bristol myerd squibb European Association for the Study of Diabetes (EASD) Highlights

1Not For Promotional UseNot For Promotional Use

EASD 2008 HighlightsEASD 2008 HighlightsInvestor Teleconference

Sept 9, 2008Investor Teleconference

Sept 9, 2008


Comments will be about the CompanyComments will be about the Company’’s future plans and s future plans and prospects that may be forwardprospects that may be forward--looking statements under looking statements under thethe Private Securities Litigation Reform Act of 1995.Private Securities Litigation Reform Act of 1995.We caution that actual results may differ materially from We caution that actual results may differ materially from those indicated by these forwardthose indicated by these forward--looking statements aslooking statements asa result of various important factors, including those a result of various important factors, including those discussed in the Companydiscussed in the Company’’s most recent annual report on s most recent annual report on Form 10Form 10--K, periodic reports on Form 10K, periodic reports on Form 10--Q and current Q and current reports on Form 8reports on Form 8--K. These documents are available from K. These documents are available from the SEC, the Bristolthe SEC, the Bristol--Myers Squibb web site or fromMyers Squibb web site or fromBristolBristol--Myers Squibb Investor Relations. While we may elect Myers Squibb Investor Relations. While we may elect to update forwardto update forward--looking statements at some point in the looking statements at some point in the future, we specifically disclaim any obligation to do so,future, we specifically disclaim any obligation to do so,even if our estimates change. even if our estimates change.


Diabetes: A Growing, Global ProblemDiabetes: A Growing, Global Problem

Source: WHOSource: WHO

Type 2 Diabetes prevalence expected to grow Type 2 Diabetes prevalence expected to grow from 190 million to 330 million by 2030from 190 million to 330 million by 2030

3

Mexico Mexico –– highest highest prevalence rates in prevalence rates in

the world: 12.4%the world: 12.4%India and China will make up India and China will make up

nearly 50% of the total nearly 50% of the total number of patients with number of patients with

diabetes in 2030diabetes in 2030

Europe prevalence is Europe prevalence is lower (~4.6%), but lower (~4.6%), but

increasing, especially in increasing, especially in the southern countriesthe southern countries

Diabetes growing rapidly Diabetes growing rapidly in U.S. in U.S. –– current current

prevalence rate 6.7%prevalence rate 6.7%


Majority of Patients Are Not Optimally Majority of Patients Are Not Optimally ControlledControlled

Source: Adelphi, 2006 Disease SpecificProgrammes, NHWS 2006

6469

5851

6257

0

20

40

60

80

100

Patie

nts

(%)

60% of US diabetic

patients do not know their A1c or FPG values

USUS UKUK FRFR GERGER ITLITL SPNSPN

Percentage of patients not controlled,Percentage of patients not controlled,by market (relative to HbAby market (relative to HbA1c1c Target of 7.0%) Target of 7.0%)


The Progressive Nature of Type 2 Diabetes The Progressive Nature of Type 2 Diabetes Ultimately Overwhelms MedicationsUltimately Overwhelms Medications

Glycemic Control in an Illustrative Patient

HbA

1c Goal*A1c=<7Goal*Goal*

A1c=<7A1c=<7

Normal***A1c=5%

Normal***Normal***A1c=5%A1c=5%

Goal**A1c=<6.5

Goal**Goal**A1c=<6.5A1c=<6.5

5yrs

~30 Years~30 Years

Slope =

0.75% per 5

yrs.

