C O M B I N I N G O U R S T R E N G T H SS H A R I N G O U R S U C C E S S E S

December 2010

Areas of Interest

Merck is known as MSD outside the United States and Canada.

D E C E M B E R 2 0 1 0 C O M B I N I N G O U R S T R E N G T H S S H A R I N G O U R S U C C E S S E S

Dear Colleagues,

I am delighted to invite you to discover more about Today’s Merck and our partnership

interests. Whether you are working for a biotechnology company, an academic institution,

or a financial organization, we welcome the opportunity to discuss our shared interests and

opportunities to partner. We are actively seeking new alliances that accelerate the discovery

and development process, improve R&D productivity, and increase the probability of

successfully commercializing novel therapeutics and vaccines.

We understand that you are using your unique strengths to identify innovative new

compounds and technologies. With Merck as your partner, you will find an organization

devoted to you and the rigorous, expeditious development of your discovery.

Inside this book you will find a list of our currently defined therapeutic areas of interest,

including research technologies and biologics. We welcome:

• Novel patented chemical or biological entities and vaccines in discovery and development

• Targets with proof of concept

• Molecules with a defined mechanism of action or testable hypothesis

• Technologies with patent protection that provide a competitive advantage

We are interested in compounds that have a large market potential for unmet medical needs.

Late-stage clinical compounds with proven therapeutic value (Phase III-ready or later) are of

particular interest in any therapeutic area.

To begin a discussion about partnering with Merck, contact our scientific licensing expert in

your region. Contact information for our licensing experts can be found in the back of this

book. Or, if you prefer, please visit our Web site at merck.com/licensing.

I’m confident that, together, we can combine our strengths and translate cutting-edge science

into breakthrough medicines.

Sincerely,

David Nicholson, PhDSenior Vice President and Head Worldwide Licensing and Knowledge Management

Deal Making—A Creative and Flexible Process

Connecting With You

Doing theDeal

Understanding Your Science

WorkingTogether

Step 1 Step 2

Step 3 Step 4

Our four-step partnership is clear and straightforward. From initial discussions

to signing the deal, through to execution and global commercialization, you’ll

experience flexibility, creativity, and the utmost professionalism.

D E C E M B E R 2 0 1 0 C O M B I N I N G O U R S T R E N G T H S S H A R I N G O U R S U C C E S S E S

Dear Colleagues,

I am delighted to invite you to discover more about Today’s Merck and our partnership

interests. Whether you are working for a biotechnology company, an academic institution,

or a financial organization, we welcome the opportunity to discuss our shared interests and

opportunities to partner. We are actively seeking new alliances that accelerate the discovery

and development process, improve R&D productivity, and increase the probability of

successfully commercializing novel therapeutics and vaccines.

We understand that you are using your unique strengths to identify innovative new

compounds and technologies. With Merck as your partner, you will find an organization

devoted to you and the rigorous, expeditious development of your discovery.

Inside this book you will find a list of our currently defined therapeutic areas of interest,

including research technologies and biologics. We welcome:

• Novel patented chemical or biological entities and vaccines in discovery and development

• Targets with proof of concept

• Molecules with a defined mechanism of action or testable hypothesis

• Technologies with patent protection that provide a competitive advantage

We are interested in compounds that have a large market potential for unmet medical needs.

Late-stage clinical compounds with proven therapeutic value (Phase III-ready or later) are of

particular interest in any therapeutic area.

To begin a discussion about partnering with Merck, contact our scientific licensing expert in

your region. Contact information for our licensing experts can be found in the back of this

book. Or, if you prefer, please visit our Web site at merck.com/licensing.

I’m confident that, together, we can combine our strengths and translate cutting-edge science

into breakthrough medicines.

Sincerely,

David Nicholson, PhDSenior Vice President and Head Worldwide Licensing and Knowledge Management

Deal Making—A Creative and Flexible Process

Connecting With You

Doing theDeal

Understanding Your Science

WorkingTogether

Step 1 Step 2

Step 3 Step 4

Our four-step partnership is clear and straightforward. From initial discussions

to signing the deal, through to execution and global commercialization, you’ll

experience flexibility, creativity, and the utmost professionalism.

Table of Contents

Atherosclerosis and Cardiovascular Diseases Lipids / Metabolic Syndrome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Specialty Hypertension / Cardiovascular. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Thrombosis and Other Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Diabetes and Obesity Diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Obesity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Infectious Diseases Antibacterials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Antifungals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Antivirals – HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Antivirals – Hepatitis C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Antivirals – Other Interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Antiviral and Anti-infective Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Neurosciences and Ophthalmology Migraine and Pain: Migraine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Migraine and Pain: Pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Neurology – Alzheimer’s Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Neurology – Parkinson’s Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Ophthalmology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Psychiatric Diseases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Sleep Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Oncology Oncology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Capabilities – Technologies to Evaluate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Respiratory and Immunology Arthritis and Immune-Based Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Asthma / COPD / Rhinitis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Women’s Health and Endocrinology Contraception . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Fertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Menopause. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Endometriosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Bone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Urology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Sarcopenia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Other Diseases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Research Technologies RNA Therapeutics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Drug Delivery and Formulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Enabling Technologies Translational Models / In Vivo Pharmacology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Biomarkers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Lead Identification and Screening Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Chemical Synthesis and Purification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Modeling Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Automated Workflows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Information Technology / Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Analytical Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

A R E A S O f I N T E R E S TD E C E M B E R 2 0 1 0

2

A R E A S O f I N T E R E S TD E C E M B E R 2 0 1 0

3

Therapeutic Areas and Research Technologies

• We have aligned our areas of interest with our franchises, plus new technologies and biologics.

• Additionally, we will continue to pursue external licensing opportunities in other disease areas where clinical proof of concept exists.

• We will also pursue niche acquisitions and partnerships in diagnostics and devices where it complements our pipeline, and not as a stand-alone business.

Table of Contents

Atherosclerosis and Cardiovascular Diseases Lipids / Metabolic Syndrome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Specialty Hypertension / Cardiovascular. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Thrombosis and Other Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Diabetes and Obesity Diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Obesity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Infectious Diseases Antibacterials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Antifungals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Antivirals – HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Antivirals – Hepatitis C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Antivirals – Other Interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Antiviral and Anti-infective Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Neurosciences and Ophthalmology Migraine and Pain: Migraine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Migraine and Pain: Pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Neurology – Alzheimer’s Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Neurology – Parkinson’s Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Ophthalmology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Psychiatric Diseases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Sleep Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Oncology Oncology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Capabilities – Technologies to Evaluate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Respiratory and Immunology Arthritis and Immune-Based Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Asthma / COPD / Rhinitis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Women’s Health and Endocrinology Contraception . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Fertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Menopause. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Endometriosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Bone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Urology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Sarcopenia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Other Diseases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Research Technologies RNA Therapeutics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Drug Delivery and Formulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Enabling Technologies Translational Models / In Vivo Pharmacology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Biomarkers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Lead Identification and Screening Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Chemical Synthesis and Purification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Modeling Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Automated Workflows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Information Technology / Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Analytical Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

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Therapeutic Areas and Research Technologies

• We have aligned our areas of interest with our franchises, plus new technologies and biologics.

• Additionally, we will continue to pursue external licensing opportunities in other disease areas where clinical proof of concept exists.

• We will also pursue niche acquisitions and partnerships in diagnostics and devices where it complements our pipeline, and not as a stand-alone business.

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LIpIds / MetAboLIc syndroMe

Areas of Interest:

• Lipid-lowering therapies – Agents with effect on LDL / Apo-B – Agents with additional effect on glucose, triglycerides,

blood pressure, body weight, and / or HDL – Basic research collaborations on novel targets• HDL-raising therapies – Acute HDL therapy for high-risk patients

(eg, HDL infusion) – Oral compounds, with known mechanism of action, that

increase HDL-C or Apo-A1 levels and have additional evidence to increase confidence that such mechanism will reduce cardiovascular risk

– Basic research collaborations on novel targets

Technology / Methods:

• Discovery – Collaborations for identifying, validating, and developing

novel lipid / metabolic and / or other emerging targets with high confidence for reducing CV risk

• Biomarkers – Methods, biomarkers, or platforms to assess

antiatherogenic properties of HDL or other lipoproteins – Biomarkers of patient subtypes – Acute methods to assess cholesterol transport in humans

(especially reverse cholesterol transport), including imaging and kinetic models

Not Interested in:

• Triglyceride-lowering therapies with no other benefit

• Fibrates or other PPAR-alpha agonists

• Nutraceuticals

Atherosclerosis and Cardiovascular Disease s

specIALty HypertensIon* / cArdIovAscuLAr

Areas of Interest:

• Diuretics

• Long-acting vasorelaxants

• Agents that inhibit aldosterone synthesis and / or action

• Agents that lower blood pressure and have pleiotropic benefits on end-organ protection (especially cardiac, renal, and vascular)

• Antihypertensive agents with additional benefits on other components of metabolic syndrome and other cardiovascular risk factors

• Agents for pulmonary artery hypertension

• Heart failure agents that affect structural cardiac remodeling and / or have antihypertensive effects

• Basic research

Technology / Methods:

• Discovery – Platform technologies for identifying novel targets for

specialty hypertension – Animal models of hypertension

• Biomarkers (clinical and preclinical) – Technologies for measuring vascular dynamics (eg, flow,

shear stress, vascular compliance) and intravascular pressure beyond tonometry

– Markers that link HTN to other metabolic syndrome phenotypes and / or atherosclerosis

– Markers for renal sequelae of HTN (eg, renal perfusion and renal injury)

– Platform technologies that enable personalized medicine for HTN

Not Interested in:

• ACE inhibitors, ARBs, CCBs, beta-blockers, adrenergic agents

• Nutraceuticals

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

* Specialty hypertension includes hypertensive segments with high unmet need such as systolic HTN, resistant HTN and HTN associated with obesity and diabetes HTN with associated heart failure, and pulmonary artery HTN

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LIpIds / MetAboLIc syndroMe

Areas of Interest:

• Lipid-lowering therapies – Agents with effect on LDL / Apo-B – Agents with additional effect on glucose, triglycerides,

blood pressure, body weight, and / or HDL – Basic research collaborations on novel targets• HDL-raising therapies – Acute HDL therapy for high-risk patients

(eg, HDL infusion) – Oral compounds, with known mechanism of action, that

increase HDL-C or Apo-A1 levels and have additional evidence to increase confidence that such mechanism will reduce cardiovascular risk

– Basic research collaborations on novel targets

Technology / Methods:

• Discovery – Collaborations for identifying, validating, and developing

novel lipid / metabolic and / or other emerging targets with high confidence for reducing CV risk

• Biomarkers – Methods, biomarkers, or platforms to assess

antiatherogenic properties of HDL or other lipoproteins – Biomarkers of patient subtypes – Acute methods to assess cholesterol transport in humans

(especially reverse cholesterol transport), including imaging and kinetic models

Not Interested in:

• Triglyceride-lowering therapies with no other benefit

• Fibrates or other PPAR-alpha agonists

• Nutraceuticals

Atherosclerosis and Cardiovascular Disease s

specIALty HypertensIon* / cArdIovAscuLAr

Areas of Interest:

• Diuretics

• Long-acting vasorelaxants

• Agents that inhibit aldosterone synthesis and / or action

• Agents that lower blood pressure and have pleiotropic benefits on end-organ protection (especially cardiac, renal, and vascular)

• Antihypertensive agents with additional benefits on other components of metabolic syndrome and other cardiovascular risk factors

• Agents for pulmonary artery hypertension

• Heart failure agents that affect structural cardiac remodeling and / or have antihypertensive effects

• Basic research

Technology / Methods:

• Discovery – Platform technologies for identifying novel targets for

specialty hypertension – Animal models of hypertension

• Biomarkers (clinical and preclinical) – Technologies for measuring vascular dynamics (eg, flow,

shear stress, vascular compliance) and intravascular pressure beyond tonometry

– Markers that link HTN to other metabolic syndrome phenotypes and / or atherosclerosis

– Markers for renal sequelae of HTN (eg, renal perfusion and renal injury)

– Platform technologies that enable personalized medicine for HTN

Not Interested in:

