Worlds Leading Drug Delivery Company

General Presentation on Elan Drug Technologies January 2011

Elan Drug Technologies | What we do

Elan Drug Technologies develops and manufactures innovative pharmaceutical products that deliver clinically meaningful benefits to patients, using its extensive experience and proprietary drug technologies in partnership with pharmaceutical companies.

Elan Drug Technologies 2011

Elan Drug Technologies | Business Overview

Unrivalled expertise in drug formulation, development, scale-up & manufacture

More than 30 products launched in 100+ countries 14 products in clinical development Extensive product development, scale-up and manufacturing capabilities in US and EU

Most robust drug delivery portfolio in the industry

NanoCrystal technology 5 licensed products launched with over $1.9B annual in-market sales Oral Controlled Release Platform delayed release, extended release, pulsatile release, chrono-timed delivery; all commercially launched Extensive patent portfolio around our technologies - 1,900+ patents/patent applications

Worlds leading drug delivery company

40 years of innovation and expertise in drug delivery Successful collaborations with majority of worlds leading pharma companies Most successful drug delivery provider in US in recent times 12 products launched since 2001

Successfully Bringing Products to Market Successfully Bringing Products to Market

Elan Drug Technologies 2011

Elan Drug Technologies Has Solved the Delivery Challenges of More Than 30 Marketed Products

Since 2001, 12 products have been launched in the US using our technologies, making us the most productive drug technology company during this period. Here are a range of products launched incorporating our technologies -

Pfizer

Janssen (Invega Sustenna)

Strativa Pharmaceuticals

Acorda (Ampyra)

Elan Drug Technologies 2011

GENERAL OVERVIEW & INTRODUCTION

Strong Partnering Capabilities Across the Pharma Sector

Successful collaborations with many of the worlds leading pharmaceutical companies.

Successful collaborations with more than 30 of the worlds leading pharmaceutical companies Successful collaborations with more than 30 of the worlds leading pharmaceutical companies for development and/or scale-up & manufacturing. for development and/or scale-up & manufacturing.
Elan Drug Technologies 2011

Robust Pipeline | 14 Products in Clinical Development

8 Products

Elan Drug Technologies 2011

Robust, Broad Platform of Validated Technologies

Ampyra Invega Sustenna

Suite of validated, commercially launched, proprietary, technology driven solutions. Suite of validated, commercially launched, proprietary, technology driven solutions.
Elan Drug Technologies 2011

Capabilities Based on Two Key Technology Platforms

NanoCrystal Technology A proprietary formulation and manufacturing approach for the delivery of poorly water- soluble drugs
Most dosage forms possible - Increases oral bioavailability; Reduces/eliminates fed/fasted variability, Decreases time to onset of action, High drug loading possible (up to 30-40% active); Fast, elegant, simple solution for poorly water soluble compounds 5 products launched - $1.9B sales in 2009

Oral Controlled Release (OCR) Platform - allows a range of release profiles and dosage forms to be engineered
Oral Controlled Release Platform delayed release, extended release, pulsatile release, chrono-timed delivery; all commercially launched 23 products launched using our OCR technology platforms

The OCR and NanoCrystal Technology Platforms are complementary The OCR and NanoCrystal Technology Platforms are complementary and can be used in combination. and can be used in combination.
Elan Drug Technologies 2011

NanoCrystal Technology | What is it?

A proprietary formulation and manufacturing approach for the delivery of poorly water- soluble drugs

Most dosage forms possible (e.g. oral, parenteral and nasal) Increases oral bioavailability & reduces fed/fasted variability Decreases time to onset of action High drug loading possible (up to 30-40% active) Combine with other technologies (e.g. controlled release) Low viscosity liquid preparations Potential for improved chemical stability compared to solutions Uses standard pharmacopoeial materials

NanoCrystal technology involves reducing drug particles to the nanometer size. By reducing particle NanoCrystal technology involves reducing drug particles to the nanometer size. By reducing particle size, we increase the drugs exposed surface area. We then stabilise the particles to maintain the size, we increase the drugs exposed surface area. We then stabilise the particles to maintain the formulations particle size. formulations particle size.
Elan Drug Technologies 2011

There Are Five Licensed NanoCrystal Technology-Based Drugs Now launched in the US

