Ardea Biosciences (RDEA) 8-K Regulation FD Disclosure

Ardea Biosciences

Company Update

November 7, 2011

Exhibit 99.2

2

Safe Harbor Statement

Statements contained in this presentation regarding matters that are not historical facts are

“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of

1995.  Because such statements are subject to risks and uncertainties, actual results may differ

materially from those expressed or implied by such forward-looking statements.  Such statements

include, but are not limited to, statements regarding: Ardea’s goals, its preclinical and clinical trial

plans, timelines and milestones, its expectations about the size of its markets and commercial

potential of its compounds, expected results of future clinical trials, expected properties of

compounds under development, financial position, cash usage, licensing and partnering

opportunities, liquidity and anticipated milestones.  Risks that contribute to the uncertain nature

of the forward-looking statements include: risks related to the outcomes of preclinical and clinical

trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical

tests, costs associated with internal development, and the outcome of our business development

activities, including collaboration or licensing agreements.  These and other risks and uncertainties

are described more fully in Ardea’s most recently filed SEC documents, including its Annual Report

on Form 10-K and Quarterly Reports on Form 10-Q, under the headings "Risk Factors."  All

forward-looking statements contained in this presentation speak only as of the date of this

presentation, and Ardea undertakes no obligation to update such statements to reflect events that

occur or circumstances that exist after the date hereof or otherwise.

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

MEKI + gemcitabine for advanced

pancreatic cancer

3

Gout

Lesinurad

(RDEA594)

RDEA3170

Next Generation

URAT1

BAY 86-9766

(RDEA119)

BAY 86-9766

(RDEA119)

Gout

Status of Development Programs

MEKI + sorafenib for primary liver cancer

HYPERURICEMIA/GOUT

4

5

1. Perez-Ruiz F, Arthritis Rheum 2002;47:356-360

Allopurinol does a very poor job of treating severe disease

(Images are courtesy of Nicola Dalbeth)

Velocity of Tophi Reduction

1

Gout Unmet Medical Need

Severe Disease Is Not Infrequent

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

Combination

Benzbromarone

Allopurinol

Gout is caused by abnormally elevated levels of serum uric acid (>6.8 mg/dL)

Increasing incidence and severity in US:  approximately 8 million patients

–

~ 90% of patients are “under-excretors”

of uric acid

•

Lesinurad increases urinary excretion of uric acid; returns excretion to normal levels

•

Allopurinol and febuxostat reduce production, which reduces excretion further

•

Less than half of the 

2.5 million patients currently taking allopurinol are flare free

•

The

combination

of

lesinurad

and

xanthine

oxidase

inhibitors

may

produce

greater

reductions

in

uric

acid

and

speed

up

clearance

of

tophi

and

body

burden

of

uric

acid

Hyperuricemia

linked

to

elevated

hypertension

in

adults

1

and

children

2

,

increased

mortality

in

Chronic

Kidney

Disease

3

and

possibly

other

cardiovascular risk factors

4,5

,

including elevated C-Reactive Protein

–

Asymptomatic hyperuricemia is treated in Japan

6

Hyperuricemia/Gout

1. Int Urol Nephrol 2007;39:1227-33 ;  2. D Feig, B Soletsky, R Johnson. JAMA. 2008;300(8):924-932;  3. Am J Kidney Dis 2009;53:796-803; 4. JAMA. 2008;300(8):924-932; 

5. Chen Abstract  2088 ACR2010     

>99%

Reabsorption

Excretion

~100% of uric acid is initially filtered through

glomerular filtration

URAT1

Enomoto; Urat1 identification in Nature May2002

D Levinson & L Sorensen; Renal Handling of Uric Acid

Proximal Tubule

RDEA594

7

URAT1 Inhibitors Increase the Urinary

Excretion of Uric Acid

Lesinurad + XO-Inhibitor

Treated Patient

XO-Inhibitor

Treated Patient

Typical Gout

Patient

Long-term

Treated Patient

Typical Gout Patient

XO-Inhibitor

Lesinurad + XO-Inhibitor

Lesinurad + XO-Inhibitor

1. Perez-Ruiz F, Arthritis Rheum 2002;47:356-360; 

8

Why Allopurinol Only Works in 30-40% of Patients

and the Addition of Lesinurad Works in 80-90%

600-800

mg/day

<400

mg/day

<400

mg/day

400 mg/day

200 mg/day

600 mg/day

<400 mg/day

90% of patients are

under-excretors of uric

acid

Decrease production of

uric acid, but also

decrease excretion

Only 30-50% of patients

(ITT analysis) reach target

of sUA < 6mg/dL in

clinical trials

Combination with XO-

inhibitor can reach

Krystexxa-like (70-80%)