• ACE inhibitors, ARBs, CCBs, beta-blockers, adrenergic agents

• Nutraceuticals

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

* Specialty hypertension includes hypertensive segments with high unmet need such as systolic HTN, resistant HTN and HTN associated with obesity and diabetes HTN with associated heart failure, and pulmonary artery HTN

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Areas of Interest:

Thrombosis (discovery onward):

• Anticoagulation agents with improved therapeutic index relative to existing agents

• Basic research collaborations on novel targets

• Biomarkers that can be used to quantify antithrombotic effects, antiplatelet effects, and bleeding risk

The following areas of interest apply to compounds that have established proof of concept (POC) in clinical Phase II studies:

• Antiarrhythmic agents for atrial fibrillation

Not Interested in:

• Agents without clinical POC for: – Acute treatments for myocardial infarction (MI) – Post- myocardial infarction therapeutics for myocardial

preservation or perfusion-reperfusion injury – Vascular inflammation targets• Treatment of restenosis

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Diabetes and Obesity

dIAbetes

Areas of Interest:

• Any treatments for glucose with risk reduction of comorbidities (eg, dyslipidemia, hypertension)

• Novel or best-in-class protein / peptide therapeutics; consider strategic alliance

– Insulin • Novel “breakthrough” insulins (eg, glucose dependent,

liver targeted) • Insulin delivered by alternate routes that also offers

an improved clinical profile (eg, oral, buccal, transdermal, nasal)

• Once-weekly basal insulin (sc) – Best-in-class GLP-1 analogues

• Oral therapies: Best-in-class and novel mechanisms – Non-PPAR insulin sensitizers – Glucose-dependent insulin secretagogues (GDIS) – Beta-cell protection or regeneration if it also affects GDIS – Ability to combine with metformin is a must-have – Additive / synergistic in combination with sitagliptin – Best-in-class SGLT inhibitor

• Microvascular complication treatments with human clinical efficacy data

– Agents that halt / reverse complications in preferably >1 target (diabetic nephropathy, neuropathy, retinopathy)

obesIty

Areas of Interest:

• Best-in-class compounds and novel mechanisms for weight loss or both weight loss and prevention of weight gain

• Novel mechanisms for weight loss or both weight loss and prevention of weight gain

– Any effective mechanism, eg, those acting centrally or peripherally on appetite, satiety, or metabolic rate, and nutrient absorption inhibitors

– Peptide, protein, or oral small molecule – Independent effects on comorbidities (blood pressure,

glucose, lipids) desirable – Early-stage opportunities: with robust animal mechanism-

based POC and preclinical safety data desirable – Clinical stage compounds: meet registration criteria for

obesity indication with better safety and tolerability vs current agents

– Mechanisms that are additive or synergistic as combination therapy

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

tHroMbosIs And otHer AreAs (outsIde LIpIds And HypertensIon)

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Areas of Interest:

Thrombosis (discovery onward):

• Anticoagulation agents with improved therapeutic index relative to existing agents

• Basic research collaborations on novel targets

• Biomarkers that can be used to quantify antithrombotic effects, antiplatelet effects, and bleeding risk

The following areas of interest apply to compounds that have established proof of concept (POC) in clinical Phase II studies:

• Antiarrhythmic agents for atrial fibrillation

Not Interested in:

• Agents without clinical POC for: – Acute treatments for myocardial infarction (MI) – Post- myocardial infarction therapeutics for myocardial

preservation or perfusion-reperfusion injury – Vascular inflammation targets• Treatment of restenosis

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Diabetes and Obesity

dIAbetes

Areas of Interest:

• Any treatments for glucose with risk reduction of comorbidities (eg, dyslipidemia, hypertension)

• Novel or best-in-class protein / peptide therapeutics; consider strategic alliance

– Insulin • Novel “breakthrough” insulins (eg, glucose dependent,

liver targeted) • Insulin delivered by alternate routes that also offers

an improved clinical profile (eg, oral, buccal, transdermal, nasal)

• Once-weekly basal insulin (sc) – Best-in-class GLP-1 analogues

• Oral therapies: Best-in-class and novel mechanisms – Non-PPAR insulin sensitizers – Glucose-dependent insulin secretagogues (GDIS) – Beta-cell protection or regeneration if it also affects GDIS – Ability to combine with metformin is a must-have – Additive / synergistic in combination with sitagliptin – Best-in-class SGLT inhibitor

• Microvascular complication treatments with human clinical efficacy data

– Agents that halt / reverse complications in preferably >1 target (diabetic nephropathy, neuropathy, retinopathy)

obesIty

Areas of Interest:

• Best-in-class compounds and novel mechanisms for weight loss or both weight loss and prevention of weight gain

• Novel mechanisms for weight loss or both weight loss and prevention of weight gain

– Any effective mechanism, eg, those acting centrally or peripherally on appetite, satiety, or metabolic rate, and nutrient absorption inhibitors

– Peptide, protein, or oral small molecule – Independent effects on comorbidities (blood pressure,

glucose, lipids) desirable – Early-stage opportunities: with robust animal mechanism-

based POC and preclinical safety data desirable – Clinical stage compounds: meet registration criteria for

obesity indication with better safety and tolerability vs current agents

– Mechanisms that are additive or synergistic as combination therapy

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

tHroMbosIs And otHer AreAs (outsIde LIpIds And HypertensIon)

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dIAbetes And obesIty

Technologies / Capabilities:

• Alternate delivery of peptides• Novel delivery devices for sc insulin • Platform technologies for the identification and validation

of novel targets to complement existing efforts• Imaging agents for monitoring pancreatic beta-cell mass• Pharmacogenetics / -genomics, proteomics, or other for

prediction of diabetes, obesity, drug response, and sub-phenotyping of disease. Clinical validation data are needed

• Clinical methods for early prediction of long-term weight loss

Not Interested in:• Nutraceuticals or natural product mixtures• Nonglucose-dependent insulin secretagogues• Cell-based insulin replacement for type 1 diabetes unless

long-term clinical POC data exists • Compounds with unknown molecular target unless clinical

POC exists

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

Infectious Diseases

AntIbActerIALs

Areas of Interest:

• Antibacterial agents with compelling data including: resistance frequency, an understanding of the mechanism of action, efficacy in animal models of infection, and preliminary toxicology data

– Narrow and broad-spectrum agents that cover problematic pathogens with either intrinsic or acquired resistance to existing agents, particularly MRSA (IV and oral formulations), Pseudomonas (IV, preferably with oral formulation), and Acinetobacter (IV, preferably with oral formulation)

– Novel approaches to C. difficile that address the recurrence rate

– Combinations that address bacterial resistance such as:

• Beta lactamase (Class A / C / D) inhibitors

• Carbapenem potentiators or synergists

Late-stage opportunities (Phase III-ready and later):• Gram-positive and / or gram-negative products that can

be meaningfully clinically differentiated* from current treatment options. Also includes:

– Gram-positive (w / MRSA): At least with oral formulation – Community RTI oral agents

Not Interested in:• Topical antibiotics• Antibodies without clinical POC• Quinolones (mechanism of action for quinolones is of

interest, but not the structural class)• Known antibacterial structural types unless they are

differentiated from current agents by safety, efficacy, route of administration, or activity on resistant strains

*Criteria that determine meaningful clinical differentiation may vary by region of the world

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dIAbetes And obesIty

Technologies / Capabilities:

• Alternate delivery of peptides• Novel delivery devices for sc insulin • Platform technologies for the identification and validation

of novel targets to complement existing efforts• Imaging agents for monitoring pancreatic beta-cell mass• Pharmacogenetics / -genomics, proteomics, or other for

prediction of diabetes, obesity, drug response, and sub-phenotyping of disease. Clinical validation data are needed

• Clinical methods for early prediction of long-term weight loss

Not Interested in:• Nutraceuticals or natural product mixtures• Nonglucose-dependent insulin secretagogues• Cell-based insulin replacement for type 1 diabetes unless

long-term clinical POC data exists • Compounds with unknown molecular target unless clinical

POC exists

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

Infectious Diseases

AntIbActerIALs

Areas of Interest:

• Antibacterial agents with compelling data including: resistance frequency, an understanding of the mechanism of action, efficacy in animal models of infection, and preliminary toxicology data

– Narrow and broad-spectrum agents that cover problematic pathogens with either intrinsic or acquired resistance to existing agents, particularly MRSA (IV and oral formulations), Pseudomonas (IV, preferably with oral formulation), and Acinetobacter (IV, preferably with oral formulation)

– Novel approaches to C. difficile that address the recurrence rate

– Combinations that address bacterial resistance such as:

• Beta lactamase (Class A / C / D) inhibitors

• Carbapenem potentiators or synergists

Late-stage opportunities (Phase III-ready and later):• Gram-positive and / or gram-negative products that can

be meaningfully clinically differentiated* from current treatment options. Also includes:

– Gram-positive (w / MRSA): At least with oral formulation – Community RTI oral agents

Not Interested in:• Topical antibiotics• Antibodies without clinical POC• Quinolones (mechanism of action for quinolones is of

interest, but not the structural class)• Known antibacterial structural types unless they are

differentiated from current agents by safety, efficacy, route of administration, or activity on resistant strains

*Criteria that determine meaningful clinical differentiation may vary by region of the world

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AntIfungALs

Areas of Interest:

• Antifungal agents with compelling data including: an understanding of the mechanism of action, efficacy in animal models of infection, and preliminary toxicology data

– IV (preferably with oral formulation) broad-spectrum agents with activity over azoles and echinocandins against Candida, Aspergillus, and rare moulds for hospital use

– Aspergillus- or mould-specific small molecule or mAb (therapeutic and / or prophylactic, clinical POC required)

Late-stage opportunities (Phase III-ready and later):

• Candida, Aspergillus, or rare mould antifungals (IV, preferably with oral formulation) that can be meaningfully clinically differentiated from current treatment options*

• Oral agents for community use active against Candida and dermatophytes that can be meaningfully clinically differentiated from current treatment options*

Not Interested in:

• Incremental improvements upon inhibitors of ergosterol biosynthesis

• Known antifungal structural types unless they are differentiated from current agents by safety, efficacy, route of administration, or activity on resistant strains

• Antibodies without clinical POC

AntIvIrALs – HIv

Areas of Interest:

Preclinical:

• Novel agents with compelling data including an understanding of the mechanism of action, activity in cell culture, resistance profile, and PK with particular interest in:

– RNase H inhibitors – Inhibitors of viral budding and / or maturation – Latency targets – HIV gene expression inhibitors – Active-site non-nucleoside inhibitors – Nucleoside reverse transcriptase inhibitors with

differentiated resistance profile to existing agents, QD dosing, >1 month tox.

– Other new mechanisms, eg, host targets – PK enhancersPhase I or later in development:

• Integrase inhibitors with new MOA or novel structural scaffold with QD dosing; BID dosing considered with a differentiated resistance profile

• Protease inhibitors that do not require ritonavir-boosted QD dosing; BID dosing considered with a differentiated resistance profile

• Non-nucleoside reverse transcriptase inhibitors dosed QD with a high barrier to resistance / efficacy against NNRTI (including 2nd-generation NNRTI)-resistant virus

Late-stage opportunities (Phase III-ready and later):

• Novel or differentiated agents, ideally combinable in fixed-dose combination with existing in-line or pipeline assets that are complementary to in-house MOAs

• Global / regional promotional partnerships

Not Interested in:

• Agents administered parenterally, including antibodies

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

*Criteria that determine meaningful clinical differentiation may vary by region of the world

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AntIfungALs

Areas of Interest:

• Antifungal agents with compelling data including: an understanding of the mechanism of action, efficacy in animal models of infection, and preliminary toxicology data

– IV (preferably with oral formulation) broad-spectrum agents with activity over azoles and echinocandins against Candida, Aspergillus, and rare moulds for hospital use

– Aspergillus- or mould-specific small molecule or mAb (therapeutic and / or prophylactic, clinical POC required)

Late-stage opportunities (Phase III-ready and later):

• Candida, Aspergillus, or rare mould antifungals (IV, preferably with oral formulation) that can be meaningfully clinically differentiated from current treatment options*

• Oral agents for community use active against Candida and dermatophytes that can be meaningfully clinically differentiated from current treatment options*

Not Interested in:

• Incremental improvements upon inhibitors of ergosterol biosynthesis

• Known antifungal structural types unless they are differentiated from current agents by safety, efficacy, route of administration, or activity on resistant strains

• Antibodies without clinical POC

AntIvIrALs – HIv

Areas of Interest:

Preclinical:

• Novel agents with compelling data including an understanding of the mechanism of action, activity in cell culture, resistance profile, and PK with particular interest in:

– RNase H inhibitors – Inhibitors of viral budding and / or maturation – Latency targets – HIV gene expression inhibitors – Active-site non-nucleoside inhibitors – Nucleoside reverse transcriptase inhibitors with

differentiated resistance profile to existing agents, QD dosing, >1 month tox.

