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Supply of HFA 227 and HFA 134a in MDIs - Past -

Supply of HFA 227 and HFA 134a in MDIs - Past - . 1980`s Synthesis of HFA 134a and HFA 227 (134a: DuPont (1993), ICI (1991), Aussimont (1994), Atofina (1993/5), Solvay (formerly Hoechst) 1994 (227ea: Solvay (formerly Hoechst): 1996, pilot plant since 1987, Great Lakes (1993)

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Supply of HFA 227 and HFA 134a in MDIs - Past -

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  1. Supply of HFA 227 and HFA 134a in MDIs - Past - 1980`s Synthesis of HFA 134a and HFA 227 (134a: DuPont (1993), ICI (1991), Aussimont (1994), Atofina (1993/5), Solvay (formerly Hoechst) 1994 (227ea: Solvay (formerly Hoechst): 1996, pilot plant since 1987, Great Lakes (1993) 1990`s Toxicological Testing of HFAs for MDIs (IPACT-I for 134a: ADIR (Institut de Recherches Internationales Servier), Aeropharm Technology, Inc., ASTA Medica AG, AstraZeneca plc, Aventis Pharma Ltd., Boehringer Ingelheim GmbH, Hoffmann-La Roche Inc., 3M, Norton Healthcare Ltd, Novartis Pharma, Inc., and TAP Holdings Inc.) (IPACT-II for 227: ASTA Medica AG, AstraZeneca plc, Aventis Pharma, Ltd., Boehringer Ingelheim GmbH, Glaxo Wellcome R&D, Hoffmann-La Roche Inc., 3M, Norton Healthcare Ltd., and Schering-Plough Corp.) 1994/5 Safety Assessment of HFAs for Use in MDIs by CPMP (134a: July 1994 for IPACT-I; Sept 1994 for Glaxo Inhalation Grade) (227ea: Sept 1995 for IPACT-II)

  2. CFC Essential Use Exemptions Approved and Actually Used (in metric tons) from 1997 to 1999 under the Montreal Protocol CFC´s approved 6636 6000 4000 2000 0 CFC´s actually used or acquired 6592 5463 4656 4660 4429 4363 4168 3665 2644 2426 2255 1997 1998 1999 1997 1998 1999 EU: USA: Source: April 2000 TE DAP Report

  3. Use of HFA 227 and HFA 134a in MDIs - 134a Present - Active Product Company Beclometasone QVAR ® (USA: 09/00), UK: 09/98)3M BECLOJET ® (F: 05/00)Chiesi BECLAZONE ® (F, J: 06/2000) Norton Salbutamol AIROMIR ®(1995;Japan 02/97)3M VENTOLIN EVOHALER ®Glaxo (D: SULTANOL N ® : 1997, UK: 01/98) Salmeterol SEREVENT ®, ARIAL®Glaxo Fluticasone FLIXOTIDE ®(D: FLUTIDE N®: 06/97)Glaxo Salmeterol SERETIDE EVOHALER® (UK: 07/00)Glaxo + Fluticasone

  4. Use of HFA 227 and HFA 134a in MDIs - 227 Present - ActiveCompany Disodium Cromoglycate INTAL Aerosol A® (J: 07/00)Aventis Pharma Ltd (Eu 12/98) (RoW 7/99) Nedocromil TILADE®(Eu 1999, RoW 2000) Aventis Pharma Ltd Disodium AARANE®N (Ge 7/99)Aventis Pharma Ltd Cromoglycate + Reproperol Allergospasmin® N(Ge 10/99)Asta Medica AG Product HFA 227 products now launched in >15 countries

  5. Use of HFA 227 and HFA 134a in MDIs - Current - • Propellant chosen by history rather than optimisation historical experiences and choices made by companies In mid 1990s price differential and availability of supply initial performance of delivery systems/valves IP web preventing free access to early formulations Product optimisation now available as properties and understanding has increased partnerships available for “proven” technologies and capabilities

  6. Use of HFA 227 and HFA 134a in MDIs From Past and Present- into the future • Major technical challenge for entire industry • Redevelopment of valves, mouthpieces and devices • > 10 yrs investment for most companies to reach new formula • Major patent/IP “web” developed by most companies • Major process and equipment development • significant capital and human resource investment • critical skills in developing and industrialising products • competitive barrier to many competitors and high entry price • Expanding use to partnerships with other companies access to know how, capability, IP and development-supply

  7. Use of HFA 227 and HFA 134a in MDIs - Future - Are HFAs going to be phased-out in MDIs ?  Phase - out of CFCs in MDIs still Priority Complete replacement by HFA in MDIs/ DPIs, corresponds to a reduction in greenhouse gas emissions of approx. 75 %; IPAC data: 73 %

  8. Use of HFA 227 and HFA 134a in MDIs - Future - Are HFAs going to be phased-out in MDIs ?  Phase - out of HFAsin MDIs would result in Almost no reduction of emissions (0.05% worldwide/ 0,13 %EU) Highest cost per t CO2 saved >100 € to > 500 €/ tonne CO2 equiv., with an average of 7 €/ tonne CO2 equiv. for 42 Mtonnes of CO2, better 1 - 2 €/ tonne CO2 equiv.; recommendation not to implement measures > 30 €/ tonne CO2 Longest duration for alternative developments (8 - 12 years; for new technology: 10 - 20 years)

  9. Use of HFA 227 and HFA 134a in MDIs - Future - Are HFAs going to be phased-out in MDIs ?  MDIs are reliable, cheap, convenient (EU wide patients primarily rely on MDIs: 85%, DPIs: 15%)  Certain patient groups depend on MDIs  Supply issue rather than legislation (year 2000:CFC MDIs in US: 100%, EU: 75%, HFA pharma grade supply ensured over long-term period (DuPont, ICI, Solvay)

  10. Use of HFA 227 and HFA 134a in MDIs - Future - Are HFAs going to be phased-out in MDIs ? European Federation of Asthma & Allergy Associations: „EFA urges the national governments, while developing policies to meet the Kyoto protocol obligations not to take measures against medical uses of HFC MDIs“, EFA Position Paper on the need for Metered Dose Inhalers (MDIs) September 17, 2000

  11. Use of HFA 227 and HFA 134a in MDIs - Future - Use of pMDI/ DPI Technology for the Treatment of:  Diabetes (e.g. insulin Pfizer/Aventis/ Inhale; EliLilly/ Generex)  Influenza (e.g. neuraminidase inhibitor, zanamivir, Relenza®; Glaxo)  Osteoporosis  Cancers  Septic Shock  Viral Diseases etc.

  12. HFA supply Mobile Addition Vessel Aqueous Clean In Place Powder Eductor Recirculate to Filling Machine In vessel Homogeniser and Agitator Process optimised for each product eg INTAL high dose hygroscopic drug • Fully enclosed process to give product/operator protection • Much reduced emissions and cleaning with aqueous system to improve environmental impact • Lab (1-10kg) – pilot (100kg)-production scale(1000kg) for solution and suspension aerosol using “identical” equipment • Aventis patented formulations and exclusive Optimised valve for HFA 227 For further details contact Dr Mike Dey Director, Respiratory Technology, Aventis Pharma London Road, Holmes Chapel, Cheshire CW4 8BE Tel +(44) 1477 538113 email Mike.Dey@aventis.com

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