webinar presentation 100909
TRANSCRIPT
© GlobalData
Cutting edge water-based Nanotechnology in drug development
Addressing key challenges in predictability, solubility, toxicity, stability and intellectual property
Dr. Ajay PanditMBBS, MS (Penn State), MBA (Penn State)
Practice Head – Healthcare Practice,
GlobalData
September 10, 2009
© 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
Table of Contents
• Unmet Needs
– Understanding unmet needs
– Quantifying unmet needs
– Forecasting unmet needs
• Nanotechnology in Pharma/Biotech Industry
• Technology Adoption Framework
© GlobalData 5
Active Ingredients in development are
poorly soluble
• Poor solubility has become a major challenge in drug delivery as 90%1 of the active ingredients are proved to be having low aqueous solubility issues and this proportion is still growing
• This implies that drug solubilization techniques could potentially impact up to 90% of R&D
Time and cost involved with
screening for salts
• Hydrophobic nature of the New Chemical Entity (NCE) prompts for screening of its various salts with the aim of identifying one with similar safety and efficacy and a better solubility/bioavailability
• 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 move from
preclinical to phase I
• Nearly 75% of preclinical stage drugs do NOT move to phase I• Around 39%3 of these failures are attributed to poor drug-like
properties of the drugs (implying low solubility)
Increase in number of poorly soluble
drugs on the market
• About 40%2 of drugs currently on the market exhibit poor solubility leading to poor dissolution kinetics and suboptimal bioavailability, in other words low product efficacy and reduced commercial success due to poor patient/physician perceptions
Understanding Unmet Needs in Drug Solubilization Market – Why is Drug Solubilization a Problem?
IssueIssue
Effect on R&D
Effect on R&D
Effect on Pipeline
Effect on Pipeline
Impact on Market Size
Impact on Market Size
© GlobalData 6
Table of Contents
• Unmet Needs
– Understanding unmet needs
– Quantifying unmet needs
– Forecasting unmet needs
• Nanotechnology in Pharma/Biotech Industry
• Technology Adoption Framework
© GlobalData 7
Impact on R&D Revenues due to Poor Drug like Properties
Poor Drug Like Property Group could be helped by advanced drug solubilization techniques $8.2B
Poor Drug Like Property Group could be helped by advanced drug solubilization techniques $8.2B
Poor Drug like
Properties 39%
N = 3,900
$8.2B
Molecules promoted
from preclinical to
phase I 25%
Molecules failed in
preclinical 75%
High Toxicity 11%
Adverse Effects 10%
Low Efficacy
30%
Others 10%
Drugs in Preclinical
Stage
Drugs in Preclinical
StageWhy do they
fail?
Why do they fail?
© GlobalData 8
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
Success rate (preclinical to phase I) 25%
Productive $s $7.1 billion
Failure rate (Do not move to phase I) 75%
R&D $s that are Unproductive $21.1 billion
Failure due to poor drug-like properties 39%
Unproductive R&D expenditure solely due to poor drug-like properties
$8.2 billion
1
2
3
© GlobalData 9
Quantifying Unmet Need for Missed Revenue Opportunity
Of 775 (39% failing due to poor drug-like properties) new compounds enter phase I from preclinical stage in 1996Assumptions
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.
