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Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. “Niche” player in a growing market. Forward Looking Statement.

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Elite Pharmaceuticals, Inc.

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  1. Elite Pharmaceuticals, Inc. “Niche” player in a growing market

  2. 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 the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending R & D activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company’s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.

  3. Company Overview • Specialty Pharmaceutical Company • Oral controlled release technology • “Niche” Drugs with High Barriers to Entry • Focus -Novel Pain Formulations • FDA Approved Compounds • Proprietary Abuse Resistant Technology “ART ™” • Unique Once Daily delivery systems • Lead Pain compounds • ELI-216 - Abuse Resistant Oxycodone (Naltrexone) • ELI-154 - 24-hour Oxycodone • Patents Filed and Pending

  4. Corporate Strategy • New Commercial Focus • Accelerate development of pain pipeline • Broaden platform technology • Strengthen IP Patent estate • Expand strategic licensing arrangements • Build a balanced portfolio of complementary CR products • Recognized presence in US Pain market

  5. Phase ICompleted No 24-hour oxycodone available on market Market ≥ $400 M* Eligible for Third Party Payment Two Lead Pain Candidates ELI-154 Once-daily Oxycodone ELI-216 Abuse Resistant Oxycodone • IND Allowed • Phase I commenced Status • Proven clinical results • Resistant to most abuse methods • Pharmacological vs Physical • Robust formulation – patent pending • No dose dumping Unique • No Abuse resistant • Oxycodone on market • Market ≥ $800 M* • Eligible for Third Party • Payment Market *Source: Defined Health

  6. Pain Management • The medical effort to treat pain • Large under served market • IMS Health – U.S. Market - $26B • High dose-Extended release opioids • Pain management treatment compromised • Abuse, Misuse, Diversion • Altering prescribing practices • Regulatory pressure-Sanctions • Physicians will use abuse deterrent formulations • Crowded field “scrambling” to find solutions • Premiums for better, safer, abuse resistant pain drugs

  7. Trends in Prescription Drug Abuse Percentage increase Source: CASA analysis of NSDUH/NHSDA 1992-2003 “The FDA should require pharmaceutical companies manufacturing controlled drugs to formulate or reformulate the drugs where possible to minimize the risk of abuse”

  8. Oxycodone Abuse in U.S. Emergency Rooms 14,087 >90%CAGR Source: U.S. Government, DAWN Report Oxycodone Abuse Addicts compromise the control release mechanism • Why Oxycontin® Abuse? • Contains a high dose of oxycodone – a strong opioid drug • Simple to abuse: • Crush & ingest • Crush & snort • Extract & inject • Delivers a quick, powerful euphoria • Drug craving makes abusers ignore the consequences of oxycodone abuse: overdoses, addiction, and death

  9. Market Analysis Survey* ABUSE RESISTANT “OPIOIDS” 61% Concept Viewed Favorably - 70% of Oxycontin use – convert to abuse resistant product with a brand co-pay. - 89% Consider Personal Liability very important when prescribing Opioids • 95% Doc’s Important to have new, unique Opioid *Rood Research

  10. Elite’s Abuse ResistantSolution– ELI-216 • Pharmacological Intervention - Combines agonist with antagonist • - Both compounds are well known / established • - Antagonist released only when crushed • - Patents filed and pending • Clinical Phase 1 Studies – “Proof Of Concept” • First study - Naltrexone Only (n = 12) • - Food Effect • - Intact vs crushed formulations • - Long term blood sampling (7 days post single dose) • Second Study - Naltrexone plus oxycodone (n = 16) • - Intact vs crushed formulations • - Long term blood sampling (7 days post single dose)

  11. ELI-216 Phase I Data Oxycodone (Agonist) Crushed vs. Intact Naltrexone (Antagonist) Crushed vs. Intact Early peak level generates the “high” addictive effect Crushed Intact Fasted Patients

  12. ELI-216 ART™ Development • Timeline* • 2005 –Phase I Results • 2006 –FDA Meetings /Phase II Studies • 2007 –Phase III Studies • 2008 –File NDA • 2009 -Market *estimated

  13. Market Assessment / ELI-216 ART™ $800 Million Opportunity Patient groups considered at high risk for abuse / diversion include HIV / AIDS, sickle cell disease and chronic pancreatitis. Patient groups considered at low risk for abuse / diversion include cancer-related pain, low back pain and osteoarthritis / rheumatoid arthritis. Defined Health

  14. ELI-216 Technology Platform • Competitive Advantage • Pharmacological approach - high barriers to abuse • 505(b)2 programs reduces risk, time lines and cost • ELI-216 only abuse deterrent combination with no significant levels of Naltrexone released • Sufficient Abuse resistant characteristics for third party payers Other Product Applications for ART™ • Hydrocodone • Hydromorphone • Morphine • Oxymorphone The ARTTM Platform will provide a number of product opportunities

  15. ELI-154 -Once Daily Oxycodone • IND allowed • Phase I completed • May be combined with ART™ • Patent pending • Pilot study completed • Eliminate mid-day trough • No “dose dumping” effect observed ELI-154vs. OxyContin®

  16. ELI-154 Development • Timeline* • Dec 2005 – IND Filed • Jan 2006 – IND Allowed • May 2006 – Begin Phase I • June 2006 –Phase I Completed • YE 2006 – Begin Phase II *estimated

  17. Generic Market Strategy Selective product focus: • Products with ≥1 barriers to entry • Limited competition • Higher margins • Partnership / Marketing exclusivity opportunities Market: • $100 B products lose patent protection by 2010 • $58 B – global sales – 2004* • $28 B – U.S. sales 2005* • 50.3% of all Rx’s are generics *Source: MedAd News 11/05

  18. Diversified Product Pipeline Elite has a promising portfolio of complimentary “niche” ANDA products

  19. Elite’s Facilities & Capabilities Facility: • Currently - 24,000 sq ft • GMP suites for development, manufacturing • DEA registration Capabilities: • Drug Formulation & Characterization • Process Optimization & Scale-up • Methods development • Manufacturing and technology transfer

  20. Recent Milestones IND acceptance for ELI-154 - once daily Oxycodone Positive results from two Phase I studies for ELI-216 ART™ Launched Lodrane 24®/Scaled-up Lodrane 24D® Strategic partnerships with Pliva, Harris Pharmaceuticals, Tish Technologies, IntelliPharmaceutics and Orit Labs Positive results from two Phase I studies for ELI-154 Near Term Catalysts Initiation of Phase II studies for ELI-216 ART™ Initiation of Phase II studies for ELI-154 Launch of Elite’s second once-daily allergy product Lodrane 24D® Filing of two ANDA’s for CR generic products

  21. Value Proposition: ELI Modest Valuation- $50 Million • Significant Technological Achievement - Large Addressable Market (800M ELI-216 & $400M ELI-154)* - Strong IP - Patent Filed & Pending Two Pain Products in Clinical Trials Distinct Marketing Advantage • Differentiated - Doc’s want abuse resistant - Pharmacological approach • 505 b(2) Pathway - - Phase III - 2007 Lower Risks Costs & Time to Market • Complimentary CR ANDA’S - 6 Partnered Projects - 1 Product on Market - 2nd Project at year end*Defined Health Diversified Portfolio

  22. Experienced Management Team

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