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					                                   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.

				
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