OTCQX Life Sciences Presentation
Released
Released
Announcement PDF
OTCQX Life Sciences Presentation
Melbourne, Australia; 1 October 2015: Starpharma Holdings Ltd (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, October 1, 2015 at 12.15pm (EDT time). The
presentation is part of a special OTCQX Life Sciences virtual Conference.
The presentation will provide an overview of the Company for new investors including recent
announcements:
EU marketing approval for VivaGel® BV; and
Drug delivery license with AstraZeneca for DEP™ technology.
Interested parties are able to register at www.virtualinvestorconferences.com or at the following
link: http://tinyurl.com/101pre . An on-demand archive will be available for 90 days at
www.virtualinvestorconferences.com.
A copy of the presentation slides is attached.
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 three core development programs:
VivaGel® portfolio, DEP™ drug delivery, and agrochemicals with the Company developing a number of products internally and
others via commercial partnerships.
Starpharma’s lead products are based on VivaGel® (SPL7013, astodrimer sodium), a proprietary dendrimer which has
antimicrobial properties. VivaGel® formulated as a water based gel and delivered vaginally now has EU regulatory approval for
topical treatment and rapid relief of bacterial vaginosis (BV) and is under clinical development for the prevention of recurrent
BV. Starpharma has also signed separate licence agreements with Ansell Limited (ASX:ANN) and Okamoto Industries. Inc., (TSE:
JP3192800005) to market a value-added, VivaGel® condom. The VivaGel® condom is available for purchase in Australia under
Ansell’s Lifestyles® Dual Protect™ brand. Ansell manufactures and sells leading condom brands worldwide, including LifeStyles®,
ZERO® and SKYN®. Okamoto is the market leader for condoms sold in Japan, which is the world’s second largest condom
market.
In the wider pharmaceutical field, Starpharma has both partnered and internal programs in Drug Delivery. A number of dendrimerenhanced, or DEP® versions of existing drugs are under development. The most advanced of these is DEP® docetaxel, a
dendrimer-enhanced version of docetaxel (Taxotere®), which is in clinical development in patients with solid tumours. In preclinical
studies DEP® docetaxel has shown significant tumour-targeting and superior anti-cancer effects across a range of important
cancer types including breast, prostate, lung and ovarian tumour, when compared to Taxotere® (docetaxel). AstraZeneca has
signed a licensing agreement with Starpharma for the use of its DEP® drug delivery platform in the development and
commercialisation of an AstraZeneca oncology compound, with potential for follow on compounds directed at a defined family of
targets.
In agrochemicals Starpharma has a series of partnerships with leading industry players including global leader Adama (formerly
Makhteshim Agan) as well as internal programs including an enhanced version of glyphosate (the active ingredient in Roundup®).
For more information please visit: www.starpharma.com
Media:
Buchan Consulting
Rebecca Wilson
Mob: +61 417 382 391
rwilson@buchanwe.com.au
Starpharma:
Dr Jackie Fairley, CEO
Nigel Baade, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
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 should underlying assumptions prove
incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is
providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements
contained in this document as a result of new information, future events or developments or otherwise.
Page 2 of 2
Dr. Jackie Fairley CEO
STARPHARMA HOLDINGS LIMITED
ASX:SPL; OTCQX:SPHRY
Corporate Overview
September/October 2015
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 health authorities’ requirements
regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any
health 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 clinical
trial results, including additional analysis of existing clinical data, and new clinical 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 should underlying assumptions prove incorrect, actual results may vary materially from those described
herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this presentation and
does not assume any obligation to update any forward-looking statements contained in this document as a result of new information,
future events or developments or otherwise.
2
One of Australia’s most innovative technology
companies
• ASX 300 company (ASX:SPL) and US (OTCQX:SPHRY).
• A platform technology with multiple product opportunities across the
pharmaceutical, life science and agrochemical industries.
• De-risked business model:
• Portfolio of products based on proprietary polymers (dendrimers) in
various stages of development including one product on market, a product
recently approved for market entry, and in late stage clinical trials;
• Developing first-in-class (new) therapies through a highly experienced inhouse commercialization team;
• Established commercial partnerships - with some of the world’s leading
companies accelerates product development, shares development risk,
and transfers development costs;
• Multiple “shots on goal” due to the versatility and broad applicability of
Starpharma’s technology.