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)
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)
Market Potential in 1st Year: $8.2 b + $1.6 b = $9.8 billionMarket Potential in 1st Year: $8.2 b + $1.6 b = $9.8 billion
© GlobalData 10
Table of Contents
• Unmet Needs
– Understanding unmet needs
– Quantifying unmet needs
– Forecasting unmet needs
• Nanotechnology in Pharma/Biotech Industry
• Technology Adoption Framework
© GlobalData 11
Impact on R&D Costs due to Better Solubilization – Forecasts
R&D Revenue Loss due to Poor Drug like Properties, 2007-15
8.29.1
10.111.2
12.413.7
15.116.7
18.5
0
2
4
6
8
10
12
14
16
18
20
2007 2008 2009 2010 2011 2012 2013 2014 2015
Rev
enu
es $
bil
lio
n
CAGR 10.7%
Entry point for Drug solubilization techniques
will fall in this group
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)
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 12
Revenue Generated by Addressing Poor Drug like Properties, 2007-15
8.2 9.1 10.1 11.2 12.4 13.7 15.1 16.7 18.510.5
18.128.2
39.351.6
59.667.5
1.6 5.1
0
10
20
30
40
50
60
70
80
90
100
2007 2008 2009 2010 2011 2012 2013 2014 2015
Rev
enu
es $
bil
lio
n
CAGR 31%Better Drug solubilization
techniques will add extra revenues to the
pharma/biotech market
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%
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%
Cost savings is relatively minor component of value added by Nanotechnology
Impact on Added Revenues due to Better Solubilization – Forecasts
© GlobalData 13
Table of Contents
• Unmet Needs
– Understanding unmet needs
– Quantifying unmet needs
– Forecasting unmet needs
• Nanotechnology in Pharma/Biotech Industry
• Technology Adoption Framework
© GlobalData 14
Impact of Nanotechnology on Product Lifecycle Management
Impact in Discover PhaseImpact in Development
PhaseLife Cycle Management
New formulation strategies to resolve the solubility issues
Fast and efficient when used during preclinical efficacy and safety studies
Bioavailability enhancement by enabling the novel oral dosage forms, improved safety profiles etc.,
Ideal medium for all routes of drug administration
Provide maximal drug exposure by various patient-friendly dosage forms
Increased dosing efficiency reduces the overall need for a drug
Nanoparticles helps in delivering large dose in small volumes
Minimize compliance issues
For marketed products, new formulation strategies using nanoparticles helps in incorporating old drug into new drug delivery platform to meet the unmet medical needs – which will grant a new IP 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
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 15
Trends for Nanotechnology Acceptance in Pharma/Biotech – Market Size of Nanotechnology Sales within Pharma/Biotech Industry
Nanotechnology enabled DDS Market Potential Forecast 2007-15
0
50
100
150
200
250
300
2007 2008 2009 2010 2011 2012 2013 2014 2015
Rev
enu
es $
bill
ion
Nano-enabled DDS Other DDS Total DDS
In 2007, the market for Nanotechnology enabled DDS is approximately $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%
In 2007, the market for Nanotechnology enabled DDS is approximately $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%
CAGR 68.4%
• Drug delivery system (DDS) targeting specific tissues
• Drug delivery of genes and vaccines through nanohydrogels and nanocarriers
• Controlled-release drug delivery systems• Increased biocompatibility
• Improved drug bioavailability and solubility
© GlobalData 16
Table of Contents
• Unmet Needs
– Understanding unmet needs
– Quantifying unmet needs
– Forecasting unmet needs
• Nanotechnology in Pharma/Biotech Industry
• Technology Adoption Framework
© GlobalData 17
Technology Adoption Framework
High unmet need exists and creates a significant challenge to drug
development
Significant bottle neck which impacts the key business metrics
As a result clients look for potential solutions that might
solve the bottleneck
New Technology Adoption Trend
Nanotechnology enabled drug solubilizers has better safety profile and enhances the bioavailability of a drug
Only 30 products have been developed using Nanotechnology, implying low evaluation rate, which needs to increase for the technology to become a gold-standard to address solubility issues
Even though, Nanotechnology has demonstrated its effectiveness in pharma/biotech industry, it has not been exploited completely due to inadequate testing methodologies
Nanotechnology is very efficient in addressing the solubility issues and thereby bioavailability needs of the pharma/biotech industry and will be a huge success by overcoming the hurdles for complete adoption
Technology Exists to Fulfill Unmet Need
