Foresight Pharma
AN INNOVATIVE PROPRIETARY GEL TO TACKLE HIV/AIDS
IDEA IDOL 2009
An Innovative Solution
to a Worldwide Problem
Foresight Pharma’s significantly more
QUICK FACTS mission is to develop effective barrier to
innovative topical virus entry and
*Foresight Pharma is hormonal agents which replication.
a biotech start-up can be used to prevent
that is developing a sexually transmitted Foresight Pharma will Resources Needed
topical hormonal infections (STIs), create commercial, Foresight Pharma will need seed investment for
clinical and social value the following activities:
agent for the including Human
through its: 1. Ongoing proof of concept scientific research
treatment of sexually Immunodeficiency Virus (1) Innovative & (post-doctoral research, lab space and
transmitted (HIV) and Herpes Simplex proprietary core equipment); and
infections (STIs), Virus (HSV). These technology; 2. Securing the PCT international patent
including Human diseases represent areas (2) Unique proprietary
application & filing further patents related to
of large and growing drug delivery to strengthen IP position (cost
Immunodeficiency position enabling approximately £20,000)
Virus (HIV), Herpes unmet medical need in accelerated time to To undertake these activities an initial seed
Simplex Virus underserved populations market and reduced investment of £50,000 is required, after which
(HSV), and Human in both the developing risk profile; and time the product would be well positioned to
investigate commercial opportunities for funding.
Papilloma Virus (HPV). and developed world. (3) Pursuit of value
Following initial research, Foresight Pharma’s
Foresight Pharma’s lead enhancing commercial lead candidate will undergo proof of concept
product, a new and partnerships to develop testing in Phase 1b or Phase 2 clinical trials, after
*These infectious proprietary topical penile both clinically and which the company will engage in collaborations
diseases represent gel, enhances the natural commercially the agent with large pharmaceutical companies to guide the
areas of large and defence mechanisms of to market. candidate through development, support late-
growing unmet humans to provide a stage clinical trials & commercialization, &
provide up-front capital & milestone payments to
medical need globally. fund further development efforts.
*Foresight Pharma’s
proprietary Background: The Need for the Product
technology platform The control, prevention and 3. HSV: Over 67 million people are to viral infections.
and uniquely management of STIs, particularly infected with HSV in the US alone,
formulated lead those caused by viral agents, the virus which causes genital warts The inner penile foreskin’s
represent a significant unmet and is also one of the most important epithelium is similar to that of
candidate has risk factors for transmitting HIV the oestrogen-deficient vagina.
healthcare challenge worldwide. STIs
resulted in a reduced are a major cause of acute illness, worldwide. That is, a person
risk profile of the infertility and death of millions of infected with HSV is up to 3 times Foresight Pharma has
agent, resulting in an men, women and infants. Three more likely to contract HIV in a investigated this relationship and
important STIs include Human sexual encounter. The estimated shown that the inner layer of the
accelerated time to Immunodeficiency Virus (HIV), cost of genital herpes in the US alone male foreskin responds to the
market and revenue Herpes Simplex Virus (HSV), and is $1.5bn annually. administration of its lead
generation. Human Papilloma Virus (HPV). candidate, a topical oestrogenic
1. HIV: Currently 40 million people
The Science Behind agent, by thickening and
hardening the foreskin cells. This
are infected with HIV, with 4.3 the Solution reduces the ability of STIs to
enter the body, which could
million new infections & 3 million The inner layer of the male foreskin
deaths occurring each year. In the US prevent millions of infections
has been shown to be the principal
alone, AIDS results in $15.5bn in worldwide each year and save
site of the entry of STIs to the penis,
annual health care costs. billions of dollars in health care
as it is rich in cells which contain
costs.
viral receptors.
2. HPV: major strains of HPV are
responsible for over 90% of cervical In women, topically-applied
cancers, the second most common oestrogen has been shown to induce
cancer among women worldwide (0.5 thickening and hardening of vaginal
million new cases each year). cells, which decreases susceptibility
Foresight Pharma
THE MARKET The Management Team
Research by The Alan Guttmacher
Institute has found that there are Dr Phoebe Williams - Oxford Student Dr Arjun Goyal – Founder Professor of Obstetrics and
nearly 60 million men of Phoebe graduated from the Arjun graduated in Medicine, Gynecology at the University of
reproductive age in the US of Australian National University with a Surgery & French from the Melbourne.