reductions of sUA

When all solid urate

is mobilized, input

and output should be

in balance

Allopurinol + URAT1

inhibitor has been shown

to resolve tophi faster

than allopurinol

alone

1

<400

mg/day

9

Allopurinol

Results

From

Uloric®

US

package

Insert*

APEX

28-week Study

FACT

52-week Study

CONFIRMS 

28-week Study

Allopurinol  Dose

(no. of patients)

300/100mg QD

(n=263)

300mg QD

(n=242)

300/100mg QD

(n=755)

% patients with sUA <6 mg/dL

39%

36%

42%

* LOCF analysis used for determination of response rates

~60% of patients on allopurinol did not reach <6 mg/dL and ~90% didn’t

reach <5 mg/dL, which is needed for patients with tophaceous disease

Response rates are only 29-38% with rigorous Intent-To-Treat (ITT) analysis

With ITT analysis, response rates for febuxostat are:

–

Febuxostat 40 mg –

38% response rate

–

Febuxostat 80 mg –

48-60% response rates

Competitive Landscape -

Allopurinol

Results From Large Phase 3 Studies

Source:  BioTrends Chart Review 2010, n=786 (patients on allopurinol and febuxostat)

10

Majority of Patients Do Not Reach sUA Target of < 6 mg/dL

on Urate Lowering Therapy (ULT) in Clinical Practice

Mild

Moderate

Severe

Mild

Moderate

Severe

Total

Allopurinol

Febuxostat

27%

35%

30%

61%

31%

32%

73%

65%

70%

39%

69%

68%

61%

39%

sUA>

6mg/dL

sUA<

6mg/dL

11

ULT Treated

Not Treated

Source:  BioTrends Chart Review 2010, n=1039 (all patients)

Percent of patients that experienced gout flares in last 12 months

Majority of Patients (ULT Treated or Not) Are Still

Having Flares in Clinical Practice

41%

35%

59%

65%

Had Gout Flares

Had Gout Flares

No Gout Flares

No Gout Flares

12

Colchicine

Prophylaxis

•

Sharp rise in flares after two

months of colchicine was stopped

•

Improvement in flares with more

potent therapy not seen until after

week 44

•

Same flare rate with allopurinol at

1 month and 1 year

Febuxostat FACT Study

13

Abstract 758: MA Becker, et al.

ACR Boston November 2007

Serum Urate in the 12

th

Month of

Treatment by 1 mg/dL

Flare Rate in Month 12 From FACT Trial Shows

Clear Relationship to sUA

0

5

10

15

20

7.0

-

<8.0 mg/dl

6.0 -

<7.0 mg/dl

5.0 -

<6.0 mg/dl

4.0 -

<5.0 mg/dl

<4.0 mg/dl

8.0 mg/dl

Diagnosed

Gout

8.3M

(1) BioTrends Chart Review 2010, for severe gout patients not responding to current therapy (n=1039); (2) NHANES; (3) Estimate NHANES & extrapolation from various sources including IMS RX data;

(4) BioTrends Chart Review 2010, 68% of patients are not adequately responding based on sUA > 6 mg/dL, and 59% of patients had a flare in the prior year (n=1039).