• Multiple commercial and product development catalysts expected
within next 12 months.
• Strong cash position: Cash balance of A$30.8M (June 2015)
Starpharma headquarters in Melbourne,
Australia
3
One of Australia’s most innovative biotechnology companies
Starpharma’s portfolio is a mix of internal programs and external commercial partnerships
Starpharma’s Dendrimer Platform
>80 granted patents
VivaGel® Portfolio
VivaGel®
Condom
Bacterial
vaginosis
VivaGel® BV
Symptomatic
Relief BV
DEP™ Drug Delivery
DEP™
docetaxel
Partner
Delivery
Programs
Agrochemicals
Priostar®
Improved
Agrochemicals
ie. Glyphosate
Partner Priostar®
Programs
DEP™
VivaGel® BV oxaliplatin
BV
(and others)
Prevention
& other
undisclosed
Top 10 Pharma
companies
>50% Top 10 Ag.
companies
4
Starpharma’s Pharmaceutical Development Portfolio
Res
Antimicrobial
/ Antiviral
(SPL7013)
VivaGel® BV
BV Symptomatic
Relief
VivaGel® BV
BV Prevention of
Recurrence
PC
PhI
PhII
PhIII
Reg.
Mkt
VivaGel®
Condom
Drug Delivery
Oncology
(Internal)
Partnered
programmes
Drug Delivery
DEP™ docetaxel
(various cancers)
DEP™ oxaliplatin
Drug Delivery
Various Oncology
DEP™
Drug Delivery -
DEP™ Delivery –
oncology, diabetes
etc.
Completed
Planned
5
EU Marketing Approval granted for VivaGel® BV
•
VivaGel® BV gains EU approval for the treatment and rapid relief
of BV
•
Allows for marketing in 28 EU countries & EFTA countries
(population >260m women)
•
EU Approval will be used as the basis for obtaining marketing
approvals for VivaGel® BV in other countries
•
Discussions regarding marketing rights for VivaGel® BV
underway with a number of potential commercial partners
•
Current market for the management of BV and associated
symptoms is estimated to be in excess of US$750 million
globally.
“It was like gone almost overnight”
“I would definitely use it again.”
“The next day I noticed a huge difference.”
“I would use it….I will use it indefinitely…”
VivaGel® Trial Participants
VivaGel® BV is a unique topical vaginal gel.
Its proprietary active is not absorbed and
acts locally to suppress the pathogens that
cause BV and the associated signs and
symptoms.
6
Starpharma’s DEP™ delivery license with AstraZeneca (LON:AZN)
•
AZ licensed DEP™ drug delivery platform in the development
and commercialisation of a novel, proprietary AZ oncology
compound
•
SPL eligible to receive development, launch and sales
milestones for the first AZ DEP™ product of USD$126 million
(A$180m) (including a signature payment US$2m)
•
Licence provides for application of DEP™ to multiple AZ
compounds directed at a defined family of targets
•
Each subsequent qualifying product successfully developed and
commercialised could yield USD$93m (A$133m) in milestone
payments
•
Tiered royalties on net sales
•
AZ will fund all development and commercialisation costs
"We already have a long-standing and successful working
“SPL estimates that each product successfully
commercialised under this agreement could
be worth around US$450m to Starpharma
and, depending on the range of indications
and degree of commercial success in the
market, potentially significantly more”
relationship with Starpharma. This license agreement will enable
us to further harness the DEP™ technology and evaluate its
potential across novel molecules within our oncology portfolio.’’