– Other new mechanisms, eg, host targets – PK enhancersPhase I or later in development:

• Integrase inhibitors with new MOA or novel structural scaffold with QD dosing; BID dosing considered with a differentiated resistance profile

• Protease inhibitors that do not require ritonavir-boosted QD dosing; BID dosing considered with a differentiated resistance profile

• Non-nucleoside reverse transcriptase inhibitors dosed QD with a high barrier to resistance / efficacy against NNRTI (including 2nd-generation NNRTI)-resistant virus

Late-stage opportunities (Phase III-ready and later):

• Novel or differentiated agents, ideally combinable in fixed-dose combination with existing in-line or pipeline assets that are complementary to in-house MOAs

• Global / regional promotional partnerships

Not Interested in:

• Agents administered parenterally, including antibodies

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

*Criteria that determine meaningful clinical differentiation may vary by region of the world

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AntIvIrALs – HepAtItIs c

Areas of Interest:

Preclinical:

• Novel agents with compelling data including an under-standing of the mechanism of action, activity in HCV repli-con, and PK in one species with particular interest in:

– Nucleoside inhibitors – Small-molecule inhibitors of HCV helicase – NS5A inhibitors – Novel mechanism agents – PK enhancersPhase I or later in development:

• Non-nucleoside inhibitors of NS5B

• Second-generation protease inhibitor with activity against genotypes 1, 2, and 3, and key mutants with preclinical safety data and PK suggestive of QD dosing suitable for development as fixed-dose combinations

• Cyclophillin inhibitorsLate-stage opportunities (Phase III-ready and later):

• Novel or differentiated agents, ideally suitable for fixed-dose combination with existing in-line or pipeline assets that are complementary to in-house MOAs

• Global / regional promotional partnerships

Not Interested in:

• Parenterally administered interferons

• TLR agonists or activators

• HCV viral entry inhibitors

AntIvIrAL And AntI-InfectIve tecHnoLogIes

Areas of Interest:

• Animal or cellular models of latency

• In vitro tissue models for HCV

• Robust cell culture systems for HCV replication

• Biomarkers / noninvasive assay technology for HIV and HCV with enhanced sensitivity and / or lower cost; particularly interested in prognostics

• Genotyping and phenotyping technologies for HCV polymerase and HCV protease

• HCV and specific gene chimera replicons

• PK enhancers

Antifungal and Antibacterial:

• Rapid (<2 hours), point-of-care, pathogen-specific (ESKAPE organisms), and host-response diagnostic tests

• Molecular biomarkers of susceptibility

AntIvIrALs – otHer Interests

Areas of Interest:

Preclinical or later in development:

• Novel approaches to HBVPhase IIb or later in development:

• HBV, RSV, CMV, EBV, flu agents with pristine safety profilesLate-stage opportunities (Phase III-ready and later):

• We will continue to consider external licensing and partnership opportunities for differentiated products directed at other viral infections in late-stage development

• Global / regional promotional partnerships

Not Interested in:• Agents administered parenterally

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

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AntIvIrALs – HepAtItIs c

Areas of Interest:

Preclinical:

• Novel agents with compelling data including an under-standing of the mechanism of action, activity in HCV repli-con, and PK in one species with particular interest in:

– Nucleoside inhibitors – Small-molecule inhibitors of HCV helicase – NS5A inhibitors – Novel mechanism agents – PK enhancersPhase I or later in development:

• Non-nucleoside inhibitors of NS5B

• Second-generation protease inhibitor with activity against genotypes 1, 2, and 3, and key mutants with preclinical safety data and PK suggestive of QD dosing suitable for development as fixed-dose combinations

• Cyclophillin inhibitorsLate-stage opportunities (Phase III-ready and later):

• Novel or differentiated agents, ideally suitable for fixed-dose combination with existing in-line or pipeline assets that are complementary to in-house MOAs

• Global / regional promotional partnerships

Not Interested in:

• Parenterally administered interferons

• TLR agonists or activators

• HCV viral entry inhibitors

AntIvIrAL And AntI-InfectIve tecHnoLogIes

Areas of Interest:

• Animal or cellular models of latency

• In vitro tissue models for HCV

• Robust cell culture systems for HCV replication

• Biomarkers / noninvasive assay technology for HIV and HCV with enhanced sensitivity and / or lower cost; particularly interested in prognostics

• Genotyping and phenotyping technologies for HCV polymerase and HCV protease

• HCV and specific gene chimera replicons

• PK enhancers

Antifungal and Antibacterial:

• Rapid (<2 hours), point-of-care, pathogen-specific (ESKAPE organisms), and host-response diagnostic tests

• Molecular biomarkers of susceptibility

AntIvIrALs – otHer Interests

Areas of Interest:

Preclinical or later in development:

• Novel approaches to HBVPhase IIb or later in development:

• HBV, RSV, CMV, EBV, flu agents with pristine safety profilesLate-stage opportunities (Phase III-ready and later):

• We will continue to consider external licensing and partnership opportunities for differentiated products directed at other viral infections in late-stage development

• Global / regional promotional partnerships

Not Interested in:• Agents administered parenterally

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

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neuroLogy: ALzHeIMer’s dIseAse

Areas of Interest*:

• Broad interest in agents and novel mechanisms with potential disease modifying activity

– Agents must have demonstrated in vivo activity – Targets of interest include: • Tau pathophysiology • Amyloid secretion, clearance, and / or toxicity• Broad interest in agents and novel mechanisms with

potential for symptomatic improvement – Characteristics at least comparable to existing approved

medications – With clinical POC, or within pathways with clinical POC – May be used as monotherapy or in combination with

current therapies

Tools and Technologies:

• Collections of CSF from healthy, MCI, and AD subjects• Prognostic, diagnostic, and progression biomarkers of

disease and disease state with clinical validation – Tau and amyloid imaging agents – Fluid-based assays for Aβ and tau species (eg, oligomers)• Novel animal models for target evaluation – Models that develop both plaques and tangles, neuronal

loss, cognitive decline correlated with age and pathology• Novel genetic / RNA-based approaches to target validation

or therapeutics

Not Interested in:

• Acetylcholinesterase inhibitors• NMDA antagonists• AD vaccines• Antioxidants• Metal chelators• Other general neuroprotectants

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

MIgrAIne And pAIn: MIgrAIne

Areas of Interest*:

• Novel therapeutic agents that, alone or in combination, address unmet needs in migraine or migraine prophylaxis

• Biologics for prophylaxis• Mechanisms that complement CGRP antagonists for acute

migraine• Synergistic combination approaches

Tools and Technologies:

• Novel and patented delivery systems for novel or existing molecules

• New formulations of existing antimigraine drugs

Not Interested in:

• Triptans• COX-2 inhibitors and NSAIDs

Neurosciences and Ophthalmology

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

MIgrAIne And pAIn: pAIn

Areas of Interest*:

• Novel therapeutic agents for neuropathic or inflammatory pain in mechanisms or pathways with human genetic or clinical validation

– Subtype selective sodium channel blockers – Anticonvulsant mechanism of action with evidence for

activity in chronic pain – Abuse deterrent opioids at or near registration• Novel proprietary targets for neuropathic and

osteoarthritis pain – With selective compounds showing robust preclinical

in vivo evidence in appropriate models• Agents for treatment of postoperative pain• Synergistic combination approaches – Therapies providing improved efficacy or safety as

add-on or part of novel combination therapy

Tools and Technologies:

• New models for chronic pain• Biomarkers and genetic markers for chronic pain• Imaging agents and sensors• Alternate formulation (eg, topical) technology

Not Interested in:

• Undifferentiated reformulations of marketed products• NSAIDs and COX-2 inhibitors• iNOS inhibitors• Serotonergics• Opioids delivered by device• FAAH inhibitors or cannabinoid agonists

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

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neuroLogy: ALzHeIMer’s dIseAse

Areas of Interest*:

• Broad interest in agents and novel mechanisms with potential disease modifying activity

– Agents must have demonstrated in vivo activity – Targets of interest include: • Tau pathophysiology • Amyloid secretion, clearance, and / or toxicity• Broad interest in agents and novel mechanisms with

potential for symptomatic improvement – Characteristics at least comparable to existing approved

medications – With clinical POC, or within pathways with clinical POC – May be used as monotherapy or in combination with

current therapies

Tools and Technologies:

• Collections of CSF from healthy, MCI, and AD subjects• Prognostic, diagnostic, and progression biomarkers of

disease and disease state with clinical validation – Tau and amyloid imaging agents – Fluid-based assays for Aβ and tau species (eg, oligomers)• Novel animal models for target evaluation – Models that develop both plaques and tangles, neuronal

loss, cognitive decline correlated with age and pathology• Novel genetic / RNA-based approaches to target validation

or therapeutics

Not Interested in:

• Acetylcholinesterase inhibitors• NMDA antagonists• AD vaccines• Antioxidants• Metal chelators• Other general neuroprotectants

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

MIgrAIne And pAIn: MIgrAIne

Areas of Interest*:

• Novel therapeutic agents that, alone or in combination, address unmet needs in migraine or migraine prophylaxis

• Biologics for prophylaxis• Mechanisms that complement CGRP antagonists for acute

migraine• Synergistic combination approaches

Tools and Technologies:

• Novel and patented delivery systems for novel or existing molecules

• New formulations of existing antimigraine drugs

Not Interested in:

• Triptans• COX-2 inhibitors and NSAIDs

Neurosciences and Ophthalmology

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

MIgrAIne And pAIn: pAIn

Areas of Interest*:

• Novel therapeutic agents for neuropathic or inflammatory pain in mechanisms or pathways with human genetic or clinical validation

– Subtype selective sodium channel blockers – Anticonvulsant mechanism of action with evidence for

activity in chronic pain – Abuse deterrent opioids at or near registration• Novel proprietary targets for neuropathic and

osteoarthritis pain – With selective compounds showing robust preclinical

in vivo evidence in appropriate models• Agents for treatment of postoperative pain• Synergistic combination approaches – Therapies providing improved efficacy or safety as

add-on or part of novel combination therapy

Tools and Technologies:

• New models for chronic pain• Biomarkers and genetic markers for chronic pain• Imaging agents and sensors• Alternate formulation (eg, topical) technology

Not Interested in:

• Undifferentiated reformulations of marketed products• NSAIDs and COX-2 inhibitors• iNOS inhibitors• Serotonergics• Opioids delivered by device• FAAH inhibitors or cannabinoid agonists

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

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neuroLogy: pArkInson’s dIseAse

Areas of Interest*:

• Agents and mechanisms for disease modification in genetically or clinically validated pathways

• Nondopaminergic agents with clinical proof of concept in palliative therapy for Parkinson’s disease

• Nondopaminergic agents that reduce / eliminate L-dopa-induced dyskinesias

• Different formulations of approved products that have demonstrated clinically significant benefits in efficacy, safety / tolerability, and / or dosing vs standard of care

Tools and Technologies:

• Approaches and biomarkers that may identify prodromal stages of disease

• Animal models of Parkinson’s disease progression

• Pathway biomarkers of neurodegeneration

• SN-MRI volumetry

Not Interested in:

• Metal chelators

• Antioxidants

• Other general neuroprotectants

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psycHIAtrIc dIseAses

Areas of Interest*:

Novel compounds and chemical leads for:Schizophrenia• Monotherapy or add-on therapy for positive, negative, and /

or cognitive symptoms• Novel mechanisms that modulate clinically validated

pathways• Mechanisms with clinical POC that lack the adverse event

profile of atypical antipsychoticsBipolar, Depression, and Anxiety • Agents with clinical POC for monotherapy and / or add-on

Tools and Technologies:

• Biological tools and expertise to address nicotinic receptor pharmacology

• Animal models for psychiatric diseases

Not Interested in:

• Monoamine-based atypical antipsychotics• SSRI / SNRI

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

opHtHALMoLogy

Areas of Interest:

Retinal diseases

• AMD – Wet AMD therapies showing less invasive dosing than

Lucentis™ / VEGF-Trap (topical, periocular) and / or additional efficacy

– Dry AMD therapies to reduce geographic atrophy progression

• Diabetic retinopathy / diabetic macular edema – Mechanisms to reduce progression of NPDR in

moderately to severely affected patients – Mechanisms to treat patients with existing vision loss

with superior efficacy and / or favorable AE profile vs laser and steroids

• Glaucoma – Nonprostanoid MOAs with efficacy and / or tolerability

≥ Xalatan™ – Additional properties of interest: trabecular outflow

enhancers, nontopical delivery formulations, neuroprotective activity

• Anterior segment disease – Allergic conjunctivitis – Bacterial conjunctivitis – Dry eye – Uveitis

The trademarks contained herein are the property of their respective owners.

