New Drug Delivery Systems: A Global Opportunity

New Drug Delivery
Systems
A Global
Opportunity
Maharukh Rustomjee
Founder and Chief Operating Officer
Rubicon Research Pvt. Ltd.
Email: maharukh@rubicon.co.in
BIOINVEST 2007 - MUMBAI - NOV 01 & 02, 1

2007
©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
2
New Drug Discovery And Development Process
DDS DDS
Getting a suitable drug delivery form is almost as important as the drug itself
3
(source:www.montrealinternational.com)
Declining R&D Productivity
R&D spend vs. NMEs approved Cost per NME approved
Global players looking for an alternatives to increase productivity
4
So. PhRMA, US FDA
Role of Drug Delivery Systems in R&D
New drug
New DDS
ENABLING
V
New Molecules New drug A
Proven DDS L
Novel Drug U
Delivery Systems Proven drug E
New DDS
&
ENHANCING
R
Life Cycle Management I
Proven drug
Proven DDS S
K
NDDS – is now considered from the earliest development stage
5
Drug Delivery Systems – Strategic Tool
Meet clinical Patent/

need Exclusivity
Reduce Competitive
Side Advantage
effects
N
Optimize D Market
Scientific Business
PK profile Penetration
D
S Market
Delivery image
by conventional Improved New patient
route compliance population
NDDS offers benefits to patients, clinicians and pharmaceutical industry
6
Desired Aspects of Drug Delivery Systems
Minimum regulatory barriers
Opportunity for IP
PATIENT BENEFIT
Cost Effective
Commercially viable
Commercial
Success
7
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
8
Source : 1 – IMS Health 2 – Pharmacircle 3 – Company Annual Reports
NDDS - Market Segment
Transmucosal Others
8% 2%
Transdermal
10%
Oral CR
50%
Pulmonary
18%
Polymer
12%
Segment wise share of NDDS –expected in 2007
Oral Controlled Release Systems continues to dominate NDDS
9
Source: FrontLine strategic Consulting Inc. 2002
Applications of NDDS
Need Technology Drug Benefit
Pharmacokinetic Profile of PEgylation Filgrastin Prolongs the length of time the

Drugs (Neulasta) drug stays in the body, and allows
for administration in a single dose
Window of Absorption Gastroretentive - Metformin Tablets retained in the stomach

(Glumetza) for > 6hrs
Side Effects OROS system Oxybutinin Reduced 1st pass effect, lesser
(Ditropan XL) metabolites, less side effects
Timed Delivery Pulsatile Release Verapamil 24H Blood pressure control

System
Drug Targeting Targit Mesalazine Local action : reduced side

effects, reduced dose
10
Case Study – LCM of an old drug
Route of administration – Oral

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
Alternate Route – Transdermal , Daytrana® by Shire
Methylphenidate – an example of
multiple technologies, dosage forms, route of administration
11
Case Study – Life cycle management
12
Case Study-BioNDDS: Nutropin Depot
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.
13
Case Study-BioNDDS : Permeability Enhancement
 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.
14
Partnership Model
Drug delivery companies develop technologies
Create business with this asset
Typical Business Model Revenue Components

– Out licensing model – R&D collaboration revenues
( Development Fees)
– Fee for service model
– License fees/ milestone
– Risk sharing model
payments / Royalties
– Material Sales Manufacturing
Revenues
15
Reasons for Partnership
Parameters that companies look at during their DDS partner
selection process:
Competitive rates 3.5

Flexible contract terms 3.6
Physical infrastructure 4.1
Business Continuity 4.6
Good repulation 5.1
Internal controls & confidentially 5.3
Commitment to quality 5.4
Adequate FTEs 5.9
Excellent technical team 6.5
0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0
Average ratings on a scale of 0 - 9
16
So. E&Y Survey, 2007
Key Criteria for Successful NDDS Partnership
rs Ac
e pt & co e ce
nc le tim st m
to d pt
o
C sib efr s RO able
am Cu nee
fea e I
competitive
landscape
Pharmaceutical
strength
end points
goods sold
clinical
NDDS
cost of
IP
Marketing
Company
company
re Fr
gu
lat
f ety to eedo ize
pa ory sa ues Op m t s
th er rke
iss ate
? ma
Are we comfortable working together ?

