2. INDEX
DECAPEPTYL® Business Case
Summary
Whole story in one page
Iran Macroenviroment
Epidemiology
Incidence, Prevalence, Patient
Characteristics,
Prostate cancer in Iran
Treatment paradigm for
treatment in Iran
Prostate cancer in Iran
Market Overview
Market environment
Market analysis
Competitor SWOT analysis
3. Pricing analysis
Price strategy after
Getting Bulk IRC
Transition Pathway
timeline,
process
critical gateways
expected launch date
Forecasts
4. Initial ideas for a structured approach to making Ferring a growing success in the Iranian
pharmaceutical Industry
Understanding
the current
situation – Ferring
analysis
Comparing
Ferring with
value chain
opportunities with
having eyes on
FDAIR policies
Identifying
improvement
opportunity
in current
portfolio
Identify
market and
synergy
opportunities
for growth
Develop
clear action
plan for
project
execution
What we have! How it
fits!
How can we
improve it?
How can we
grow it?
What actions
should we take?
Summary
Iran FDA is bound to
restriction volume programme
for imported products in
coming year.
Day Holding has competency
to produce imported products
locally in different level:
Secondary packaging
Primary packaging
Bulk
API
Day Holding will get the
permission from FDA to not
have volume restriction in new
business model
Day Holding is to be made
into pioneer of local
manufacturing for
Multinational companies for
different Dosage forms. Day
holding will be first company
which has EU GMP approval.
Our early evaluations is likely
to be implementing with
current resources and has
capability to be customized for
different scope.
5. Iran Overview
79 Million population
GDP : 415 b USD
GDP Per Capita: 4,763 USD
Health Exp. : 6%
Pharma CAGR 5Y: 24%
8 million >60 YRS
16 million Obesity
168
124
18 million HTN
45000 Dies by cancer
120 Medicine Importer
36 API Producer
53 Local Distributor
(80% by 10)
98 Pharma Local Producer
53%
.
47%
2nd largest nationin the Middle East - geographically covering1,648,195 km2(18th largest in the world)
strongruralPrimary Health Care(PHC).
Iranholds 10%ofthe world's current oil reserves andhas theworld's secondlargest reservesof naturalgas (15%of theworld's total)
96122 Active Bed
60K Active Physician
73 YRS life expectancy
1.4 new born baby
9 million Diabetes
6. 2015
Iran Macro Today
PESTEL
Analysis
POLITICAL
Iran and 5+1 agreement on 2015
Political violence in Middle east
Rouhani in Presidential elections in June 2013 is leading to a
gradual improvement in relations with the West.
ECONOMICAL
Inflation rate is decreasing dramatically and is on 14%
Growth rate is 1.50%. GDP per capita is 4,7637 USD
18th largest economy purchasing power parity
Iran is 21th market in world
Health Expenditure: 6% of GDP
TECHNOLOGY
There are over 98 pharmaceutical manufacturer operating in Iran
Poor R&D activity but FDA is directing to improve local manufacturing
Few manufacture licensed by GMP
Manufactures almost import API from india
LEGAL
IDL list entering (Big Obstacle)
4% tax, complicated regulation of MOH,
Brand & price restrictions, 4% tariffs, and
IRC code ( Medium)
Pricing committee ( Great Challenge)
Importation permission
Reimbursement
ENVIRONMENT
Growth is shifting from primary care to specialty care area
Enforcing good manufacturing practice GMP rules has increased go
to market launch timelines
An important new increased stakeholder has emerged in the form
of the family physician FP requiring pharma companies to adjust
their go-to market approach
SOCIAL
Population Growth Rate: 1.2%
6 million over 65 years old
Total adult population (20-79 years) : 51,145.45(1000s)
Number of deaths in adults due to diabetes : 38,002 per Y
Prevalence of diabetes in adults (20-79 years) (8.43 %)
1% incidence of Diabetes
Total cases of adults (20-79 years) with diabetes :4,395.93 (1000s
7. Prostate cancer accounts for 33% of all newly diagnosed malignancies among men in the United States.1
According to the American Cancer Society, an estimated 220,900 men will be diagnosed with prostate cancer
in 2003, and 28,900 men will die of it, making it the second most common cause of cancer death in men. The
incidence of prostate cancer varies worldwide, with the highest rates found in the United States, Canada, and
Scandinavia, and the lowest rates found in China and other parts of Asia.