The following areas of interest apply to compounds that have established POC in clinical Phase II studies and are Phase III-ready and later.

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

Areas of Interest*:

• Novel therapeutic agents that address unmet needs in sleep difficulties and common co-morbidities

• Expansion of orexin portfolio (Best in Class and new indications)

• Novel proprietary targets for Excessive Daytime Sleepiness• Synergistic combination approaches – Therapies providing improved efficacy or safety as

add-on or part of novel combination therapy with Orexin Antagonists

Tools and Technologies:

• Biological or physiological markers for insomnia• Alternative formulations to facilitate administration to

elderly and adolescent patients• Diagnostic tool for insomnia

Not Interested in:

• Benzodiazepines• Devices for OSA

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

sLeep dIsorders (InsoMnIA, excessIve dAytIMe sLeepIness, osA)

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neuroLogy: pArkInson’s dIseAse

Areas of Interest*:

• Agents and mechanisms for disease modification in genetically or clinically validated pathways

• Nondopaminergic agents with clinical proof of concept in palliative therapy for Parkinson’s disease

• Nondopaminergic agents that reduce / eliminate L-dopa-induced dyskinesias

• Different formulations of approved products that have demonstrated clinically significant benefits in efficacy, safety / tolerability, and / or dosing vs standard of care

Tools and Technologies:

• Approaches and biomarkers that may identify prodromal stages of disease

• Animal models of Parkinson’s disease progression

• Pathway biomarkers of neurodegeneration

• SN-MRI volumetry

Not Interested in:

• Metal chelators

• Antioxidants

• Other general neuroprotectants

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psycHIAtrIc dIseAses

Areas of Interest*:

Novel compounds and chemical leads for:Schizophrenia• Monotherapy or add-on therapy for positive, negative, and /

or cognitive symptoms• Novel mechanisms that modulate clinically validated

pathways• Mechanisms with clinical POC that lack the adverse event

profile of atypical antipsychoticsBipolar, Depression, and Anxiety • Agents with clinical POC for monotherapy and / or add-on

Tools and Technologies:

• Biological tools and expertise to address nicotinic receptor pharmacology

• Animal models for psychiatric diseases

Not Interested in:

• Monoamine-based atypical antipsychotics• SSRI / SNRI

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

opHtHALMoLogy

Areas of Interest:

Retinal diseases

• AMD – Wet AMD therapies showing less invasive dosing than

Lucentis™ / VEGF-Trap (topical, periocular) and / or additional efficacy

– Dry AMD therapies to reduce geographic atrophy progression

• Diabetic retinopathy / diabetic macular edema – Mechanisms to reduce progression of NPDR in

moderately to severely affected patients – Mechanisms to treat patients with existing vision loss

with superior efficacy and / or favorable AE profile vs laser and steroids

• Glaucoma – Nonprostanoid MOAs with efficacy and / or tolerability

≥ Xalatan™ – Additional properties of interest: trabecular outflow

enhancers, nontopical delivery formulations, neuroprotective activity

• Anterior segment disease – Allergic conjunctivitis – Bacterial conjunctivitis – Dry eye – Uveitis

The trademarks contained herein are the property of their respective owners.

The following areas of interest apply to compounds that have established POC in clinical Phase II studies and are Phase III-ready and later.

* Biomarkers: An important aspect for all successful neuroscience licensing submissions is a focus on target engagement, PK / PD, and efficacy and safety biomarkers to be used in conjunction with the program

Areas of Interest*:

• Novel therapeutic agents that address unmet needs in sleep difficulties and common co-morbidities

• Expansion of orexin portfolio (Best in Class and new indications)

• Novel proprietary targets for Excessive Daytime Sleepiness• Synergistic combination approaches – Therapies providing improved efficacy or safety as

add-on or part of novel combination therapy with Orexin Antagonists

Tools and Technologies:

• Biological or physiological markers for insomnia• Alternative formulations to facilitate administration to

elderly and adolescent patients• Diagnostic tool for insomnia

Not Interested in:

• Benzodiazepines• Devices for OSA

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

sLeep dIsorders (InsoMnIA, excessIve dAytIMe sLeepIness, osA)

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oncoLogy

Areas of Interest:

Late-stage clinical

• Must demonstrate clinical benefits (improvements in clinical end points) based on results from a Phase IIB program

• Clinical data in medium-to-large market solid tumor indications or hematological malignancies – synergies with current portfolio is a plus

• Global or regional deals (US, EU, and / or Asia Pacific)Early-stage (up to and including clinical POC)

• Agents that have synergy with in-house Oncology pipeline therapies in clinical development; agents that have a well-defined responder ID strategy

• Agents that have efficacy in tumors that are resistant to SOC therapy (preclinical POC data or Phase I data with a clear registration strategy)

Not Interested in (applies to Early and Late Stage):

• Preventive care • Personalized immunotherapy / autologous therapies• Gene therapy• Intratumoral delivery (except for RNAi delivery)• Radiopharmaceuticals

Oncology Therapeutics

cApAbILItIes – tecHnoLogIes to evALuAte

Areas of Interest:

• Biomarkers and diagnostics – Diagnostic platforms that are ready for clinical

application, including imaging tracers, cell-based, blood, nucleic acid, and IVD capabilities with WW distribution to support in-house Oncology pipeline programs

– Pharmacodynamic and response biomarkers for PI3K and DNA damage / checkpoint pathways

– Minimally invasive platforms for measuring tumor biology: circulating tumor cells, circulating nucleic acids, novel imaging tracers (particularly those in the PI3K pathway or those used to assess apoptosis)

• RNAi – Tumor-targeted delivery systems for systemic

administration of RNAi – Relevant preclinical models of HCC for the evaluation and

validation of siRNA targets

• Other – Robust technology that could predict in vitro therapeutic

index of combination therapies – Platforms that have high predictive value for clinical

efficacy (eg, primary tumors passaged in mice) – Genome-wide scanning with the ability to measure copy

# variation in tumor samples in a CLIA-certified lab – Gene expression from FFPET in a CLIA-certified lab – Sequencing in a CLIA-certified lab – Software tools to correlate genomic data with clinical

outcomes for oncology

ArtHrItIs And IMMune-bAsed dIseAses

Areas of Interest:

• Disease-modifying antirheumatic drugs (DMARDs) with a strong preference for:

– Mechanisms targeting clinically proven pathways – Mechanisms effective in patients with an inadequate

response to anti-TNFa therapies

• Th17 pathway modulators

• Cartilage / joint imaging technologies

• Biomarkers that can be used for patient segmentation

• Disease-modifying drugs for psoriasis, SLE, or IBD that have achieved POC in Phase II trials

• Disease-modifying osteoarthritis drugs (DMOADs) with clinical POC and a clearly defined path to registration

Not Interested in:

• Drugs whose primary clinical indication is the prevention of graft rejection

Respiratory and Immunology

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

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oncoLogy

Areas of Interest:

Late-stage clinical

• Must demonstrate clinical benefits (improvements in clinical end points) based on results from a Phase IIB program

• Clinical data in medium-to-large market solid tumor indications or hematological malignancies – synergies with current portfolio is a plus

• Global or regional deals (US, EU, and / or Asia Pacific)Early-stage (up to and including clinical POC)

• Agents that have synergy with in-house Oncology pipeline therapies in clinical development; agents that have a well-defined responder ID strategy

• Agents that have efficacy in tumors that are resistant to SOC therapy (preclinical POC data or Phase I data with a clear registration strategy)

Not Interested in (applies to Early and Late Stage):

• Preventive care • Personalized immunotherapy / autologous therapies• Gene therapy• Intratumoral delivery (except for RNAi delivery)• Radiopharmaceuticals

Oncology Therapeutics

cApAbILItIes – tecHnoLogIes to evALuAte

Areas of Interest:

• Biomarkers and diagnostics – Diagnostic platforms that are ready for clinical

application, including imaging tracers, cell-based, blood, nucleic acid, and IVD capabilities with WW distribution to support in-house Oncology pipeline programs

– Pharmacodynamic and response biomarkers for PI3K and DNA damage / checkpoint pathways

– Minimally invasive platforms for measuring tumor biology: circulating tumor cells, circulating nucleic acids, novel imaging tracers (particularly those in the PI3K pathway or those used to assess apoptosis)

• RNAi – Tumor-targeted delivery systems for systemic

administration of RNAi – Relevant preclinical models of HCC for the evaluation and

validation of siRNA targets

• Other – Robust technology that could predict in vitro therapeutic

index of combination therapies – Platforms that have high predictive value for clinical

efficacy (eg, primary tumors passaged in mice) – Genome-wide scanning with the ability to measure copy

# variation in tumor samples in a CLIA-certified lab – Gene expression from FFPET in a CLIA-certified lab – Sequencing in a CLIA-certified lab – Software tools to correlate genomic data with clinical

outcomes for oncology

ArtHrItIs And IMMune-bAsed dIseAses

Areas of Interest:

• Disease-modifying antirheumatic drugs (DMARDs) with a strong preference for:

– Mechanisms targeting clinically proven pathways – Mechanisms effective in patients with an inadequate

response to anti-TNFa therapies

• Th17 pathway modulators

• Cartilage / joint imaging technologies

• Biomarkers that can be used for patient segmentation

• Disease-modifying drugs for psoriasis, SLE, or IBD that have achieved POC in Phase II trials

• Disease-modifying osteoarthritis drugs (DMOADs) with clinical POC and a clearly defined path to registration

Not Interested in:

• Drugs whose primary clinical indication is the prevention of graft rejection

Respiratory and Immunology

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

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AstHMA / copd / rHInItIs

Areas of Interest:

• Compounds / biologics for asthma

– Anti-inflammatory agents with novel mechanisms

– Anti-inflammatory agents, additive or differentiated from a glucocorticoid

– Anti-inflammatory agents that are effective in glucocorticoid-resistant asthma

– Selective glucocorticoid receptor modulators

– Novel and / or differentiated bronchodilator mechanisms

– Inhaled compounds including combination therapies

• Compounds / biologics for COPD with clinical POC or compelling biological rationale

– Oral or inhaled compounds including combination therapies

• Disease-modifying compounds for rhinitis, atopic dermatitis, and allergy with clinical POC

• Technologies

– Biomarkers

– Predictive animal models of asthma pathophysiology

– Human lung cell / tissue-based systems for investigating new therapeutic mechanisms

– Translational medicine platforms

– Inhaled technologies / formulations that provide improved drug delivery / compliance / patient acceptance

Not Interested in:

• Acute lung injury

• Antioxidants (ie, direct scavengers)

• Adenosine antagonists (A1, A

2, and A

3)

• Antihistamine antagonists (H1, H

2)

• IL5 antagonists

• Leukotriene receptor antagonists

• VLA4 antagonists

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

contrAceptIon

Areas of Interest:

