New Drug Delivery System

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

Overview: 

2 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

New Drug Discovery And Development Process: 

3 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

Declining R&D Productivity: 

4 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

Role of Drug Delivery Systems in R&D: 

5 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 V A L U E & R I S K

Drug Delivery Systems – Strategic Tool: 

6 Drug Delivery Systems – Strategic Tool N D D S Scientific Meet clinical need Optimize PK profile Reduce Side effects Delivery by conventional route Improved compliance Business Patent/ Exclusivity Competitive Advantage Market Penetration Market image New patient population NDDS offers benefits to patients, clinicians and pharmaceutical industry

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7 Desired Aspects of Drug Delivery Systems Commercial Success PATIENT BENEFIT Minimum regulatory barriers Opportunity for IP Cost Effective Commercially viable

New Drug Delivery Systems (NDDS) Market: 

8 Source : 1 – IMS Health 2 – Pharmacircle 3 – Company Annual Reports New Drug Delivery Systems (NDDS) Market Global pharmaceutical - $555.5 billion in 2006 1 ~ $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 technologies 2 Worldwide NDDS market ten times Indian Pharma market

NDDS - Market Segment: 

9 Segment wise share of NDDS –expected in 2007 NDDS - Market Segment Oral Controlled Release Systems continues to dominate NDDS Source: FrontLine strategic Consulting Inc. 2002

Applications of NDDS: 

10 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 1 st 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

Case Study – LCM of an old drug: 

11 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

Case Study – Life cycle management : 

12 Case Study – Life cycle management

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 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

Case Study-BioNDDS : Permeability Enhancement : 

14 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

Partnership Model: 

15 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

Reasons for Partnership: 

16 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

Key Criteria for Successful NDDS Partnership : 

17 clinical end points NDDS Company Concept feasible IP strength regulatory path cost & timeframe safety issues Customers need Pharmaceutical Marketing company competitive landscape Freedom to Operate? market size cost of goods 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 ?

NDDS Partnership Success Stories: 

18 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

NDDS Partnership Success Stories: 

19 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

NDDS Partnership - Advantage India: 

20 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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21 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

DDS Technologies of Rubicon Research: 

22 DDS Technologies of Rubicon Research RubiEn TM - Bioenhanced Drug Delivery System RubiODT TM - Orally Disintegrating Tablet RubiDT TM - Novel Dispersible Tablet RubiReten TM - Gastroretentive Solubilised Drug Delivery System RubiCoat TM - Aqueous Wax Coating System RubiERT TM - Extended Release Tablet RubiXcip TM - Novel Multifunctional Excipient

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23 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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24 THANK YOU