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©Rubicon Research Pvt. Ltd. 2007
New Drug Delivery Systems
Maharukh RustomjeeFounder and Chief Operating Officer
Rubicon Research Pvt. Ltd.Email: [email protected]
A Global Opportunity
BIOINVEST 2007 - MUMBAI - NOV 01 & 02, 2007
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©Rubicon Research Pvt. Ltd. 2007
Overview
Product Development Cycle
Role of Drug Delivery Systems in Product Life Cycle
New Drug Delivery Systems Business opportunity
Case studies
NDDS Partnership Model
Advantage India
NDDS at Rubicon Research
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©Rubicon Research Pvt. Ltd. 2007
New Drug Discovery And Development Process
(source:www.montrealinternational.com)
DDS DDS
Getting a suitable drug delivery form is almost as important as the drug itself
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©Rubicon Research Pvt. Ltd. 2007
Declining R&D Productivity
R&D spend vs. NMEs approved Cost per NME approved
So. PhRMA, US FDA
Global players looking for an alternatives to increase productivity
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©Rubicon Research Pvt. Ltd. 2007
Role of Drug Delivery Systems in R&D
NDDS – is now considered from the earliest development stage
Novel Drug
Delivery Systems
ENABLING
New Molecules
New drug New DDS
New drug Proven DDS
ENHANCING
Life Cycle Management
Proven drug New DDS
Proven drug Proven DDS
VALUE
&
R I S K
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©Rubicon Research Pvt. Ltd. 2007
Drug Delivery Systems – Strategic Tool
N
D
D
S
Scientific
Meet clinical need
Optimize PK profile
Reduce Side
effects
Delivery by conventionalroute
Improvedcompliance
Business
Patent/Exclusivity Competitive
Advantage
MarketPenetration
Marketimage
New patientpopulation
NDDS offers benefits to patients, clinicians and pharmaceutical industry
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©Rubicon Research Pvt. Ltd. 2007
Desired Aspects of Drug Delivery Systems
CommercialSuccess
PATIENT BENEFIT
Minimum regulatory barriers
Opportunity for IP
Cost Effective
Commercially viable
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©Rubicon Research Pvt. Ltd. 2007
Source : 1 – IMS Health 2 – Pharmacircle 3 – Company Annual Reports
New Drug Delivery Systems (NDDS) Market
Global pharmaceutical - $555.5 billion in 20061
~ $72 billion (~13%) is accounted for drugs incorporating NDDS 1
NDDS market has a CAGR of ~15% v/s ~6% CAGR of global
pharmaceutical market
There are 700 NDDS companies with more than 1700
technologies2
Worldwide NDDS market ten times Indian Pharma market
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©Rubicon Research Pvt. Ltd. 2007
Polymer12%
Pulmonary18%
Transdermal10%
Transmucosal8%
Others2%
Oral CR50%
Segment wise share of NDDS –expected in 2007
NDDS - Market SegmentNDDS - Market Segment
Oral Controlled Release Systems continues to dominate NDDS
Source: FrontLine strategic Consulting Inc. 2002
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©Rubicon Research Pvt. Ltd. 2007
Applications of NDDS
Need Technology Drug Benefit
Pharmacokinetic Profile of Drugs
PEgylation Filgrastin (Neulasta)
Prolongs the length of time the drug stays in the body, and allows for administration in a single dose
Window of Absorption Gastroretentive - Metformin
(Glumetza)
Tablets retained in the stomach for > 6hrs
Side Effects OROS system Oxybutinin (Ditropan XL)
Reduced 1st pass effect, lesser metabolites, less side effects
Timed Delivery Pulsatile Release System
Verapamil 24H Blood pressure control
Drug Targeting Targit Mesalazine Local action : reduced side effects, reduced dose
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©Rubicon Research Pvt. Ltd. 2007
Case Study – LCM of an old drug
Brand Name Marketed By
Technology Patent Status
Concerta Alza OROS® Patented technology
Ritalin SR Novartis Matrix Non- Infringing technology
Ritalin LA Novartis SODAS® Licensed from Elan
Metadate Celltech Diffucaps® Licensed from Eurand
Focalin XR Novartis Pure isomer Patented technology
Route of administration – Oral
Alternate Route – Transdermal , Daytrana® by Shire
Methylphenidate – an example of
multiple technologies, dosage forms, route of administration
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©Rubicon Research Pvt. Ltd. 2007
Case Study – Life cycle management
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©Rubicon Research Pvt. Ltd. 2007
Marketed by Genentech using technology of Alkermes Injection SR formulation of human growth hormone Children deficient in Growth Harmone – Receives injection for years until completion of puberty.