• Novel targets and molecular pathways for contraception

• Compounds and biologicals for contraceptive targets

• Basic research collaborations towards validation of novel targets for contraception

• Male contraception

Technology / Methods:

• Biomarkers – Methods, translational biomarkers for reproductive

biology• Delivery / Formulation – Novel delivery / formulation technologies

Not Interested in:

• Emergency contraception

Women’s Health and Endocrinology

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AstHMA / copd / rHInItIs

Areas of Interest:

• Compounds / biologics for asthma

– Anti-inflammatory agents with novel mechanisms

– Anti-inflammatory agents, additive or differentiated from a glucocorticoid

– Anti-inflammatory agents that are effective in glucocorticoid-resistant asthma

– Selective glucocorticoid receptor modulators

– Novel and / or differentiated bronchodilator mechanisms

– Inhaled compounds including combination therapies

• Compounds / biologics for COPD with clinical POC or compelling biological rationale

– Oral or inhaled compounds including combination therapies

• Disease-modifying compounds for rhinitis, atopic dermatitis, and allergy with clinical POC

• Technologies

– Biomarkers

– Predictive animal models of asthma pathophysiology

– Human lung cell / tissue-based systems for investigating new therapeutic mechanisms

– Translational medicine platforms

– Inhaled technologies / formulations that provide improved drug delivery / compliance / patient acceptance

Not Interested in:

• Acute lung injury

• Antioxidants (ie, direct scavengers)

• Adenosine antagonists (A1, A

2, and A

3)

• Antihistamine antagonists (H1, H

2)

• IL5 antagonists

• Leukotriene receptor antagonists

• VLA4 antagonists

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

contrAceptIon

Areas of Interest:

• Novel targets and molecular pathways for contraception

• Compounds and biologicals for contraceptive targets

• Basic research collaborations towards validation of novel targets for contraception

• Male contraception

Technology / Methods:

• Biomarkers – Methods, translational biomarkers for reproductive

biology• Delivery / Formulation – Novel delivery / formulation technologies

Not Interested in:

• Emergency contraception

Women’s Health and Endocrinology

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endoMetrIosIs

Areas of Interest:

• Compounds and biologicals for endometriosis

• Novel targets / pathways for endometriosis

• Anti-inflammatory approaches

• Pain prevention methods (endometriosis-specific pain)

• Basic research collaborations towards validation of novel targets

Technology / Methods:

• Discovery – Diagnostics / imaging techniques – Translational animal models – Methods to score efficacy of endometriosis treatments – Technologies for identifying novel targets for

endometriosis – Preclinical models of endometriosis• Biomarkers (clinical and preclinical) – Biomarkers for endometriosis

Not Interested in:

• Contraceptives for use in endometriosis treatment

bone

Areas of Interest:

• Osteoanabolic agents

– Novel mechanisms with known molecular target

• Biomarkers

– Surrogate biomarkers of bone strength and / or fracture risk

– More sensitive and faster biomarkers of bone anabolism

– Selective markers for cortical and trabecular bone anabolism

– Markers for specific bone loss / fracture risk in:

• Postmenopausal and male osteoporosis

• Glucocorticoid osteoporosis

• Cancer-related bone loss

• Novel bone-imaging technologies and measures of bone quality

• Osteoporosis diagnostics

– Self-assessment tools

– Inexpensive BMD / BMx and fracture risk measures

Not Interested in:

• Growth hormone or secretagogues

• ER alpha agents

• Classic antiresorptive agents, including bisphosphonates with improved formulations that allow less frequent dosing or better tolerability

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

fertILIty

Areas of Interest:

• Compounds / biologics for female infertility

• Novel mechanism of action related to female fertility

• Targets for infertility treatment

• Basic research collaborations towards validation of novel targets

Technology / Methods:

• Discovery – Cell-based screening assays for testing compounds – Technologies for identifying novel targets for infertility

treatment• Biomarkers – Biomarkers and diagnostics for endometrial quality /

implantation and efficacy – Biomarkers for oocyte / embryo quality• Delivery / Formulation – Novel delivery / formulation technologies for biologicals

for fertility

Not Interested in:

• Progestagens for luteal support

• Obstetrics

MenopAuse

Areas of Interest:

• Compounds / biologics for menopausal complaints

• Basic research collaborations related to the discovery and / or validation of novel targets

Technology / Methods:

• Discovery – Novel targets for menopausal complaints – Technologies for identifying novel targets for menopause – Preclinical models of menopausal complaints• Biomarkers (clinical and preclinical) – Biomarkers for treatment of menopausal complaints

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endoMetrIosIs

Areas of Interest:

• Compounds and biologicals for endometriosis

• Novel targets / pathways for endometriosis

• Anti-inflammatory approaches

• Pain prevention methods (endometriosis-specific pain)

• Basic research collaborations towards validation of novel targets

Technology / Methods:

• Discovery – Diagnostics / imaging techniques – Translational animal models – Methods to score efficacy of endometriosis treatments – Technologies for identifying novel targets for

endometriosis – Preclinical models of endometriosis• Biomarkers (clinical and preclinical) – Biomarkers for endometriosis

Not Interested in:

• Contraceptives for use in endometriosis treatment

bone

Areas of Interest:

• Osteoanabolic agents

– Novel mechanisms with known molecular target

• Biomarkers

– Surrogate biomarkers of bone strength and / or fracture risk

– More sensitive and faster biomarkers of bone anabolism

– Selective markers for cortical and trabecular bone anabolism

– Markers for specific bone loss / fracture risk in:

• Postmenopausal and male osteoporosis

• Glucocorticoid osteoporosis

• Cancer-related bone loss

• Novel bone-imaging technologies and measures of bone quality

• Osteoporosis diagnostics

– Self-assessment tools

– Inexpensive BMD / BMx and fracture risk measures

Not Interested in:

• Growth hormone or secretagogues

• ER alpha agents

• Classic antiresorptive agents, including bisphosphonates with improved formulations that allow less frequent dosing or better tolerability

Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

fertILIty

Areas of Interest:

• Compounds / biologics for female infertility

• Novel mechanism of action related to female fertility

• Targets for infertility treatment

• Basic research collaborations towards validation of novel targets

Technology / Methods:

• Discovery – Cell-based screening assays for testing compounds – Technologies for identifying novel targets for infertility

treatment• Biomarkers – Biomarkers and diagnostics for endometrial quality /

implantation and efficacy – Biomarkers for oocyte / embryo quality• Delivery / Formulation – Novel delivery / formulation technologies for biologicals

for fertility

Not Interested in:

• Progestagens for luteal support

• Obstetrics

MenopAuse

Areas of Interest:

• Compounds / biologics for menopausal complaints

• Basic research collaborations related to the discovery and / or validation of novel targets

Technology / Methods:

• Discovery – Novel targets for menopausal complaints – Technologies for identifying novel targets for menopause – Preclinical models of menopausal complaints• Biomarkers (clinical and preclinical) – Biomarkers for treatment of menopausal complaints

uroLogy

Areas of Interest:

• Novel therapies for OAB (Phase I or greater)

• Novel therapies for stress urinary incontinence (Phase I or greater)

• Novel therapies for BPH (Phase I or greater)

• Biomarkers

– Surrogate biomarkers of bladder dysfunction

– Imaging approaches for indices of bladder function, including control of bladder function

• Diagnostics to improve specificity of diagnosing OAB from stress incontinence

• Diagnostics to predict response or nonresponse to therapy including anticholinergics or other mechanisms of action

Not Interested in:

• Anticholinergics for OAB (unless Phase III or later)• 5a reductase inhibitors for BPH• Alpha-1 adrenergic blockers for BPH

sArcopenIA

Areas of Interest:

• Mechanisms that preserve / restore fibers (both biologics and small molecule)

– Myoanabolic agents and targets

– Anticatabolic agents and targets

– Translational models

• Mechanisms that improve fiber function (both biologics and small molecule)

– Neuromuscular junction / alpha motor unit maintenance

– Fiber recruitment

– Fiber type switching

– Fiber metabolism

– Sarcomere dysfunction

• Biomarkers and diagnostics

– Biochemical markers of muscle functional state (remodeling, metabolism)

– Imaging markers of muscle function

– Physical tests

Not Interested in:

• Growth hormone (GH), growth hormone-releasing hormone (GHRH), or derivatives by any route

• Growth hormone secretagogues

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Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

otHer dIseAses

Areas of Interest:

• Compounds, medications, and / or treatments with new mode of actions in the following areas

– Uterine fibroids

– Dysmenorrhea

– Sexually transmitted diseases

– Female sexual dysfunction

bIoLogIcs

Areas of Interest:

• Biosimilars

• Novel biologics and biobetters that fit franchise strategies

• Novel devices for SQ and IV delivery

Technologies of Interest:

• Fc engineering to enhance / improve effector functions, half-life

• Targeted delivery technologies that: – Address / overcome the blood brain barrier – Glycan mediated targeting• Bispecific platforms with promising stability and

manufacturing yield• Technologies that enhance expression, production,

formulation, stability, and bioavailability (via SQ admin) of proteins

• Platforms for the identification, generation, and modification of monoclonal antibodies (mAbs, Fabs, scFvs) and engineered proteins displaying pharmaceutical properties

– High throughput screening • Including function-based screens – De-immunization

Not Interested in:

• Transgenic animal-based or plant-based production systems for therapeutics

• Inhaled delivery of biologics

Biologics

uroLogy

Areas of Interest:

• Novel therapies for OAB (Phase I or greater)

• Novel therapies for stress urinary incontinence (Phase I or greater)

• Novel therapies for BPH (Phase I or greater)

• Biomarkers

– Surrogate biomarkers of bladder dysfunction

– Imaging approaches for indices of bladder function, including control of bladder function

• Diagnostics to improve specificity of diagnosing OAB from stress incontinence

• Diagnostics to predict response or nonresponse to therapy including anticholinergics or other mechanisms of action

Not Interested in:

• Anticholinergics for OAB (unless Phase III or later)• 5a reductase inhibitors for BPH• Alpha-1 adrenergic blockers for BPH

sArcopenIA

Areas of Interest:

• Mechanisms that preserve / restore fibers (both biologics and small molecule)

– Myoanabolic agents and targets

– Anticatabolic agents and targets

– Translational models

• Mechanisms that improve fiber function (both biologics and small molecule)

– Neuromuscular junction / alpha motor unit maintenance

– Fiber recruitment

– Fiber type switching

– Fiber metabolism

– Sarcomere dysfunction

• Biomarkers and diagnostics

– Biochemical markers of muscle functional state (remodeling, metabolism)

– Imaging markers of muscle function

– Physical tests

Not Interested in:

• Growth hormone (GH), growth hormone-releasing hormone (GHRH), or derivatives by any route

• Growth hormone secretagogues

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W O M E N ’ S H E A l T H A N D E N D O C R I N O l O G yD E C E M B E R 2 0 1 0

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Late-Stage Opportunities:We will continue to pursue external licensing and partnership opportunities for differentiated products in all disease areas in late-stage development (Phase III-ready and later).

otHer dIseAses

Areas of Interest:

• Compounds, medications, and / or treatments with new mode of actions in the following areas

– Uterine fibroids

– Dysmenorrhea

– Sexually transmitted diseases

– Female sexual dysfunction

bIoLogIcs

Areas of Interest:

• Biosimilars

• Novel biologics and biobetters that fit franchise strategies

• Novel devices for SQ and IV delivery

Technologies of Interest:

• Fc engineering to enhance / improve effector functions, half-life

• Targeted delivery technologies that: – Address / overcome the blood brain barrier – Glycan mediated targeting• Bispecific platforms with promising stability and

manufacturing yield• Technologies that enhance expression, production,

formulation, stability, and bioavailability (via SQ admin) of proteins

• Platforms for the identification, generation, and modification of monoclonal antibodies (mAbs, Fabs, scFvs) and engineered proteins displaying pharmaceutical properties

– High throughput screening • Including function-based screens – De-immunization

Not Interested in:

• Transgenic animal-based or plant-based production systems for therapeutics

• Inhaled delivery of biologics

Biologics

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vAccInes

Areas of Interest:

• Viral, bacterial, fungal vaccine candidates in areas of high medical need / high incidence