14

90%

59-68%

Allopurinol

Responders

Gout Pts

on ULT

2.6M

Allo Inadequate

Responders

1.5-1.7M

4

Increasing prevalence/aging

population

Education, advertising (DTC)

Allopurinol

Intolerant

125 -

250K

Allopurinol

Treated

2.5M

Improved Compliance

Growing evidence of CV risk

Gout Market Breakdown

2

3

Patients

Restarting

Therapy

Trx Refractory

Gout

~100K

1

Placebo

2-4 weeks

4 weeks

2 weeks

Population: 

–

208

gout

patients

with

serum

urate

(sUA)

6

mg/dL

while

receiving

a

stable

dose

of allopurinol for at least 6 weeks

Duration:

–

4-week double-blind treatment period with doses escalated weekly

Endpoints:

–

Primary: Mean reduction in sUA at Week 4

–

Key Secondary: proportion of subjects with sUA < 6.0 mg/dL at Week 4

–

Safety and tolerability of the combination versus allopurinol alone

Colchicine

Treatment

(0.5

mg

–

0.6

mg/day)

Randomize

if no gout

flare during 2

weeks of

colchicine

15

Allopurinol

Treatment

(200

mg

–

600

mg/day)

Screening

Period:

Patients

must have

sUA >

6

mg/dL on

stable

dose of

allopurinol

Study 203: Lesinurad Phase 2b Combination Study

with Allopurinol in Allopurinol-Refractory Patients

Off drug

Off drug

Off drug

Placebo

Placebo

200 mg Lesinurad

400 mg Lesinurad

600 mg Lesinurad

200 mg

200 mg

400 mg

p<0.0001

16

ITT Population

p<0.0001

p<0.0001

Baseline sUA =      6.7                                  6.4   

6.9                                 7.3

(mg/dL)

P-values are for comparison to placebo group using an ANCOVA model

Study 203: Primary Endpoint -

Mean Percent

Change in Serum Urate at Week 4

3

-16

-22

-30

-35

-30

-25

-20

-15

-10

-5

0

5

Placebo

Lesinurad 200mg +

Allopurinol

Lesinurad 400mg +

Allopurinol

Lesinurad 600mg +

Allopurinol

17

p<0.0001

p<0.0001

p<0.0001

*  Patients with missing Week 4 results are analyzed as treatment failures, regardless of the reason for the missing data

p-values are for comparison to allopurinol alone (placebo group) using a Fisher’s exact test

(N = 72)

(N = 46)

(N = 42)

(N = 48)

Study 203: Percent of Patients with sUA < 6

mg/dL at Week 4 –

Intent to Treat Analysis*

25%

63%

74%

79%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Placebo + Allopurinol

Lesinurad 200mg +

Allopurinol

Lesinurad 400mg +

Allopurinol

Lesinurad 600mg +

Allopurinol

18

p<0.0001

p<0.0001

p<0.0001

LOCF analysis used in febuxostat US package insert

Study 203: Percent of Patients w/ Serum Urate

< 6 mg/dL at Last Visit –

LOCF Analysis*

28%

71%

76%

87%

* Last observation carried forward analysis  (LOCF) uses a prior week’s sUA results when Week 4 results are missing

   p-values are for comparison to allopurinol alone (placebo group) using a Fisher’s exact test

(N = 46)

(N = 72)

(N = 48)

(N = 42)

19

Study 203 Lesinurad Allopurinol Add-on

Lesinurad Consistently Lowers sUA Across Renal

Function Categories

20

Adverse Events

Allopurinol + Lesinurad Dose Group

Allopurinol +

200mg

(N=46)

n (%)

400mg

(N=42)

n (%)

600mg

(N=48)

n (%)

Combined

Lesinurad

(N=136)

n (%)

Pooled

Placebo

(N=72)

n (%)

Any Adverse Event

1 (2.2)

4 (9.5)

5 (10.4)

10 (7.4)

10 (13.9)

Diarrhea

0

1 (2.4)

0

1 (0.7)

2 (2.8)

Dyspepsia

0

0

1 (2.1)

1 (0.7)

1 (1.4)

Lipase Increased

0

2 (4.8)

0

2 (1.5)

1 (1.4)

Hematuria

0

1 (2.4)

0

1 (0.7)

2 (2.8)

Nausea

0

0

0

0

2 (2.8)

*AEs reported by a total of  2 or more subjects that were considered possibly related to drug; excludes gout flares

EULAR 2011 update

Incidence of the Most Frequent Adverse

Events*

21

EULAR 2011 update

Study 203: Safety Continued

No Serious Adverse Events (SAEs) in main study

5 discontinuations due to adverse events in main study:

2 combination patients (urticaria, elevated lipase)

1 allopurinol patient (hematuria) and 2 baseline patients on

allopurinol + colchicine (QT prolongation, elevated CK)

One patient died on allopurinol and colchicine prior to receiving

lesinurad.