Epidemiology
Defined the Unmet Strategy with diagnosis pathway to expand Ferring presence in Iran
Unfortunately, in Iran, most Prostate Cancer is already associated with nonorgan-
confined disease or bone metastasis at detection
10.2147/CMR.S18147
8. 8000Of Total population
Prostate
Epidemiology
Opportunity scanning
4175
patient
79 Million
GDP : 368.9 b USD
GDP PC : 4763 USD
Health Exp. : 6%
11% of total
880
20% of total
1670
69% of total
5520
459 Patient 835 Patient 29100 Patient
<55 YRS 50-60YRS >70 YRS
Total Patient
Diagnosed
Patient
8000
Distribution of Prostate prevalence based on patients age groups and gender for the population in Iran .
39% > Male
The results showed that 9 of 100,000, including 50% of diagnosed and 50% of late diagnosed patient in Iran .
61-70YRS
0 50 100 150
China
India
Iran
Pakistan
Turkey
kuwait
japan
Poland
Spain
UK
Netherland
Sweden
USA
Per 100,000 person Year
9. Treatment Guideline:
Early Stages
Close monitoring
Radical prostactomy
Brachytherapy
Internal radiation
External radiation
Advance stage
Hormone therapy
chemotherapy
Treatment paradigm In Iran
Prostate Cancer
10. Prescriber
2 main category
80 % of patient with PCA visited by urologist
20 % of patient with PCA firstly visited by Oncologist
80%
20%
Urologist : 2700
Prescriber urologist : 1500
Urologist (Tier A) : 300
Urologist (Tier B) : 500
Urologist (Tier C) : 700
Oncologist : 350
Prescriber Oncologist : 300
Oncologist (Tier A) : 50
Oncologist (Tier B) : 100
Oncologist (Tier C) : 150
If prostate cancer is found at an early stage, is growing slowly, and treating the cancer would cause more discomfort than the
disease, a doctor may recommend active surveillance or watchful waiting. During active surveillance, the cancer is monitored
closely with regular PSA tests, DRE tests, and watching for symptoms with periodic biopsies. Active treatment only begins if the
tumor shows signs of becoming more aggressive or spreading, causes pain, or blocks the urinary tract. Active surveillance is
usually preferred for men with a long life expectancy who may benefit from curative local therapy if the cancer shows signs of
getting worse.
11. Oncologist & Urologist
Treatment paradigm of prostate cancer in Iran
Diagnosed
Surgery or Radiation
Therapy
Hormone Therapy Immunotherapy
PROVENGE
CHEMOTHERAPY Secondary
Chemotherapy or
other Hormone
Therapy
60%
How Urologist and Oncologist Diagnose and treat their patients
Males
Early prostate Cancer
(only in prostate)
Advanced Prostate cancer
(Spread beyond prostate)
23%
Respond
36%
Respond
PSA every 3 months,
Radiographic studies if
clinically indicated
(bone scans, CT of
abdomen and pelvis)
Triptorelin, a decapeptide (pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH2), is a gonadotropin-releasing hormone agonist (GnRH agonist) used as the acetate or
pamoate salts. By causing constant stimulation of the pituitary, it decreases pituitary secretion of gonadotropins luteinizing hormone (LH) and follicle stimulating hormone
(FSH). Like other GnRH agonists, Triptorelin may be used in the treatment of hormone-responsive cancers such as prostate cancer or breast cancer, precocious puberty,
estrogen-dependent conditions (such as endometriosis or uterine fibroids), and in assisted reproduction. It is also used as therapy in cases of gender dysphoria. Triptorelin
is marketed under the brand names Decapeptyle (Ipsen) and Diphereline and Gonapeptyl (Ferring Pharmaceuticals). In the United States, it is sold by Watson
Pharmaceuticals as Trelstar. In Iran Triptorelin is marketed under the brand name Variopeptyl (Varian Darou Pajooh).
