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Neil Flanzraich Vice Chairman and President

Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004. Neil Flanzraich Vice Chairman and President. IVAX Corporation. Multinational Corporation Leading Generic Company Albuterol Inhalation Aerosol (CFC) Verapamil HCl ER Tablets Paclitaxel Injection

JasminFlorian
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Neil Flanzraich Vice Chairman and President

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  1. Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004 Neil Flanzraich Vice Chairman and President

  2. IVAX Corporation • Multinational Corporation • Leading Generic Company • Albuterol Inhalation Aerosol (CFC) • Verapamil HCl ER Tablets • Paclitaxel Injection • Extensive Proprietary Drug Pipeline • Strong Focus on Products for Respiratory Conditions

  3. Leader in Providing Generic Albuterol Inhalation Aerosol (CFC) • First U.S. Generic Albuterol Inhaler • FDA Interactions – Establishing Guidance • Expanded Use of Albuterol • Significant Reduction in Price

  4. Leader in Providing CFC-Free Branded Respiratory Products • IVAX’ 17-year Commitment to Development • World’s First CFC-Free Beclomethasone in MDI • QVAR – First CFC-Free Aerosol Corticosteroid for Asthma in U.S. • NDA Filed Jan. 2003 for HFA Albuterol in MDI (Received Approvable Letter 11/28/03) • NDA Filed Aug. 2003 for HFA Albuterol in IVAX’ Patented Breath Activated Easi-Breathe® Inhaler • IVAX’ Other CFC Alternatives • Dry Powder Inhaler Airmax™ • Inhalation Solution Products for Nebulization

  5. Health Concerns • Depletion of Stratospheric Ozone Health Risks • Increase Formation of Ground Level Ozone Health Risks

  6. IVAX’ HFA Albuterol MDI and HFA Albuterol Easi-Breathe • Will Meet FDA Regulations on Same Active Moiety, Same Route of Administration, Same Indications and Approximately Same Level of Convenience of Use • Will Provide at Least One Year of Post Marketing Data on Equivalent HFA Albuterol Products Sold in Europe

  7. IVAX’ HFA Albuterol MDI and HFA Albuterol Easi-Breathe • Capacity • FDA Approved Plant in Waterford, Ireland • 50-60 Million Units a Year in the Near Term • CFC Availability is Rapidly Decreasing in Europe

  8. IVAX and Pricing • 17 Years of Demonstrated Commitment to Affordable Medicine – Generic and Branded Products • Substantial Free Sampling Program • Patient Assistance Program • Additional Competitors Create Downward Pricing Pressure

  9. IVAX Request Based on: • Continued CFC Hazards • FDA Criteria for Removal Now Met • Huge Industry Investments • US Pledge to Citizens and International Community IVAX Request: • Removal of Essential Use Exemption, Effective no Later than Dec. 31, 2005

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