– Preclinical efficacy or clinical POC achieved, an advantage but not required

• HIV: Novel immunogens that elicit broadly cross-neutralizing immunity antibodies

• Influenza: – Universal flu vaccines: Preclinical data demonstrating

broadly cross-reactive HAI and / or neutralizing antibodies (ie, not just cellular immunity) and protection from challenge (survival and weight loss) comparable to seasonally matched control vaccines

– Seasonal influenza vaccines that have clinical data demonstrating differentiation from marketed products, eg, higher HAI and / or neutralizing antibodies in elderly subjects

• Improvements on existing in-house vaccines, which would allow for reduced dosing or increased cross-strain protection

• Novel adjuvants and immunomodulators – Highly desirable if preclinical efficacy or clinical POC

achieved, but not necessarily required – Preclinical toxicology data demonstrating acceptable

safety profile

Tools and Technologies:

• Novel technologies for: – Antigen selection, discovery, and identification – Viral vector approaches – Vaccine administration, eg, dermal or mucosal delivery

of vaccines – Multiplexed clinical assay platforms – Production of virus-like particles – Studying human cellular and B cell responses to

vaccination, including novel human tissue culture systems and humanized mouse systems

– Enhance thermostability of vaccines during transport and storage

• Novel cell lines for vaccine or recombinant protein production, preferably with Phase I safety data

Not Interested in:

• Biodefense targets• Products containing thimerosal or unmodified animal /

human components• Seasonal vaccines (eg, influenza) that are not clinically

differentiated from marketed products• DNA-based vaccines for infectious diseases• Viral vectors based on pox viruses, retroviruses, and

adeno-associated viruses

Vaccines

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rnA tHerApeutIcs

Areas of Interest:

• siRNA delivery platforms for systemic and / or local administration

– Ability to demonstrate dose-dependent, RNAi-mediated gene silencing in vivo with at least a 10-fold margin for severe toxicities

– Chemical and / or biological components suitable for enhancing cellular uptake, intracellular trafficking, endosomal escape, and cytosolic release of oligonucleotides

– Chemical and / or biological components capable of conferring improved biocompatibility of RNA nanoparticles / formulations

– Targeting ligands (antibodies, peptides, aptamers, or small molecules) suitable for direct siRNA conjugation or for nanoparticle, polymer, or liposome delivery

• Assays – Novel particle size characterization methods – Novel colloid surface characterization methods – Biochemical assays for Ago / RISC binding and

catalytic activity

• siRNA sequence, structure, and modification – Novel chemistries for: • Improving resistance to enzymatic and chemical

degradation • Reducing immunostimulation • Enhancing Ago2 / RISC incorporation and potency • Improving target specificity – Predictive bioinformatic and molecular models

• miRNA – Novel chemistries to create miRNA mimics and / or

antagonists – Assays for pharmacodynamic evaluation of miRNA activity – Potential therapeutic agents that: • Reduce miRNA levels in animals and generate the

expected phenotypic effects • Mimic natural miRNA, reduce mRNA levels, and have

the expected phenotypic effects

• RNA manufacturing – Advancements in large-scale production of

modified siRNA – Improved processes for increased quality, efficiency,

and reduced COG – Novel chemistries – Universal linker-based solid support for production

of siRNAs – Robust LC-MS method for determination of impurity

profile of phosphoramidite raw materials and oligonucleotides (siRNAs)

– Alternative methods to produce siRNA clinical supplies

• AAV production – High-titer, high-volume AAV production for non-clinical

applications and POC

Not Interested in:

• Plasmid DNA-based methods for RNA therapies

• Viral delivery methods for RNA therapies

• Aptamers as therapeutics

Research Technologies

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vAccInes

Areas of Interest:

• Viral, bacterial, fungal vaccine candidates in areas of high medical need / high incidence

– Preclinical efficacy or clinical POC achieved, an advantage but not required

• HIV: Novel immunogens that elicit broadly cross-neutralizing immunity antibodies

• Influenza: – Universal flu vaccines: Preclinical data demonstrating

broadly cross-reactive HAI and / or neutralizing antibodies (ie, not just cellular immunity) and protection from challenge (survival and weight loss) comparable to seasonally matched control vaccines

– Seasonal influenza vaccines that have clinical data demonstrating differentiation from marketed products, eg, higher HAI and / or neutralizing antibodies in elderly subjects

• Improvements on existing in-house vaccines, which would allow for reduced dosing or increased cross-strain protection

• Novel adjuvants and immunomodulators – Highly desirable if preclinical efficacy or clinical POC

achieved, but not necessarily required – Preclinical toxicology data demonstrating acceptable

safety profile

Tools and Technologies:

• Novel technologies for: – Antigen selection, discovery, and identification – Viral vector approaches – Vaccine administration, eg, dermal or mucosal delivery

of vaccines – Multiplexed clinical assay platforms – Production of virus-like particles – Studying human cellular and B cell responses to

vaccination, including novel human tissue culture systems and humanized mouse systems

– Enhance thermostability of vaccines during transport and storage

• Novel cell lines for vaccine or recombinant protein production, preferably with Phase I safety data

Not Interested in:

• Biodefense targets• Products containing thimerosal or unmodified animal /

human components• Seasonal vaccines (eg, influenza) that are not clinically

differentiated from marketed products• DNA-based vaccines for infectious diseases• Viral vectors based on pox viruses, retroviruses, and

adeno-associated viruses

Vaccines

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rnA tHerApeutIcs

Areas of Interest:

• siRNA delivery platforms for systemic and / or local administration

– Ability to demonstrate dose-dependent, RNAi-mediated gene silencing in vivo with at least a 10-fold margin for severe toxicities

– Chemical and / or biological components suitable for enhancing cellular uptake, intracellular trafficking, endosomal escape, and cytosolic release of oligonucleotides

– Chemical and / or biological components capable of conferring improved biocompatibility of RNA nanoparticles / formulations

– Targeting ligands (antibodies, peptides, aptamers, or small molecules) suitable for direct siRNA conjugation or for nanoparticle, polymer, or liposome delivery

• Assays – Novel particle size characterization methods – Novel colloid surface characterization methods – Biochemical assays for Ago / RISC binding and

catalytic activity

• siRNA sequence, structure, and modification – Novel chemistries for: • Improving resistance to enzymatic and chemical

degradation • Reducing immunostimulation • Enhancing Ago2 / RISC incorporation and potency • Improving target specificity – Predictive bioinformatic and molecular models

• miRNA – Novel chemistries to create miRNA mimics and / or

antagonists – Assays for pharmacodynamic evaluation of miRNA activity – Potential therapeutic agents that: • Reduce miRNA levels in animals and generate the

expected phenotypic effects • Mimic natural miRNA, reduce mRNA levels, and have

the expected phenotypic effects

• RNA manufacturing – Advancements in large-scale production of

modified siRNA – Improved processes for increased quality, efficiency,

and reduced COG – Novel chemistries – Universal linker-based solid support for production

of siRNAs – Robust LC-MS method for determination of impurity

profile of phosphoramidite raw materials and oligonucleotides (siRNAs)

– Alternative methods to produce siRNA clinical supplies

• AAV production – High-titer, high-volume AAV production for non-clinical

applications and POC

Not Interested in:

• Plasmid DNA-based methods for RNA therapies

• Viral delivery methods for RNA therapies

• Aptamers as therapeutics

Research Technologies

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drug deLIvery And forMuLAtIon

Areas of Interest:

• Oral delivery technologies: – Technologies for delivery of water-insoluble compounds

(especially mitigation of food effect) – Oral-controlled release technologies to modify

pharmacokinetics (eg, increase Cmax

, AUC, and / or T1/2

, reduce peak-to-trough ratio):

• For poorly soluble compounds (<0.1 mg / mL) • For compounds with narrow absorption windows

(eg, those with poor colonic absorption) – Ingredients or formulations that can enhance permeability – Orally disintegrating tablet (ODT) technology or film

technology with robust in vivo performance and simple packaging

– Sublingual delivery for fast onset – Technologies that protect actives from the GI

environment (eg, gastric acid or GI metabolism) – Novel oral protein / peptide delivery systems (eg, insulin)

• Inhalation / nasal delivery: – Delivery systems for small and large molecules – Novel in situ modeling (eg, lung solubility or IVIVC)

• Injectable delivery, alternative routes of administration: – Injection devices (eg, novel and easy-to-use self-

injection systems, improved liquid / dry reconstitution technologies)

– Infusion systems (IV and subcutaneous delivery that facilitate hospital and home infusion therapies)

– Novel skin-based delivery technologies for high concentration antibody formulations and large volumes of liquid (>2 mL)

– Technologies for delivery of water-insoluble compounds (eg, IV-administered nanosuspensions or dispersed systems for small molecules and peptides)

– Systems (including implants) for sustained release of small and large molecules from one week to several months, up to years (long-acting implants)

– Vaginal ring and intrauterine delivery

• Back-of-the-eye delivery systems (eg, invasive and noninvasive, clinically proven technologies for retinal delivery of small molecules, siRNAa and trophic factors)

• Novel passive and active transdermal and topical technologies for small molecule and peptideb delivery

• Intelligent delivery systems capable of modulated delivery (eg, signal or drug concentration); personalized / feedback control

• Technology with potential to improve compliance with any dosage form – especially for pediatric and geriatric populations

• Delivery formulations or targeting ligands that provide selectivity and activity through enhanced cell association and uptake in target tissues

Areas of Interest:

• Quick-turnaround mid-density expression, genotyping, protein expression platforms

• Technologies that can perform multiplexed biomarker analysis with wide dynamic range – RNA, proteins, peptides, and / or small molecules – Animals and / or clinic – More streamlined with fewer repeats due to dilutions for individual analytes

• Identify vendors / academics that have identified and / or discovered / validated / qualified biomarkers – Translation to humans (cell lines → human cells → animals → humans) – Target engagement, pharmacologic activity, efficacy, and toxicity – Sources of samples or model systems for biomarker discovery and development

bIoMArkers

trAnsLAtIonAL ModeLs / In vIvo pHArMAcoLogy

Areas of Interest:

• In vivo platforms that replicate human metabolism and disease state

• Technologies to assess gene function in tissue-specific manner for MOA and target tissue specificity

• In vivo models with improved assessment of human-specific ADME and safety / toxicity

• In vitro platforms that robustly reproduce clinical indications, ADME, and clinical safety / toxicity

• Label free assay / non-invasive in vivo technologies capable of translating from basic to clinical for MOA, drug distribution, and safety / toxicity

Enabling Technologies

aSee RNA Therapeutics section for complete listing of interests related to delivery of nucleic acids.bSee Peptide Therapeutics section for complete listing of interests in peptide delivery.

