business presentation june 2009 business presentation june 2009
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Business PresentationJune 2009
prepared for
about us…
Our Partners
Product Licensing & Business Development - 1
Marketed
Product Licensor Indication
Avonex Biogen Idec (USA) Multiple Sclerosis
Apo goBritannia Pharmaceuticals (UK) acquired by STADA
Parkinson’s Disease
Dysport Ipsen (FR) Dystonia
Modiodal Cephalon (USA) CNS stimulation
Allergodil Meda (SWE)Allergic rhinitis& allergic conjunctivitis
Somatuline Autogel
Ipsen (FR)Acromegaly, carcinoid tumors
Thioctacid HR Meda (SWE)Diabetic polineuropathy
IVIG Sichuan Yuanda ShuyangVarious neurological &hematological diseases
Product licensing & Business development - 2
PipelineProduct Licensor Indication
Trisenox Cephalon (USA) Acute Promyelocytic Leukemia
Tysabri Biogen Idec / Élan Multiple Sclerosis
Increlex Ipsen (FR) IGF-1 deficiency
Xenazine Cambridge (USA) Huntington's Disease
Nutropin Ipsen & Genentech GH deficiency
Fosrenol Shire (UK) Renal Failure/P binder
Trientine Univar Wilson’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
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 procedures2-2,5 years
Hemodialysis market - 1
2004 2005 2006 2007
459 539 691 750
Number of Hemodialysis Centers
2004 2005 2006 2007
1138 1365 1660 1891
Number of Doctors in HD Centers
2004 2005 2006 2007
2827 3095 3764 4080
Number of Nurses in HD Centers
Hemodialysis market - 2
2004 2005 2006 2007
4914 6978 8760 9632
Number of HD Equipments
2004 2005 2006 2007
NA 391 1200 1710
Number of PD Equipments
Phosphate binding agents used in prevalent HD patients
Year /Patient No
Calcium Acetate
Calcium Carbonate
Sevelamer Aluminium
2004 / 25321
60.7% 13.3% 2% 4.7%
2005 / 28507
56.4% 14.6% 7.3% 6.5%
2006 / 33950
59.8% 12.6% 9% 3.2%
2007/ 39267
59,5% 13.3% 12% 2.6%
Phosphate binding agents used in prevalent PD patients
Year /Patient No:
Calcium Acetate
Calcium Carbonate
Sevelamer Aluminium
2004 / 3320
56.4% 23% 2.5% 6.1%
2005 / 3361
52.7% 18.5% 7.3% 3.2%
2006 / 4103
53.7% 12.8% 7.1% 5.1%
2007 / 5307
52.4% 11.7% 11,4% 4.2%
Number of HD patients
Year Patiens
1990 3,069
1991 6,527
2000 14,086
2001 18,815
2002 20,600
2003 23,387
2004 25,321
2005 28,507
2006 33,950
2007 39,267
Sevelamer price
Reference Country Italy
Ex-factory Price € 148.08
Approval Date 09.09.2004
Reimbursement Discount 11%
1 Bottle of 180ct 800mg Tablets VAT Including Retail Sales price : 386.77 TL € 179.89
Sevelamer sales (IMS)
UnitsJan/09
UnitsFeb/09
UnitsMar/09
UnitsApr/09
Est. UnitsYear/09
3.309 2.958 3.729 3.888 48.000
UnitsYear/05
UnitsYear/06
UnitsYear/07
UnitsYear/08
21.270 18.528 32.332 43.985
Renagel (Sevelamer) marketed by Eczacıbaşı.
Hemodialysis market.
UnitsYear/07
UnitsYear/08
UnitsJan/09
UnitsFeb/09
UnitsMar/09
UnitsApr/09
Units/Est.
Year/09
309.867 361.772 33.665 28.306 32.252 32.886 396.000
Sevelamer sales
Renagel0
10,000
20,000
30,000
40,000
50,000
60,000
21,27018,528
32,332
43,98548,000
20052006200720082009/Est.
IMS (Units)
Sevelamer sales
Renagel0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
3,3092,958
3,729 3,888
Jan/09Feb/09Mar.09Apr/09
IMS (Units)
Hemodialysis market
Total Market0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,00033,665
28,30632,25232,886
Jan/09Feb/09Mar.09Apr/09
IMS (Units)
Hemodialysis market (
IMS (Units)
Total Market0
50,000100,000150,000200,000250,000300,000350,000400,000450,000
309,867
361,772396,000
200720082009/Est.
Fosrenol Forecast
2012 2013 2014 2015 2016
900.000 tab. 1.850,000 tab.
2.951,000 tab.
3.892,000 tab.
5.196,000 tab.
Fosrenol Forecast
Fosrenol0
1,000,000
2,000,000
3,000,000
4,000,000
5,000,000
6,000,000
900,000
1,850,000
2,951,000
3,892,000
5,196,000
20122013201420152016
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 : 10
2. 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 2009-2010-2011
• 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
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