Once a month or twice a month dosage form highly desired
Nutropin depot was developed using ProLease® Technology comprising of biodegradable polymeric microspheres.
Case Study-BioNDDS: Nutropin Depot
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©Rubicon Research Pvt. Ltd. 2007
Emisphere has designed and synthesized >1800 delivery agents to
facilitate delivery of therapeutic agents.
Technology enables to select and customize delivery agents to facilitate
the oral delivery of broad range of actives. e.g. Heparin.
Case Study-BioNDDS : Permeability Enhancement
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©Rubicon Research Pvt. Ltd. 2007
Partnership Model
Typical Business Model
– Out licensing model
– Fee for service model
– Risk sharing model
Revenue Components
– R&D collaboration revenues ( Development Fees)
– License fees/ milestone payments / Royalties
– Material Sales Manufacturing Revenues
Drug delivery companies develop technologies
Create business with this asset
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©Rubicon Research Pvt. Ltd. 2007
Reasons for Partnership
Parameters that companies look at during their DDS partner
selection process:
Average ratings on a scale of 0 - 9
So. E&Y Survey, 2007
6.5
5.9
5.4
5.3
5.1
4.6
4.1
3.6
3.5
0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0
Excellent technical team
Adequate FTEs
Commitment to quality
Internal controls & confidentially
Good repulation
Business Continuity
Physical infrastructure
Flexible contract terms
Competitive rates
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©Rubicon Research Pvt. Ltd. 2007
clinical
end
po
ints
NDDS Company
Concept
feasible
IP
stre
ng
th
regulatory path
cost & timeframe
safety
issues
Customers
need
Pharmaceutical
Marketing
company
com
pet
itiv
e
lan
dsc
ape
Freedom to Operate? market s
ize
cost o
f
go
od
s sold
Acceptable ROI
Key Criteria for Successful NDDS Partnership
Are we comfortable working together ?Do our company’s share the same long term ideology on the product partnership ?
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©Rubicon Research Pvt. Ltd. 2007
NDDS Partnership Success Stories
Drug NDDS DDS COMPANY
Pharma company
Peak Sales USD Bn
Duragesic Transdermal Patch
Alza Janssen 2.08 (2004)
Wellbutrin XL ER tablet Bioavail GSK 1.84 (2006)
Lupron Injectable Depot TAP TAP 1.10 (2002)
Procardia XL OROS Alza Pfizer 1.18 (1994)
Cardizem SR/CD
ER tablet Elan Aventis 1.01 (1999)
Source : Specialty Pharma Jul/Aug 2006 Vol.2 No.4
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©Rubicon Research Pvt. Ltd. 2007
NDDS Partnership Success Stories
Drug NDDS DDS company
Pharma company
Deal in USD Mn
Cipro OD ER tablet Ranbaxy < 65 (1999)
Keppra Extended release tablets Alembic 11 (2007)
Trambex Mouth Dissolving Tablets Ethypharm In Licensing (2006)
Not Disclosed
CDT technology SCOLR Not Disclosed
Source : Internet
Bayer
UCB
Ranbaxy
DRL
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©Rubicon Research Pvt. Ltd. 2007
• Signatory to WTO, acceptance of IPR
• Proven scientific talent pool
• No language barrier
• Cost effective
• Established regulatory skills
– India has highest number of US-FDA approved facilities outside USA
– Indian players account for about 25-30% of the total DMFs filed with the US FDA
NDDS Partnership - Advantage India
A number of Indian companies have developed various DDS
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©Rubicon Research Pvt. Ltd. 2007
Identification of unmet therapeutic need
Determining novel technologies to meet the need
Product with desired therapeutic benefits
DEVELOPED SEVERAL TECHNOLOGIES BASED ON THIS APPROACH
R&D Initiatives at Rubicon Research
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©Rubicon Research Pvt. Ltd. 2007
DDS Technologies of Rubicon Research
RubiEnTM - Bioenhanced Drug Delivery System
RubiODTTM - Orally Disintegrating Tablet
RubiDTTM - Novel Dispersible Tablet
RubiRetenTM - Gastroretentive Solubilised Drug Delivery System
RubiCoatTM - Aqueous Wax Coating System
RubiERTTM - Extended Release Tablet
RubiXcipTM - Novel Multifunctional Excipient
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©Rubicon Research Pvt. Ltd. 2007
The true potential (Significance) of drug delivery
technologies lies in their ability to improve the safety,
efficacy and medical utility of several drugs
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©Rubicon Research Pvt. Ltd. 2007
THANK YOU