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drug deLIvery And forMuLAtIon

Areas of Interest:

• Oral delivery technologies: – Technologies for delivery of water-insoluble compounds

(especially mitigation of food effect) – Oral-controlled release technologies to modify

pharmacokinetics (eg, increase Cmax

, AUC, and / or T1/2

, reduce peak-to-trough ratio):

• For poorly soluble compounds (<0.1 mg / mL) • For compounds with narrow absorption windows

(eg, those with poor colonic absorption) – Ingredients or formulations that can enhance permeability – Orally disintegrating tablet (ODT) technology or film

technology with robust in vivo performance and simple packaging

– Sublingual delivery for fast onset – Technologies that protect actives from the GI

environment (eg, gastric acid or GI metabolism) – Novel oral protein / peptide delivery systems (eg, insulin)

• Inhalation / nasal delivery: – Delivery systems for small and large molecules – Novel in situ modeling (eg, lung solubility or IVIVC)

• Injectable delivery, alternative routes of administration: – Injection devices (eg, novel and easy-to-use self-

injection systems, improved liquid / dry reconstitution technologies)

– Infusion systems (IV and subcutaneous delivery that facilitate hospital and home infusion therapies)

– Novel skin-based delivery technologies for high concentration antibody formulations and large volumes of liquid (>2 mL)

– Technologies for delivery of water-insoluble compounds (eg, IV-administered nanosuspensions or dispersed systems for small molecules and peptides)

– Systems (including implants) for sustained release of small and large molecules from one week to several months, up to years (long-acting implants)

– Vaginal ring and intrauterine delivery

• Back-of-the-eye delivery systems (eg, invasive and noninvasive, clinically proven technologies for retinal delivery of small molecules, siRNAa and trophic factors)

• Novel passive and active transdermal and topical technologies for small molecule and peptideb delivery

• Intelligent delivery systems capable of modulated delivery (eg, signal or drug concentration); personalized / feedback control

• Technology with potential to improve compliance with any dosage form – especially for pediatric and geriatric populations

• Delivery formulations or targeting ligands that provide selectivity and activity through enhanced cell association and uptake in target tissues

Areas of Interest:

• Quick-turnaround mid-density expression, genotyping, protein expression platforms

• Technologies that can perform multiplexed biomarker analysis with wide dynamic range – RNA, proteins, peptides, and / or small molecules – Animals and / or clinic – More streamlined with fewer repeats due to dilutions for individual analytes

• Identify vendors / academics that have identified and / or discovered / validated / qualified biomarkers – Translation to humans (cell lines → human cells → animals → humans) – Target engagement, pharmacologic activity, efficacy, and toxicity – Sources of samples or model systems for biomarker discovery and development

bIoMArkers

trAnsLAtIonAL ModeLs / In vIvo pHArMAcoLogy

Areas of Interest:

• In vivo platforms that replicate human metabolism and disease state

• Technologies to assess gene function in tissue-specific manner for MOA and target tissue specificity

• In vivo models with improved assessment of human-specific ADME and safety / toxicity

• In vitro platforms that robustly reproduce clinical indications, ADME, and clinical safety / toxicity

• Label free assay / non-invasive in vivo technologies capable of translating from basic to clinical for MOA, drug distribution, and safety / toxicity

Enabling Technologies

aSee RNA Therapeutics section for complete listing of interests related to delivery of nucleic acids.bSee Peptide Therapeutics section for complete listing of interests in peptide delivery.

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cHeMIcAL syntHesIs And purIfIcAtIon

Areas of Interest (Chemical Synthesis):

• Improved reactions – Asymmetric cyclopropanation – Selective functionalization of heterocyclic compounds – Nitroreductases as a platform for accessing chiral aliphatic

amines, and anilines – Greener oxidations

• Method to determine the cost of separations for scale up reactions

• Enzyme immobilization

• t-Bu cross-coupling

• Automation tools for DOE experiments

• Analysis and purification of lipids

• 14C labeled carbonylation

• N=O chemistry

• Preparation of alkyl fluorides

• C-H oxidations

• Reactions to introduce fluorine and CF3

Areas of Interest (Purification):

• Scalable membrane separations

• “One shot” separations system

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LeAd IdentIfIcAtIon And screenIng AssAys

Areas of Interest:

• Improved miniaturized high throughput assays for MoA and toxicity assays – Toxicity Assessment with limited amounts of compounds – Continuous kinetic cell-based assays of second messenger kinetics (Ca++, cAMP, phosphorylation, Ion Channels, etc) for

determination of On rate, Off rate, desensitization in cellular contest – Measurements of the GPCR-mediated physiological responses, including heterodimer formation – Cellular protein-protein interactions – Technologies for automated siRNA and cDNA screening

• Physiological cellular models and translational ex vivo cellular models – In vitro / ex vivo / in vivo predictive models – Improved technologies for primary cell immortalization of disease tissues – Metabolically competent hepatocyte-like cellular systems – Improvement on BACMAM vectors for cell transfection – Disease predictive physiological cellular models

• High throughput imaging and flow cytometry platforms – Advanced cellular image analysis software – Imaging-based tools to measure morphological / biomechanical changes in cells – High throughput flow-based imaging for screening primary stem cells – 3D-imaging tools and analysis software – Novel fluorophores for measurements of the cellular changes, including structural proteins

ModeLIng tooLs

Areas of Interest:

• ADME models and databases – Large, diverse datasets for less common metabolic pathways, such as aldehyde oxidase, sulfotransferases, BCRP, and other

transporters, etc – Models for observable phenomena that are composites of multiple processes, eg, bioavailability, volume of distribution,

clearance

• Ligand design – Fragment-based de novo design software – Assessment of relative synthetic tractability with performance appropriate for prioritizing thousands to millions of

novel structures

• Protein and protein-ligand modeling – Reliable screening of multiple mutations including multiple templates – Antibody structure prediction and protein loop prediction – Flexible backbone design and simultaneous de novo modeling of multiple loops – Ab-initio prediction of protein structures, including cases where predicted domain is part of a multi-domain protein or complex – 3D docking software for pose prediction that incorporates binding site flexibility and alternate protonation states

• Molecular mechanics and dynamics – Setup and analysis software for MD calculations – Molecular mechanics force-fields that can reliably model geometries and energies of small molecules and proteins including

solvent effects

• Virtual screening for lead finding and lead optimization – Ligand or protein-based methods to find actives more efficiently with demonstrated performance on experimental datasets

for multiple targets – Ligand or protein-based methods to find actives representing greater diversity of chemical classes with demonstrated

performance on experimental datasets for multiple targets – Improved scoring for compound ranking that include explicit waters or configurational entropy with demonstrated ranking

performance on experimental datasets for multiple targets in 3D docking experiments (eg, methods)

AutoMAted WorkfLoWs

Areas of Interest:

• Microfluidics – Coupling microfluidics to conventional automation and analytical tools to maximize productivity, eg, Empyrean microfluidic

UV / Vis plate reader – Miniaturization of screening tools compatible with organic solvents capabilities for analytical measurements, reactions,

formulations

• Nanoscale sample transfer automation – 1–100 nL range with improved precision / accuracy and speed, solvent compatibility – Acoustic, inkjet, piezo-based technologies

• MicroArray type methodologies applied to chemical / analytical questions

• Consolidation of sample prep unit operations with analytical autosamplers – Sample filtration, dilution, quenching, pretreatment, etc, for compounds, tablets, etc

• Coupling conventional HTS liquid handling approaches with techniques beyond plate readers

• Automation of routine sample / buffer preparation

• Quick-turnaround mid-density expression, genotyping, protein expression platforms

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cHeMIcAL syntHesIs And purIfIcAtIon

Areas of Interest (Chemical Synthesis):

• Improved reactions – Asymmetric cyclopropanation – Selective functionalization of heterocyclic compounds – Nitroreductases as a platform for accessing chiral aliphatic

amines, and anilines – Greener oxidations

• Method to determine the cost of separations for scale up reactions

• Enzyme immobilization

• t-Bu cross-coupling

• Automation tools for DOE experiments

• Analysis and purification of lipids

• 14C labeled carbonylation

• N=O chemistry

• Preparation of alkyl fluorides

• C-H oxidations

• Reactions to introduce fluorine and CF3

Areas of Interest (Purification):

• Scalable membrane separations

• “One shot” separations system

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LeAd IdentIfIcAtIon And screenIng AssAys

Areas of Interest:

• Improved miniaturized high throughput assays for MoA and toxicity assays – Toxicity Assessment with limited amounts of compounds – Continuous kinetic cell-based assays of second messenger kinetics (Ca++, cAMP, phosphorylation, Ion Channels, etc) for

determination of On rate, Off rate, desensitization in cellular contest – Measurements of the GPCR-mediated physiological responses, including heterodimer formation – Cellular protein-protein interactions – Technologies for automated siRNA and cDNA screening

• Physiological cellular models and translational ex vivo cellular models – In vitro / ex vivo / in vivo predictive models – Improved technologies for primary cell immortalization of disease tissues – Metabolically competent hepatocyte-like cellular systems – Improvement on BACMAM vectors for cell transfection – Disease predictive physiological cellular models

• High throughput imaging and flow cytometry platforms – Advanced cellular image analysis software – Imaging-based tools to measure morphological / biomechanical changes in cells – High throughput flow-based imaging for screening primary stem cells – 3D-imaging tools and analysis software – Novel fluorophores for measurements of the cellular changes, including structural proteins

ModeLIng tooLs

Areas of Interest:

• ADME models and databases – Large, diverse datasets for less common metabolic pathways, such as aldehyde oxidase, sulfotransferases, BCRP, and other

transporters, etc – Models for observable phenomena that are composites of multiple processes, eg, bioavailability, volume of distribution,

clearance

• Ligand design – Fragment-based de novo design software – Assessment of relative synthetic tractability with performance appropriate for prioritizing thousands to millions of

novel structures

• Protein and protein-ligand modeling – Reliable screening of multiple mutations including multiple templates – Antibody structure prediction and protein loop prediction – Flexible backbone design and simultaneous de novo modeling of multiple loops – Ab-initio prediction of protein structures, including cases where predicted domain is part of a multi-domain protein or complex – 3D docking software for pose prediction that incorporates binding site flexibility and alternate protonation states

• Molecular mechanics and dynamics – Setup and analysis software for MD calculations – Molecular mechanics force-fields that can reliably model geometries and energies of small molecules and proteins including

solvent effects

• Virtual screening for lead finding and lead optimization – Ligand or protein-based methods to find actives more efficiently with demonstrated performance on experimental datasets

for multiple targets – Ligand or protein-based methods to find actives representing greater diversity of chemical classes with demonstrated

performance on experimental datasets for multiple targets – Improved scoring for compound ranking that include explicit waters or configurational entropy with demonstrated ranking

performance on experimental datasets for multiple targets in 3D docking experiments (eg, methods)

AutoMAted WorkfLoWs

Areas of Interest:

• Microfluidics – Coupling microfluidics to conventional automation and analytical tools to maximize productivity, eg, Empyrean microfluidic

UV / Vis plate reader – Miniaturization of screening tools compatible with organic solvents capabilities for analytical measurements, reactions,

formulations

• Nanoscale sample transfer automation – 1–100 nL range with improved precision / accuracy and speed, solvent compatibility – Acoustic, inkjet, piezo-based technologies

• MicroArray type methodologies applied to chemical / analytical questions

• Consolidation of sample prep unit operations with analytical autosamplers – Sample filtration, dilution, quenching, pretreatment, etc, for compounds, tablets, etc

• Coupling conventional HTS liquid handling approaches with techniques beyond plate readers

• Automation of routine sample / buffer preparation

• Quick-turnaround mid-density expression, genotyping, protein expression platforms

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InforMAtIon tecHnoLogy / softWAre

Areas of Interest:

• Knowledge management and data-mining tools – Finding and accessing existing data – Ability to integrate external and internal datasets – Technology to improve information connectivity and sharing within MRL as well as with external partners – Information and document tagging technologies for smart retrieval of information and documents for export and data / text

mining – Technology to support the reusability of information, eg, through collaborative / structured authoring – Knowledge capture technology to capture tacit knowledge as well as when knowledge is generated through collaborative

research

• Collaboration tools – Collaborative contribution / decision-making tools, eg, such as predictive market technology

• Workflow management – Ability to track work requests between groups and perform resource management / prioritization

• In vivo information technology platforms – Global in vivo database and analytical platform for preclinical data and ability to compare associated clinical data – Animal facility management tools

• Modeling, and predictive analysis capabilities that: – Allow better prediction of in vivo (human) drug performance based on in vitro testing – Sharing of macromolecular structure models

• Efficient, easy-to-use software for visualizing, manipulating, and processing large amount of data – Multidimensional data analysis and reporting tools

AnALytIcAL tecHnoLogy

Areas of Interest:

• Improved efficiency of analytical workflows – Fast and high throughput analysis tools – More efficient analytical method development – Novel PAT tools – Automation of analysis

• Methods to analyze large molecules (siRNAs, peptides, polymers), biologics, and vaccines

• Improved platform analytical tools (HPLC, MS, etc) that require smaller samples, including microfluidic devices to run complex analytical assays

Mapping of Franchise AOIs to Corresponding Technology AOIs for Potential Platform Extensions:

Athero and Cardio Respiratory and Immunology

Women’s Health Diabetes and Obesity Infectious Diseases

Neuro and Ophthalmology

Oncology Biologics Vaccines

Target Identification / Validation

• Novel lipid /metabolic and / or other emerging targets with high confidence for reducing CV risk

• Novel targets for specialty hypertension

• Human lung cell/ tissue-based systems for investigating new therapeutic mechanisms