After a minimum of two week washout, patients were eligible for restarting lesinurad / matched  

placebo in blinded extension period

126 patients restarted at a dose of lesinurad 200 mg / matched placebo at Week 0

The dose may be escalated for response

Allopurinol continued throughout washout and extension phase

Lesinurad 200mg / matched placebo  + Allopurinol  

Lesinurad 400mg / matched placebo  + Allopurinol

Lesinurad 600mg / matched placebo  + Allopurinol

Optional -

Lesinurad 600mg/ matched

placebo  + increased Allopurinol (in

100 mg increments)

Weeks 0 -

4      

Weeks 9 -

12

Weeks 5 -

8

Weeks 15 -

44

22

Study 203 -

Optional Blinded Extension Period

90%

Lesinurad sample sizes before LOCF:

78            76            71             75       

73                              71         

68                                           

66            31

Data presented with LOCF analysis through Week 28; Week 44 is observed cases

23

Study 203: Patients Continue to Respond in Long-Term

Extension With 90% Response at 44 Weeks

Placebo sample sizes before LOCF:

48            46             47             48       

46                              43         

40                                           

36            11

44

55%

24

Study 203: Patients Receiving Lesinurad 200 mg or

400 mg Have >90% Response at 44 Weeks

Lesinurad group does not include patients who were escalated to 600 mg at any time.

LOCF imputation used through Week 28.  Week 44 is observed cases (11 placebo, 21 lesinurad)

n =         22        21       18        19                  19

20                    19                     

19                                            13

12

After 4 weeks, non-responding patients can be escalated to 400 mg

and then later to 600 mg; patients that moved to higher doses are

excluded

from

this

analysis

to

see

the

effect

of

just

the

200

mg

dose

Mean Change in sUA for Patients Staying on Lesinurad 200 mg

Confidential

Study 203: Patients on Lesinurad 200mg

Continue to Decline for 16 Weeks

26

~40% higher drop-out rate on placebo than lesinurad, with ~3-times as many

patients in the lesinurad arms completing 44 weeks of blinded extension; after

44 weeks most placebo patients are switched to lesinurad

Consistently lower flare rates on lesinurad 200 mg than placebo months 6-12

4 SAEs; none considered treatment-related (angina pectoris, cerebral artery

embolism resulting in death, muscle rupture, bursitis infective)

30 discontinuations or study completions:

-

14 allopurinol alone (placebo) patients and 16 lesinurad + allopurinol

combination patients

6 patients (2 on allopurinol alone and 4 on lesinurad plus allopurinol)

discontinued due to adverse events (none were considered an SAE):

-

1 patient on allopurinol alone and 3 patients on lesinurad plus allopurinol

were discontinued due to elevated serum creatinine; there were no

differences in mean serum creatinine between lesinurad and placebo out

to Week 44

03 October 2011 data cut-off

Study 203 Extension: Safety

Population: 

–

21

gout

patients

with

hyperuricemia

(sUA

=

8

mg/dL)

•

febuxostat 40 mg panel: 12 patients with median sUA of 9.2 mg/dL

•

febuxostat 80 mg panel: 9 patients with median sUA of 10.4 mg/dL

Objectives: 