Basis for filing Efficacy/Safety Rapamune

PK

Launched by Wyeth in 2001

Provides a stable tablet formulation (replaced a liquid dosage form) with 23% improvement in bioavailability Easier storageno refrigeration required More precise dosage/dosage linearity

Emend Launched by Merck in 2003

Elimination of food requirement for drug (drug would otherwise have been abandoned) with 600% improvement in bioavailability

TriCor 145 Launched by Fournier and Abbott in 2004

Could market lower dosage strength with 9% improvement in bioavailability Minimised food effect

Megace ES approved in 2005, launched by Par Pharmaceuticals (Strativa)

Equivalent efficacy achieved with dramatically lower absolute dosage with 28% improvement in bioavailability Easier administration Lower API cost

Invega Sustenna long acting IM JNJ product approved July 2009

1 month Intramuscular dosage form Ease of administration & potential higher patient compliance

Elan Drug Technologies 2011

Our Controlled Release Technology Platform Allows a Range of Release Profiles and Dosage Forms to Be Engineered

SODAS Spheroidal Oral Drug Absorption System

IPDAS Intestinal Protective Drug Absorption System

CODAS Chrono-therapeutic Oral Drug Absorption System

PRODAS Programmable Oral Drug Absorption System

MXDAS MatriX Drug Absorption System

DUREDAS DUal Release Drug Absorption System

Combo IR, CR & Delayed Multi-particulate beads Delivery profile Controlled absorption over a Polymer blend to control Bilayer tablet, IR or SR Release profiles, reduction in a tablet , Intestinal designed to period, targeted delivery to absorption over a period, release of two drug in peak-to-trough ratios protective complement circadian absorption sites targeted delivery components pattern

23 products launched using our OCR technology platforms including Avinza,,Cardizem SR and CD, 23 products launched using our OCR technology platforms including Avinza Cardizem SR and CD, Focalin XR,,Ritalin LA, Verelan,,Verelan PM, Naprelan Luvox CR,,Zanaflex Capsules and Focalin XR Ritalin LA, Verelan Verelan PM, Naprelan Luvox CR Zanaflex Capsules and Ampyra. Other technologies developed by Elan Drug Technologies include PharmaZome technology Ampyra. Other technologies developed by Elan Drug Technologies include PharmaZome technology and INDAS technology. and INDAS technology.

Elan Drug Technologies 2011

Avinza, Ritalin LA and VerelanPM Demonstrate Oral Controlled Release Technologies Applicability in Life Cycle Management

Basis for filing Efficacy/Safety Avinza Launched in 2002, marketed by King

Matches pain coverage of existing BID forms Minimises fluctuation in blood levels Fast onset Sprinkle dosing

PK

Ritalin LA Launched by Novartis in 2002

Once-a-day, oral dosage form Eliminate need for mid-day dosing during school - mimic twice daily dosing regime, with unique bi-modal release profile Onset consistent with need at start of school day

Verelan PM Launched by Schwarz in 1999

Reduced dosage form dependence on gastric motility, posture and food 4.5hr lag in onset of plasma concentrations while patient asleep Therapeutic concentrations achieved in the high-risk wakening period cMax occurs approximately 11 hrs after dosing Therapeutic effect maintained during wakening hours Sprinkle indication

Elan Drug Technologies 2011

Dalfampridine which was approved by the FDA in 2010 uses MXDAS Technology
Dalfampridine (4-Aminopyridine)
Original academic use to study nerve cell conduction Clinically studied in spinal cord injury and MS Required multiple daily doses Inconsistent clinical outcomes Side effect challenges

Dalfampridine
Created with MXDAS technology Controls release to allow for twice daily dosing Minimises peak to through fluctuations Mitigates CNS side effects
Timed Walk Responders (%)

MSF-203 Timed 25-foot Walk ITT Population

Timed Walk Responders (%)

MSF-204 Timed 25-foot Walk ITT Population

42.9%

Clinical Development Received priority review Orphan drug status Approved for walking ability in MS patients in US, filed in Europe and Canada

34.8%

8.3%

9.3%

Approved and launched Q1 2010 Approved and launched Q1 2010 under trade name Ampyra under trade name Ampyra

Placebo (N=72) Fampridine SR (N=224)

Elan Drug Technologies 2011

Placebo (N=118)

Fampridine SR (N=119)