• Targets for menopausal complaints

• Platform technologies for the identification and validation of novel targets

• Novel genetic / RNA-based approaches to target validation or therapeutics

Translational Models / In Vivo Pharmacology

• Animal models of hypertension

• Predictive animal models of asthma pathophysiology

• Models for endometriosis

• Animal or cellular viral latency models

• Animal or cellular viral latency models

• Robust cell culture systems for HCV replication

• Models that develop both plaques and tangles and that show neuronal loss

• New models for chronic pain

• Parkinson’s disease progression models

• Models for psychiatric diseases

• Biological tools to address nicotinic receptor pharmacology

• Models of HCC for the evaluation and validation of siRNA targets

• Antigen selection, discovery, and Identification

Robust In Vitro Platforms That Translate to Animal and Human Studies

• In vitro tissue models for HCV

• In vitro therapeutic index of combination therapies

• Identification, generation, and modification of monoclonal antibodies and engineered proteins displaying pharmaceutical properties

Biomarkers • Methods, biomarkers, or platforms to assess antiatherogenic properties of HDL or other lipoproteins

• Biomarkers of patient subtypes

• Technologies for measuring vascular dynamics and intravascular pressure beyond tonometry

• Markers that link HTN to other metabolic syndrome phenotypes and /or atherosclerosis

• Markers for renal sequelae of HTN

• Platform technologies that enable personalized medicine for HTN

• Biomarkers that can be used for patient segmentation

• Translational medicine platforms

• Biomarkers for reproductive biology, oocyte / embryo quality, endometrial quality / implantation, menopausal complaints and endometriosis

• Surrogate biomarkers of bone strength and / or fracture risk

• Selective markers for cortical and trabecular bone anabolism

• Markers for specific bone loss / fracture risk

• Surrogate biomarkers of bladder dysfunction

• Biochemical markers of muscle functional state associated with sarcopenia

• Pharmacogenetics / -genomics, proteomics, or other for prediction of diabetes, obesity, drug response, and sub-phenotyping of disease

• Prognostic HIV and HCV markers

• Molecular biomarkers of susceptibility

• Markers for chronic pain

• Parkinson’s disease markers that may identify prodromal stages

• Neurodegeneration pathway markers

• Markers for PI3K and DNA damage / checkpoint pathways

• Minimally invasive platforms for measuring circulating tumor cells, circulating nucleic acids, novel imaging tracers.

Near Real-time Assays to Screen Patients Faster for Clinical Trials

• Acute methods to assess cholesterol transport in humans (especially reverse cholesterol transport), including imaging and kinetic models

• Clinical methods for early prediction of long-term weight loss

The complete therapeutic area technology needs can be found in the associated therapeutic area section of the book.

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InforMAtIon tecHnoLogy / softWAre

Areas of Interest:

• Knowledge management and data-mining tools – Finding and accessing existing data – Ability to integrate external and internal datasets – Technology to improve information connectivity and sharing within MRL as well as with external partners – Information and document tagging technologies for smart retrieval of information and documents for export and data / text

mining – Technology to support the reusability of information, eg, through collaborative / structured authoring – Knowledge capture technology to capture tacit knowledge as well as when knowledge is generated through collaborative

research

• Collaboration tools – Collaborative contribution / decision-making tools, eg, such as predictive market technology

• Workflow management – Ability to track work requests between groups and perform resource management / prioritization

• In vivo information technology platforms – Global in vivo database and analytical platform for preclinical data and ability to compare associated clinical data – Animal facility management tools

• Modeling, and predictive analysis capabilities that: – Allow better prediction of in vivo (human) drug performance based on in vitro testing – Sharing of macromolecular structure models

• Efficient, easy-to-use software for visualizing, manipulating, and processing large amount of data – Multidimensional data analysis and reporting tools

AnALytIcAL tecHnoLogy

Areas of Interest:

• Improved efficiency of analytical workflows – Fast and high throughput analysis tools – More efficient analytical method development – Novel PAT tools – Automation of analysis

• Methods to analyze large molecules (siRNAs, peptides, polymers), biologics, and vaccines

• Improved platform analytical tools (HPLC, MS, etc) that require smaller samples, including microfluidic devices to run complex analytical assays

Mapping of Franchise AOIs to Corresponding Technology AOIs for Potential Platform Extensions:

Athero and Cardio Respiratory and Immunology

Women’s Health Diabetes and Obesity Infectious Diseases

Neuro and Ophthalmology

Oncology Biologics Vaccines

Target Identification / Validation

• Novel lipid /metabolic and / or other emerging targets with high confidence for reducing CV risk

• Novel targets for specialty hypertension

• Human lung cell/ tissue-based systems for investigating new therapeutic mechanisms

• Targets for menopausal complaints

• Platform technologies for the identification and validation of novel targets

• Novel genetic / RNA-based approaches to target validation or therapeutics

Translational Models / In Vivo Pharmacology

• Animal models of hypertension

• Predictive animal models of asthma pathophysiology

• Models for endometriosis

• Animal or cellular viral latency models

• Animal or cellular viral latency models

• Robust cell culture systems for HCV replication

• Models that develop both plaques and tangles and that show neuronal loss

• New models for chronic pain

• Parkinson’s disease progression models

• Models for psychiatric diseases

• Biological tools to address nicotinic receptor pharmacology

• Models of HCC for the evaluation and validation of siRNA targets

• Antigen selection, discovery, and Identification

Robust In Vitro Platforms That Translate to Animal and Human Studies

• In vitro tissue models for HCV

• In vitro therapeutic index of combination therapies

• Identification, generation, and modification of monoclonal antibodies and engineered proteins displaying pharmaceutical properties

Biomarkers • Methods, biomarkers, or platforms to assess antiatherogenic properties of HDL or other lipoproteins

• Biomarkers of patient subtypes

• Technologies for measuring vascular dynamics and intravascular pressure beyond tonometry

• Markers that link HTN to other metabolic syndrome phenotypes and /or atherosclerosis

• Markers for renal sequelae of HTN

• Platform technologies that enable personalized medicine for HTN

• Biomarkers that can be used for patient segmentation

• Translational medicine platforms

• Biomarkers for reproductive biology, oocyte / embryo quality, endometrial quality / implantation, menopausal complaints and endometriosis

• Surrogate biomarkers of bone strength and / or fracture risk

• Selective markers for cortical and trabecular bone anabolism

• Markers for specific bone loss / fracture risk

• Surrogate biomarkers of bladder dysfunction

• Biochemical markers of muscle functional state associated with sarcopenia

• Pharmacogenetics / -genomics, proteomics, or other for prediction of diabetes, obesity, drug response, and sub-phenotyping of disease

• Prognostic HIV and HCV markers

• Molecular biomarkers of susceptibility

• Markers for chronic pain

• Parkinson’s disease markers that may identify prodromal stages

• Neurodegeneration pathway markers

• Markers for PI3K and DNA damage / checkpoint pathways

• Minimally invasive platforms for measuring circulating tumor cells, circulating nucleic acids, novel imaging tracers.

Near Real-time Assays to Screen Patients Faster for Clinical Trials

• Acute methods to assess cholesterol transport in humans (especially reverse cholesterol transport), including imaging and kinetic models

• Clinical methods for early prediction of long-term weight loss

The complete therapeutic area technology needs can be found in the associated therapeutic area section of the book.

A R E A S O f I N T E R E S TD E C E M B E R 2 0 1 0

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E N A B l I N G T E C H N O l O G I E SD E C E M B E R 2 0 1 0

34

Mapping of Franchise AOIs to Corresponding Technology AOIs for Potential Platform Extensions:

Athero and Cardio Respiratory and Immunology

Women’s Health Diabetes and Obesity

Infectious Diseases

Neuro and Ophthalmology

Oncology Biologics Vaccines

Diagnostics / Imaging Techniques and Genotyping / Phenotyping

• Methods to detect endometriosis

• Imaging approaches for indices of bladder function

• Diagnostics to improve specificity of diagnosing OAB from stress incontinence

• Diagnostics to predict response to therapy including anticholinergics or other mechanisms of action associated with urology related disorders

• Imaging agents for monitoring pancreatic beta-cell mass

• Genotyping and phenotyping technologies for HCV polymerase and HCV protease

• Rapid point-of-care, pathogen-specific and host-response diagnostic tests

• CSF collections from healthy, MCI and AD subjects

• Tau and amyloid imaging agents

• Fluid-based assays for Aβ, ADDLs, and tau

• SN-MRI volumetry

• Imaging tracers, cell-based, blood, nucleic acid, and IVD diagnostics

• Genome-wide scanning with the ability to measure copy number variation in tumor samples

• Gene expression from FFPET

Production, Purification & Analysis

• Fc engineering to enhance / improve effector functions, half-life

• Bispecific platforms with promising stability and manufacturing yield

Drug Delivery and Formulation

• Inhaled technologies / formulations

• Contraceptive technologies

• Novel delivery / formulation technologies for biologicals for fertility, contraception

• Alternate delivery of peptides

• Novel delivery devices for sc insulin

• PK enhancers • Novel delivery systems for novel or existing migraine treatments

• New formulations of existing anti-migraine drugs

• Tumor-targeted delivery systems for systemic administration of RNAi

• Methods to address blood brain barrier

• Glycan mediated targeting

• Dermal or mucosal delivery

Information Technology / Knowledge Management

The complete therapeutic area technology needs can be found in the associated therapeutic area section of the book.

notes

A R E A S O f I N T E R E S TD E C E M B E R 2 0 1 0

35

E N A B l I N G T E C H N O l O G I E SD E C E M B E R 2 0 1 0

34

Mapping of Franchise AOIs to Corresponding Technology AOIs for Potential Platform Extensions:

Athero and Cardio Respiratory and Immunology

Women’s Health Diabetes and Obesity

Infectious Diseases

Neuro and Ophthalmology

Oncology Biologics Vaccines

Diagnostics / Imaging Techniques and Genotyping / Phenotyping

• Methods to detect endometriosis

• Imaging approaches for indices of bladder function

• Diagnostics to improve specificity of diagnosing OAB from stress incontinence

• Diagnostics to predict response to therapy including anticholinergics or other mechanisms of action associated with urology related disorders

• Imaging agents for monitoring pancreatic beta-cell mass

• Genotyping and phenotyping technologies for HCV polymerase and HCV protease

• Rapid point-of-care, pathogen-specific and host-response diagnostic tests

• CSF collections from healthy, MCI and AD subjects

• Tau and amyloid imaging agents

• Fluid-based assays for Aβ, ADDLs, and tau

• SN-MRI volumetry

• Imaging tracers, cell-based, blood, nucleic acid, and IVD diagnostics

• Genome-wide scanning with the ability to measure copy number variation in tumor samples

• Gene expression from FFPET

Production, Purification & Analysis

• Fc engineering to enhance / improve effector functions, half-life

• Bispecific platforms with promising stability and manufacturing yield

Drug Delivery and Formulation

• Inhaled technologies / formulations

• Contraceptive technologies

• Novel delivery / formulation technologies for biologicals for fertility, contraception

• Alternate delivery of peptides

• Novel delivery devices for sc insulin

• PK enhancers • Novel delivery systems for novel or existing migraine treatments

• New formulations of existing anti-migraine drugs

• Tumor-targeted delivery systems for systemic administration of RNAi

• Methods to address blood brain barrier

• Glycan mediated targeting

• Dermal or mucosal delivery

Information Technology / Knowledge Management

The complete therapeutic area technology needs can be found in the associated therapeutic area section of the book.

notes

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notes

— David Nicholson, PhD, Senior Vice President and Head Worldwide Licensing and Knowledge Management

Merck is passionate about our commitment to partnering. Let’s explore the possibilities of combining our strengths to deliver novel medical breakthroughs that save and improve lives.

A R E A S O f I N T E R E S TD E C E M B E R 2 0 1 0

36

notes

— David Nicholson, PhD, Senior Vice President and Head Worldwide Licensing and Knowledge Management

Merck is passionate about our commitment to partnering. Let’s explore the possibilities of combining our strengths to deliver novel medical breakthroughs that save and improve lives.

Copyright © 2009–2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. LIC-2010-W-85943-AH

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