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Cutting edge water-based Nanotechnology in

drug development
Addressing key challenges in predictability, solubility, toxicity,
stability and intellectual property

September 10, 2009

Dr. Ajay Pandit


MBBS, MS (Penn State), MBA (Penn State)

Practice Head – Healthcare Practice,


GlobalData
apandit@globaldata.com

© GlobalData
Table of Contents

• Unmet Needs
– Understanding unmet needs

– Quantifying unmet needs

– Forecasting unmet needs

• Nanotechnology in Pharma/Biotech Industry

• Technology Adoption Framework

© GlobalData 3
Table of Contents

• Unmet Needs
– Understanding unmet needs

– Quantifying unmet needs

– Forecasting unmet needs

• Nanotechnology in Pharma/Biotech Industry

• Technology Adoption Framework

© GlobalData 4
Understanding Unmet Needs in Drug Solubilization
Market – Why is Drug Solubilization a Problem?
• Poor solubility has become a major challenge in drug delivery as
Active Ingredients in 90%1 of the active ingredients are proved to be having low aqueous
Issue development are solubility issues and this proportion is still growing
poorly soluble • This implies that drug solubilization techniques could potentially
impact up to 90% of R&D

• Hydrophobic nature of the New Chemical Entity (NCE) prompts for


Time and cost screening of its various salts with the aim of identifying one with
Effect on R&D involved with similar safety and efficacy and a better solubility/bioavailability
screening for salts • Salt selection is a time consuming process and delays the drug
development, thereby adding to the development cost of a drug

Failure of drugs to • Nearly 75% of preclinical stage drugs do NOT move to phase I
Effect on
move from preclinical • Around 39%3 of these failures are attributed to poor drug-like
Pipeline to phase I properties of the drugs (implying low solubility)

• About 40%2 of drugs currently on the market exhibit poor solubility


Increase in number of
Impact on leading to poor dissolution kinetics and suboptimal bioavailability, in
poorly soluble drugs
Market Size other words low product efficacy and reduced commercial success
on the market
due to poor patient/physician perceptions

© GlobalData 5
Table of Contents

• Unmet Needs
– Understanding unmet needs

– Quantifying unmet needs

– Forecasting unmet needs

• Nanotechnology in Pharma/Biotech Industry

• Technology Adoption Framework

© GlobalData 6
Impact on R&D Revenues due to Poor Drug like
Properties

Drugs in
Why do they fail?
Preclinical Stage

High Toxicity Adverse Effects


11% 10%

Molecules Molecules Poor Drug like


promoted failed in Properties
from N = 3,900
preclinical 39%
preclinical to 75%
phase I Low
25% Efficacy $8.2B
30%

Others
10%

Poor Drug Like Property Group could be helped by advanced drug solubilization
techniques  $8.2B

© GlobalData 7
Calculating Unproductive R&D Costs due to
Poor Drug-like Properties
Preclinical
Development
Number of products in preclinical phase 2007 3,9004

Average R&D expenditure per product in preclinical phase $7.24 million

Total R&D expenditure on products in preclinical phase $28.2 billion5


1
Success rate (preclinical to phase I) 25%

Productive $s $7.1 billion

Failure rate (Do not move to phase I) 75%


2 R&D $s that are Unproductive $21.1 billion

Failure due to poor drug-like properties 39%

3 Unproductive R&D expenditure solely due to poor drug-like $8.2 billion


properties

© GlobalData 8
Quantifying Unmet Need for Missed
Revenue Opportunity
Of 775 (39% failing due to poor drug-like properties) new compounds enter
Assumptions phase I from preclinical stage in 1996

If at least, 18-30 compounds are approved and enters the market in 2006

Product Revenues at an average of $84 million per product (Based on the


sales of NCE’s in 2007, which are released in 2006)

Extra revenues of approximately $1.6 billion can be generated in


pharma/biotech industry in first year of launch alone.

