dr. stephen little vice president personalized healthcare · sample & assay technologies....

Sample & Assay Technologies

QIAGEN 2011 Analyst & Investor DayDr. Stephen LittleVice President Personalized Healthcare

Sample & Assay Technologies Agenda

QIAGEN 2011 Analyst & Investor Day 2

All stakeholders benefit from Personalized Healthcare

Pharma is embracing the transformation

QIAGEN is the clear leader in co-development projects

Creating a fast-growing and sustainable business

Sample & Assay Technologies Perspectives on Personalized Healthcare

The use of a companion diagnostic to predict in advance which patients are most likely to benefit from a particular therapy



EGFRtesting

Notesting

Consider other options

Treat with appropriate drug

Better treatment outcomes

More efficient spending

“Trial and error”

Lung cancer patients

Worse treatment outcomes

Wasted healthcare spending

Lost time

Part of the solution: Personalized Healthcare


Sample & Assay Technologies All stakeholders benefit from Personalized Healthcare

Payors Cost savings

Physicians Confidence in decisions

Patients Better medicines

Pharma companies Value creation

Providers of diagnostics New market opportunities




All stakeholder benefit from Personalized Healthcare




Sample & Assay Technologies Pharma faces increasingly challenging environment

Healthcare costs

Technology and science

Patients, Physicians and Payors

Billions wasted on ineffective treatments

Technology to measure genetic variationScience to establish meaning

Better, safer medicines


Pharma increasingly seeing diagnostics as part of the solution

Sample & Assay Technologies Pharma is embracing Personalized Healthcare

Pharma pipelines adding biomarkers (% of projects with a biomarker)

Regulatory influence

May refuse approval without a diagnostic

Improve overall safety profile

Strengthen reimbursement

Supporting healthcare economic data

Can lead to premium pricing

More competitive products

Patients and doctors want drugs that work

Better chances for success

Reduce risks for expensive late-stage trials

~65%

~50%

~35%


Source: Tufts Center for the Study of Drug Development

Sample & Assay Technologies Pharma willing to go to very low stratification levels

Drug Biomarker Frequency

Vectibix(Amgen) KRAS 60%

Herceptin(Roche) HER2 20%

Iressa(AstraZeneca) EGFR 15%

Xalkori(Pfizer) ALK 5%


Sample & Assay Technologies Pharma sees significant growth opportunities

80% of pharma companies working on personalized medicines2

Up to 50% of current clinical development projects involve personalized medicines2

Anticipating 70% increase in pharma R&D (2006 – 2010)

By 2015, >50% investment increase

Within 5-10 years, all new oncology drugs will have a companion diagnostic2

1 The Science of Personalized Medicine: Translating the Promise into Practice. PricewaterhouseCoopers LLP 20092 Tufts Center for the Study of Drug Development 2010U.S. companion diagnostics market outlook source: Frost & Sullivan


U.S. companion diagnostics market (Companion diagnostics and lab testing sales)

~$150 million.

~$1.5 billion

Sample & Assay Technologies QIAGEN’s Personalized Healthcare strategy

Pharma pays for companion diagnostics development

Solve clinical utility issues

Drug success guarantees companion diagnostic market

Unique content encourages platform uptake

Co-marketing with Pharma

“Develop once, sell often” – develop a biomarker and provide to various partners

QIAGEN benefits Pharma benefits

QIAGEN’s global presence and high-quality brand

Proven automation platforms

Flanking menu and Sample & Assay Technologies

Regulatory expertise in U.S., Europe and other markets

Co-commercialization skills


Co-development the best route to co-commercialization


Pharmaceutical partners

High importanceLow importance High importance Low importance

Diagnostic laboratories

Global presence

Independence

Addressing different customers with different needs


Sample & Assay Technologies QIAGEN well positioned to address customer needs


Customer needs QIAGEN

Global presence

Worldwide presence

Direct operations in >30 countriesAutomated lab solutions

QIAsymphony

Rotor-Gene RGQManufacturing

Specialized cGMP facilities

Regulatory

U.S./EU regulatory experience

Specialized expertsBroad test menu

>20 commercial assays

Extensive portfolioIndependence

No pharma operations, so no conflict

Intellectual property

Strong position

Licenses: EGFR,PI3K and JAK2

Academia ties to translational research

Sample & Assay Technologies Leading co-development project portfolio

Project Partner Indication Biomarker Status

Eribitux (cetuximab)