Dr Susan Galbraith,
Head of the Oncology Innovative Medicines Unit at AstraZeneca
7
DEP™ Drug Delivery
Starpharma’s DEP™ docetaxel: Multiple benefits
• Docetaxel (Taxotere®) is a blockbuster chemotherapeutic
• Docetaxel sales: US$3.1B(2012)
• Docetaxel is used in major cancer types including breast,
prostate and lung cancer
• Starpharma’s patented DEP™ docetaxel is a nanoparticle
formulation with multiple advantages compared to Taxotere®
DEP™ docetaxel vs. Taxotere®
1. Elimination of major dose-limiting
side effect (neutropenia)
2. Detergent-free formulation (less
toxic)
3. Tumour-targeting (40-70x more)
• DEP™ patents filed will offer coverage to 2032
4. Extended duration (half-life)
• DEP™ docetaxel Phase 1 Trial in Australia progressing
5. Improved efficacy (breast,
well; promising preliminary findings with very good
ovarian, prostate)
tolerability
9
DEP™ docetaxel preclinical findings:
Multiple advantages - Better efficacy and less toxicity
T1/2 and Targeting
Safety
Efficacy
Patents filed will offer coverage to 2032
10
DEP™ docetaxel: Phase 1 Clinical Trial
Encouraging initial clinical data
•
Underway at 4 Australian sites* ; Open label study - allowing progressive release of results
•
Estimated sample: 25-30 cancer patients (various solid tumours)
Current Status
•
DEP™ docetaxel administered every 3-4 weeks (no steroid pre-treatment required)
•
Patients currently being enrolled in dose escalation phase
•
several dosed with multiple cycles (up to 6 cycles)
•
dose-level exceeds commonly used Taxotere® dose 75mg/m2
•
> 2/3 recruitment
Interim Findings: DEP™ docetaxel well tolerated with encouraging anticancer activity
•
No neutropenia (docetaxel DLT) observed so far (c.f Taxotere® where published data indicates severe neutropenia
will be suffered by 75% of patients given 60mg/m2 )
•
No alopecia/hair loss or vomiting reported
•
A sizable number of patients have exhibited efficacy signals/anticancer activity (one with pancreatic Ca. stable disease
over > 20 weeks; prostate, lung, H&N)
•
Enhanced Pharmacokinetics demonstrated (longer half-life, higher AUC and lower Cmax)
•
Expansion phase to follow at MTD
*Alfred, Austin Health/Olivia Newton John CC, Liverpool and Royal Brisbane & Women’s Hospital
11
DEP™ docetaxel Pharmacokinetics (PK) in humans cf. Taxotere®^
Enhanced PK in humans
1. Extended duration of exposure with DEP™ docetaxel
•
DEP™ docetaxel plasma half-life substantially longer (~8 x)
than Taxotere® (~150x longer in the initial, rapid phases of
plasma clearance)
2. Increased extent of exposure with DEP™ docetaxel
•
DEP™ docetaxel drug exposure or Area Under the Curve
(AUC) for total docetaxel, ~500-800x greater than an
equivalent dose of docetaxel administered as Taxotere®
•
reflects the gradual release of docetaxel (DEP™ docetaxel
acts as a ‘depot’ of docetaxel )
3. Reduced peak drug levels with DEP™ docetaxel
•
Cmax (peak blood level) of docetaxel is substantially (~50100 times) lower for DEP™ docetaxel than Cmax of an
equivalent dose of docetaxel administered as Taxotere®
Example plasma drug levels over
time DEP™ docetaxel
vs.Taxotere®)
^ Taxotere® parameters based on published data (Bruno et al, 1996)
12
DEP™ docetaxel compared with BIND’s docetaxel
Compelling product benefits for DEP™
DEP™ docetaxel
Starpharma Benefit
Manufacture
complex, self assembled
particles; potential for
inconsistency b/w batches
Standard chemistry
SPL dendrimer manufacture readily
scalable and validated through extensive
FDA input
Stability
self loading particle;
inherently unstable
Excellent stability
Important for drug approval, storage and
subsequent shelf life
Drug loading w/w
10%
25%
SPL delivers higher dose per mg of drug
10-15nm
Smaller particles enter tissues more easily
Aspect
BIND^
^
Particle Size
60-120nm
Tumour
concentration of
active
10-20x
30-60x
Higher level of docetaxel
delivery to tumour
SPL - better efficacy & reduced toxicity
Plasma Half life
6-20 hours
>50 hours
Longer duration of effect, less frequent
dosing and greater anti cancer effect
Water soluble
(detergent free)
No
Yes; solubility
~ 20,000 fold
increased
