism of action studies for
SPL7013 completed at the prestigious Scripps Research Institute confirm that SPL7013
achieves potent inhibition of SARS-CoV-2 ‘spike protein’ binding (>90%) to the cell target.
Blocking and targeting of spike proteins is the approach taken in the development of many
COVID-19 vaccines including by Moderna and Pfizer.
About VIRALEZE™
VIRALEZE™ is an antiviral nasal spray for coronavirus and other viruses such as
influenza and respiratory syncytial virus (RSV). VIRALEZE™ is an easy to use
preventative nasal spray, which can be stored at room temperature and does not
require refrigeration.
VIRALEZE™ contains SPL7013, a broad spectrum antiviral, which is the active in
products approved in more than 40 countries and on market in the UK, Europe,
Asia, Australia and New Zealand.
1 disallowed/world/europe/someone-in-europe-is-dying-every-17-seconds-from-covid-19-who-says-20201120-p56gag.html
3
SPL7013 has been shown in laboratory studies to be virucidal, inactivating more than
99.99% of SARS-CoV-2 (the coronavirus that causes COVID‑19), when applied to the cells
before or after exposure to the virus.
The broad spectrum antiviral activity of VIRALEZE™ is a compelling differentiating feature
and means that the product could have an important role in future pandemics.
About Starpharma
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a global biopharmaceutical company and a world
leader in the development of new pharmaceutical and medical products based on proprietary polymers called
dendrimers, with programs for COVID-19, DEP® drug delivery and VivaGel®. Starpharma is developing
VIRALEZE™, an antiviral nasal spray for COVID-19 which is complementary to vaccines and other preventative
measures such as distancing and PPE. VIRALEZE™ also has potential use in future pandemics and is afforded
expedited development because it is repurposing an already-marketed, broad-spectrum antiviral dendrimer,
SPL7013. SPL7013 is utilised in approved products - the VivaGel® condom and VivaGel® BV. VivaGel® BV has
been licensed in >160 countries, is approved in >40 countries and available in for sale in the UK, Europe, South
East Asia, Australia and New Zealand.
As a leading company in dendrimer based drug delivery, Starpharma’s proprietary drug delivery platform
technology, DEP®, which is being used to improve pharmaceuticals, to reduce toxicities and enhance their
performance. There are numerous internal and partnered programs underway to develop DEP® versions of
existing drugs, particularly in the area of anti-cancer therapies. DEP® partnerships include programs with
AstraZeneca and other world leading pharmaceutical companies, which have the potential to generate significant
future milestones and royalties.
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.
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