During the treatment of prostate cancer it does cause a surge of testosterone (an initial uplevel of testosterone levels), known as a flare effect. In men a reduction of serum
testosterone levels into the range normally seen after surgical castration occurs approximately two to four weeks after initiation of therapy. In contrast, gonadotropin-
releasing hormone antagonists do not cause a surge, but a sudden reduction of testosterone levels.
Systematic IUPAC Name: [d-Trp6] GnRH
23%
Respond
Response to
Treatment
3.75 mg intramuscularly (IM) every 4 weeks
12. Reducing health expenses strategy was the top priority of Ministry of health in last decade .It caused a
creation of hurdles in the way of entering brand products in Iran health market where there are same generic
molecules have been locally produced .Following recent strategy there are great number of deals in favour of
implementing this strategy more persistly.
Market Overview
Current situation
A brief Data of Triptorelin agents
14. Market Overview of Triptorelin :
29.5 Million Euro Market value of Triptorelin Molecule in all formations (95Billion Toman)
7 main Supplier
Patients age segmentation 45 years to 80 years (there is also indication to be used in young )
Our Focous Mostly scattered in main major indication Form prostat cancer 3.75mg
Its mandatory to be treated and effect life performance
Generic producer supply 2 Dosage Form (TRIPTORELIN ACETATE 3.75MG VIAL, TRIPTORELIN ACETATE 95.6 MCG VIAL)
Local Producer ( Pooyesh Darou , Varian Farmed ) from 2012 .
Imported supplier ( Daryan Salamat , Daya Teb )
Leader of Triptorelin is Daryan Salamat with 76% of market share of value and 43 % market share of Volume . (1393)
Leader of Triptorelin Brand is Dipherelin from Ipsen from 2005 , IPSEN has 1 % share in global oncology(701 million $) market and is The twenty-third largest pharmaceutical company in
oncology(88934 million $ ), based on its 2014 revenues
In terms of growth Daryan Salamat is key driver in market of Triptorelin with 5 year CAGR 31% and all market was imported till 2012
In 2012 pooyesh darou and Varian started to produce triptorelin Localy but it seems it was contract manufacturing till 2014
The market is becoming increasingly dominated by Local generic treatments , mostly on dosage form of 3.75mg and following self sufficiency policies of FDA in Iran restriction on importation
volume will be a tool to direct forieng vendors to plan for local production.
Imported - 96% Local - 4%
2015
15. Market OverviewTriptrolin
Volume of dosages
TRIPTORELIN ACETATE 3.75MG VIAL
TRIPTORELIN PAMOATE 11.25MG VIAL
TRIPTORELIN ACETATE 0.1MG/1ML
SYRINGE
TRIPTORELIN 0.1MG AMP
TRIPTORELIN ACETATE 95.6MCG
INJECTION
83%
Focous Mostly scattered in main major Dosage Form 3.75mg
-
5
10
15
20
25
30
35
40
2010 2011 2012 2013 2014 2015
Mill.Euro
Value Grand Total
-
100
200
300
400
500
600
700
2010 2011 2012 2013 2014 2015
Kunit
Grand Total
19. Comparison of Triptorelin price with turkey prices could be very helpful Vs. imported Generic products, But
according the cost-plus structure but still there is exception for Brand products.
