kappaproct (ulcerative colitis) - forecast and market pharmapoint: psoriasis – global drug...

REFERENCE CODE GDHC344DFR| PUBLICATION DATE FEBRUARY 2014

KAPPAPROCT (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

Kappaproct (Ulcerative Colitis) – Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

KAPPAPROCT (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

Table below provides a summary of the key

metrics for Kappaproct in the 8MM Ulcerative

Colitis (UC) markets in 2022.

Kappaproct: Key Metrics in the 8MM UC Market , 2022

Key Events (2012–2022) Level of Impact

Kappaproct entering the EU in 2014 ↑↑↑

2022 Market Sales

US N/A

5EU $20.83m

Japan N/A

Canada N/A

Total Global $20.83m Global = US, France, Germany, Italy, Spain, UK, Japan, Canada, China, and India 5EU = France, Germany, Italy, Spain, and UK; 8MM = US, 5EU, Japan and Canada N/A: Not Applicable Source: GlobalData

Sales for Kappaproct in Global Ulcerative Colitis Market, 2022

InDeX Pharmaceuticals will launch Kappaproct in

the EU market in 2014. In its first year, sales of

Kappaproct in the Ulcerative Colitis market are

projected to reach $3.97 million. By 2022, we

project its sales to increase upto $20.83 million in

the Ulcerative Colitis market. Key factors affecting

the sales of Kappaproct will include.

Major growth drivers of Kappaproct in the UC

market over the forecast period include:

 Refractory UC patients who are more likely to

benefit from Kappaproct treatment could be

identified, and could serve to illustrate the

usefulness of a personalized treatment

approach.

 Rapid response; only one 30mg dose needed

to induce clinical remission in 43% of the

Phase IIb study patients.

 Being the only rescue treatment (for colectomy

avoidance), so it is close to receiving

marketing authorization.

 Promising clinical results thus far. Patients on

Kappaproct seem to be successfully avoiding

colectomy.

Conversely, major barriers to the growth of the

Kappaproct in UC market include:

 Rectal administration

 Cannot be used with biologics.

Kappaproct (Ulcerative Colitis) – Forecast and Market Analysis to 2022 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

KAPPAPROCT (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

Figure below illustrates the global Kappaproct

sales by region in 2022

Sales of Kappaproct by Region, 2022

100%

2022 Total: $20.83m

5EU

Source: GlobalData

What Do Physicians Think?

Physicians interviewed by GlobalData expressed

doubts about the use of Inflectra (an infliximab

biosimilar) following its approval in Europe in

September 2013.

“I do not comprehend what the EMA based the

label extrapolation upon. I would like to see data

from a clinical trial of Inflectra done on UC patients.

I’m afraid, though, that we [physicians] might

receive pressure to prescribe this biosimilar

treatment because of the healthcare funding cuts”

[EU] key opinion leader, October, 2013

The physicians also underscored the need for a

curative treatment for UC.

“Essentially, there is no adequate treatment for

severe UC patients. AZA [azathioprine] has an

unpredictable array of adverse effects and no

guaranteed efficacy. The biologics only work in

40% of the severe UC patients, and in most cases,

they are underdosed. We need a curative

treatment.”

[EU] key opinion leader, October 2013

Some KOLs expressed the opinion that UC

patients should be referred to a specialist before

they develop bloody diarrhea, as well as the desire

for companies to develop disease severity

prediction tests, which could allow for the earlier

detection of UC.

“Patients usually go to their primary care

physicians and complain about chronic diarrhea,

some sort of uveitis, poor quality of life, etcetera. If

colonoscopy is considered necessary, and a heavy

colonic inflammatory burden is observed, then the

patient undergoes regular monitoring. This doesn’t

happen with everyone, though, and in 90% of the

cases, UC is diagnosed upon the presence of

bloody diarrhea. But, I think we can catch it sooner.

We need a [disease] severity prediction test.”

[US] key opinion leader, November, 2013

The physicians also commented on the clinical

positioning that they would choose for Takeda’s

pipeline therapy, Entyvio.

Kappaproct (Ulcerative Colitis) – Forecast and Market Analysis to 2022 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

KAPPAPROCT (ULCERATIVE COLITIS) - FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

“I think if vedolizumab is as good as it looks, it will

be [a] first- or second-line treatment in place of

azathioprine. If you have a UC patient relapsing

frequently, despite the use of mesalazine,

vedolizumab will be an ideal candidate. I regard it

as safer than azathioprine and more effective [for

UC]. [However,] I would carry on using anti-TNFs

for the treatment of CD.”

[EU] key opinion leader, September 2013

The physicians also shared their thoughts on the

high risk of colorectal cancer in inflammatory

bowel.

Kappaproct (Ulcerative Colitis) – Forecast and Market Analysis to 2022 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

KAPPAPROCT (ULCERATIVE COLITIS) - DRUG FORECAST AND MARKET ANALYSIS TO 2022

1 Table of Contents

1 Table of Contents ....................................................................................................................... 5

1.1 List of Tables ...................................................................................................................... 8

1.2 List of Figures ..................................................................................................................... 9

2 Introduction ............................................................................................................................... 10

2.1 Catalyst ............................................................................................................................. 10

2.2 Related Reports ................................................................................................................ 10

2.3 Upcoming Related Reports ............................................................................................... 12

3 Disease Overview ..................................................................................................................... 13

3.1 Etiology and Pathophysiology ........................................................................................... 13

3.1.1 Etiology ......................................................................................................................... 13

3.1.2 Pathophysiology ............................................................................................................ 15

3.2 Symptoms ......................................................................................................................... 17

3.2.1 Quality of Life ................................................................................................................ 17

4 Disease Management ............................................................................................................... 19

4.1 Diagnosis and Treatment Overview .................................................................................. 19

4.1.1 Diagnosis ...................................................................................................................... 19

4.1.2 Treatment Guidelines and Leading Prescribed Drugs ................................................... 22

4.1.3 Clinical Practice ............................................................................................................. 24

5 Competitive Assessment .......................................................................................................... 28

5.1 Overview ........................................................................................................................... 28

5.2 Strategic Competitor Assessment ..................................................................................... 29

Kappaproct (Ulcerative Colitis) – Forecast and Market Analysis to 2022 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

KAPPAPROCT (ULCERATIVE COLITIS) - DRU