SwedenBIO

the Swedish Life Science Industry Organisation

Norsk Biotekforum - Mteplass kliniske studier, Oslo 10 Juni 2013
Sara Gunners, PhD, Senior Manager Science & IP

SwedenBIO - the national Life Science industry association

SwedenBIO is a member driven, private non-profit
organisation.
200 member companies
Head office in Stockholm with 5 employees.
Working groups involving more than 50 persons
from member companies.
EU Support Office (financed by VINNOVA).
Member of EuropaBIO, Eucope and BIO (US)
History: SwedenBIO was founded in 2002 by the CEOs of seven leading
Swedish life science companies: Amersham Biosciences (now GE Healthcare), Active Biotech, Biovitrum (now Sobi), Karo Bio, Medivir, Melacure
Therapeutics and Pharmacia Diagnostics (now Thermo Fisher).

SwedenBIO office:
Wallingatan 24
11124 Stockholm

SwedenBIO - member profile

200 member companies located nation wide
70% Life Science companies
Biotech, Pharma, Medtech, & Diagnostics
From Start-Ups to Big Pharma

30% service providers and non-profit organizations

Lawers, IP-firms, PR, IT etc.

Regional BIO-organisations etc.

3%
Non-profit
organizations

27 %
Service providers

Life Science
companies 0-10
employees

40 %
Life Science
companies >10
employees

30%

SwedenBIO - we help innovative companies succeed!

Improve conditions for the life science industry in Sweden.

Promote industry expertise and networks.
Inform the public, policymakers and the media how life science
companies can improve the quality of life and contribute
to positive social development.
Vision statement

SwedenBIO will facilitate development of a world class

environment for the Life Science industry in Sweden

SwedenBIO Nordic Life Science Days 2013

SwedenBIO and nordic co-hosts invite you to Nordic Life Science Days,
Stockholm Waterfront, Oct 14-15, 2013
Key Participants

Nordic Life Science Companies

International Big Pharma,Biotech, MedTech etc
looking for new opportunities
International Investors
Decision makers

Company Presentations
One-to-one Meetings
Exhibition
Parallel Sessions

www.nlsdays.com

The Swedish Drug Development Pipeline

June 2013

Two parts

1. Company analysis

/public information

2. Pipeline survey /web-based survey + public information

Swedish R&D companies

95 companies identifies as actively involved in R&D

of new drugs for human use

55% of the companies have one or more

4%

projects in clinical trials (phase I-III).

61% of the companies are located in

Stockholm/Uppsala
61%

14%

21%

Is the company located at a Science Park?

Karolinska Science Park

Stockholm

Medicon Village
Lund

54%
Yes

46%
No

Uppsala Science Park

Sahlgrenska Science Park

Gteborg

Ideon Science Park

Lund

Uminova Science Park

Ume

0%

20%

40%

60%

No of employees (FTE)

+8300 FTEs including AstraZeneca

70% of the companies have <10 FTE

8 companies have > 50 FTE

95% of all FTEs work at the 8 largest

companies.

Source: allabolag.se, 2011. AZ: 6782 FTE

Pipeline survey - study objectives

Aim - provide descriptive information about the current pipeline of drugs.
Focus - drugs that have entered clinical trials, phase I - III.
Clinical trials
Discovery
& Preclin

Phase I

Approval

Phase II

Phase III

Phase IV

Data collection - companies are invited to answer a web-based survey. In addition,

information was collected from companies webpages and clinicaltrials.gov.
Note - data is shown in comparison to results from previous reports (2006 - 2012).
AstraZeneca is not included in the analysis.

Overview of Number of Projects and Companies

76

74

78

73

65

63

67

46

30

34

33

2008

2009

38

35

2010

2011

1.9

1.8

42

46

24

2006
Projects/ company

1.9

2007
2.2

2.2

No of projects

2.2

No of companies

78 projects currently in clinical trials, phase I-III

2012
1.6

2013
1.7

Pipeline overview projects

80
70

78

64

60
50

40
30
20
10
0
Compounds
Indications

64 compounds are tested for 78 indications, phase I-III.

Pipeline overview companies

30
30
25
20

16

15
10
5
0

65% of the the companies have

1 project in clinical trials

35% of the the companies have

>1 projects in clinical trials

35% of the companies have more than 1 project in clinical trials, phase I-III.

Projects in Clinical Trials, phase I-III

50

45

40
30

19

20

14
10
0

Phase I
2006

2007

2008

58% of all projects in phase II

Phase II
2009

2010

Phase III
2011

2012

2013

Projects in Clinical Trials, phase I-III

100 %
9%

75 %

Non disclosed

35%

Abroad

33%

Sweden & Abroad

32%

Sweden

50 %

25 %

0%

2009 2010
Number of projects
in clinical trials

74

73

2011
63

2012
67

2013
78

Swedish patients are included in 65% of all clinical trials, phase I -III,

Small and Large Molecules

small molecules

50

large molecules

40
30
20

10
0
2006

2007

2008

2009

2010

2011

Ratio small & large molecules stabilizes around 50/50

2012

2013

Therapeutic Area, Phase I - III

Cancer
Infection
CNS
Gastro-Intestinal
Diabetic/Metabolism
Pain
Inflammation
Endocrinology
Obstetrics

Cardiovascular
Dermatology
Other
0

10

15

New cancer treatments dominate the pipeline, phase I-III

20

25

Selected Therapeutic Areas, Phase I - III

10

Phase I

Phase II

Phase III

4
2

Cancer

Infection

0
CNS

Gastro-intestinal

Orphan Drug Designations

250

EMA, number of orphan designations

FDA, number of orphan designations

200

150

100

50

0
2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

Orphan drugs designation - an emerging trend in drug development

2012

Orphan Drug Projects in Sweden

Q: Type of Project?

10
EMA, Swedish companies

FDA, Swedish companies

6
4
2
0

19% of projects in clinical trials, phase I-III, are orphan drug projects

Orphan
drug 19%

Q: Do you have a partner for the project?

No answer
18%

Big pharma
14%

Biotech
company 3%

Q: Future plan for the project?

Other
14%

No partner
65%

Partner or
licensing
33%

Move project
to next phase
53%

33% of projects without partner are looking for a partner to move the project further

Q: What are the major bottlenecks

for your project to proceed all the
way to the market?

Other
16%

Clinical
Trials 24%

Regulatory
issues 6%
Finding a
partner 24%
Funding 36%

Funding is always the most critical issue for reaching the market/patient

Key findings
At least 95 companies are actively involved in developing future drugs for
human use
55% have ongoing clinical trials.
17% of the companies have more than one project in clinical trial.

64 compounds are currently in clinical trials and tested for 78 indications

65% of ongoing clinical trials include Swedish patients
14 indications are currently tested in phase III trials

19% of the projects are orphan drug projects

28%

New cancer treatments dominate the pipeline, phase I-III.

Financing and finding a partner = the major bottlenecks to take a project all
the way to the market.

Thank you!
All pipeline reports may be downloaded from: www.swedenbio.com/rapporter

NLSDays 13-14 October

Stockholm Waterfront
Welcome!

www.nlsdays.com