which 7.7 million would be Bachelor of Science (Psychology) and University of Melbourne in 2006. He
interested in using a gel to Bachelor of Commerce with majors is a qualified doctor with Dr Andrew Pask is a molecular
prevent STI infection, even if the in Finance and Development experience in internal medicine & biologist upon whose research
product was not 100% effective Economics in 2005. She worked in surgery at academic hospital Foresight Pharma’s core
and its cost was more than twice equity markets before entering centres in Australia & United technology is based. He is an A/
that of a condom ($1). This graduate school and completed a Nations health policy. Furthermore, Professor of Molecular Biology at
results in a conservative market Bachelor of Medicine / Bachelor of he led Yabbipharm, a medical the University of Connecticut
estimation of $1.4bn in the US Surgery, with Honours, in 2008. She device start-up to the award of
alone, with a world market is currently a full Clarendon scholar 2007 Melbourne University Dr James Cherry is an intellectual
estimation of greater than $4bn. at Oxford University as a candidate Entrepreneurship Challenge’s Best property lawyer at Freehills, a
for the MSc (Global Health Science). Biotechnology Company Prize. He is leading Australian law firm, who
A second market application is As the Founder of the International currently completing a specialises in IP law.
condom coatings. The current NGO Hands of Help postgraduate degree in bioscience
coating used on condoms is (www.handsofhelp.org) she has 6 enterprise at the University of Dr Joshua Funder is an Associate
Nonoxynol 9 (N=9), which has years experience working in Cambridge on a full scholarship. at GBS Ventures, Australia’s
been shown to increase the risk of developing countries, which, leading life science venture fund.
STI transmission. Foresight combined with her financial, health Professor Roger Short AM FRS is an He is a Rhodes Scholar with a
Pharma’s lead candidate could economics and medical skills gives internationally recognized DPhil in intellectual property law
replace N-9 as a condom coating her a unique knowledge base with reproductive biologist upon whose and his expertise lie in Venture
which would result in diminished which to effectively institute research Pharma Foresight’s core Capital & Intellectual Property
STI transmission, giving the Foresight Pharma across the world. technology is based. He is a
product access to the US$3.26bn
global annual retail market for
condoms (with a forecast annual
growth rate of 4-5%).
The Competition Foresight Pharma’s competitive INTELLECTUAL
PROPERTY
advantage extends to:
There are no other hormonal agents in 1. Being the first in class Foresight Pharma has filed
development for the prevention of STIs. compound – no other competitor one pending international
Currently, microbicides are being patent
hormonal compounds are
investigated as the compound of choice, yet (#PCT/AU2008/00065) to
currently in development phase
secure its proprietary
BUSINESS to date there has been no approved
technology. This will allow
microbicide to reach the market and 2. A proprietary technology it to pursue a focused
OPERATIONS efficacy data has proved largely equivocal. platform which will enable clinical development
Foresight Pharma will develop its accelerated time to market and program & value enhancing
Currently there are over 40 microbicides reduced risk profile, as the basic commercial partnerships to
proprietary lead candidate in
being evaluated, with 5 undergoing advanced formulation has already undergone take its lead candidate to
partnership with a large
clinical development. However, these are all extensive clinical and regulatory market. Foresight Pharma
pharmaceutical partner through
vaginal microbicides targeting women and review for other indications will use seed funding to
clinical development &
there are no other topical penile agents strengthen its IP position by
commercialisation. The global shift
under clinical investigation. Foresight 3. Scope for unique proprietary filing additional patents
to preventative medicine to reduce that cover innovative drug
Pharma therefore has the competitive drug delivery systems to extend
increasing healthcare costs & the delivery systems to further
advantage of being the only use to other topical indications
significant global unmet need in the differentiate our product.
penile agent that may be used to prevent the
prevention of STIs will mean there is
transmission of STIs.
a compelling case for reimbursement
by national healthcare payers, Pharma Foresight’s Fusion Inhibitors Gp120 Binders Acid
medical charities & philanthropic Lead Candidate (Vaginal (Vagibal Buffering
organisations. We will also pursue a (Penile oestrogen) Microbicide) MIcrobicide) Agents
price differentiation strategy which (Vaginal
will ensure equitable access of our MIcrobicide)
drug in the developing world. We do Candidates Oestrogenic PRO2000 Cyanovirin Buffergel
not discount a trade sale to a Compound Carraguard Vivagel Acidform
pharmaceutical partner in the event
that key clinical milestones are met, Efficacy Untested Moderate (30% Pending: Unequivocal
given the significant unmet need in reduction) Unequivocal protection
protection
growing markets our drug addresses.
Safety Good safety profile of Good Poor Good
Profile oestrogenic
compounds
Cost of manufacture Low High High Low
Potential for Yes Yes Yes Yes
Combination Therapy
Table 1: Comparison between the 3 Categories of Vaginal Microbicide in development and Pharma
Foresight’s Lead Candidate, a penile oestrogenic compound.