Extensive R&D, Scale-up and Manufacturing Capabilities in US and Europe

Athlone
Dedicated cGMP facility FDA & EMA licensed Recently modernised 420,000 sq ft, 2.0B oral dose capacity

Gainesville
Dedicated cGMP facility FDA and DEA licensed 87,000sq ft, 500M unit dose capacity
Dedicated research, development, scale-up and commercial manufacturing Modern facilities in Europe and US 2.5 billion units annually in solid oral dosage form manufacturing capacity 250,000sq ft of cGMP manufacturing facilities between US and Ireland DEA approved controlled substance manufacturing plant in US Excellent compliance record Packaging facilities US and Ireland Mature infrastructure Development and tech transfer capabilities A focus on partnering with customers
Elan Drug Technologies 2011

King of Prussia
Dedicated 50,000sq ft cGCP facility FDA & DEA licensed NanoCrystal technology

Elan Drug Technologies Campus Athlone, Ireland

Athlone, Ireland Facility

Located on 40 acres site, the facility has approximately 505,000 square feet of space. Operates under cGMP standards. FDA/EMA Licensed. Formulation through scale-up and full scale manufacturing. 10 different products are manufactured and/or packaged at this site at present. Manufactures product for US, European and Asian markets. The facility has an equipped capacity of 2 billion unit solid oral doses.

Elan Drug Technologies 2011

SCALE-UP & MANUFACTURING CAPABILITIES

Elan Drug Technologies facility, Gainesville, Georgia, USA

Gainesville, GA, USA Facility

Located on 148 acres of land, the facility has approximately 87,000 square feet of space. Includes 288 pallet vault built in accordance with DEA specifications. Operates under cGMP standards. Two-level facility. FDA/EMA/DEA Licensed. Formulation through scale-up and full scale manufacturing. 10 different products are manufactured and/or packaged at this site at present. Manufactures product for US, European and Asian markets. The facility has an equipped capacity of 500 million unit solid oral doses.

Elan Drug Technologies 2011

Development Services and Capabilities

Development Services
Product concept strategy evaluation Formulation development Analytical method development, materials and product

Development Capabilities
Pre-formulation Characterisation Active, excipient, in-process and finished

characterisation, pilot and commercial stability Process development, scale-up and transfer to on-site commercial manufacture Clinical studies, bio analytical, PK management Stability services Bio pharmaceutics including IV/IVC Full project leadership and management

product characterisation
Formulation Feasibility laboratory cGMP area - pilot scale formulation prototype

Registration support
regulatory authorities in the U.S., Europe and Japan

manufacture Experimental design - formulation/process optimisation

Our regulatory department has successfully assisted a number of companies with various applications to the

We can provide assistance to our clients with the preparation of New Drug Applications and updates,

Investigational New Drug Applications, Drug Master files and post-marketing supplements

Reformulations and Scale-up activities for client-based projects has contributed to more than Reformulations and Scale-up activities for client-based projects has contributed to more than U.S. $20 billion+ in-market sales for these clients. U.S. $20 billion+ in-market sales for these clients.

Elan Drug Technologies 2011

We Offer Real Advantage to Our Partners

Improve R&D productivity and cost effectiveness Enable the development of NCEs Enable the development of new and improved formulations of existing products Enable solutions to challenging formulation issues Provide later stage pipeline opportunities based on internal product development activities Maintain and enhance revenue streams

Elan Drug Technologies 2011

SUMMARY

Elan Drug Technologies | Strength in Numbers

3 million patients benefit from drugs incorporating our drugs daily 40 years experience in drug delivery 36 products launched in 100+ markets 1,900+ patents/patent applications in US and Internationally 14 products in clinical development 50+ products in various stages of development from feasibility through Phase III 30+ pharma companies have trusted us to develop their products for them 250,000 sq ft dedicated GMP manufacturing facilities in US and Europe 2.5 billion solid oral dosages can be manufactured annually $20 billion+ in-market sales generated for our licensees

Elan Drug Technologies -Elan Drug Technologies The Worlds Leading Drug Delivery Company. The Worlds Leading Drug Delivery Company.

Elan Drug Technologies 2011

SUMMARY

Elan Drug Technologies The Worlds Leading Drug Delivery Company

Top Drug Delivery Company of the Decade -Drug Delivery Technology Survey, May 2010

For more information go to our website www.elandrugtechnologies.com Queries: edtqueries@elan.com

Elan Drug Technologies 2011