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Bioterm Pharmaceuticals Ltd. Investor Presentation

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Executive Staff Dr. I. Shamir Leibovitz: President, founder, Chief Medical Officer, inventor of Preventerm & Inducterm Ceo. Prof. Eliezer Shalev: Director of Clinical ... – PowerPoint PPT presentation

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Title: Bioterm Pharmaceuticals Ltd. Investor Presentation


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  • Executive Staff
  • Dr. I. Shamir Leibovitz President, founder,
  • Chief Medical Officer, inventor of Preventerm
    Inducterm
  • Ceo.
  • Prof. Eliezer Shalev Director of Clinical Trials
  • Prof. Daniel Siedman Associate Director of
    Clinical Trials
  • Board of Advisors
  • Prof. Robert Goldenberg
  • Prof. Phillip Robert Bennet
  • Prof. Emile Papiernik
  • Dr. Joseph Blankstein

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  • Preterm Labor
  • Afflicting more than one out of ten pregnancies,
    preterm birth is responsible for 75 of infant
    deaths and up to 50 of neurological handicaps
  • In spite of great advances in medical research
    and development of drugs, clinical therapies and
    surgical procedures, thus far no effective
    solution exists to prevent preterm labor
  • Postterm Pregnancy
  • Likewise, treatments currently available to
    induce labor have proven to be unsafe, costly,
    and mostly ineffectual
  • Induction of labor is generally initiated when
    the cervix has not sufficiently softened to
    facilitate birth

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Treatments for Preterm Labor Preventerm Tocolytics Tractocile
Efficiency High Low Medium
Duration of Prevention Up to a full week 48 hrs. max 48 hrs. max
Major Side Effects None Some, but rare None
Drug Origin Natural/ Organic Natural/ Synthetic Synthetic
Possible office use? Yes Impractical No
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Treatments for Postterm Preg. Inducterm Prostaglandins Oxytocin
Success Rate Potentially over 80 30-55 40-60
Side Effects Potentially insignificant Uterine tetany, potential fetal distress, uterine rupture, water intoxication Very rarely fetal or maternal death Uterine tetany, potential fetal distress, uterine rupture Very rarely fetal or maternal death
Time to Delivery Est. 3-5 hours 12-48 hours 6-24 hours
Office Use? Yes No No

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Preventerm (patent pending) blocks 3 out of the 5
factors that prepare the cervix for labor,
representing an extremely effective multi-step
inhibition of the enzymes that begin the labor
process Attacking metalloproteinases and
cytokine precursors, Preventerm interrupts
several steps in the biological pathway thereby
preventing labor for an unprecedented length of
time up to a week, and with 90
efficacy Inducterm (patent issued) works by the
reverse process, providing collagenase to begin
the breakdown of cervix proteins and thereby
inducing labor in a matter of 3-5 hours Both
drugs are based on already scientifically and
clinically proven molecules that are safe,
inexpensive, and easily administered with minor
to no side effects
7
Preventerm is derived from a naturally occurring
amino acid derivative and thiol reducing
agent This drug is exceptionally easy to
manufacture, as it draws from a widely available
molecule Preventerm is ready to begin Phase II
testing by our research team Inducterm is
created from ubiquitous collagenase, an enzyme
that governs the breakdown of collagen in various
human and animal systems Collagenase is already
FDA approved for unrelated indications and in use
by Biospecifics Technology Corp. (US) for tissue
healing therapies Inducterm is ready to begin
pre-clinical trials
8
Preterm births occur in approximately 11 of all
deliveries, affecting 1.5 million pregnancies in
Europe, Japan, and the US alone ICU costs for
these cases amount to a staggering 50 billion
per year based on an average incubation of 21
days Health complications following delivery from
preterm birth increase this amount
substantially Induction of labor must be
performed in close to 17-24 of pregnancies,
accounting for 3.0-3.4 million births Methods of
inducing labor are dangerous, controversial, and
largely ineffective raising the need for
cesarean sections and creating other costly
complications
9
  • Ferring (Sweden) manufactures Tractocile
    (Atosiban) to prolong labor for up to 48 hours
    our major competitor
  • Average cost 1,500/dose usually given several
    times
  • Tractocile produces a yearly revenue of 650
    million
  • Various drugs exist to induce labor
  • Cytotec (Pharmacia/Pfizer)
  • Prepadil Gel (Pharmacia/Pfizer)
  • Cervadil (Controlled Therapeutics)
  • Pitocin (King Pharmaceuticals)
  • Cervadil alone accounts for over 67.5 million
    in sales per year

10
With 1.5 million premature births in Europe,
Japan, and US per year, and a planned cost price
of 2,000 for Preventerm, each 1 of market share
or 15,000 treatments translate into 30 million
in revenues With annualy 3.0-3.4 million births
requiring labor induction treatment, and a
planned cost price of 1,000 per treatment with
Inducterm, each 1 market share or 32,000
treatments means 32 million in revenues
11
Various scientific case reports on the use of the
Preventerm source molecule report no adverse side
effects to the mother or infant Preventerm stands
to decrease the overall expense of preterm infant
health care and will reduce infant mortality as
well as post-natal complications
considerably Initial tests of Preventerm have
shown a 90 efficacy rate in preventing preterm
labor overwhelmingly more effective than any of
the currently available treatment modalities
12
Inducterms source molecule has also been tried
and tested and carries an FDA approval for
unrelated indications As a result, much of Phase
I testing can be foregone, saving a considerable
amount of time and needed capital Inducterm has
also shown a considerably higher efficacy rate
than any drug currently available, and induces
labor in over 80 of cases in a period of 3-5
hours
13
We intend to generate revenue through joint
and/or strategic collaborations with large
pharmaceutical and biotechnology companies in
order to further develop our products, jointly
facilitate regulatory approval, and subsequently
to bring our products to the global markets Our
partners will be bearing the costs of pre-market
regulatory approvals, marketing, distribution and
sales of our drug products
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  • Our revenues will derive from an upfront lump
    sum for the licensing of our Preventerm and
    Inducterm, and subsequent royalties on sales
  • In addition we will continue our own development
    of drug products for other specific indications,
    i.e. veterinary, independently
  • We expect to generate cash flow within one year
    by means of our licensing and/or partnering
    arrangements (i.e. veterinary)
  • Longer term, we plan to generate proprietary
    drug portfolios independently and bring them to
    market

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  • Bioterm Pharmaceuticals Ltd. is a unique
    investment opportunity due to its
  • Patented and patent-pending breakthrough drugs
  • Direct solution to a pressing market need
  • Vast expertise in the OB/Gyn industry
  • Several discrete multi-billion dollar markets
  • Strategic value to large pharmaceutical
    companies
  • By 2010 we envisage revenues to approach 43
    million with net income reaching 18 million

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The vast growth in medical care expenses has
generated substantial attention to finding
treatments that are not only useful and safe, but
cost effective as well. In 1999, gross domestic
expenditure on healthcare in the U.S. reached
1.3 trillion and is projected to grow to 2.1
trillion by 2007. - National Center for Health
Statistics, 1995. Similar to the overall
healthcare market, the OB/Gyn market had
experienced increasing pressures to cut down
expenses while maintaining the quality of care.
Despite this trend, expenditures in this market
are on the rise. - Am. Family Physician, 1999
  • Our comprehensive business plan, executive
    summary, and extensive scientific and medical
    data are available upon request
  • Shamir Lebovitz President CEO
  • sibiotec_at_yahoo.com
  • 972-54 6375565
  • T 972 (0)54 755 614
  • Bioterm Pharmaceuticals
  • http//www.bio-term.com
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