Potential Potential treatment treatment changechange

FirstAgent

Sources: ADOPT, UKPDS(*) According to the ADA; (**) according to the AACE/ACE;(***) according to the NIH

There remains a need for new therapiesThere remains a need for new therapies


EASD 2008: DapagliflozinEASD 2008: DapagliflozinData on dapagliflozin was presented from the largest and longestData on dapagliflozin was presented from the largest and longest(12 weeks) trial of an SGLT2 Renal Glucose Reabsorption Inhibito(12 weeks) trial of an SGLT2 Renal Glucose Reabsorption Inhibitor r to date. Results demonstrated that dapagliflozin:to date. Results demonstrated that dapagliflozin:

Induced controlled Induced controlled glucosuriaglucosuria

Improved glycemic controlImproved glycemic control–– Reduced fasting glucoseReduced fasting glucose–– Reduced postprandial glucoseReduced postprandial glucose–– Reduced HbA1cReduced HbA1c

Lowered weightLowered weight

Showed little propensity to cause hypoglycemiaShowed little propensity to cause hypoglycemia

Demonstrated no clear adverse safety or tolerability signals Demonstrated no clear adverse safety or tolerability signals over 12 weeksover 12 weeks

Phase 2 Study, EASD Sept 2008Phase 2 Study, EASD Sept 2008


Saxagliptin OverviewSaxagliptin Overview

Specifically designed to be a selective inhibitor Specifically designed to be a selective inhibitor with extended binding to the DPPwith extended binding to the DPP--4 enzyme4 enzyme

Completed Phase 3 registrational programCompleted Phase 3 registrational program

New Drug Application officially filed by the FDANew Drug Application officially filed by the FDA

Marketing Authorization Application accepted for Marketing Authorization Application accepted for review by the EMEA review by the EMEA


Patient Exposures Throughout Patient Exposures Throughout Saxagliptin ProgramSaxagliptin Program

Phase 1 and 2Phase 1 and 2~110 subjects exposed to saxagliptin at 20~110 subjects exposed to saxagliptin at 20--80x the80x the5 mg dose for up to 6 weeks5 mg dose for up to 6 weeks~670 subjects exposed to saxagliptin at 2~670 subjects exposed to saxagliptin at 2--10x the10x the5 mg dose for up to 12 weeks5 mg dose for up to 12 weeks

Phase 3 Phase 3 ~1000 patients treated at 10 mg dose for up to 2 years~1000 patients treated at 10 mg dose for up to 2 years>3000 patients treated at any dose in Phase 3>3000 patients treated at any dose in Phase 3


Saxagliptin Profile is CompetitiveSaxagliptin Profile is Competitive

Produced significant reductions in all key Produced significant reductions in all key measures of glucose control in treatment nameasures of glucose control in treatment naïïve ve patients and patients treated with commonly patients and patients treated with commonly used oral agentsused oral agents

Generally well tolerated in clinical trials across Generally well tolerated in clinical trials across all usage situationsall usage situations–– Clinical correlates to the skin lesions in monkeys Clinical correlates to the skin lesions in monkeys

have not been identified in human clinical trials have not been identified in human clinical trials of saxagliptinof saxagliptin

Life cycle program underwayLife cycle program underway


*MET IR titration: Forced titration from 500 mg to 1000 mg at wk*MET IR titration: Forced titration from 500 mg to 1000 mg at wk 1, then elective titration at wks 2, 3, 4, and 1, then elective titration at wks 2, 3, 4, and 5 to achieve mean fasting plasma glucose (FPG) 5 to achieve mean fasting plasma glucose (FPG) <110 mg/dL (maximum MET 2000 mg total daily dose).<110 mg/dL (maximum MET 2000 mg total daily dose).††If rescue criteria met in short term, add pioglitazone 15If rescue criteria met in short term, add pioglitazone 15--45 mg o.d. and enter long45 mg o.d. and enter long--term phase; pioglitazone term phase; pioglitazone rescue also available in longrescue also available in long--term extension.term extension.

