Elite Pharmaceuticals, Inc. · OTC:ELTP

Elite Pharmaceuticals — Investor Presentation (November 2005)

33 slides from Elite Pharmaceuticals's investor presentation, November 2005

  1. Slide 1: Elite Pharmaceuticals, Inc.

    Elite Pharmaceuticals, Inc. November 2005

  2. Slide 2: Forward Looking Statement

    Forward Looking Statement This presentation contains forward looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company’s control, which may cause actual results, performance or achievements of the Company to be materially different from t

  3. Slide 3: Overview

    Overview „ Specialty Pharmaceutical Company „ Engaged in the development, manufacturing and commercialization of oral controlled release (CR) drugs „ Focus on highly specialized and difficult-to-formulate oral controlled release drugs „ High barriers to entry aimed at niche market segments (ANDA’s,

  4. Slide 4: Historical Perspective

    Historical Perspective „ Elite was founded in 1990 „ Unique broad based controlled release drug delivery technology „ Early success developing controlled release drugs on a contract basis for large pharmaceutical clients (e.g. Celgene/Novartis) „ Elite publicly traded and listed on American Stock Ex

  5. Slide 5: New Strategic Direction

    New Strategic Direction „ In 2003, Elite replaces Chairman, CEO/President and installed new management team „ Changed composition of the Board „ Improved operating performance „ New commercial strategy focusing on: „ Pain Management utilizing controlled release products utilizing proprietary ART™ „

  6. Slide 6: Management Team

    Management Team Bernard Berk ƒ Over 30 years of experience in the field of pharmaceutical management ƒ Served as President and Chief Chairman & Executive Officer of Michael Andrews CEO Corporation from 1996 - 2003 ƒ Served as President and Chief Executive Officer of Nale Pharmaceuticals Corporation

  7. Slide 7: Management Team

    Management Team Dr. Charan Behl ƒ Joined Elite from Nastech Pharmaceutical Corporation – Executive Vice President of R&D from 1995 - 2001 Chief Scientific ƒ Served as research leader of the Pharmaceutical R&D Department of Hoffmann La Officer Roche from 1981 – 1994 ƒInternationally known for his sci

  8. Slide 8: Growth Strategy

    Growth Strategy „ Focus: Pain Management „ Opioid abuse resistant technology „ Unique 24 hour drug delivery systems „ Expand, strengthen & optimize unique drug delivery platforms „ Balanced, Diversified portfolio of controlled release products „ Novel CR formulations „ NDAs, 505(b)2: Manage product

  9. Slide 9: Elite's Technology

    Elite’s Technology „ Oral multiparticulate release systems: „ Delayed, sustained release; e.g. once-a-day „ Pulsed release; e.g. double peak „ Targeted release „ Barrier Coatings (abuse resistant) „ Chrono release for circadian rhythms „ Taste Masking 9

  10. Slide 10: Generic Product Strategy

    Generic Product Strategy „ Selective focus: „ Highly specialized-difficult to formulate CR drugs „ High barriers to entry „ Complex legal / regulatory / manufacturing challenges „ Difficult raw material sourcing issues „ Niche therapeutic areas „ Narcotics (CII) „ Limited competition „ Higher margin

  11. Slide 11: Product Pipeline

    Product Pipeline Stage of Development Therapeutic Preclinical/ Pilot/ Pivotal/ Current U.S. Launch Product Category Research PK Phase III Status Partner Oxycodone Pilot Phase Pain No Once daily Completed Oxycodone Pilot Phase Pain No ART™ I Completed Lodrane 24 Allergy Launched Yes Allergy II Allerg

  12. Slide 12: Strategic Alliances / Partnerships

    Strategic Alliances / Partnerships „ Pliva - Development and license agreement to develop a controlled release anti-infective generic with a branded market in 2004 of approximately $90 million „ Harris Pharmaceuticals, Inc. and Tish Technologies - Development, manufacturing and distribution agreemen

  13. Slide 13: Elite's Patents & Proprietary Processing Techniques

    Elite’s Patents & Proprietary Processing Techniques „ 6 United States patents issued „ 3 United States patents pending „ 4 International patents pending 13

  14. Slide 14: Facilities & Capabilities

    Facilities & Capabilities Facilities Capabilities ƒ Offices & Labs ƒ Drug Formulation & Characterization ƒ 20,000 sq ft facility ƒ Process Optimization & Scale-up ƒ GMP suites for development and ƒ Methods development manufacturing ƒ Manufacturing and technology ƒ DEA registration transfer Biostudie

  15. Slide 15: Pain Management Market

    7 Pain Management Market

  16. Slide 16: Pain Market

    Pain Market „ Pain „ Most costly and significant health care issue „ Changing attitudes towards pain „ $19 billion pain market in 2004, $6.4 billion Opioid market „ Pain is still under treated „ Drug abuse controversies „ Medical professionals rethink prescribing practices „ Pharma pressure to devel

  17. Slide 17: Pain Market: Large Opportunities

    Pain Market: Large Opportunities “Drugs used to fight pain 5 – Year $ CAGR today essentially the Opioid 20% same as those used in Non-Opioid 14% ancient times” „ Treat symptoms – not disease „ Opioid abuse effecting the way we $6.4B treat patients $12.6B „ Need for better, safer pain medication more

  18. Slide 18: Opioid Abuse Problem

    Opioid Abuse Problem „ Most widely prescribed Opioid is OxyContin® „ Diversion of drug for non-medical purposes increased over 400% „ Abuse heightened by new generation high dose ER „ “Hillbilly heroin” „ How addicts abuse OxyContin® „ Euphoric high produced by breaking down CR mechanism „ Crush and

