SwedenBIO the Swedish Life Science Industry Organisation

Norsk Biotekforum - Møteplass kliniske studier, Oslo 10 Juni 2013

Sara Gunnerås, PhD, Senior Manager Science & IP

SwedenBIO office: Wallingatan 24

11124 Stockholm

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 Health-care), Active Biotech, Biovitrum (now Sobi), Karo Bio, Medivir, Melacure Therapeutics and Pharmacia Diagnostics (now Thermo Fisher).

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.

27 %

Service providers

Life Science companies 0-10

employees

40 %

Life Science companies >10

employees

30%

3% Non-profit

organizations

SwedenBIO - we help innovative companies succeed!

conditions for the life science industry in Sweden.

industry expertise and networks.

the public, policymakers and the media how life science companies can improve the quality of life and contribute to positive social development.

Improve

Promote

Inform

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

95 companies identifies as actively involved in R&D

of new drugs for human use

55% of the companies have one or more

projects in clinical trials (phase I-III).

61% of the companies are located in

Stockholm/Uppsala

Swedish R&D companies

21%

61% 14%

4%

Uminova Science Park

Ideon Science Park

Sahlgrenska Science Park

Uppsala Science Park

Medicon Village

Karolinska Science Park

0% 20% 40% 60%

Is the company located at a Science Park?

Stockholm

54%

Yes

46%

No

Lund

Göteborg

Lund

Umeå

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

Aim - provide descriptive information about the current pipeline of drugs.

Focus - drugs that have entered clinical trials, phase I - III.

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.

Pipeline survey - study objectives

Discovery

& Preclin Phase I Phase II Phase III Phase IV

Clinical trials Approval

Overview of Number of Projects and Companies

78 projects currently in clinical trials, phase I-III

46

65

76 74 73

63 67

78

24 30

34 33 38 35

42 46

2006 2007 2008 2009 2010 2011 2012 2013

No of projects No of companies

Projects/ company 1.9 2.2 2.2 2.2 1.9 1.8 1.6 1.7

Pipeline overview – projects

0

10

20

30

40

50

60

70

80

Compounds Indications

64

78

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

Pipeline overview – companies

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

0

5

10

15

20

25

30

30

16

65% of the the companies have

1 project in clinical trials

35% of the the companies have

>1 projects in clinical trials

Projects in Clinical Trials, phase I-III

0

10

20

30

40

50

Phase I Phase II Phase III

2006 2007 2008 2009 2010 2011 2012 2013

14

45

19

58% of all projects in phase II

Projects in Clinical Trials, phase I-III

0 %

25 %

50 %

75 %

100 %

2009 2010 2011 2012 2013

Number of projects

in clinical trials 74 73 63 67 78

32% Sweden

33% Sweden & Abroad

35% Abroad

9% Non disclosed

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

Small and Large Molecules

0

10

20

30

40

50

2006 2007 2008 2009 2010 2011 2012 2013

small molecules

large molecules

Ratio small & large molecules stabilizes around 50/50

Therapeutic Area, Phase I - III

New cancer treatments dominate the pipeline, phase I-III

0 5 10 15 20 25

Other

Dermatology

Cardiovascular

Obstetrics

Endocrinology

Inflammation

Pain

Diabetic/Metabolism

Gastro-Intestinal

CNS

Infection

Cancer

Selected Therapeutic Areas, Phase I - III

0

2

4

6

8

10

Cancer Infection CNS Gastro-intestinal

Phase I Phase II Phase III

0 0

Orphan drugs designation - an emerging trend in drug development

Orphan Drug Designations

0

50

100

150

200

250

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

EMA, number of orphan designations

FDA, number of orphan designations

Orphan Drug Projects in Sweden

0

2

4

6

8

10

EMA, Swedish companies

FDA, Swedish companies

Orphan

drug 19%

Q: Type of Project?

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

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

Biotech

company 3%

No answer

18%

Big pharma

14% No partner

65%

Q: Do you have a partner for the project? Q: Future plan for the project?

Partner or

licensing

33%

Move project

to next phase

53%

Other

14%

Clinical

Trials 24%

Other

16%

Regulatory

issues 6%

Finding a

partner 24%

Funding 36%

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

Q: What are the major bottlenecks

for your project to proceed all the

way to the market?

• 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

• 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.

Key findings

28%

Thank you!

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

NLSDays 13-14 October

Stockholm Waterfront

Welcome!

www.nlsdays.com