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Business Presentation June 2009

Business Presentation June 2009. prepared for. about us…. Our Partners. Pr oduct L icensing & B usiness D evelopment - 1. Marketed. P roduct l icensing & B usiness d evelopment - 2. Pipeline. Offices. Reimbursement. Reimbursement.

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Business Presentation June 2009

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  1. BusinessPresentation June2009

  2. preparedfor

  3. about us…

  4. OurPartners

  5. ProductLicensing& BusinessDevelopment- 1 Marketed

  6. Product licensing & Business development - 2 Pipeline

  7. Offices

  8. Reimbursement

  9. Reimbursement SGK (SosyalGuvenlikKurumu-Social Security Organisation) is a state controlled organisation which acts independently. Of course has close ties with the MOH and MOF(finance) and MOL (labour). MOH is responsible for registration of pharmaceuticals and SGK is the main body for reimbursement. Almost 2/3 of the population has State controlled social security coverage. Private insurance companies control 3-4% of the population. Pharmaceuticals pricing formula: The cheapest ex-factory price (hospital price if ex-factory is not available) in reference countries (France, Italy, Portugal, Spain, Greece) and country of origin will be accepted as Turkish ex-factory price. Reimbursement: For all reimbursed products 11% reimbursement discount is by law. Additional discount may be asked in some cases. Registered products may apply for reimbursement (fully or partly) which is a very difficult process. It takes time and huge effort is necessary.

  10. Reimbursement • MOH, MOF and SGK decides the product to be reimbursed (fully/partly) or not. There may be a indication limitation. Company applies for the reimbursement after getting the registration. If there is any competitor (as a generic) which is already registered, the new product’s reimbursement price must be lower than the competitor’s. If there is a registered therapeutic competitor, than the company should prove that the new product is more efficacious or has less side effects in order to get a higher, same or lower reimbursement price. • Pharmaco-economical data is required. Fosrenolwill be 100% reimbursed for patients whohave a health reportprepared by a nephrologist or a doctor who has adialysiscertificate.

  11. Reimbursementcriterias (SGK SUT 12.July.08) • Other phosphate binders should be used at least for 3months prior to sevelamer. At the end of this period; • 1. Multiplication of calcium and phosphorus levels shouldbe 72 or more (or) • 2.PTH levels should be 100 pg/ml or less with adynamicbone disease symptoms (or) • 3. Kt/V value should be more than 1.4 and Ca x P levels 55and more (or) • 4. Kt/V value is more than 1.4 and PTH value is more than300 pg/ml • Ref: SGK SUT 12July08 : Tedaviye başlamak için diğer fosfor düşürücü ilaçların en az 3 ay süreyle kullanılmış olması ve bu hususun raporda belirtilmiş olması gerekir. Bu süre sonunda: 1)      Kalsiyum ve fosfor çarpımı 72 ve üzerinde olan veya2)      PTH düzeyinin 100 pg/ml değerinin altında olan adinamik kemik hastalığı olguları veya3)      Hastanın Kt/V değeri 1.4’ün üzerinde olmasına rağmen düzeltilmiş kalsiyum ve fosfor çarpımı 55’in üzerinde olan veya4)      Kt/V değeri 1.4'ün üzerinde olan hastanın PTH değeri 300 pg/ml ve üzerinde  olan, hemodiyaliz veya periton diyaliz tedavisi altındaki hastalara

  12. Registrationtimelinesandprocedures 2-2,5 years

  13. Hemodialysis market - 1 Number of HemodialysisCenters Number of Doctors in HD Centers Number of Nurses in HD Centers

  14. Hemodialysis market - 2 Number of HD Equipments Number of PD Equipments

  15. Phosphate binding agents used in prevalent HD patients

  16. Phosphate binding agents used in prevalent PD patients

  17. Number of HD patients

  18. Sevelamerprice 1 Bottle of 180ct 800mg Tablets VAT IncludingRetail Sales price: 386.77 TL € 179.89

  19. Sevelamersales (IMS) Renagel (Sevelamer) marketedby Eczacıbaşı. Hemodialysis market.

  20. Sevelamersales IMS (Units)

  21. Sevelamersales IMS (Units)

  22. Hemodialysis market IMS (Units)

  23. Hemodialysismarket ( IMS (Units)

  24. FosrenolForecast

  25. FosrenolForecast Farecastfor 5 years (tablets)

  26. Target & Team 1. Number of Calls Needed Target : 1800 – 2000 Number of doctors for each ABM : 200 Visited target : 1600 Daily calls per ABM : 10 Number of ABMs required : 10 2. Sales and Marketing Team for FOSRENOL 1 PM 1 MM 10ABM (FTE) 3. Cost of Sales and Marketing Team (Per Head-Annual-Euro) PM : 60 K MM : 60 K ABM : 30 K

  27. Sales and Marketing Team for Renagel 1 PM 1 MM 6RM 20 ABM (8 FTE)

  28. Pre-launchandlaunchprograms • Premarketing activities2009-2010-2011 • KOL visits, • Namedpatientsales, • Determination of opinionleaders/board membersforlocalmeetings/presentations. • Introductionof Fosrenolviapresentations/meetingsbyopinionleaders/board membersand PM/MM presentations • National/Internationalcongresssponsorships • Selectionof thetargetphysicians • October2011: estimateddate of registrationapproval • Teasing • Posting

  29. Pre-launchandlaunchprograms • March2012: salesteamtraining • Preparationof visualaid • Preparationof promotions April 2012: estimateddate of reimbursement May 2012: Starting marketing activities

  30. Events in 2009 • NationalCongress of Nephrology (date not certain) • WorldCongress of Nephrology • ICS 2009 SAN FRANCISCO MEETING • Localmeetings..

  31. ThankYou

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