Water soluble; detergent free
(see below)
Neutropenia
prevented
No
Yes
Avoids risks & need for expensive rescue
therapies / GCSF and hospitalisation
Polysorbate used
Yes - cortisone pre-treatment
required
No - cortisone
pre-treatment is not
required
Avoids potentially fatal toxicities with
polysorbate-containing formulations
^ parameters based on published data
13
Additional DEP™ candidates
• SPL’s dendrimer enhanced product (DEP™) nanoparticle technology
broad applicability, especially in oncology
allows for new patent filings creating proprietary products
• Proof of DEP™ concept for docetaxel, doxorubicin, oxaliplatin, methotrexate, gemcitabine and
paclitaxel, proteins (insulin), peptides and Targeted agents (ADCs)
• A number of additional DEP™ candidates from the list below are currently in preclinical testing
2014 Sales / Peak Sales
prior to loss of
exclusivity (US$ M)
Brand
Generic Name
Type of Drug
Innovator
Company
Taxotere
Docetaxel
Cytotoxic
Sanofi Aventis
3,036
Alimta
Pemetrexed
Anti-metabolite
Eli Lilly
2,792
Eloxatin
Oxaliplatin
Cytotoxic
Sanofi Aventis
2,293
Gemzar
Gemcitabine
Anti-metabolite
Eli Lilly
1,720
Camptosar
Irinotecan
Cytotoxic
Pfizer
1,100
Jevtana
Cabazitaxel
Cytotoxic
Sanofi Aventis
363
Kadcyla
Ado-trastuzumab emtansine
ADC
Roche
624
Adcetris
Brentuximab vedotin
ADC
Takeda
395
14
Targeted DEP™ Conjugates (TDCs)
A new approach to drug conjugate design
More than 20 ADC
drug licensing
deals in the past 5
years
50% of the top 10
products are
antibodies with
2013 sales in
excess of $US38B
The top 3 oncology
products are
antibodies with
combined sales of
US$20B
THE
WORLD’S
FIRST
ANTI-VIRAL
CONDOM
VivaGel® Portfolio
VivaGel® Condom – World’s first antiviral condom
Lifestyles® DUAL PROTECT™ - Available in Australian retail outlets
Extensive consumer research of the VivaGel® condom^:
•
Confirms strong interest and purchase intent (~90%)
•
Strong consumer interest across genders, ages and relationship status
“I would buy this product
right now if I could…..”
“I like the idea of a condom
doing more for us than just
being a barrier….seems
more reassuring to know it’s
doing extra”
“I would definitely buy this
product without a shadow of
a doubt…..”
VivaGel® Condom
Consumer Research
“I think that this product
is amazing…... This
product is very special
and interesting.”
“I have rated this product
a 5/5 as this is a major
breakthrough in the
condom market and for
world health…”
THE
WORLD’S
FIRST
ANTIVIRAL
CONDOM
DUAL PROTECT™ with VivaGel® :
lubricated with VivaGel® which has
been shown to inactivate up to
99.9% HIV, HPV and HSV
(Herpes) in laboratory studies
VivaGel ® Condom
Consumer Research
^ Formal research conducted in 1800 condom users across USA, Europe, Asia and Sth America
17
VivaGel® condom: A compelling and differentiated product
•
Condom coated with SPL’s patented antiviral lubricant (VivaGel®)
•
VivaGel® shown in laboratory studies to inactivate up to 99.9% HIV, HPV & Herpes
•
Licensed to Ansell and Okamoto (SPL receives royalties on sales)
•
Regulatory Certification received in Japan and Australia, NZ other filings in progress
•
Product selling in Australia under Lifestyles® Dual Protect™ brand
•
Extensive international consumer research indicates strong consumer interest
•
Branded global condom market: $1.1B
•
VivaGel® condom patents to 2027
Partner
Market Position/Share
•
Okamoto Industries
(listed on TSE)
Major Brands
No. 1 in Japan with ~60% Japanese
market
Skinless®
(the 2nd largest condom mkt. Est.
~US$500M)
•
Ansell Limited
ASX:ANN
•
003®
Total revenues >US$760M
No. 2 globally for condom sales ~ 20%
global share of branded condom market
(~$1.1B)
Lifestyles®
SKYN®
ZERO®
Manix®
18
Bacterial Vaginosis and VivaGel® BV:
Two product opportunities
Bacterial Vaginosis:
•
the most common vaginal infection worldwide
•
~29% women infected in US; up to 51% in some groups
•
Recurrent BV an issue in 50-60% of BV sufferers
•
Current therapies have low cure rates and nasty side effects
•
No approved products for Recurrent BV (R-BV)
“It was like gone almost overnight”
“I would definitely use it again.”
