Business Presentation June 2009 Business Presentation June 2009
prepared for
about us…
Our Partners
Product Licensing & Business Development - 1 Marketed ProductLicensorIndication AvonexBiogen Idec (USA)Multiple Sclerosis Apo go Britannia Pharmaceuticals (UK) acquired by STADA Parkinson’s Disease DysportIpsen (FR)Dystonia ModiodalCephalon (USA)CNS stimulation AllergodilMeda (SWE) Allergic rhinitis & allergic conjunctivitis Somatuline Autogel Ipsen (FR) Acromegaly, carcinoid tumors Thioctacid HRMeda (SWE)Diabetic polineuropathy IVIGSichuan Yuanda Shuyang Various neurological & hematological diseases
Product licensing & Business development - 2 Pipeline ProductLicensorIndication TrisenoxCephalon (USA)Acute Promyelocytic Leukemia TysabriBiogen Idec / ÉlanMultiple Sclerosis IncrelexIpsen (FR)IGF-1 deficiency XenazineCambridge (USA)Huntington's Disease NutropinIpsen & GenentechGH deficiency FosrenolShire (UK)Renal Failure/P binder TrientineUnivarWilson’s Disease
Offices
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. 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. Fosrenol will be 100% reimbursed for patients who have a health report prepared by a nephrologist or a doctor who has a dialysis certificate.
Reimbursement criterias (SGK SUT 12.July.08) Other phosphate binders should be used at least for 3 months prior to sevelamer. At the end of this period; 1. Multiplication of calcium and phosphorus levels should be 72 or more (or) 2. PTH levels should be 100 pg/ml or less with a dynamic bone disease symptoms (or) 3. Kt/V value should be more than 1.4 and Ca x P levels 55 and more (or) 4. Kt/V value is more than 1.4 and PTH value is more than 300 pg/ml Ref: SGK SUT 12 July 08 : 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 veya 2) PTH düzeyinin 100 pg/ml değerinin altında olan adinamik kemik hastalığı olguları veya 3) Hastanın Kt/V değeri 1.4’ün üzerinde olmasına rağmen düzeltilmiş kalsiyum ve fosfor çarpımı 55’in üzerinde olan veya 4) Kt/V değeri 1.4'ün üzerinde olan hastanın PTH değeri 300 pg/ml ve üzerinde olan, hemodiyaliz veya periton diyaliz tedavisi altındaki hastalara
Registration timelines and procedures 2-2,5 years
Hemodialysis market - 1 Number of Hemodialysis Centers Number of Doctors in HD Centers Number of Nurses in HD Centers
Hemodialysis market - 2 Number of HD Equipments Number of PD Equipments
Phosphate binding agents used in prevalent HD patients
Phosphate binding agents used in prevalent PD patients
Number of HD patients
Sevelamer price 1 Bottle of 180ct 800mg Tablets VAT Including Retail Sales price : TL € Bottle of 180ct 800mg Tablets VAT Including Retail Sales price : TL €
Sevelamer sales (IMS) Renagel (Sevelamer) marketed by Eczacıbaşı. Hemodialysis market.
Sevelamer sales IMS (Units)
Sevelamer sales IMS (Units)
Hemodialysis market IMS (Units)
Hemodialysis market ( IMS (Units)
Fosrenol Forecast
Farecast for 5 years (tablets)
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 : Sales and Marketing Team for FOSRENOL 1 PM 1 MM 10 ABM (FTE) 3. Cost of Sales and Marketing Team (Per Head-Annual-Euro) PM : 60 K MM : 60 K ABM : 30 K
Sales and Marketing Team for Renagel 1 PM 1 MM 6 RM 20 ABM (8 FTE)
Pre-launch and launch programs Premarketing activities KOL visits, Named patient sales, Determination of opinion leaders/board members for local meetings/presentations. Introduction of Fosrenol via presentations/meetings by opinion leaders/board members and PM/MM presentations National/International congress sponsorships Selection of the target physicians October 2011: estimated date of registration approval Teasing Posting
Pre-launch and launch programs March 2012: sales team training Preparation of visual aid Preparation of promotions April 2012: estimated date of reimbursement May 2012: Starting marketing activities
Events in 2009 National Congress of Nephrology (date not certain) World Congress of Nephrology ICS 2009 SAN FRANCISCO MEETING Local meetings..
Thank You