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1 Development of a Generic Agrochemical Dr Nigel Uttley Enigma Marketing Research Registration of Agrochemicals in an Enlarged Europe 22nd September 2003, Brussels

2 Presentation Coverage Global market for agrochemicals Why are generics so important to multinational companies? Getting a generic to market

3 Definitions Generic - an active ingredient that is off-patent in most of its major markets Marketing companies - strong in the development of me-too products for a national or regional market

4 Global Sales of Conventional Agrochemicals (excluding agbiotech) at Distributor Level ($bn) Conventional agrochemicals Agricultural biotechnology

5 Agrochemical Industry Restructuring mergers acquisitions alliances product line rationalisation marketing and distribution deals R&D collaborations

6 Sales of top six in 2002 Company Crop Protection Sales ($m) Market Share (%) Syngenta 5, Bayer 4, Monsanto 2, BASF 2, Dow 2, DuPont 1,800 7

7 Generic/Marketing Companies Major generic companies with significant global presence, include: Makhteshim-Agan, Nufarm, Cheminova Small generic manufacturers (ca. 300) Marketing companies (> 1,000)

8 Product Range Rationalisation forced by anti-trust commissions internal strategic rationalisation

9 Acquisition of Aventis by Bayer global fipronil business (sold to BASF) global acetamiprid business or, if this cannot be achieved, the thiacloprid neonicotionid insecticide tribufos business, (sold to Amvac) flucarbazone wheat herbicide business in the US to an FTCapproved buyer or, if this cannot be achieved, the production plants for flucarbazone and propoxycarbazone European rights to: cypermethrin, ethiprole, phosalone, acrinathrin, cyfluthrin, beta-cylfuthrin, fenamiphos, oxydemeton-methyl, linuron, metamitron, iprodione, prochloraz, pyrimethanil, triticonazole and fluquinconazole European licences for thiodicarb and to develop combination products with propoxycarbazone

10 Syngenta Divestments In 2000, combined number of active ingredients = 121 By end of 2002, reduced to 89 Target is to reduce this to just 76 by 2005 Phasing out/divestment of these less profitable brands across the product range is likely to reduce sales by approximately $220 million 3,000 jobs from a total work force of 20,000 and 12 plant closures

11 Why Are Generics So Important To Multinational Companies? Decline in New Chemical Entities (NCEs) Increasing R&D costs Future generic products

12 Decline in Agrochemical New Chemical Entities (NCEs) The number of active ingredients receiving ISO (International Standards Organisation) common names indicates the decline in NCEs * Data only available for half year *

13 R&D Costs R&D costs for the agrochemical industry typically 9-12% of revenue Not far behind pharmaceutical industry s 14-16% Combinatorial chemistry and high throughput screening Significant increase in candidate molecules being screened

14 Recent US Fast-track Approvals fludioxonil azoxystrobin mefenoxam S-metolachlor cyprodinil pymetrozine mesotrione thiamethoxam

15 Future Generics Company Bayer (incl. Aventis) BASF DuPont Syngenta Dow Monsanto % Sales Subject to Patent Expiry in Next 5 Years

16 Syngenta s New Future Generics Active Ingredient Brand Name Activity Sales ($m) Approx. Patent Expiry Tralkoxydim Grasp Selective herbicide Tefluthrin Force Insecticide Primisulfuron Beacon Selective herbicide Alto Fungicide Flauzinam Omega Fungicide Cyproconazole Difenoconazole Score Fungicide Lufenuron Match Insecticide Clodinafop Topik Selective herbicide

17 Getting a Generic to Market. or how to walk through a minefield without being blown up

19 New Generic Agrochemicals Post 2002 bensulfuron-methyl clethodim clodinafop-propargyl clomazone cyproconazole cyprodinil difenoconazole diflufenican dimethenamid epoxiconazole fipronil fluazinam fludioxonil flusilazole imazaquin imazethapyr imidacloprid kresoxim-methyl mefenacet nicosulfuron primisulfuron-methyl sulcotrione thifensulfuron-methyl tebuconazole tralkoxydim tribenuron-methyl

20 How to Choose the Right Generic to Develop Market potential Synthesis/technology/manufacturing issues Intellectual Property Rights (IPR) status Registrations issues Economics

32 Market Potential Straight or mixtures Market price Competition from other products Geographic spread Market Segmentation

33 Market Segmentation Mixture products Branded products Extended branded products Distributor deals

34 What is the available market? For example: the UK tebuconazole market Tebuconazole was protected by EP , expired but extended by SPC until registrations in total by 6 companies 25 mixture products, 10 straight products

35 UK Tebuconazole Registrations Co-mixture a.is. - carbendazim, fenpropidin, imidacloprid, prochloraz, propiconazole, spiroxamine triadimenol, triazoxide. Triazoxide, triadimenol, imidacloprid and spiroxamine are Bayer products and not available to generic manufacturers from other sources or are still covered by patents Propiconazole and fenpropidin are Syngenta products and unavailable from other sources Thus only mixture products with carbendazim and prochloraz are possible Of the ten straight tebuconazole registrations, six are registered under Bayer s name The remaining four Barclay Chemicals, Clayton Plant Protection, ME2 Crop Protection Ltd. and Standon Chemicals Ltd. are parallel imports or the tebuconazole used in these products is supplied by Bayer.

