Drug delivery technology that could make a drug more effective and less harmful to patients. 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 .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 R&D 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 activity—even if they show promising therapeutic activity in cell culture. Meda’s 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). Scale. The process has been specifically developed to achieve commercial manufacturing scale. Simplicity. The technology is unique in its simplicity as the process can be performed using normal manufacturing equipment that is present in most development and manufacturing facilities. Cost & Increased Profitability. Because the development costs for new chemical entities are so high, many companies are instead working to optimize existing marketed molecules – this saves R&D expenses and should also have decreased drug approval costs. This is perhaps the only available technology that delivers a synergistic and potentiating partnership with a soluble formulation. Technology-Patented Experience –More than 40 drugs Creativity – A new approach from our discovery Combining technology, experience, and creativity, Meda Biotech would like to explore the opportunities with you.

1. Meda Biotech LLc.
Water Soluble Hybrid
Drug Delivery Systems
A straight-forward technology aimed at
reducing dosage (frequency & total
amount) requirements and side effects
Mewa Singh
609-902-7128
mewasinghsandhu@hotmail.com

2. Water Soluble Drug Delivery Systems - Approach
 Hybridize the drug to achieve (increase) water
solubility
 Maintain basic chemistry of active molecules
 Potentiate efficacy of the drug
 Synergistic effects
Copyright: Meda Biotech/Mewa Singh 2

3. WHO Report
 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
Copyright: Meda Biotech/Mewa Singh 3

4. Technology Platform-Drug
Delivery
Synergistic /Potentiating Hybrids
Insoluble Hybrid Formulation Technology Soluble
Copyright: Meda Biotech/Mewa Singh 4

5. Impact of Drug Delivery:
Summary
 Drug delivery provides measurable value
 Utilized in some capacity in 40% of Top 20
pharmaceutical products with sales of 51
billion USD worldwide.
 Drug delivery increases revenues via patent
protection and life cycle products
 Delays generic introduction in some cases
and provides additional franchise revenues.
 Drug delivery has to make sense
 Does not provide inherent value to all
programs. Must be product/market driven.
Copyright: Meda Biotech/Mewa Singh 5

6. Impact of DD Technology on
Products
 Emend
Solubilization technology enabled product to reach market. Sales of
$380 million USD in 2010.
 MegaceES
Eliminated food effect and reduced dose size. Important for patient
population that has difficulties eating/swallowing. Sales of approx.
$70 million USD.
 Intelence
Solubilization technology enabled product to reach market
 Invega
OROS and Nano-crystal technologies created products with good
safety/efficacy profiles. May be difficult for Generics to copy. Sales
of $424 million USD in 2010.
 TriCor
Reduced dose, eliminate food effect, LCM delayed Generic
introduction. Sales of $1.6 billion USD in 2010.
 Geoden
Allowed for an injectable form to reach market. Franchise sales of
over $1 billion USD in 2010
Copyright: Meda Biotech/Mewa Singh 6

7. Proprietary Synergistic Hybrid
Technology
 Main focus: improve an existing or new
drug to make a better product
 Increased Water Solubility improves
effectiveness
 Increased Water Solubility indirectly reduces
toxicity
 Added bonus: potentially decreased cost of
manufacturing
 Overall great increases in ease and
convenience.
Copyright: Meda Biotech/Mewa Singh 7

8. Successfully improved Hybrid Drugs for
solubility
Paclitaxel Tadalafil Rapamycin
Bexarotene verdenafil 5-aminosalicylic acid
Aspirin Celecoxib Docetaxel
Combretastatin Ibuprofen Epothione A
Prednisone Quinine Itraconazole
Azathioprine Artemisinin Cyclosporin
Nimesulide Rapamycin Tadalafil
Sildenafil Camptothecin Statin
Aripiprazole Paliperidone Megastrol
Carbenicillin verdenafil 5-aminosalicylic acid
Ofloxacin Budesonide Tamoxifen
Finofibrate Clopidogrel Valsartan
List is growing
Copyright: Meda Biotech/Mewa Singh 8

9. Problem
Effectiveness of the drug is directly proportional to
the amount of drug reached at disease site
 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 R&D 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 activity—even if they
show promising therapeutic activity in cell culture.
 Meda’s 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). Copyright: Meda Biotech/Mewa Singh 9

10. Meda: Hybrid Technology
Q: How does Meda differ from other
nanoformulation and solubility technology
on the market?
 Existing techniques, they use multiple
expensive steps and almost everyone use just
polymers or proteins to make these drugs
more soluble.
 Meda’s hybrid formulation technology is
simple and cost effective to achieve required
solubility. Meda uses a partner molecule for
solubility, which also provides synergistic
and potentiating effects to parent drug.
Copyright: Meda Biotech/Mewa Singh 10

11. Meda Advantages
 Scale. The process has been specifically developed to
achieve commercial manufacturing scale.
 Simplicity. The technology is unique in its simplicity as
the process can be performed using normal
manufacturing equipment that is present in most
development and manufacturing facilities.
 Cost & Increased Profitability. Because the
development costs for new chemical entities are so
high, many companies are instead working to optimize
existing marketed molecules – this saves R&D
expenses and should also have decreased drug
approval costs.
 This is perhaps the only available technology that
delivers a synergistic and potentiating partnership with
a soluble formulation.
Copyright: Meda Biotech/Mewa Singh 11

12. Collaboration
 How can I work with Meda Hybrid
Technology?
Meda is targeting commercial activity in
drug discovery and development as a
formulation resource for industry and
academic researchers.
We can work with you to create an
efficient and effective way to leverage
existing libraries of compounds with
known solubility issues but with great
commercial potential.
Copyright: Meda Biotech/Mewa Singh 12

13. Meda: Our Strengths
 Technology-Patented
 Experience –More than 40 drugs
 Creativity – A new approach from our
discovery
 Combining
technology, experience, and
creativity, Meda Biotech would like to
explore the opportunities with you.
Copyright: Meda Biotech/Mewa Singh 13

14. Product and Technology Deals
 Need to understand past and current deal
terms
 Upfront Payments
 Royalties
 Milestones
 Development Fees
 Phase Deal Signed
 Therapeutic Category
 Route
 Technologies licensed (DD, Discovery)
Copyright: Meda Biotech/Mewa Singh 14

15. Proof of Concept
 We are currently working on furthering a water-
soluble version of Taxol that is garnering substantial
interest
 We are so confident in our technology and it’s
cost/manufacturing efficiency that we are willing to
discuss a proof-of-concept proposal: from your
product portfolio we will work with you to select a
candidate to adapt into a new, water-soluble form
that can then be evaluated for various characteristics.
◦ Our process is fairly quick and cost efficient so the
expenses related to this should be minimal (and
probably close to nothing except for provision of the
starting molecule)
Copyright: Meda Biotech/Mewa Singh 15