Paclitaxel

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MewTaxelA new treatment for Cancer
Meda Biotech llc. 4000 McHugh Rd. Zachary,LA70791

• Next Generation nanomedicine
• Hybrid-Nanoengineering

Think big and different, start small, and fail
fast and often to succeed for sure-----MewTaxel
is the outcome of that!
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What is MewTaxel?

• It is a new combination of two drugs to treat
  cancer
• One is Paclitaxel (a known drug to treat many
  types of cancer).
• Second molecule is MR007(a newly identified
  molecule to make nanoparticles)
• Resultant formulation of these molecules leads to
  a nanomedicine that has a potential to treat
  cancer much more aggressively and safely.

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Problem

• Paclitaxel existing formulation is very toxic.
• It has many side effects.
• Dose is not optimal.
• Poor bioavailability.
• Long administration time at doctors site

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Opportunity

• 4.5B established market
• Market is growing
• Patent is expired
• Nanotechnology is the need of coming decades.
• We are not me-too technology like other
  nanomedicine formulations.
• A strong discovery behind our patent.
• All discovery and research phase paid.
• Minimal risk.

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Ongoing path to success

• 1st year Preclinical
• IND 26 weeks
• 2nd Year Safety study in dogs
• 3rd Year license out to vet
  market
• 4th 5th Year Phase-l and
  Phase-ll
• EXIT 500M

3M
Efficacy in canine

25M

8-15 Rl


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Common Problem for many drugs

• Currently, about 30 of drugs that appear on the
  World Health Organization (WHO) Essential Drug
  List were reported to be poorly water-soluble,
  based on the Biopharmaceutics Classification
  System (BCS) .
• Over 40 of newly developed pharmaceutically
  active substances have solubility issues.
• The poor dissolution and/or permeability of these
  drugs often result in low and highly variable
  bioavailability.
• The major obstacle of successfully
  commercializing these compounds is the difficulty
  of enhancing their dissolution rate and extent of
  dissolution.

Not only Paclitaxel we have 95 more products in
pipeline
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More Specific Problems

• In a word bioavailability. As much as 40
  billion is invested annually in drug discovery.
  Unfortunately, many of the drug leads that result
  exhibit poor water solubility and an inability to
  deliver therapeutic agents in vivo. In fact, it's
  estimated that 40-50 percent of these new
  chemical entities are poorly water soluble.
  (which leads to a number of otherwise promising
  technologies to be abandoned)
• Despite the solubility issue, worldwide sales of
  poorly soluble drugs are about 108 billion and
  it is going to increase further. It is reasonably
  expected that improving water solubility would
  only increase this number.
• The result is inefficiency in the RD process.
  Due to the challenges of evaluating efficacy in
  biologic models for a poorly bio-available
  compound, these compounds are often shelved with
  no further development activityeven if they show
  promising therapeutic activity in cell culture.
• Medas hybrid formulation technology addresses
  this problem by improving water solubility,
  bioavailability, effectiveness and efficiency.
• Poor water solubility for many drugs and drug
  candidates remains a major obstacle to their
  development and clinical application.
  Conventional formulations to improve solubility
  suffer from low bioavailability and poor
  pharmacokinetics, with some carriers rendering
  systemic toxicities (e.g. Cremophor1 EL).

We have no competitor to our technology
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Available Solutions Limitations