Client Awareness of Technology
Evaluation of Technology
Technology Trial – Proof of Concept
Complete Adoption
Unmet Need Fulfillment
Awareness of Nanotechnology in pharma/biotech R&D is low. Full market potential of Nanotechnology will be captured only by increasing the awareness of this technology
Nanotechnology has not been adopted completely in pharma/biotech industry due to the huge investments involved in the initial stages and low awareness levels
© GlobalData 18
Typical Technology Adoption Curve
Nanotechnology is in early stages of
adoption in pharma/biotech
industry
1 2 3 4 5
© GlobalData 19
Market Drivers for NanotechnologyD
rive
rs
• Innovative technologies such as NeoWater, NanoCrystal and NanoEdge for enhancing drug solubilization
• New approaches such as tissue targeting and permeation enhancement are being explored in tandem with the nano-sizing concept
Innovations in drug solubilization technology
• High demand for innumerable formulation-related performance issues such as poor solubility, toxicity, poor bioavailability, lack of dose proportionality, safety issues with use of co-solvents, and slow onset of action
High demand due to unmet needs
• Pharma/biotech companies with number of potential treatments that remain unexplored due to poor solubility issues adding to the unproductive spent, are exploring the newer ways to generate ROI
Adopting effective and superior technologies
• Nanotechnology-enabled drug delivery systems help in extending the product and patent lifecycles by creating novel reformulations of existing or discontinued compounds
Extending product and patent lifecycles
© GlobalData 20
Barriers and Challenges for NanotechnologyIn
hib
ito
rs
Huge investments in the initial stages to evaluate the new technologies
• ‘Known Devil is better than Unknown God’ seems to be the rule followed by pharma/biotech industry. Uncertainty of ROI on new technology investments is inhibiting the companies from adopting Nano-enabled technologies
Environmentalists perceptions
Need for advanced facilities
• Nanotechnology has drawn severe criticism from health advocacy groups, environmentalists and other non-government organizations due to hypothetical safety concerns
• Need for new equipment and manufacturing support to use Nanotechnologies• Testing methodologies are not yet been placed or developed to keep pace with
Nanotechnology in R&D
Industry Awareness regarding role of nanotechnology in R&D
• As is seen from Technology adoption curve, awareness is relatively low amongst industry stakeholders with regards to potential of nanotechnology applications in Pharma/Biotech R&D. If the awareness does not increase, it could have a potential impact on growth of nanotechnology in Pharma/Biotech industry
© GlobalData 21
Trends Indicating Growth of Nanotechnology Market
Shift in patent patterns with the
entry of Nanotechnology
• Nanotechnology patent filings are increasing across the globe and there by protecting 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 by U.S. Patent and Trademark Office (USPTO)
Increasing M&A activities in
Nanomarkets
• Nanotechnology companies have become very popular in addressing the key unmet needs across all the industry segments
• In Pharma/Biotech industry, companies are looking for potential mergers and acquisitions with Nano companies to handle pressure and overcome the issues such as generics entering the market, low productivity
Cross industry applications of
Nanotechnology
• Nanotechnology applications are being used across all the sectors such as pharma/biotech, electronics & IT, machinery & engineering, consumer goods and equipment, agriculture and food, instruments etc.,
• In healthcare, drug delivery technologies, Nano-structured medical devices etc• In electronics and IT, manufacturing advanced memory chips and electronic displays
• Government programs to fund Nanotechnology R&D has increased significantly in the US, the UK, 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 Nanotechnology research worldwide and in 2009 alone it is estimated to be approximately $10 billion
Increased government funding
for Nano projects
© GlobalData 22
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/590452
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/590452
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
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-410A license agreement recently signed between Champions biotechnology Inc. and Do-Coop Biotechnology Ltd.
Neo CyclosporineA formulation of Cyclosporine A based on Neowater®
Business ModelLegal Process
Questions to be addressed
Technology/business process
2-4 weeks 3-6 months1 month 3 months
Total process, Approx. 1 year