–

Plasma

PK

and

urinary

excretion

of

lesinurad

in

combination

with

febuxostat

–

PK of colchicine alone and in combination with febuxostat or both febuxostat and

lesinurad

–

Effect of febuxostat alone and in combination with lesinurad on serum urate

concentrations and urinary urate excretion

febuxostat 80mg QD

7 days

7 days

7 days

Screening

Period

-21 day to day 0

Colchicine Treatment

febuxostat 80mg QD +

400mg lesinurad

febuxostat 80mg QD +

600mg lesinurad

febuxostat 40mg QD

febuxostat 40mg QD +

400mg lesinurad

febuxostat 40mg QD +

600mg lesinurad

27

Lesinurad Study 111 –

Phase 1b Febuxostat and

Lesinurad Dose Titration Study in Gout Patients

febuxostat 40 mg

febuxostat 80 mg

All 600 mg combination values are at least

p<0.05 versus 400 mg combination

All combination values are

p<0.001 versus to

febuxostat alone

28

All combination values are

p<0.001 compared to

febuxostat alone

All 600 mg combination values are at least

p<0.05 versus 400 mg combination

RDEA594 Study 111 –

Mean sUA and

Percent Change in sUA

0

2

4

6

8

10

12

Week 1

Week 2                 Week 3

febuxostat

Febuxostat+

lesinurad

400 mg

Febuxostat+

lesinurad

600 mg

-100

-80

-60

-40

-20

0

Week 1

Week 2                Week 3

febuxostat

febuxostat+l

lesinurad

400 mg

febuxostat+l

lesinurad

600 mg

* P<0.05, **P<0.01,***P<0.001 versus FBX 40 mg alone

# P<0.05, ## P<0.01,### P<0.001 versus FBX 80 mg alone

***

**

**

*

*

###

##

#

#

#

##

###

29

Study 111: Combining Lesinurad and Febuxostat

Produces Much Greater Responses than Can Be

Achieved with Highest Dose of Febuxostat

0%

20%

40%

60%

80%

100%

120%

FBX 40 mg               

(n=12)

FBX 40 mg +           

Lesinurad 400 mg

FBX 40 mg +              

Lesinurad 600 mg

FBX 80 mg               

(n=9)

FBX 80 mg +          

Lesinurad 400 mg

FBX 80 mg +               

Lesinurad 600 mg

< 6 mg/dL

< 5 mg/dL

< 4 mg/dL

< 3 mg/dL

21 days

2 weeks

4 weeks

2 weeks

30

Labs  X                                          X X           

X                           X                     

X                        XX                 X              

Study 202 -

Phase 2b Lesinurad

Monotherapy -

Design

Screening

Period

Washout

of urate

lowering

therapy

200 mg Lesinurad

Off drug

Off drug

Off drug

200 mg

Placebo

400 mg Lesinurad

200 mg

400 mg

600 mg Lesinurad

Colchicine Treatment

Randomize

if no gout

flare during

1-2 weeks of

colchicine

Off drug

Population: 

–

gout patients with hyperuricemia (serum uric acid =

8 mg/dL)

–

total of 123 patients in 4 treatment arms

Duration:

–

8 wks: 2-wk run-in, 4-wk treatment, 2-wk follow-up: dose was titrated up weekly

Endpoints:

–

Proportion of subjects with sUA level < 6.0 mg/dL at Week 4

–

Safety and tolerability of the combination versus placebo

31

ITT population

n=   27                                      31                

33                                        32

P=0.0001

P<0.0001

Plasma urate assay using direct LC-MS method of analysis.

Study 202 –

Phase 2b Monotherapy Study

Response Rates for Urate Reduction

0%

13%

42%

60%

0%

10%

20%

30%

40%

50%

60%

70%

Placebo

Lesinurad 200 mg

Lesinurad 400 mg

Lesinurad 600 mg

Baseline sUA

32

ITT population

n=   27                                   31                   

33                                32

Plasma urate assay for response using direct LC-MS method of analysis.

Study 202 –

Response Rates for Plasma

Urate Reduction by Baseline Urate Levels

0%

10%

20%

30%

40%

50%

60%

70%

80%

Placebo

Lesinurad 200 mg

Lesinurad 400 mg

Lesinurad 600 mg

sUA >10 mg/dL

sUA < 10 mg/dL

P=0.0004

P=0.0095

P<0.0001

33

Lesinurad Consistently Lowers sUA Across

Renal Function Categories

34

*Adverse events reported by at least 2 subjects that were considered at least possibly related to treatment

No Serious Adverse Events

Two discontinuations due to adverse events, both on 400 mg dose:

one patient with vertigo, and

one patient with elevated SCr that returned to normal range while receiving lesinurad

No clinically relevant lipase or ALT elevations on lesinurad; one on placebo

Study 202 -

Incidence of the Most Frequent

Adverse Events*

Adverse Events

200mg

(N=31)

400mg

(N=33)

600mg

(N=32)

Placebo

(N=27

)

Any Adverse Event

7%

15%

16%

15%

Diarrhea

3%

0

3%

4%

Dyspepsia

0

6%

0

0

Headache

0

3%

3%

7%

Lesinurad Dose Group

Long-term

Allopurinol

Safety

Trial

(LASSO)