• Here are some basic pluses and minuses of the
  different options.
• pH adjustment is the best option if you can get
  decent solubility and good stability within a
  reasonable pH range. Although you have probably
  heard pH 4 pH 10 batted around, there is really
  no fixed range of acceptable pH. It depends on
  rate, duration, and route (small vein versus
  large vein) of administration and on the buffer
  capacity of the formulation.
• Cyclodextrins are the next best option in terms
  of safety and ease of preparation, but until
  someone forks out the cash for a good enough
  lawyer to challenge the very questionable
  Jannsen/JJ patent on hydroxypropyl-beta-cyclodext
  rin, there will be licensing arrangements and
  royalties involved. Nephrotoxicity is the primary
  physiological issue associated with
  cyclodextrins, but as long as you dont give too
  much too fast, you should be okay.
• Co-solvent formulations typically require very
  high concentrations of co-solvents, and these
  formulations are not dilutable without
  precipitation. Because of their high osmolality,
  these formulations must be administered through a
  large vein, where there is good blood flow.
• Micellar formulations are easy to prepare but
  have a major liability, which is that they tend
  to cause the occasional patient to go into
  anaphylaxis. In many cases a drug can be
  dissolved in a mixture of a solvent and a
  surfactant such as Cremophor or Polysorbate to
  provide a dilute-for-use formulation. Generally
  patients will need to be pre-dosed with steroids
  and antihistamines so that the drug product
  doesnt accidentally kill them.
• Emulsions and liposomes have generally low
  toxicity profiles but are a pain to make.
  Liposomes tend to have a lot of physical
  stability issues and are typically lyophilized.
  However, this is good and bad since, unlike
  emulsions, they can be lyophilized quite easily.
  The one caveat to the good safety profile of
  these formulations is that they can cause
  hyperlipidemia and liver enzyme elevation if too
  much is administered too fast.

Here are some me-too old technologies Competing
with each other
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What our technology Offer

• New concept and new approach
• There have never been used two active molecule in
  nanomedicine
• There have never been developed a hybrid
  nanomedicine
• There have never been used an active molecule to
  developed a water soluble drug formulation
• Two water insoluble drugs have never been used
  to developed a water soluble formulation, at
  least without changing the chemistry
• Chemistry of individual drugs remains unchanged
• A better treatment

IT IS NOT JUST nanomedicine BUT A BETTER
TREATMENT
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Success Technology making money

• Hybrid-Nanoengineering
• Like Abraxane approved for human-success
• Doxil-success
• In process to raise 25-26M for human trials-will
  make success
• We will able to have our 1st exit to out license
  to veterinary market with a fee of 25M and use
  the same to human clinical trials A successful
  deal made by Abbott.

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Hybrid-Nanoengineering Technology Advantages

• New discovery and patented
• Synergistic effects
• Potentiating effects
• Passive targeted nanomedicine
• Less toxic
• Low manufacturing cost
• Multiple mode of action

A major driving force in the hybrid drug
development community is to overcome one of the
worst things that can happen to a drug the
development of resistance in its target
population. In most such hybrids, the two drug
like portions, also called pharmacophores, have
independent modes of action that make the
emergence of drug resistance less likely.
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Technology
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Next Steps

• cGMP manufacturing and pre clinical
• Determine maximum tolerated dose, safety and
  therapeutic efficacy
• Evaluate efficacy in canine indications
• Perform a Phase I clinical trial in companion
  dogs presenting with ..
• Human clinical
• Approvals

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Road Map To Clinical, Funding And Exit
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PROGRESS
MewTaxel

• PROOF OF CONCEPT ------ESTABLISHED
• R D----------------------------ESTABLISHED
• PILOT SCALE MANUFACTURING ---ESTABLISHED
• IN-VITRO STUDY---PRELIMINARY TESTING ESTABLISHED
• Pre clinical--------------
• Phase-l
• Phase-ll

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Why Paclitaxel?

• There are 1989 ongoing clinical trials associated
  with Paclitaxel in various combinations and
  formulation compositions. Among them 83 are with
  nanoparticles. This reflect a further growth of
  the product.

Hybrid-Nanoengineering Will be the winner and a
game changer in the field of nanomedcines
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Team

• Dr.Mewa Singh- 15 years of drug discovery
• Dr.Timothy A,M.D-20 years drug development
• Dr.Khushi Matta- 40 years of cancer research

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Technology
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Hybrid-Nanoengineering(MewTaxel)
Proprietary
Docetaxel
EGRF
P13
x
Efflux Pump
IL-6 TNF
The COX-2 produced by a malignant tumor and COX-2
produced by the surrounding host tissue both
contribute to new vessel formation, which
explains how selective COX-2 inhibition reduces
tumor growth where the tumor COX-2 gene has been
silenced by methylation
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Mode of action
Mewtaxel
A better approach
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Mode of action
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Contact Information

• Mewa Singh PhD
• Meda Biotech llc
• 609-902-7128
• mewasinghsandhu_at_hotmail.com
• www.nanomeda.com
• www.nanosgroup.com