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Product Strategy

ONGLYZA™ dan KOMBIGLYZE-XR™


Saxagliptin 5 mg dan Saxagliptin+Metformin-XR 5/500 mg

#BringItAllBack

Fauzi Imam Sambodo


Optima Care - 2017
Indonesia adalah negara dengan penderita DM terbesar ke-4 di dunia..!!!

Indonesia

Brazil

IDF Diabetes Atlas; 7th Edition, 2015.


Definisi Diabetes

 Suatu kelainan yang ditandai oleh kadar


glukosa darah yang tinggi (hiperglikemi)
• Definisi International Diabetes Federation
(IDF)/ World Health Organization (WHO)
• WHO: diabetes merupakan kelainan
metabolik akibat berbagai penyebab,
ditandai oleh hiperglikemi kronik dan
gangguan metabolisme karbohidrat, lemak
dan protein yang terjadi akibat gangguan
sekresi insulin, kerja insulin atau keduanya

1. IDF Diabetes Atlas; 7th Edition, 2015.


2. Report of a WHO Consultation, 1999.
Tanda dan Gejala Diabetes

Tanda dan gejala yang umum dijumpai (gejala


klasik)
Gejala-gejala lain
– Glukosuria: glukosa dalam urin
– Lelah dan iritabilitas
– Penyembuhan luka lambat
4P – Infeksi saluran kemih
– Poliuria: sering berkemih – Penglihatan kabur
– Nyeri neuropati
– Polidipsia: haus berlebihan
– Polifagia: rasa lapar berlebihan
– Penurunan BB yang tidak dapat
dijelaskan
Pengaturan Kadar Gula Darah

Fisiologi : Pengaturan Kadar Glukosa Darah Oleh Insulin Dan Glukagon

Langkah
menurunkan kadar Kadar Glukosa
glukosa darah glukosa ditransport ke
darah tinggi dalam sel
Sel β pankreas
(Insulin) mensekresi insulin
otot, lemak
dan hati

Kadar glukosa darah normal


(70-99 mg/dL)

Hati men-sintesis lebih


banyak glukosa
Langkah
meningkatkan kadar
glukosa darah Kadar
glukosa
darah
(Glukagon) rendah Sel α pankreas
mensekresi glukagon

Kim, W., & Egan, J. M. (December 2008).


Sistem Hormon Inkretin

Fisiologi : Sistem Hormon Inkretin


Asupan makanan
Sel β Efek GLP-1 dan GIP
pada sel β:
↑ sekresi insulin
Lambung Incretin

Sal.
cerna
Pankreas

Incretin, yaitu Efek GLP-1 pada Kerja incretin


Usus GLP-1 dan GIP, terbatas karena
sel α :
halus dilepaskan dari dengan cepat
saluran cerna Sel α ↓ sekresi glukagon dirusak oleh
setelah makan enzim DPP-4

2 menit

Kim, W., & Egan, J. M. (December 2008).


Incretin Based Therapy

Incretin Based Therapy (incretin mimetics & enhancers)

 Pendekatan pada target sistem hormon inkretin

 Inkretin cepat didegradasi oleh enzim dipeptidyl peptidase-4 (DPP-4) sehingga


membatasi penggunaan inkretin alami sebagai terapi

 Dua cara untuk mengatasi keterbatasan inkretin alami tersebut :


– incretin mimetics : Meniru efek inkretin endogen namun lebih resisten
terhadap proses degradasi GLP-1 Agonist
– incretin enhancers : Memperlambat pemecahan incretin alami melalui
DPP-4 Inhibitor
Incretin Based Therapy di Indonesia

• Incretin Mimetics :
 Exenatide (Byetta™ – AstraZeneca)
 Liraglutide (Victoza® – Novo Nordisk)

• Incretin Enchancers :
 Saxagliptin (Onglyza™ – Kalbe Farma)
 Linagliptin (Trajenta™ – Boehringer Ingelheim)
 Sitagliptin (Januvia™ – Merck Sharp & Dohme)
 Vildagliptin (Galvus® – Novartis)
DPP-IV Inhibitors Market