“The next day I noticed a huge
difference.”
“I would use it….I will use it
indefinitely…”
VivaGel® BV Trial Participants
Product Proposition:
VivaGel® BV:
•
a non-antibiotic therapy
•
management of BV symptoms and
•
prevention of Recurrent BV
•
a selective antimicrobial effect for
pathogens that cause BV
•
a local effect and is not systemically
absorbed
•
Large market opportunity for both
prevention of recurrent BV and BV
Symptomatic Relief
* Global Data, IMS, various Industry reports
19
Bacterial Vaginosis and VivaGel® BV:
Two product opportunities
Drivers of Value
Significant
Market Size
BV Indications
VivaGel®
Prevention of
BV Recurrence
>US$1B
(Chronic use)
VivaGel® BV:
Symptomatic
Relief
(Acute use: 7d)
US$750-1B
Competitive
Advantages
•
•
•
•
Unmet need
No Approved
Products
Designed for
long term use
• Not absorbed
•
•
•
•
•
Rapid onset
Good efficacy
Not absorbed
Non antibiotic
Tolerability
benefits
Development and
Commercial Progress
• Phase 3 Trials Underway (SPA)
• Late stage License
• Partner engagement underway
• Efficacy at 5-7 days and excellent
symptomatic relief
• EU approval granted, further
submissions
• Partner engagement underway
20
VivaGel® BV
Treatment & Symptomatic Relief of BV
•
VivaGel® BV gains EU approval for the treatment and rapid relief of BV
•
Allows for marketing in 28 EU countries & EFTA countries (population
>260m women)
•
EU Approval will be used as the basis for obtaining marketing approvals
for VivaGel® BV in other countries
•
Discussions regarding marketing rights for VivaGel® BV underway with a
number of potential commercial partners
•
Current market for the management of BV and associated symptoms is
estimated to be in excess of US$750 million globally.
Time to resolution of odour as
reported by clinical trial patients
VivaGel® BV is a
unique topical vaginal
gel. Its proprietary
active is not absorbed
and acts locally to
suppress the
pathogens that cause
BV and the associated
signs and symptoms.
“It was like gone
almost overnight”
“I would definitely
use it again.”
“The next day I
noticed a huge
difference.”
“I will use it
indefinitely…”
VivaGel® BV Trial Participants
21
VivaGel® BV : Treatment & Symptomatic Relief of BV
Odour Resolution and time to resolution
80%
**
**
70%
7.00
*
50%
Placebo
40%
VivaGel®
30%
20%
*p<0.05
10%
** p<0.001
0%
SPL7013-013
SPL7013-015
Time to Resolution (Days)
% resolution
60%
8.00
6.00
5.00
86%
Placebo
4.00
VivaGel®
3.00
2.00
1.00
SPL7013-016
-
VivaGel® - 3 Clinical trials
In 3 separate randomised , placebo-controlled trials
VivaGel® consistently provided a statistically
significantly greater improvement in odour
resolution as compared to placebo
SPL7013-013
Time to resolution of odour, as reported by patients,
showed that VivaGel® resolved odour in 1 day,
compared to 7 days for placebo
22
BV Prevention of Recurrence Phase 3 Program
Two double-blind, multi-centre, randomised trials
SPA granted by
FDA
~600 p per trial
~100 sites across USA, EU,
Asia, Mexico
PERIODIC STUDY VISITS
“Enriched” R-BV population:
Nugent Score 4-10
Primary Endpoint: Recurrence of BV at or by week 16 visit
Oral
Metronidazole
7 days
BASELINE
SCREENING
1% SPL7013 Gel
1:1 randomization
WEEK
16
12-weeks follow-up
Placebo Gel
16-WEEK TREATMENT PERIOD
(DURING WHICH PRIMARY ENDPOINT IS MEASURED)
Dosing regimen: 5g gel every second day at bedtime
SPA granted by FDA on trial design (EMA agreement also gained)
Phase 3 Trials progressing well
23
Agrochemicals
The Opportunity for Starpharma’s Priostar® Dendrimers in Agrochemicals
The Challenge for
Agrochemical Companies
•
•
•
The cost and risk of registering new
agrochemical actives to market is rising.
fewer new actives being developed
(~70 30 between 2000 and 2012)
Agrochemical companies have more focus
on creating new products with existing actives
However most formulation components are
available to all formulators
Priostar® benefits for innovative
crop protection formulations
Better in the can:
• Solubility
enhancement
Better in the field:
• Increased efficacy
• Increased loading
• Modification of soil
penetration
• Formulation stability
• Protection of Actives
• Reduction/removal of
solvents – “greener”
formulations
Challenge for agrochemical companies…
Starpharma’s Patented Priostar® offers…
How to create defendably
differentiated products
without new actives?