BMS / Lilly / ImClone

Colorectal cancer KRAS U.S. submission

(PMA) in H1 2011

Vectibix (panitumumab) Amgen Colorectal

cancer KRAS U.S. submission(PMA) in H1 2011

PF-00299804 (dacomitinib) Pfizer Lung cancer

(NSCLC) KRAS In development

Iressa (gefitnib) AstraZeneca Lung cancer

(NSCLC) EGFR CE-IVD kit in Europe and other non-U.S. markets

Tomtovok (afatinib)

Boehringer Ingelheim

Lung cancer (NSCLC) EGFR U.S. submission planned

for 2012

Early-stage compound Lilly Blood cancer JAK2 In development

Not disclosed Confidential Non-oncology Confidential In development

Selected co-development projects

Partner of choice: Industry-leading 15 projects under way


Sample & Assay Technologies Quickly maximizing Ipsogen’s portfolio

Providesaccess to JAK2

Enables new project

INCB 18424WP1066

AZD1480

CEP-701CYT-387

XL019

TG101348



2.8

2.6

2.4

2.22.0

1.8

1.61.4

1.2

1.0

0.8

0.60.4

0 1.4 1.5 1.6 1.7 1.8 1.9 2.5 2.6 2.7Economic potential of companion diagnostics1

Growth factorsAntihistamines

Diabetes

Asthma

Autoimmune drugs

OncologyAnti-infectives

Anticoagulants

AntipsychoticsCNS drugs

Antidepressants

Statins

Proton pump inhibitors

Antihypertensives

Anti-inflammatories

Antiarrhythmics

1 Rank order estimates for scientific and commercial potential of development of companion diagnostics in various therapeutic areas, based on both qualitative factors (e.g., expert interviews) and quantitative factors (e.g., data on price premiums for drugs launched in the same therapeutic class). Results should be taken as directional only.

Source: McKinsey Quarterly February 2010

Scientific potential of companion diagnostics1

Personalized Healthcare moving beyond oncology


Sample & Assay Technologies Covering full Personalized Healthcare roadmap


Used by pharma on clinical trial patients

Used by diagnostic labs on samples of “real world”

patients

Identify biomarkers Develop approved CDx Sell CDx

Used by pharma on preclinical and clinical samples

Pharmaceuticals pathway

Tools for biomarker selection

Development and regulatory expertise

Product distribution and marketing

Drug development Phase I and II

Drug development Phase II and III Sell drugs

Diagnostics pathway

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North America China

JapanEurope / Middle East / Africa

Creating a global Personalized Healthcare business


* Pending

All countries where at least one of the biomarker assays (PCR or Pyrosequencing) is registered

*

*

Priority markets

Asia-Pacific

Latin America

*

Sample & Assay Technologies Sustainable growth in Personalized Healthcare


Milestone payments

Portfolio expansion

New indications (KRAS)

Regulatory approvals

Co-development projects

Automation

Market exclusivity

Geographic expansion

QIAsysmphony RGQ

Lab standardization

Ease of use

Broad test menu

Secure IP rights

JAK2, EGFR, PI3K

Close ties to Academia

2012: First U.S. approvals

Emerging markets

Sales & Marketing network

Sustainable growth

Sample & Assay Technologies QIAGEN Personalized Healthcare in 2015

Biomarker data transforming medical practice

Moving beyond oncology

Proven benefits for all stakeholders

Ending “trial and error“ treatments

More effective healthcare spending

Faster regulatory approvals and

QIAGEN the dominant market leader

Meeting lab and pharma customer needs

Partner of choice for co-development projects

Expanding global presence


dr. stephen little vice president personalized healthcare · sample & assay technologies....

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