70 ITMA MAT Q4 2016 A10N (TC IV) 20%


Miliar Rupiah

17,06%
MARKET SIZE: 186 M
60 GROWTH: 12,36% 16%

Market DPP-IV Inhibitors sebesar 186 M per


50 12%
tahun dengan pertumbuhan 12,36%

40 6,41% 8%
Sebagai Market-leader dan pertumbuhan
terbesar adalah Boehringer-Ingelheim
30 4%
1,45%
Market DPP-IV Inhibitors murni bertumbuh dari
sektor Reguler, dan semua obat belum off-
20 0%
patent
-3,03%

10 -4%

0 -8%
B.INGELHEIM MSD NOVARTIS A.ZENECA
Q4 14 Q4 15 Q4 16 GR 2016
DPP-IV Inhibitors Market
60 ITMA MAT Q4 2016 A10N (TC IV)
Miliar Rupiah

110%
Market leader adalah Trajenta (Boehringer
50 Ingelheim) memliki brand equity yang sangat
kuat, dengan sales 48 M / tahun dan masih
sangat agresif dengan support ilmiah dalam
70%
40 dan luar negeri
51%
Pertumbuhan yang lebih di gerakan oleh
32% 33%
golongan DPP-IV Inhibitor kombinasi +
30
Metformin, dimana saat ini mengarah ke Terapi 30%
13% Agreif pada pasien DM Tipe-2
7% 8%
20 -1%
Dengan strategi yang tepat, Kombiglyze-XR
-16%yang sangat besar khususnya -10%
memiliki potensi
di dokter Internist dan Endokrin
10

- -50%
TRAJENTA - JANUMET GALVUSMET - JANUVIA - TRAJENTA DUO GALVUS - KOMBIGLYZE - ONGLYZA -
B.INGELHEIM - MSD NOVARTIS MSD - B.INGELHEIM NOVARTIS A.ZENECA A.ZENECA
Q4 16 Growth
International Guidelines
ONGLYZA (Saxagliptin 5 mg)
Manufactured by AstraZeneca Pharmaceuticals LP, Mount
Vernon, IN 47620, USA.
Packaged by Bristol-Myers Squibb S.r.l. 03012 Anagni, Italy.
For AstraZeneca UK Limited, Macclesfield, Cheshire, SK10
2NA, United Kingdom
Imported by PT AstraZeneca Indonesia, Cikarang, Bekasi –
Indonesia
Reg. No.: DKI1196300817A1
Store below 30°C.
Pack size : Box of 2 blisters @ 14 film-coated tablets

Shelf life: 3 years.


Diferensiasi Obat Antidiabetes KALBE

NAMA PRODUK ONGLYZA PIONIX METRIX NEVOX-XR EZELIN

KOMPOSISI Saxagliptin Pioglitazone Glimepiride Metformin-XR Insulin Glargine

Penurunan HbA1c ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Efek Samping
● ● ● ● ● ● ● ● ● ● ●
Hipoglikemia
Peningkatan Berat
Badan ↓↓ ↑ ↑↑ ↓ ↑↑↑
Diabetes +
Diabetes + Diabetes + Obat Diabetes Diabetes HbA1c
Positioning Gangguan
Obesitas Dislipidemia Lini Pertama > 7,5%
Fungsi Hati

Biaya Terapi $$$ $$ $$ $ $$

Masing-masing Obat Diabetes Memiliki Fungsi


dan Peran yang Berbeda untuk Setiap Kasus Diabetes
KOMBIGLYZE-XR (Saxagliptin 5 mg + Metformin-XR 500 mg)

Shelf Life: 2 years


Store: below 30°C
Pack size: Box of 4 blisters @
7 film-coated tablets

Manufactured by: AstraZeneca


Pharmaceuticals LP, Mount Vernon, IN
Reg. No.: DKI1359602217A1 47620, USA
Imported by: PT AstraZeneca Indonesia,
Cikarang, Bekasi – Indonesia
Mekanisme Kerja Sinergis Saxagliptin+Metformin

Saxagliptin Metformin
Gut Gut
Lower levels of the incretin hormone
GLP-1 are released from the gut
Decreases
Decreases(↓)
(↓)intestinal
intestinal
S
DPP-4
in patients with type 2 diabetes
Saxagliptin inhibits DPP-4 enzyme glucose
glucose
absorption
absorption
Enzymes
activity
Saxagliptin increases (↑) incretin
concentrations in the bloodstream