Market Potential in 1st Year: $8.2 b + $1.6 b = $9.8 billion

If new drug solubilization technology becomes the new benchmark for all the R&D
products, then above number would be much higher (at least 2X)

© GlobalData 9
Table of Contents

• Unmet Needs
– Understanding unmet needs

– Quantifying unmet needs

– Forecasting unmet needs

• Nanotechnology in Pharma/Biotech Industry

• Technology Adoption Framework

© GlobalData 10
Impact on R&D Costs due to Better
Solubilization – Forecasts
R&D Revenue Loss due to Poor Drug like Properties, 2007-15

20
10 .7 % 16.7
18 CAGR
16 15.1
13.7
Revenues $ billion 14 12.4
Entry point for Drug 12 11.2
solubilization techniques 10.1
10 9.1
will fall in this group 8.2
8
6
4
2
0
2007 2008 2009 2010 2011 2012 2013 2014

In 2007, there is a loss of $8.2 billion approximately due to poor drug like properties
in the R&D and will rise to $18.5 billion by 2015, with a compound annual growth
rate of 10.7% (if better solubilization techniques are not used)

© GlobalData 11
Impact on Added Revenues due to Better
Solubilization – Forecasts
Revenue Generated by Addressing Poor Drug like Properties, 2007-15

100
90
80 Better Drug solubilization
%
R 31 techniques will add extra
CAG
Revenues $ billion

70 revenues to the
60 pharma/biotech market
67.5
50 59.6
40 51.6
39.3
30 28.2
Cost savings is relatively minor
20 18.1
5.1
10.5 component of value added
10 1.6 16.7 18.5
10.1 11.2 12.4 13.7 15.1 by Nanotechnology
8.2 9.1
0
2007 2008 2009 2010 2011 2012 2013 2014 2015

In 2007, nearly $9.8 billion potential value could have been created if better
solubilization techniques were employed.
This value could increase to $86.0 billion by 2015, with a growth rate of 31%

© GlobalData 12
Table of Contents

• Unmet Needs
– Understanding unmet needs

– Quantifying unmet needs

– Forecasting unmet needs

• Nanotechnology in Pharma/Biotech Industry

• Technology Adoption Framework

© GlobalData 13
Impact of Nanotechnology on Product Lifecycle
Management

Impact in Development
Impact in Discover Phase Life Cycle Management
Phase

 New formulation strategies  Provide maximal drug  Minimize compliance


to resolve the solubility exposure by various patient- issues
issues friendly dosage forms  For marketed products,
 Fast and efficient when  Increased dosing efficiency new formulation
used during preclinical reduces the overall need for strategies using
efficacy and safety studies a drug nanoparticles helps in
 Bioavailability enhancement  Nanoparticles helps in incorporating old drug
by enabling the novel oral delivering large dose in into new drug delivery
dosage forms, improved small volumes platform to meet the
safety profiles etc., unmet medical needs –
 Ideal medium for all routes which will grant a new IP
of drug administration and allow to launch new
compound in the market

The potential applications of Nanotechnology has been implemented successfully to


commercialize more than 30 drugs like Abraxane, Docetaxel, and TriCor are very
few to name

© GlobalData 14
Trends for Nanotechnology Acceptance in
Pharma/Biotech – Market Size of Nanotechnology
Sales within Pharma/Biotech Industry
Nanotechnology enabled DDS Market Potential Forecast 2007-15

300

250
Revenues $ billion

• Drug delivery system (DDS) targeting specific


200 tissues
• Drug delivery of genes and vaccines through
nanohydrogels and nanocarriers
150 • Controlled-release drug delivery systems
%
6 8.4 • Increased biocompatibility
G R
100 CA
• Improved drug bioavailability and solubility

