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Business Presentation

Business Presentation. 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. P roduct l icensing & B usiness d evelopment - 2. Pipeline. Offices. Reimbursement.

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Business Presentation

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  1. BusinessPresentation

  2. preparedfor

  3. about us…

  4. OurPartners

  5. ProductLicensing & BusinessDevelopment - 1 Marketed

  6. Product licensing & Business development - 2 Pipeline

  7. Product licensing & Business development - 2 Pipeline

  8. Offices

  9. Reimbursement

  10. Reimbursement SGK (Sosyal Guvenlik Kurumu-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.

  11. 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.

  12. Registrationtimelinesandprocedures 2-2,5 years

  13. Registrationtimelinesandprocedures We apply Agrylin as a generic product. Approval will take 18-22 months and reimbursement related costs will be met by GEN ILAC .

  14. Current SUT SGK SUT 12.7.21. Reimbursement conditions for Anagrelid Can only be prescribed based on the expert (oncology specialist or child / adult hematology specialist) medical reports for essential thrombocytemia patients with high-risk vascular disease in case of resistance to hydroxyurea + asetil salicylic acid treatment or hydroxyureainduced persistent cytopenia (anemia and / or leukopenia). SGK SUT 12.7.21. Anagrelid kullanım ilkeleri Hidroksiüre + asetil salisilik asit tedavisine dirençli olduğu ya da hidroksiüre ile dirençli sitopeni (anemi ve/veya lökopeni) geliştiği belgelenen, yüksek vasküler risk taşıyan esansiyel trombositemi hastalıklarında erişkin/çocuk hematoloji veya tıbbi onkoloji uzman hekimlerinden biri tarafından düzenlenen uzman hekim raporuna dayanılarak bu uzman hekimler tarafından reçete edilmesi halinde bedeli ödenir.

  15. Prices Thromboreductin 0,5 Mg 100 caps – Dem Ilac Agrylin 0,5 Mg 100 caps – Gen Ilac * Reimbursement discount and VAT not including

  16. Anti Platelets (IMS Data) IMS (Units)

  17. Anagrelide Market (IMS Data)

  18. Anagrelide Market (Fiveyearforecast)

  19. Anagrelide Market (Fiveyearforecast)

  20. Market Share

  21. Sales and Marketing Team for Thromboreductin Turkish distributor: Dem Ilac Oncology-Hematology group (promoting3 drugs) 1 PM 1 MM 6 RM (they are responsible for 2 groups) 17 ABM DEM’s Oncology-Hematology group also have Fanhdi 500 IU (factor VIII) and Pamidem 30/90mg I.V. (Paget disease of bone, hypercalcemia related to tumor)

  22. Team structure Gen’s Oncology-Hematology group will be responsible for :

  23. Target & TeamforOncology-HematologyGroup Potential Targets Oncologists: 140 Hematologists: 210 Infectious diseases: 998 Dermatologists: 1500 Selected Targets (Will be visited) Oncologists: 120 Hematologists: 180 Infectious diseases: 150 Dermatologists: 250 Total selected target: 700 Number of Reps needed to visit the total selected target: 8 FTE as a start 1 Medical Manager and 1 PM is necessary as a start

  24. ThankYou

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