–

open-label

interventional

study

of

allopurinol

in

gout patients otherwise eligible for our Phase 3 studies

Combination Study of Lesinurad in Allopurinol Standard of Care Inadequate Responders

(CLEAR #1) –

randomized, placebo-controlled trial of lesinurad added to allopurinol in

patients not reaching sUA target with allopurinol alone; North America

Combination Study of Lesinurad in Allopurinol Standard of Care Inadequate Responders

(CLEAR #2) –

randomized, placebo-controlled trial of lesinurad added to allopurinol in

patients not reaching sUA target with allopurinol alone; Global

Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT) –

randomized, placebo-controlled trial of lesinurad monotherapy in patients where febuxostat

and/or

allopurinol

are

contraindicated

(due

to

intolerance,

drug

interactions,

co-morbidities,

etc); Global

Combination Treatment Study in Subjects with Tophaceous Gout Using Lesinurad and

Febuxostat

(CRYSTAL)

–

randomized,

placebo-controlled

trial

of

lesinurad

in

combination

with febuxostat for the treatment of hyperuricemia in gout patients with tophi (resolution of

tophi is a key secondary endpoint); Global

Total

patients

planned

for

Phase

3

studies:

2000

–

2500

35

Lesinurad Phase 3 Program

Population:

–

Up to 2500 pts with hyperuricemia (sUA

8 mg/dL) at ~300 centers

Design:

–

Provide therapy with allopurinol at the medically appropriate doses; monitor patients

for a minimum of 2 months prior to their being eligible for enrollment into Phase 3

program (~3 months or greater on allopurinol prior to Phase 3 baseline)

Objectives:

–

Generate patients for the Phase 3 program with well-documented inadequate

efficacy or intolerance to allopurinol (should accelerate enrollment of Phase 3

program)

36

Allopurinol prescribed at

labeled dose

Long-term Allopurinol Safety Study Evaluating Outcomes

in Gout Patients (LASSO -

N. America & Global)

Phase 3 - Allopurinol SoC Inadequate Responders North America

Phase 3 - Allopurinol SoC Inadequate Responders NA and ROW

Phase 3 – Allopurinol Intolerant Study

Population: 

–

Gout patients with sUA > 6.5 mg/dL on stable dose of allopurinol between 300 mg

to 800 mg (200 mg acceptable for moderate renal impairment) for

12 weeks

–

2 gout flares in preceding 12 months

Endpoints:

–

Primary: proportion of subjects with sUA level < 6.0 mg/dL after 6 months

–

Key Secondary: Studies would be pooled for assessment of gout flare rate, tophi

resolution and quality of life measurements. Prospective efficacy analysis in

subjects treated with >300 mg/day.

Screening

Period

Colchicine for gout flare prophylaxis

37

RDEA594

200 mg + ALLO 200-800 mg

RDEA594

400 mg + ALLO 200-800 mg

3 weeks

1 week

Month 6 Primary Endpoint (sUA)

Month 12 Secondary Endpoints

RDEA594

Placebo+ ALLO 200-800 mg

Combination Study of LEsinurad in Allopurinol Standard of

Care Inadequate

Responders (CLEAR #1 & #2)

2 wks

1 wk

Month 6 primary endpoint (sUA)

Month 12 Secondary Endpoints

Population: 

–

Gout patients with hyperuricemia (sUA dependent on previous therapy)

and

1 measureable tophus

–

Prospective assessment of patients not responding to FBX 80 mg during

run-in period

Endpoints:

–

Primary: proportion of subjects with sUA level < 5.0 mg/dL after 24 wks

–

Key Secondary: tophus resolution, tophus response, and HAQ-DI at

month 12

105

pts:

Lesinurad

200mg

+FBX

80

mg

Colchicine for gout flare prophylaxis

38

105

pts:

Lesinurad

Placebo

+FBX

80

mg

105

pts:

Lesinurad

400mg

+FBX

80

mg

Combination TReatment StudY

in Subjects with TophAeous

Gout Using LesInurad and Febuxostat  (CRYSTAL

-

Global)

Population: 

–

Gout patients with sUA

6.5 mg/dL with medical history in which XO

therapy is contraindicated (e.g., hypersensitivity, intolerance,

or toxicity)