37 Manufacturing Aspects Manufacturing process easy or difficult? IPR process patents etc Intermediates available or restricted? Synthetic pathway same as originator? Know-how

39 Patents (IPR) Active ingredient patent term extensions Novel formulations Synergistic mixtures of active ingredients Methods of manufacture Key intermediates Resolution of racemic mixture to the optically active isomer

40 Patent Term Extension Hatch-Waxman SPCs Data (field trials) for registrations

41 Hatch-Waxman 5 year period of data exclusivity for innovator products Patent term extensions for the active ingredient if the date of first marketing of the drug was delayed as a result of the regulatory review Abbreviated New Drug Application (ANDA) 180 days of marketing exclusivity for the first generic

42 Generic Drug Share of US Prescription Market % 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% % generic prescription

43 Supplementary Protection Certificates European patents post 1 st January 1985 Initially for pharmaceuticals, then extended to plant protection products SPC is for a product from within a patent and grants a maximum term of exclusivity of 15 years from first market approval in a European member state

45 Registration Data and IPR Issues Field trials during the life of a patent deemed to be infringement Field trials during the life of an SPC anticipated to be infringement

46 Patent Term Time-line For Pharmaceuticals And Agrochemicals AGROCHEMICALS 20 years standard patent term 2 years - time taken to generate registration data (field trials) Market entry for generic agrochemicals months 27 YEARS Date of filing of patent PHARMACEUTICALS Patent Term Extension Supplementary Protection Certificate (SPC)/Hatch Waxman US market entry for other generic pharmaceuticals Exclusive US market entry for 1st generic pharmaceutical

47 Registration and Data Protection Issues - Timescales List 1 90 products being reviewed 34 to be completed by 2005 List products supported Review complete by 2005 List products supported Review complete by 2008

48 Registration and Data Protection Issues Pre-Annex 1 listing prove product comparability field trials

51 Registration and Data Protection Issues Post-Annex 1 listing negotiate for animal tox data under data protection negotiate for eco-tox data under data protection generate own eco-tox data under data protection develop own product once Annex II data loses protection

52 Registration barriers to market entry for generics Lack of transparency Time factors No system for data compensation Inconsistencies in requirements at country level Cost of data

53 Lack of transparency AS product profiles confidential to the registration authorities Advanced Analytical techniques result in more complicated profiles than submitted by originator Process methods not declared in detail except for hazardous impurities, product profiles can differ from those registered Interpretation of recipes inconsistent and sometimes inaccurate

54 Time factor Post Annex 1 listing the monograph list is often inaccurate - Takes time to check out and establish true list at member state level Some studies take 2 year to generate, revocation can occur before data list and new data is complete Requirements escalate year on year

55 Data compensation USA - data compensation exists with an arbitration system, no EU equivalent Directive 92/32/EEC and 86/609/EEC requires that animal toxicology data is not duplicated No such Directive for eco-tox studies

59 Cost of getting a generic product to market pre Annex 1 Simplest data package and registration fees for 2 /3 countries will cost Euros 80,000 to 100, 000 Field trial data may be required additional cost Euros 150,000 to 250, 000 Market research costs Process development costs Registration consultancy and fees

60 Cost of getting a generic product to market post Annex 1 Data compensation for protected animal tox data Data compensation for protected eco-tox data Generate own eco-tox data Risk assessment and modelling

61 Summary Maturing agrochemical market, agrochemical innovation declining, GM innovation increasing A greater percentage of the market is open to generic competition Major consolidation has occurred Large % of sales by multinationals are off patent products Recent IPR changes have assisted R&D sector

62 Summary Registrations increasingly more complicated and costly favours R&D sector Registration of agrochemicals is more complicated in the EU than in the US Registration of agrochemicals in the US is harder than registration of pharmaceuticals Rewards for generic pharmaceuticals is much greater than that of generic agrochemicals Fragmented generic segment with little influence on legal and registration framework

74 Dr Nigel Uttley Enigma Marketing Research Tel: (44) Fax: (44)

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