Treatment-Naïve T2D

(HbA1C ≥8%-≤12%)

PBO + MET IR (with titration)*†

SAXA 5 mg + MET IR (with titration)*†

Superiority TestSuperiority Test

24 Wks N=1306

SAXA 10 mg + PBO†

SAXA 10 mg + MET IR (with titration)*†

1 Wk PBO

Lead-in

Superiority TestSuperiority Test

Phase 3 Study Phase 3 Study --039, EASD Sept 2008039, EASD Sept 2008

Saxagliptin Initial Combination with Saxagliptin Initial Combination with Metformin Design: EASD 2008Metformin Design: EASD 2008


-2.5 -2.5

-1.7-2.0

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

HbAHbA1C1C Adjusted Mean Changes fromAdjusted Mean Changes fromBaseline at Week 24*Baseline at Week 24*

**LOCF=last observation carried forwardLOCF=last observation carried forward††PP<<.0001 vs Saxa 10 mg.0001 vs Saxa 10 mg‡‡PP<.0001 vs Met<.0001 vs Met

ΔΔ HbAHbA1C1C (%)(%)with 95% CIwith 95% CI

DoseDose 5 + Met5 + Met 10 + Met10 + Met 1010 MetMetn =n = 306306 315315 317317 313313

Baseline mean (%) Baseline mean (%) 9.49.4 9.59.5 9.69.6 9.49.4

†‡ †‡


Saxagliptin (mg)Saxagliptin (mg)


0

20

40

60

Patients Achieving Therapeutic Glycemic Patients Achieving Therapeutic Glycemic Response (HbAResponse (HbA1C1C ≤≤6.5% and <7%) at Week 24* 6.5% and <7%) at Week 24*

PatientsPatientsAchievingAchievingGlycemicGlycemic

Response (%) Response (%) withwith 95% CI95% CI

*LOCF*LOCF††PP<.0001 vs Saxa 10 mg and vs Met<.0001 vs Saxa 10 mg and vs Met‡‡P P <.0001 vs Saxa 10 mg and <.0001 vs Saxa 10 mg and PP =.0026 vs Met=.0026 vs Met

45.3† 60.3† 40.6‡ 20.3 29.0 41.132.259.7†

Saxa 5 mgSaxa 5 mg+ Met+ Met

n = 307n = 307

Saxa 10 mgSaxa 10 mg+ Met+ Met

n = 315n = 315

Saxa 10 mgSaxa 10 mgn = 320n = 320

MetMetn = 314n = 314

≤6.5% <7.0% ≤6.5% ≤6.5% ≤6.5%<7.0% <7.0% <7.0%



-3.3

-1.9

-1.1

-2.5

-3.3

-2.0

-1.0

-2.5 -2.5

-1.5-1.2

-0.5

-2.0

-1.4

-2.7

-1.0

-4.0

-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

HbAHbA1C1C Adjusted Mean Change:Adjusted Mean Change:Subgroup Analysis by Baseline HbASubgroup Analysis by Baseline HbA1C1C

<8% ≥8%-<9% ≥9%-<10% ≥10%


Saxagliptin + MetSaxagliptin + Met

MetMet5 mg5 mg 10 mg10 mg Saxa 10 mgSaxa 10 mg

ΔΔH

bAHbA

1C1C(( %

) %

) with

95%

CI

with

95%

CI

Baseline HbABaseline HbA1C1C


-60 -62

-31

-47

-70

-60

-50

-40

-30

-20

-10

0

FPG Adjusted Mean Changes fromFPG Adjusted Mean Changes fromBaseline at Week 24* Baseline at Week 24*

ΔΔ FPG (mg/dL)FPG (mg/dL)with 95% CIwith 95% CI

Dose 5 + Met 10 + Met 10 Metn = 315 317 327 320

Baseline mean (mg/dL) 198.9 204.3 200.9 199.1

*LOCF*LOCF††PP<<.0001 vs Saxa 10 mg.0001 vs Saxa 10 mg‡‡PP=.0002 vs Met=.0002 vs Met§§PP<.0001 vs Met<.0001 vs Met

†‡† §


Saxagliptin (mg)Saxagliptin (mg)


Most Common (Most Common (≥≥5%) Reported 5%) Reported Adverse EventsAdverse Events