Price AnalysisTurkey is the reference for Iranian pharmaceutical market
20. 0 1000000 2000000 3000000 4000000 5000000 6000000 7000000 8000000
DIPHERELINE SR® 11.25MG VIAL
DECAPEPTYL CR® 3.75MG prefilled syringe
DIPHERELINE® 3.75MG VIAL
CHEMORELIN® 3.75MG VIAL
MICRORELIN® 3.75MG VIAL
VARIOPEPTYL® 3.75MG SYRINGE
DECAPEPTYL® 0.1MG/1ML PRE-FILLED SYRINGE
DIPHERELINE® 0.1MG VIAL
VARIOPEPTYL® 0.1MCG PREFILLED SYRINGE
DECAPEPTIL® 0.1MG AMP
End User Price
Price Analysis
An overview of anti- Enuresis agents in Iran
End User Price
1,950,000
2,000,000
2,050,000
2,100,000
2,150,000
2,200,000
2,250,000
2,300,000
2,350,000
2,400,000
2,450,000
End user Distributor to pharmacy Importer to distributor
Price Structure Decapeptyle
8%
5%
Rial
The Price will be
preserved even
after local
production
21. It will take approximately 6 months to transit Decapeptyle® at IRC list .
Transition Pathway
Triptorelin is existed in Iran pharmacopeia and getting IRC code is the Milestone for importing
Bulk.
22. API Primary packaging Secondary packaging
Triangle of Technology Transfer
Technology Triangle
Procedures and
Algorithm
R&D
Education
and Breeding
Instructions, Documents
and Instruments
SkillLevel Learning and Skills
Development
Development
Process
*Source: Paul
(1995)
Knowledge and
Science
Physical ToolsPeople
Knowledge
Level
Equipmentmaterial
andHardware
Finish Goods
IRFDA policies and restriction levelFDA Support level
R&D
QA
QC
Planning
Regulatory
Supply chain
Sales & Marketin
QA
QC
PR
SC
REG
R&D Supply Chain
Manager
Technical
engineering
Production Product
Managers
Quality
Control
Responsible
Pharmacy
Finance Planning Quality
Assurance
Business
Unit Head
Marketing
manager
District
Sales
manager
Regulatory Managing
Director
QA
QC
PR
SC
REG
Involved Team
23. We have tried to map most important parameters in defining accurate forecast for Decapeptyle® . we have
interview with Oncologist KOLs .
ForecastsBest, Base, Worse
24. Forecast Scenarios Dynamics
Risk & Uncertainty
Price
60% Price of Turkey
40% Price of Turkey
MOH Cut The price to be 40%
above local production price
Affordability
80 %
50%
20%
Volume restriction
Brest Cancer
Early Puberty
30,00
10,00
0
Assumptions
DECAPEPTYL® registration process will take 6 months.
Price approval is the main issue of registration .
Country Economic improvement will affect flexibility on
prices both for patients and payer .
The forecast scenarios are highly dependent on these 4
factors + resource allocation .
The generic entry have been evaluated and the
probability of generic entry is low .
25. Best Base Worse Scenarios
Dynamics
Volume restriction
Affordability
80 %
50%
20%
New Patient due to awareness
Brest Cancer
Early Puberty
Resources
High Investment
Medium Investment
Low investment
Best
Base
Worse
Price
60% Price of Turkey
40% Price of Turkey
MOH Cut The price to be 40%
above local production price
26. Best Scenario
3 year Forecast of Decapeptyle®
3.75mg PFS (price 2400K Rial End user price )
1st Year
Vol : 100,000 pack
2nd Year
Vol : 160,000 pack
3rd Year
Vol : 230,000 pack
95 96 97
TOTAL 324,583 331,071 337,688.16
Growth 2% 2%
M/S 31% 48% 68%
Volume Syrenge 100,620 158,914 229,628
Distributor Price Rial 2,400,000 2,400,000 2,400,000
Value RIAL 168,000,000,000 381,393,377,280 551,107,077,977
27. Base Scenario
3 year Forecast of Decapeptyle®
3.75mg PFS (price 2400K Rial End user price )
1st Year
Vol : 100,000 pack
2nd Year
Vol : 120,000 pack
3rd Year
Vol : 170,000 pack
95 96 97
TOTAL 324,583 331,071 337,688.16
Growth 2% 2%
M/S 31% 36% 50%
VolumeSyrenge 100,620.67 119,185 168,844
Distributor Price Rial 2,400,000 2,400,000 2,400,000
Value RIAL 241,489,603,200 286,045,032,960 405,225,792,630
28. worse Scenario
3 year Forecast of Decapeptyle®
3.75mg PFS (price 2400K Rial End user price )
1st Year
Vol : 50,000 pack
2nd Year
Vol : 60,000 pack
3rd Year
Vol : 60,000 pack
95 96 97
TOTAL 324,583 331,071 337,688.16
Growth 2% 2% 2%
M/S 15% 18% 18%
VolumeSyrenge 48,687 59,593 60,784
Distributor Price Rial 2,400,000 2,400,000 2,400,000
Value RIAL 116,849,808,000 143,022,516,480 145,881,285,347
29. References :
1. Steenland K, Rodriguez C, Mondul A, Calle EE, ThunM. Prostate cancer incidence and survival in relation toeducation (United States). Cancer Causes Control. 2004;15: 939 – 945.
