new drug delivery system

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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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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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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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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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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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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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Desired Aspects of Drug Delivery Systems

CommercialSuccess

PATIENT BENEFIT

Minimum regulatory barriers

Opportunity for IP

Cost Effective

Commercially viable

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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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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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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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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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Case Study – Life cycle management

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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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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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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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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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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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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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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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• 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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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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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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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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THANK YOU

new drug delivery system

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