  19. Slide 19: Approaches to Curb Opioid Abuse

    Approaches to Curb Opioid Abuse „ Pharmacological Intervention „ Antagonist based (Naltrexone) „ Physical Deterrence (gummy based formulations) „ Formulations with polymers „ Makes crushing more difficult „ Pro drug, NCEs „ Create new drug entity „ Use of enzymes „ Others „ Irritants „ Resins 19

  20. Slide 20: Elite's Approach

    Elite’s Approach Antagonist / Agonist Concept: ƒ Co administration of beads in a capsule such that antagonist is released only when capsule is tampered with Challenges: ƒ Prevent leakage of Naltrexone in unaltered form (Elite has achieved very low release rates at LOQ of 7.5 pg/mL) 20

  21. Slide 21: Pain Portfolio

    Pain Portfolio „ 24 hour Oxycodone without ART™ „ 24 hour Oxycodone with ART™ „ 12 hour Oxycodone with ART™ „ Plus potential for: „ AB rated Oxycodone „ Ancillary Products „ Compete in twice daily OxyContin™ market of $2 billion per year 21

  22. Slide 22: ART Summary

    ART™ Summary „ ART™ worked in human subjects as intended „ Unaltered pellets did not release significant levels of Naltrexone „ Tampered/crushed pellets released significant levels of Naltrexone „ Limit of Quantitation (LOQ): 7.5 pcg/ml „ Intellectual Property „ Unique polymers and permeability „ Un

  23. Slide 23: Elite's In Vivo Study Results

    Elite’s In Vivo Study Results „ Unaltered/Intact pellets did not release significant levels of Naltrexone „ Tampered/crushed pellets release significant levels of Naltrexone „ No fed-fasted effects observed „ Both formulations performed similarly „ Plasma levels from two formulations were comparable

  24. Slide 24: ART Intact Capsule Dissolutions Results

    ART™ Intact Capsule Dissolutions Results RELEASE OF NALTREXONE AND OXYCODONE FROM UNALTERED 120.0 PELLETS USP Basket Method, 100 RPM, 900 mL Gradient Medium: pH 2.0 for 1hr; pH 4.5 for 2hr; pH 6.8 for 21hrs. 100.0 % Dissolved 80.0 60.0 40.0 OXYCODONE 20.0 NALTREXONE 0.0 0 4 8 12 Hours 24

  25. Slide 25: ART - Crushed Pellets Dissolution Results

    ART™ - Crushed Pellets Dissolution Results RELEASE OF NALTREXONE & OXYCODONE FROM CRUSHED PELLETS 120.0 USP Basket Method, 100 RPM, 900 mL, Gradient pH Media (pH 2.0 - pH 4.5 pH 6.8) 100.0 80.0 % Dissolved 60.0 40.0 OXYCODONE 10 SEC OXYCODONE 30 SEC OXYCODONE 60 SEC 20.0 NALTREXONE 10 SEC NALTREXONE

  26. Slide 26: ART - Intact and Crushed Pellets Human Testing

    ART™ - Intact and Crushed Pellets Human Testing 4000 BLOOD LEVELS (pg/mL 3500 3000 2500 tampered 2000 1500 1000 500 unaltered 0 0 5 10 15 20 25 TIME (hrs) Unaltered Antagonist Beads Do Not Release Tampered Antagonist Beads Release 26

  27. Slide 27: No Release of Antagonist in Unaltered Pellets

    No Release of Antagonist in Unaltered Pellets Fasting Conditions Table 1: Pharmacokinetic Evaluation of Undamaged Formulation 1 of Naltrexone HCl in Healthy Human in Volunteers Under Fasting Conditions - 24 Hour Blood Sampling; n = 12 Plasma Concentration, pg/mL; Subject Numbers Hrs 1 2 3 4 5 6 7 8

  28. Slide 28: 24 hr Oxycodone (Once-a-day)

    24 hr Oxycodone (Once-a-day) „ Products „ 24 hr Oxycodone without ART™ „ 24 hr Oxycodone with ART™ „ No once daily Oxycodone on market „ Current Status „ Phase I pharmacokinetic study completed „ 13 subject single dose 4 way cross over „ Patent filed „ Compiling IND 28

  29. Slide 29: 24 hr Oxycodone versus OxyContin

    24 hr Oxycodone versus OxyContin® Multiple Dose Oxycodone from IVIVC 30 Elite Oxycodone 25 Blood Level (ng/ml) 20 15 10 ® OxyContin 5 0 48 60 72 84 96 Time After Initial Dose (hr) •Based on IVIVC (correlation method using in vivo and in vitro data) •Steady state dosing (3rd and 4th day) •Therapeutic

  30. Slide 30: Other Opioid Applications for ART

    Other Opioid Applications for ART™ „ Morphine „ Hydromorphone „ Oxymorphone „ Hydrocodone 30

  31. Slide 31: Recent Milestones

    Recent Milestones „ Launched Lodrane 24, a branded Rx allergy product with ECR Pharmaceuticals. The oral antihistamine market in 2004 was approximately $3 billion. „ Manufactured commercial batches of Lodrane 24 „ Scaled-up second branded allergy product with an addressable market of approximately $

  32. Slide 32: Recent Milestones

    Recent Milestones „ A development and license agreement with Pliva to develop a controlled release anti-infective generic with a generic market in 2004 of approximately $90 million „ A development, manufacturing and distribution agreement with Harris Pharmaceuticals, Inc. and Tish Technologies to de

  33. Slide 33: Company Summary

    Company Summary „ Elite is poised for growth „ Modest current valuation „ Proven management team „ Clearly defined strategy „ Near term revenue expectations „ Committed shareholder base „ Balanced ANDA & NDA portfolio – low risk „ Strong IP and technology platform „ Licensing alliances in place „ Pr

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