2. 29 Lund-Nilsen TI, Johnsen R, Vatten LJ. Socioeconomicand lifestyle factors associated with the risk of prostate cancer. Br J Cancer. 2000; 82: 1358 – 1363.
3. 30 Coley CM, Barry MJ, Fleming C, Mulley AG. Earlydetection of prostate cancer. Part I: prior probability andeffectiveness of tests. The American College of
4. Physicians. Ann Intern Med. 1997; 126: 394 – 406.
5. 31 Hsing AW, Deng J, Sesterhenn IA, Mostofi FK, StanczykFZ, Benichou J, et al. Body size and prostate cancer: apopulation-based case-control study in China. Cancer Epidemiol
Biomarkers Prev. 2000; 9: 1335 – 1341.
6. 32 Du SF, Shi LY, He SP. A case-control study of prostate cancer. Zhonghua Liu Xing Bing Xue Za Zhi. 1996; 17: 343 – 345.
7. 33 Armitage P, Doll R. The age distribution of cancer and amulti-stage theory of carcinogenesis. Br J Cancer. 2004; 91: 1983 – 1989.
8. 34 Greenwald P. Clinical trials in cancer prevention: current results and perspectives for the future. J Nutr. 2004; 134
9. (supp 12): 3507S – 3512SSecondary Data of Oncology BU ( ODS )
10. Primary research with KOLs
11. Medical Department ( Omid Darou Salamat )
Business Development
Department
29
30. The Meeting Objective
Ferring and DayHolding cooperation
www.dayholding.com
01 02 03 04 GOAL
01 21 Products in 7
Therapeutic area
Portfolio Review
02 Selecting and agreeing on
Product
Product Selection
03 LMstepsand Timeline
Review LM
04 Due diligence steps
Regulatory and
cooperation business
model
To Do List
31. Ferring
Therapeutic Areas
FERTILITY
UROLOGY
Ferring Portfolio
Status in Iran Market Data
Total Market : 51.8 Million Euro
Ferring Market Share : 8%
Market Data
Total Market : 1 Million Euro
Ferring Market Share : 0%
Market Data
Total Market : 1.2 Million Euro
Ferring Market Share : 0%
.