Endpoints:

–

Primary: Proportion of patients whose sUA levels are < 6.0 mg/dL by 6

months

39

RDEA594 400 mg

RDEA594 Placebo

Screening

Period

Colchicine for gout flare prophylaxis

RDEA594 400mg

RDEA594 400 mg extension

4 Weeks

Month 6 primary endpoint (sUA)

LesInurad Monotherapy in Gout Subjects Intolerant

to Xanthine Oxidase Inhibitors (

LIGHT

-

Global)

RDEA3170

40

41

Comparison Between Uricosuric Agents for

Inhibition of Uric Acid Transport by URAT1

N=6, fasted state

60%

Sustained

Reduction

in

sUA

After

a

Single

Dose

of

RDEA3170

40

mg

0

12

24

36

48

60

72

Time (hr)

-80

-70

-60

-50

-40

-30

-20

-10

0

CANCER

43

Nexavar

MEK

Ras

Raf

c-Myc

Herceptin, Erbitux

Proliferation

Angiogenesis

Differentiation

Apoptosis

cPLA2

PDE4

MNK1/2

Elk-1

MAPKAPK1/3

BAY86-9766

(RDEA119)

RTK

Bcl-2

Mcl-1

c-Jun

Tarceva

GF

ERK2

ERK2

44

BAY80-6946

The Age of Targeted Cancer Treatments

mTOR

AKT

PI3K

MEK1/2 Enzyme IC

50

17-50 nM

Cellular pERK EC

50

2.5-8.7 nM*

>100-fold selectivity in kinase panel of 205 enzymes at 10 µM**

*Cell lines: Colo205, A375, A431, HT-29

** In-house data

MEK1 & MEK2

40

60

80

100

45

RDEA119 is Potent, Highly Specific MEK

Inhibitor

1

6

11

16

21

26

31

0

20

1

6

11

16

21

26

31

0

20

40

60

80

100

MEK1 & MEK2

Ron

SRC

46

0

20

40

60

80

100

120

control

Sorafenib-

3.5uM

RDEA119-

0.1uM

RDEA119

+Sorafenib

Huh7, day 6

control

Sorafenib-3.5uM

RDEA119 -

0.25uM

RDEA119

+Sorafenib

HepG2, day 6

Synergy between RDEA119 and Sorafenib in

Hepatoma Cancer Lines

A Phase 2 Trial of BAY86-9766 Plus Sorafenib as First Line Systemic

Treatment for Hepatocellular Carcinoma (HCC)

A Multi-center, Phase 1/2 Study of BAY86-9766 in Combination With

Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic

Pancreatic Cancer

Phase 1b Trial of the Combination of PI3K Inhibitor BAY80-6946 and

Allosteric-MEK Inhibitor BAY86-9766 in Subjects With Advanced Cancer

Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With

Advanced or Refractory Solid Tumors

First data expected mid-2012

47

*Further details are available on www.clinicalTrials.gov and www.bayerpharma.com/en/research_and_development/clinical_trials

Current Bayer Clinical Trials with BAY86-9766*

MEK program licensed to Bayer HealthCare on April 27, 2009

–

$35 million upfront license fee

–

$15 million milestone received January 2011 for initiation of Phase 2

study in primary liver cancer by Bayer (NCT01304177)

–

Bayer has also initiated a Phase 1/2 combination study with

gemcitabine in advanced pancreatic cancer (NCT01251640)

–

Additional $7.5 million milestone due upon initiation of a second

Phase 2 study in a different indication

–

Payments could total $407 million, excluding royalties

–

Low double-digit royalties on worldwide sales

48

MEK Inhibitor Program

26.8 million common shares outstanding

Summary Statement of Operations

(In thousands, except per share data)

Nine Months Ended

September 30, 2011

Revenue

Operating expenses

Other income, net

$       5,636

61,460

17

NET LOSS

$(55,807)

NET LOSS PER SHARE

$(2.11)

Condensed Balance Sheet Data

(In thousands)

September 30,

2011

Dec. 31, 2010

Cash, cash equivalents & ST invest

Receivables

Total assets

Total stockholders’

equity

$122,732

$1,918

$129,795

$109,550

$80,612

$16,959

$100,454

$77,123

49

Financial Position