Do our company’s share the same long term ideology on the product partnership ?
17
NDDS Partnership Success Stories
Drug NDDS DDS Pharma Peak Sales

COMPANY company USD Bn
Duragesic Transdermal Alza Janssen 2.08 (2004)

Patch
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 ER tablet Elan Aventis 1.01 (1999)

SR/CD
Source : Specialty Pharma Jul/Aug 2006 Vol.2 No.4

18
NDDS Partnership Success Stories
Drug NDDS DDS Pharma Deal in USD

company company Mn
Cipro OD ER tablet Ranbaxy Bayer < 65 (1999)
Keppra Extended release tablets Alembic UCB 11 (2007)
Trambex Mouth Dissolving Tablets Ethypharm Ranbaxy In Licensing

(2006)
Not CDT technology SCOLR DRL Not Disclosed

Disclosed
Source : Internet
19
NDDS Partnership - Advantage India
• 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
A number of Indian companies have developed various DDS

20
R&D Initiatives at Rubicon Research
Identification of unmet therapeutic need
Determining novel technologies to meet the need
Product with desired therapeutic benefits
DEVELOPED SEVERAL TECHNOLOGIES BASED ON THIS APPROACH

21
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
22
The true potential (Significance) of drug delivery
technologies lies in their ability to improve the safety,
efficacy and medical utility of several drugs
23
THANK YOU
24

New Drug Delivery Systems: A Global Opportunity

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New Drug Delivery

BIOINVEST 2007 - MUMBAI - NOV 01 & 02, 1

 Product Development Cycle

 Role of Drug Delivery Systems in Product Life Cycle

 New Drug Delivery Systems Business opportunity

 NDDS Partnership Model

 NDDS at Rubicon Research

R&D spend vs. NMEs approved Cost per NME approved

Global players looking for an alternatives to increase productivity

NDDS – is now considered from the earliest development stage

Meet clinical Patent/

NDDS offers benefits to patients, clinicians and pharmaceutical industry

Minimum regulatory barriers

 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

 There are 700 NDDS companies with more than 1700

Worldwide NDDS market ten times Indian Pharma market

Segment wise share of NDDS –expected in 2007

Oral Controlled Release Systems continues to dominate NDDS

Pharmacokinetic Profile of PEgylation Filgrastin Prolongs the length of time the

Window of Absorption Gastroretentive - Metformin Tablets retained in the stomach

Timed Delivery Pulsatile Release Verapamil 24H Blood pressure control

Drug Targeting Targit Mesalazine Local action : reduced side

Route of administration – Oral

Concerta  Alza OROS® Patented technology

Ritalin LA Novartis SODAS® Licensed from Elan

Metadate Celltech Diffucaps® Licensed from Eurand

Focalin XR Novartis Pure isomer Patented technology

Alternate Route – Transdermal , Daytrana® by Shire

Marketed by Genentech using technology of Alkermes

Injection SR formulation of human growth hormone

Children deficient in Growth Harmone – Receives

Once a month or twice a month dosage form highly

Nutropin depot was developed using ProLease®

 Emisphere has designed and synthesized >1800 delivery agents to

Drug delivery companies develop technologies

Create business with this asset

Typical Business Model Revenue Components

Competitive rates 3.5

0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0

Average ratings on a scale of 0 - 9

Are we comfortable working together ?

Drug NDDS DDS Pharma Peak Sales

Duragesic Transdermal 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 ER tablet Elan Aventis 1.01 (1999)

Source : Specialty Pharma Jul/Aug 2006 Vol.2 No.4

Drug NDDS DDS Pharma Deal in USD

Cipro OD ER tablet Ranbaxy Bayer < 65 (1999)

Keppra Extended release tablets Alembic UCB 11 (2007)

Trambex Mouth Dissolving Tablets Ethypharm Ranbaxy In Licensing

Not CDT technology SCOLR DRL Not Disclosed

• Signatory to WTO, acceptance of IPR

A number of Indian companies have developed various DDS

Identification of unmet therapeutic need

Determining novel technologies to meet the need

Product with desired therapeutic benefits

DEVELOPED SEVERAL TECHNOLOGIES BASED ON THIS APPROACH

RubiEnTM - Bioenhanced Drug Delivery System

RubiODTTM - Orally Disintegrating Tablet