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1 Neil Flanzraich Vice Chairman and President Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004
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2 IVAX Corporation Multinational Corporation Multinational Corporation Leading Generic Company Leading Generic Company Albuterol Inhalation Aerosol (CFC) Albuterol Inhalation Aerosol (CFC) Verapamil HCl ER Tablets Verapamil HCl ER Tablets Paclitaxel Injection Paclitaxel Injection Extensive Proprietary Drug Pipeline Extensive Proprietary Drug Pipeline Strong Focus on Products for Respiratory Conditions Strong Focus on Products for Respiratory Conditions
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3 Leader in Providing Generic Albuterol Inhalation Aerosol (CFC) First U.S. Generic Albuterol Inhaler First U.S. Generic Albuterol Inhaler FDA Interactions – Establishing Guidance FDA Interactions – Establishing Guidance Expanded Use of Albuterol Expanded Use of Albuterol Significant Reduction in Price Significant Reduction in Price
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4 Leader in Providing CFC-Free Branded Respiratory Products IVAX’ 17-year Commitment to Development IVAX’ 17-year Commitment to Development World’s First CFC-Free Beclomethasone in MDI World’s First CFC-Free Beclomethasone in MDI QVAR – First CFC-Free Aerosol Corticosteroid for Asthma in U.S. 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 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 NDA Filed Aug. 2003 for HFA Albuterol in IVAX’ Patented Breath Activated Easi-Breathe ® Inhaler IVAX’ Other CFC Alternatives IVAX’ Other CFC Alternatives Dry Powder Inhaler Airmax™ Dry Powder Inhaler Airmax™ Inhalation Solution Products for Nebulization Inhalation Solution Products for Nebulization
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5 Health Concerns Depletion of Stratospheric Ozone Health Risks Depletion of Stratospheric Ozone Health Risks Increase Formation of Ground Level Ozone Health Risks Increase Formation of Ground Level Ozone Health Risks
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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 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 Will Provide at Least One Year of Post Marketing Data on Equivalent HFA Albuterol Products Sold in Europe
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7 IVAX’ HFA Albuterol MDI and HFA Albuterol Easi-Breathe Capacity Capacity FDA Approved Plant in Waterford, Ireland FDA Approved Plant in Waterford, Ireland 50-60 Million Units a Year in the Near Term 50-60 Million Units a Year in the Near Term CFC Availability is Rapidly Decreasing in Europe CFC Availability is Rapidly Decreasing in Europe
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8 IVAX and Pricing 17 Years of Demonstrated Commitment to Affordable Medicine – Generic and Branded Products 17 Years of Demonstrated Commitment to Affordable Medicine – Generic and Branded Products Substantial Free Sampling Program Substantial Free Sampling Program Patient Assistance Program Patient Assistance Program Additional Competitors Create Downward Pricing Pressure Additional Competitors Create Downward Pricing Pressure
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9 IVAX Request Based on: Continued CFC Hazards Continued CFC Hazards FDA Criteria for Removal Now Met FDA Criteria for Removal Now Met Huge Industry Investments Huge Industry Investments US Pledge to Citizens and International Community US Pledge to Citizens and International Community IVAX Request: Removal of Essential Use Exemption, Effective no Later than Dec. 31, 2005 Removal of Essential Use Exemption, Effective no Later than Dec. 31, 2005
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