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