Pancreas Pancreas
Pancreas
…in response to ↑ GLP-1 concentrations: Insulin secretion
Insulin remains
secretion remainsunchanged
unchanged
 ↓ glucagon release  ↑ insulin release while fasting insulininsulin
while fasting levels levels
and and
from  cells from  cells day-long
day-longplasma
plasma insulin response
insulin may
response may
decrease decrease
Liver
Liver
…in response to ↓ glucagon release:
↓ glucose output by the liver
↓ hepatic glucose output
Muscle/Fat Muscle/Fat
…in response to ↑ insulin release: Improves
Improves insulin
insulin sensitivity
sensitivity and
and ↑
↑ peripheral glucose uptake ↑glucose
glucose uptake
uptake and andutilization
utilization

GLP=glucagon-like peptide; DPP=dipeptidyl peptidase.


1. Verspohl EJ. Pharmacol Ther. 2009;124:113-138.
Diferensiasi KOMBIGLYZE-XR
Kombiglyze XR1 Janumet2 Trajenta Duo3 Galvusmet4
Pharmaceutical Company AstraZeneca MSD Boehringer Ingelheim Novartis

Ingredient Saxagliptin + Metformin XR Sitagliptin + Metformin Linagliptin + Metformin Vildagliptin + Metformin

Dosage Once Daily Twice Daily Twice Daily Twice Daily

Efficacy data from T2DM naïve patient combination with metformin

Baseline HbA1C <8% - >10% >7.5% - <11% >7.5% - >9% >7.5% - <11%

HbA1C reduction
combination with 3.3% 3% 1.7% 3.2%
metformin

Safety data in CV outcome

Trial Name SAVOR TIMI 53 TECOS CAROLINA Not Available

Patient enrolled 16.429 14.000 6.000 Not Available

Result Non-inferiority Non-inferiority Not available until 2018 Not Available

Year of published 2013 2015 2018 Not Available


DPP-4=dipeptidyl peptidase-4.
1. Jadzinsky M. doi: 10.1111/j.1463-1326.2009. 1. Scirica et al, NEJM 2013. 2. Debora W. Current medical research 25;3:569-583, 2009. 2. Green B. NEJM 2015 3. Haak et al,diabetes and
metabolism 14: 565-574,2012. 4. Bosi E. doi: 10.1111/j. 1463-1326.2009
Daily Cost-Therapy

Pack Price Daily Cost


Pack (ITMA Q3 2016) Dose
IDR Therapy

TRAJENTA TAB FLM CTD 5MG 30 BLIS 389,328 once daily 12,977.59
TRAJENTA DUO TAB FLM CTD 2.5MG/500 30 BLIS 199,605 twice a day 13,306.97
TRAJENTA DUO TAB FLM CTD 2.5MG/850 30 BLIS 199,605 twice a day 13,306.97
TRAJENTA DUO TAB FLM CTD 2.5MG/1G 30 BLIS 199,605 twice a day 13,306.97
JANUVIA TAB FLM CTD 100MG 28 362,342 once daily 12,940.79
JANUVIA TAB FLM CTD 50MG 28 362,342 once daily 12,940.79
JANUMET TAB FLM CTD 50MG/500 28 BLIS 182,381 twice a day 13,027.21
JANUMET TAB FLM CTD 50MG/1G 28 BLIS 182,381 twice a day 13,027.21
GALVUS TAB 50MG 28 BLIS 175,000 twice a day 12,500.00
GALVUSMET TAB FLM CTD 50MG/500 30 BLIS 187,500 twice a day 12,500.00
GALVUSMET TAB FLM CTD 50MG/850 30 BLIS 187,500 twice a day 12,500.00
ONGLYZA TAB FLM CTD 5MG 28 BLIS 302,781 once daily 10,813.61
KOMBIGLYZE TAB FC XR 5MG/500 28 BLIS 313,725 once daily 11,204.46
Brand Communication
(2) Steady Release of Insulin Overnight
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