Improved formulations with high
barrier to entry for competitors,
with or without new actives
25
Starpharma’s Priostar® Agrochemical Programs
Partnered Priostar® Programs
Internal Priostar® Programs
• Commercial agreements with many of the
leading global agrochemical companies
including Adama ( #7 globally; 2014 sales:
~US$3.2B )
• SPL is also developing a small number of complete
formulations of selected generic actives with enhanced
characteristics
• Several programs, including glyphosate, are underway with
numerous field trials conducted through the year
•
Field trials conducted both domestically and internationally
to address different regional weed populations for global
coverage
• Internal development candidates include (USD sales 2012):
Recent
partnerships
Glyphosate
($4-5B)
Improve efficacy
Metolachlor
($605M)
Improve efficacy
• Several have now progressed to field trials, with
positive interim results
Deltamethrin
($340M)
Improve efficacy/ remove solvent
• Anticipate move towards product registration
subject to continued positive results
Propiconazole ($350M)
Improve efficacy / Loading
Imidacloprid
Improve efficacy / Loading
(>$1B)
• Priostar® exclusivity offered in a region on a per
active basis
multiple potential opportunities for
revenue streams
• Estimated value of partners share of market
for actives under development: >US$5B
26
Priostar® Dendrimer Glyphosate Formulation – Field Trial Data
More effective in hard-to-kill weeds than comparable marketed formulation
•
100
Percentage of controlled weeds
90
80
Dendrimer Glyphosate
Product
Dendrimer product more effective in a number of
hard-to-kill weeds than comparable marketed
glyphosate product
• 7 regulatory-compliant field trials have now been
completed
• Tested in 16 weed species in Australia and overseas
Leading Glyphosate Product
70
60
50
Conclusion: Priostar® formulation performance has
consistently exceeded marketed formulations in these
field studies.
40
30
20
•
Two key benefits identified with Priostar® formulation:
10
•
0
5 days after
application
14 days after
application
28 days after
application
Proposition:
Priostar® offers a unique opportunity to
develop value-added, IP-protected
agrochemical formulations with less
expense and risk than new cropprotection actives
Better overall effectiveness
Dendrimer formulation leaves only minimal
number of weeds alive at end of study whereas
the marketed product had > 30% survival.
•
Early feedback of effectiveness to grower
3 to 4 times as much “brownout” after 5 days than
marketed product
27
Starpharma Holdings – Key Financials (A$)
Strong financial position
(Financial Year to 30 June)
FY 2015
AUD $M
FY 2014
AUD $M
Total revenue and income
1.7
1.3
R&D Tax Incentive
3.5
4.2
Net loss after tax
(19.0)
(14.6)
Cash outflow from operations
(13.6)
(9.8)
30.8
24.0
Key Financial Data
Cash at 30 June
28
Expected Short-Medium Term News Flow
VivaGel® Portfolio:
•
Regulatory approvals for BV Symptomatic Relief product
•
Commercialisation agreements for BV Symptomatic Relief product
•
Progress VivaGel® Phase 3 BV Prevention of Recurrence trials
•
Launches of VivaGel® condom, further approvals/geographic roll-out
DEP™ Drug Delivery:
•
Further data/completion DEPTM docetaxel clinical trial (MTD, efficacy signals)
•
Partnered program announcements and new deals
•
Advance additional DEPTM candidates through preclinical and into clinic
Priostar® Dendrimers in Agrochemicals:
•
Advance internal candidates eg. glyphosate (Roundup®) including regulatory-compliant field trials
•
Pre-registration activities to support commercialisation
•
Partnered program announcements eg. Licences from existing and new deals
29
For Further Information
Dr Jackie Fairley, CEO
+613 8532 2704
Investor.relations@starpharma.com
Twitter: @Starpharma_ASX
VivaGel®
Drug Delivery
Agrochemicals
30
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