Market Data
Total Market : 11.2 Million Euro
Ferring Market Share : 16%
Market Data
Total Market : 57 Million Euro
Ferring Market Share : 0%
LUTINUS®
Therapeutic Area arrangement according Market
value in Iran
IDL +
IDL -
IRC +/IDL+
32. Transmission of finish good importation to local manufacturing
DECAPEPTYL® Timeline
OMID DAROU Business Unit (Sales & marketing)
Forecasted
Amount located in
warehouse
Marketing Plan
Budget
Server &
Database Entry
Recruit , Train &
Deploy Sales
force
Engage KOLs
Accelerate
Adoption &
Adherence
Prove product
value
Integrated
Channel
Management
KOL Engagement
Services
(Kol Management)
Execute RE-
launch
Perform physician
Message
Testing
Registration
Committee
Food and Drug Organization
Bulk importation
permission
Official permission letter by defined
duration
Tracking
( 3,6,12,24,36 )
Submitting CTD
EAN Number
IRC
Madrid Brand
registration
6-9 Months 4 Months
production site
QC Test
Manufacturing process
PFS filling
plungering
Labeling
Primary
packaging in
proper blister
pack
Secondary
packaging
In process
controls
Finish
products
sampling and
QC test
Bach records reviewing
Bach
released
by QP
2 Months for preparation and briefing
Overlapped
33. Product Therapeutic Area Ferring CAGR Ferring Value Euro Ferring Share (Value) Total Value Euro
Total
Volume
Ferring Share Volume
share Local
(Volume)
ATC Code IDL IRC
MENOPUR® / MENOGON® / REPRONEX® (HP-hMG)
Menotropins ( human menopausal gonadotrophin)
FERTILITY -12%
4,962,000
41%
12,102,439 1,423,000
32% 41% G03GA02 YES YES
BRAVELLE® (uFSH) Urofollitropin
FERTILITY NA 0 0%
1,933,000 155,000
0% 6% G03GA04 YES YES
LUTINUS® / ENDOMETRIN® (progesterone)
FERTILITY NA
262,000
37%
703,923 838,000
18% 0% G03DA04 YES YES
GONAPEPTYL® / DECAPEPTYL® daily (triptorelin
acetat)
FERTILITY 18%
2,810,000
10%
28,100,000 598,000
15% 36% L02AE04 YES YES
CHORAGON® / BREVACTID® (u-hCG)
FERTILITY -2% 156000 2%
9,017,341 2,525,000
0.4% 63% G03GA01,8 YES YES
NORPROLAC® (quinagolide hydrochloride) prolactine
Inhibitor
FERTILITY NA NA NA NA NA NA NA G02CB04 NO NO
LUTREPULSE® / LUTRELEF® (gonadorelin acetate)
test for fertility disturbance
FERTILITY NA NA NA NA NA NA NA V04CM01 NO NO
TRACTOCILE® (atosiban) inhibitor of oxytocin
Hormone
OBSTETRICS NA NA NA NA NA NA NA G02CX01 NO NO
PROPESS® / CERVIDIL® (dinoprostone)
prostaglandins
OBSTETRICS NA NA NA NA NA NA NA G02AD02 NO NO
PABAL® / DURATOCIN® / LONACTENE® /
DURATOBAL® (carbetocin)
OBSTETRICS NA NA NA NA NA NA NA H01BB03 NO NO
MISODEL® / MYSODELLE® / MYSPESS® (misoprostol
vaginal insert)
OBSTETRICS NA NA NA NA NA NA NA G02AD06 NO NO
LYSTEDA® (tranexamic acid)
GYNAECOLOGY NA NA NA
1,224,000 16,940,000
NA 99% B02AA02 YES NO
MINIRIN® (desmopressin)
UROLOGY 84%
1,255,590
63%
1,993,000 926,000
53% 46% H01BA02 YES YES
FIRMAGON® (degarelix) UROLOGY NA NA NA NA NA NA NA L02BX02 NO NO
TESTIM® (testosterone)
UROLOGY NA NA NA
3,552,000 4,755,000
NA 74% G03BA03 YES NO
PENTASA® (mesalazine)
GASTROENTROLOGY -20%
1,800,000
16%
11,250,000 202,792,000
2% 93% A07EC02 YES YES
PICOPREP® (sodium picosulphate, magnesium oxide,
citric acid)
GASTROENTROLOGY NA NA NA NA NA NA NA NO NO
GLYPRESSIN® (terlipressin) GASTROENTROLOGY NA NA NA NA NA NA NA H01BA04 NO NO
CORTIMENT®MMX® (budesonide)
GASTROENTROLOGY NA NA NA
6,000 4,000
NA 0% A07EA06 YES NO
ZOMACTON® (somatropin)
ENDOCRINOLOGY NA NA NA
57,000,000 1,776,000
NA 10% H01AC01 YES NO
EUFLEXXA (1% sodium hyaluronate)
ORTHOPAEDICS NA NA NA
1,414,000 41,000
NA 0% S0AkA01 YES NO