50

0
2007 2008 2009 2010 2011 2012 2013 2014 2015
In 2007, the market forDDS
Nano-enabled Nanotechnology enabled DDS
Other DDS Total is
DDSapproximately $3.4 billion.
If Nanotechnology is completely adopted, the market is expected to be $216 billion
by 2015, with a compound annual growth rate of 68.4%

© GlobalData 15
Table of Contents

• Unmet Needs
– Understanding unmet needs

– Quantifying unmet needs

– Forecasting unmet needs

• Nanotechnology in Pharma/Biotech Industry

• Technology Adoption Framework

© GlobalData 16
Technology Adoption Framework

High unmet need exists and creates a As a result clients look for potential
Significant bottle neck which
significant challenge to drug solutions that might solve the
impacts the key business metrics
development bottleneck

New Technology Adoption Trend

Technology Exists
Client Awareness Evaluation of Technology Trial – Unmet Need
to Fulfill Unmet Complete Adoption
of Technology Technology Proof of Concept Fulfillment
Need

     
Nanotechnology Awareness of Only 30 products Even though, Nanotechnology Nanotechnology is
enabled drug Nanotechnology in have been Nanotechnology has not been very efficient in
solubilizers has pharma/biotech developed using has demonstrated adopted addressing the
better safety R&D is low. Full Nanotechnology, its effectiveness in completely in solubility issues
profile and market potential of implying low pharma/biotech pharma/biotech and thereby
enhances the Nanotechnology evaluation rate, industry, it has not industry due to the bioavailability
bioavailability of a will be captured which needs to been exploited huge investments needs of the
drug only by increasing increase for the completely due to involved in the pharma/biotech
the awareness of technology to inadequate testing initial stages and industry and will
this technology become a gold- methodologies low awareness be a huge success
standard to levels by overcoming the
address solubility hurdles for
issues complete adoption

© GlobalData 17
Typical Technology Adoption Curve

Nanotechnology is in
early stages of
adoption in
pharma/biotech
industry

1 2 3 4 5

© GlobalData 18
Market Drivers for Nanotechnology

• Innovative technologies such as NeoWater, NanoCrystal and NanoEdge for enhancing drug
Innovations in drug
solubilization
solubilization • New approaches such as tissue targeting and permeation enhancement are being explored in
technology tandem with the nano-sizing concept

• High demand for innumerable formulation-related performance issues such as poor solubility,
High demand due to
toxicity, poor bioavailability, lack of dose proportionality, safety issues with use of co-solvents,
unmet needs and slow onset of action
sr evi r D

• Pharma/biotech companies with number of potential treatments that remain unexplored due to
Adopting effective and
poor solubility issues adding to the unproductive spent, are exploring the newer ways to generate
superior technologies ROI

Extending product and • Nanotechnology-enabled drug delivery systems help in extending the product and patent
patent lifecycles lifecycles by creating novel reformulations of existing or discontinued compounds

© GlobalData 19
Barriers and Challenges for Nanotechnology

Huge investments in
• ‘Known Devil is better than Unknown God’ seems to be the rule followed by pharma/biotech
the initial stages to
industry. Uncertainty of ROI on new technology investments is inhibiting the companies from
evaluate the new adopting Nano-enabled technologies
technologies

Industry Awareness • As is seen from Technology adoption curve, awareness is relatively low amongst industry
regarding role of stakeholders with regards to potential of nanotechnology applications in Pharma/Biotech R&D. If
nanotechnology in the awareness does not increase, it could have a potential impact on growth of nanotechnology
sr oti bi hnI

R&D in Pharma/Biotech industry

Environmentalists • Nanotechnology has drawn severe criticism from health advocacy groups, environmentalists and
perceptions other non-government organizations due to hypothetical safety concerns

• Need for new equipment and manufacturing support to use Nanotechnologies


Need for advanced • Testing methodologies are not yet been placed or developed to keep pace with Nanotechnology
facilities in R&D

