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World’s Leading Drug Delivery Company General Presentation January  2011
Elan Drug Technologies   |  What we do   ,[object Object]
Elan Drug Technologies  |  Business Overview   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Successfully 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.  Strong Partnering Capabilities Across the Pharma Sector
Robust Pipeline  | 14 Products in Clinical Development   8 Products
Robust, Broad Platform of Validated Technologies  Suite of validated, commercially launched, proprietary, technology driven solutions.   Invega ®  Sustenna ® Ampyra ®
Capabilities Based on Two Key Technology Platforms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The OCR and NanoCrystal ®  Technology Platforms are complementary  and can be used in  combination.
NanoCrystal ®  Technology  |  What is it? •  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 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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Efficacy/Safety PK   Five Licensed NanoCrystal ®  Technology-Based  Drugs Launched in the US     
Our Controlled Release Technology Platform Allows a Range of Release Profiles and  Dosage Forms to be Engineered 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. 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
Avinza ® , Ritalin ®  LA and Verelan ® PM Demonstrate Oral Controlled Release Technologies - Applicability in Life Cycle Management Basis for filing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Efficacy/Safety PK   
Dalfampridine Approved by the FDA in 2010 - Utilises  MXDAS ®  Technology  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],MSF-203 Timed 25-foot Walk ITT Population MSF-204 Timed 25-foot Walk ITT Population Approved and launched Q1 2010  under trade name Ampyra ®
Extensive R&D, Scale-up and Manufacturing Capabilities in US and Europe  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Athlone Gainesville King of Prussia
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 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.
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   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
We Offer Real Advantage to Our Partners ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Elan Drug Technologies  |   Strength in Numbers   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Elan Drug Technologies -  The World’s Leading Drug Delivery Company.  SUMMARY
For more information go to our website  www.elandrugtechnologies.com SUMMARY  ,[object Object],[object Object],Queries:  edtqueries@elan.com Elan Drug Technologies  |  World Leading Drug Delivery Company

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World’s Leading Drug Delivery Company

  • 1. World’s Leading Drug Delivery Company General Presentation January 2011
  • 2.
  • 3.
  • 4. 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
  • 5. 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. Strong Partnering Capabilities Across the Pharma Sector
  • 6. Robust Pipeline | 14 Products in Clinical Development 8 Products
  • 7. Robust, Broad Platform of Validated Technologies Suite of validated, commercially launched, proprietary, technology driven solutions. Invega ® Sustenna ® Ampyra ®
  • 8.
  • 9. NanoCrystal ® Technology | What is it? • 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 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.
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  • 11. Our Controlled Release Technology Platform Allows a Range of Release Profiles and Dosage Forms to be Engineered 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. 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
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  • 15. 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.
  • 16. 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.
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