elan general presentation short jan 2011

World’s Leading Drug Delivery CompanyGeneral Presentation on Elan Drug Technologies

January 2011

Elan Drug Technologies © 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 | 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

World’s leading drug delivery company• 40 years of innovation and expertise in drug delivery

• Successful collaborations with majority of world’s leading pharma companies

• Most successful drug delivery provider in US in recent times – 12 products launched since 2001

Successfully Bringing Products to MarketSuccessfully Bringing Products to Market


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 -

Acorda(Ampyra®)

Janssen(Invega® Sustenna®)

Pfizer

Strativa Pharmaceuticals


Successful collaborations with many of the world’s leading pharmaceutical companies.

Successful collaborations with more than 30 of the world’s leading pharmaceutical companies for development and/or scale-up & manufacturing.

Successful collaborations with more than 30 of the world’s leading pharmaceutical companies for development and/or scale-up & manufacturing.

Strong Partnering Capabilities Across the Pharma SectorGENERAL OVERVIEW & INTRODUCTION


Robust Pipeline | 14 Products in Clinical Development

8 Products


Robust, Broad Platform of Validated Technologies

Suite of validated, commercially launched, proprietary, technology driven solutions.Suite of validated, commercially launched, proprietary, technology driven solutions.

Invega® Sustenna®

Ampyra®


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 and can be used in combination.

The OCR and NanoCrystal® Technology Platforms are complementary and can be used in combination.


• 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

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

NanoCrystal® Technology | What is it?

NanoCrystal® technology involves reducing drug particles to the nanometer size. By reducing particle size, we increase the drug’s exposed surface area. We then stabilise the particles to maintain the formulation’s particle size.

NanoCrystal® technology involves reducing drug particles to the nanometer size. By reducing particle size, we increase the drug’s exposed surface area. We then stabilise the particles to maintain the formulation’s particle size.


Basis for filing

Rapamune® Launched by Wyeth in 2001– Provides a stable tablet formulation (replaced a liquid dosage form) with 23% improvement in

bioavailability– Easier storage—no 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

Efficacy/Safety PK

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


Our Controlled Release Technology Platform Allows aRange 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 Release profiles, reduction

in peak-to-trough ratios

Multi-particulate beads in a tablet , Intestinal

protective

Delivery profile designed to

complement circadian pattern

Controlled absorption over a period, targeted delivery to

absorption sites

Polymer blend to control absorption over a period,

targeted delivery

Bilayer tablet, IR or SR release of two drug

components

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 Ampyra™. Other technologies developed by Elan Drug Technologies include PharmaZome® technology and INDAS™ technology.

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 Ampyra™. Other technologies developed by Elan Drug Technologies include PharmaZome® technology and INDAS™ technology.


Avinza®, Ritalin® LA and Verelan®PM Demonstrate OralControlled Release Technologies Applicability in LifeCycle Management

Basis for filing

Avinza® Launched in 2002, marketed by King– Matches pain coverage of existing BID forms – Minimises fluctuation in blood levels– Fast onset– Sprinkle dosing

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

Efficacy/Safety PK


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• Clinical Development

– Received priority review – Orphan drug status– Approved for walking ability in MS patients in US,

filed in Europe and Canada 8.3%

34.8%

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

Tim

ed W

alk

Res

pond

ers

(%)

MSF-203 Timed 25-foot Walk ITT Population

MSF-204 Timed 25-foot Walk ITT Population

9.3%

42.9%

Placebo(N=118)

Fampridine SR(N=119)

Tim

ed W

alk

Res

pond

ers

(%)

Approved and launched Q1 2010 under trade name Ampyra®

Approved and launched Q1 2010 under trade name Ampyra®


• Dedicated 50,000sq ft cGCP facility

• FDA & DEA licensed• NanoCrystal®

technology

• Dedicated cGMP facility• FDA and DEA licensed • 87,000sq ft, 500M unit

dose capacity

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

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

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

Athlone

Gainesville

King of Prussia


Elan Drug Technologies CampusAthlone, 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 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.

SCALE-UP & MANUFACTURING CAPABILITIES


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

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

Development Services and Capabilities

Development Services

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

Development Capabilities

•Pre-formulation Characterisation •Active, excipient, in-process and finished product characterisation

•Formulation •Feasibility laboratory •cGMP area - pilot scale formulation prototype manufacture •Experimental design - formulation/process optimisation

Registration support

• Our regulatory department has successfully assisted a number of companies with various applications to the regulatory authorities in the U.S., Europe and Japan

• 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


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 | 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 -The World’s Leading Drug Delivery Company.

Elan Drug Technologies -The World’s Leading Drug Delivery Company.

SUMMARY


Elan Drug TechnologiesThe World’s Leading Drug Delivery Company

For more information go to our website www.elandrugtechnologies.com

SUMMARY

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

Queries: [email protected]

elan general presentation short jan 2011

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