© GlobalData 20
Trends Indicating Growth of Nanotechnology
Market

• Nanotechnology patent filings are increasing across the globe and there by protecting the
Shift in patent patterns with the Intellectual Property (IP) due to the favorable changes by the regulatory authorities by creating a
separate registration category for the Nanotechnology inventions for example, Class 977 in the US
entry of Nanotechnology
by U.S. Patent and Trademark Office (USPTO)

• Nanotechnology companies have become very popular in addressing the key unmet needs across
all the industry segments
Increasing M&A activities in
• In Pharma/Biotech industry, companies are looking for potential mergers and acquisitions with
Nanomarkets Nano companies to handle pressure and overcome the issues such as generics entering the
market, low productivity

• Government programs to fund Nanotechnology R&D has increased significantly in the US, the UK,
Increased government funding for Russia, Japan, China, Germany and many nations in Europe and Asia
• In the last five years, more than $40 billion in government funds have been invested into
Nano projects Nanotechnology research worldwide and in 2009 alone it is estimated to be approximately $10
billion

• Nanotechnology applications are being used across all the sectors such as pharma/biotech,
Cross industry applications of electronics & IT, machinery & engineering, consumer goods and equipment, agriculture and food,
instruments etc.,
Nanotechnology • In healthcare, drug delivery technologies, Nano-structured medical devices etc
• In electronics and IT, manufacturing advanced memory chips and electronic displays

© GlobalData 21
Bibliography

1. Kathrin Nollenberger, Andreas Gryczke, Takayuki Morita, Tatsuya Ishii, ‘Using Polymers to Enhance Solubility of Poorly Soluble
Drugs’, April 2009,
http://pharmtech.findpharma.com/pharmtech/Ingredients/Using-Polymers-to-Enhance-Solubility-of-Poorly-Sol/ArticleStandard/Article/detail/59045
2. Kathrin Nollenberger, Andreas Gryczke, Takayuki Morita, Tatsuya Ishii, ‘Using Polymers to Enhance Solubility of Poorly Soluble
Drugs’, April 2009,
http://pharmtech.findpharma.com/pharmtech/Ingredients/Using-Polymers-to-Enhance-Solubility-of-Poorly-Sol/ArticleStandard/Article/detail/59045
3. Elizabeth B. Vadas, ‘Selection of the Best Candidate for Development’,
http://www.bioscienceworld.ca/SelectionoftheBestCandidateforDevelopment
4. ‘Drug development by world status’, http://www.pharmaprojects.com/contentimg/0407/Graph-2pr.gif
5. ‘Integrated Research and Development Center’, June 2006,
http://www.mpsidc.org/mp07/state-profile/Short-project-profiles/R_D_Center.pdf

© GlobalData 22
DO-COOP TECHNOLOGIES LTD.
PBR Webinar
September 10th , 2009
Webinar Agenda

•Neowater®
•Actual Cases
•Business Model
•Contact Us
An existing Technology available today which addresses the unmet
needs raised by Dr. Ajay is Neowater®

Understanding water and Nanotechnology led to the revolutionary


invention protected by a strong IP portfolio

•Neowater® displays a clear shift in the physical and chemical


properties of water due to a unique
organization and interaction between water,
suspended minute amount of nanoparticles and carbon dioxide.
• Neowater® physical properties mimic that of intracellular water using
inorganic, insoluble crystals introduced in water in a
patented process.
•Neowater® Solves key challenges in predictability, solubility, efficacy,
toxicity, stability and intellectual property
•Neowater® is non-toxic hence safe to use
Neowater® Patented process
SG-410
A license agreement recently signed between Champions biotechnology Inc. and Do-Coop Biotechnology Ltd.
Neo Cyclosporine
A formulation of Cyclosporine A based on
Neowater®
Business Model
Legal Process

Technology/business process

Questions to be
addressed

2-4 weeks 1 month 3-6 3 months


months1
Total process, Approx.
year
Contact Us

business@docoop.com
+972-3-5333804
www.docoop.com