Saxa 5 mg Saxa 5 mg + Met+ Metn=320n=320

Saxa 10 mg Saxa 10 mg + Met+ Metn=323n=323

SaxaSaxa10 mg10 mgn=335n=335

MetMetn=328n=328

Total patients with Total patients with at least 1 AE, n (%)at least 1 AE, n (%) 177 (55.3)177 (55.3) 185 (57.3)185 (57.3) 179 (53.4)179 (53.4) 192 (58.5)192 (58.5)

NasopharyngitisNasopharyngitis 22 (6.9)22 (6.9) 8 (2.5)8 (2.5) 14 (4.2)14 (4.2) 13 (4.0)13 (4.0)

HeadacheHeadache 24 (7.5)24 (7.5) 32 (9.9)32 (9.9) 21 (6.3)21 (6.3) 17 (5.2)17 (5.2)

DiarrheaDiarrhea 22 (6.9)22 (6.9) 31 (9.6)31 (9.6) 10 (3.0)10 (3.0) 24 (7.3)24 (7.3)

HypertensionHypertension 15 (4.7)15 (4.7) 17 (5.3)17 (5.3) 15 (4.5)15 (4.5) 11 (3.4)11 (3.4)



ConclusionsConclusions

Saxagliptin, given in combination with metformin as Saxagliptin, given in combination with metformin as initial therapy, led to clinically relevant improvements initial therapy, led to clinically relevant improvements that were significantly greater than either treatment that were significantly greater than either treatment alone across all key glycemic parameters studied alone across all key glycemic parameters studied including:including:

–– HbAHbA1C1C

–– FPG FPG –– Proportion of patients with HbAProportion of patients with HbA1C1C <7%<7%–– PPG during OGTT PPG during OGTT

Saxagliptin, given in combination with metformin as Saxagliptin, given in combination with metformin as initial therapy, was well tolerated over the course of the initial therapy, was well tolerated over the course of the studystudy



Stable Dose TZD†‡ ≥12 WkT2D

HbA1c ≥7.0%–≤10.5%

PBO + TZD*

24 Wk (N=565)

*If rescue criteria met in short-term phase, add metformin 500–2500 mg total daily dose, and enter LTE phase; metformin rescue was also available in the LTE phase. †Stable dose of TZD defined as pio 30 or 45 mg total daily dose or rosi 4 or 8 mg total daily dose. TZD dose at entry fixed for duration of study. ‡If determined to be medically appropriate, a switch from rosi to pio was permitted.

12 Months LTE

SAXA 5 mg o.d. + TZD*

PBO + TZD*

SAXA 5 mg o.d. + TZD*

Superiority

SAXA 2.5 mg o.d. + TZD* SAXA 2.5 mg o.d. + TZD*

Superiority

2-Wk TZD + PBO Lead-in

[CSR Fig 3.1]

Saxagliptin AddSaxagliptin Add--on TZD Study Design: on TZD Study Design: EASD 2008EASD 2008



-0.7

-0.9

-0.3

-1.1

-0.9

-0.7

-0.5

-0.3

-0.1

DoseDose 2.52.5 55 Pbo + TZDPbo + TZDn =n = 192192 183183 180180

8.198.19Baseline MeanBaseline Mean 8.258.25 8.358.35

HbAHbA1C1C Adjusted Mean Change from BaselineAdjusted Mean Change from Baselineat Week 24 (LOCF)at Week 24 (LOCF)

Saxagliptin (mg) + TZDSaxagliptin (mg) + TZD

Sour

ce:

CV

1810

13 –

Figu

re 7

.2.1

A


ΔΔ HbAHbA1C 1C (%)(%)with 95% CIwith 95% CI

p = .0007p = .0007

p <.0001p <.0001


Fasting Plasma Glucose Adjusted Mean Fasting Plasma Glucose Adjusted Mean Change from Baseline at Week 24 (LOCF)Change from Baseline at Week 24 (LOCF)

Sour

ce:

CV

1810

13 –

Figu

re 7

.3.1

A

ΔΔ FPG (mg/dL)FPG (mg/dL)with 95% CIwith 95% CI

Saxagliptin (mg) + TZDSaxagliptin (mg) + TZDDoseDose 2.52.5 55 Pbo + TZDPbo + TZD

n =n = 193193 185185 181181162.4162.4Baseline Mean (mg/dL)Baseline Mean (mg/dL) 163.0163.0 159.5159.5

-14.3-17.3

-2.8

-25.0

-20.0

-15.0

-10.0

-5.0

0.0

5.0


p = .0053p = .0053

p = .0005p = .0005


Postprandial Glucose AUC Adjusted Mean Postprandial Glucose AUC Adjusted Mean Change from Baseline at Week 24 (LOCF)Change from Baseline at Week 24 (LOCF)

CV

1810

13 –

Figu

re 7

.3.3

ΔΔ PPG AUCPPG AUC(mg(mg minmin/dL)/dL)with 95% CIwith 95% CI

-7849

-9269

-2690

-12000

-10000

-8000

-6000

-4000

-2000

0

Saxagliptin (mg) + TZDSaxagliptin (mg) + TZDDoseDose 2.52.5 55 Pbo + TZDPbo + TZD

n =n = 151151 131131 12312347256 47256 Baseline MeanBaseline Mean

(mg(mg min/dL)min/dL)4830148301 4786647866


p <.0001p <.0001

p <.0001p <.0001


Most Common (Most Common (≥≥5%) Reported Adverse Events 5%) Reported Adverse Events During 24During 24--Week TreatmentWeek Treatment


Saxa 2.5 mg Saxa 2.5 mg + TZD+ TZD

N = 195N = 195

Saxa 5 mg Saxa 5 mg + TZD+ TZD

N = 186N = 186

All Saxa All Saxa + TZD+ TZD

N = 381N = 381Pbo + TZDPbo + TZD

N = 184N = 184Total subjects with AETotal subjects with AE 121 (62.1)121 (62.1) 138 (74.2)138 (74.2) 259 (68.0)259 (68.0)

32 (8.4)32 (8.4)

19 (5.0)19 (5.0)15 (3.9)15 (3.9)16 (4.2)16 (4.2)

HeadacheHeadache 9 (4.6)9 (4.6) 10 (5.4)10 (5.4) 19 (5.0)19 (5.0) 7 (3.8)7 (3.8)DizzinessDizziness 5 (2.6)5 (2.6) 6 (3.2)6 (3.2) 11 (2.9)11 (2.9) 10 (5.4)10 (5.4)Oedema peripheralOedema peripheral 6 (3.1)6 (3.1) 15 (8.1)15 (8.1) 21 (5.5)21 (5.5) 8 (4.3)8 (4.3)HypertensionHypertension 11 (5.6)11 (5.6) 8 (4.3)8 (4.3) 19 (5.0)19 (5.0) 9 (4.9)9 (4.9)

123 (66.8)123 (66.8)Adverse Events (Adverse Events (≥≥ 5%)5%)

Upper respiratory tract Upper respiratory tract infectioninfection 15 (7.7)15 (7.7) 17 (9.1)17 (9.1) 13 (7.1)13 (7.1)

Urinary tract infectionUrinary tract infection 7 (3.6)7 (3.6) 12 (6.5)12 (6.5) 12 (6.5)12 (6.5)

Arthralgia or joint painArthralgia or joint pain 11 (5.6)11 (5.6) 5 (2.7)5 (2.7) 5 (2.7)5 (2.7)NasopharyngitisNasopharyngitis 6 (3.1)6 (3.1) 9 (4.8)9 (4.8) 11 (6.0)11 (6.0)


ConclusionsConclusionsIn patients with type 2 diabetes not achieving In patients with type 2 diabetes not achieving glycemic control on TZD monotherapy, the glycemic control on TZD monotherapy, the addition of saxagliptin provided statistically addition of saxagliptin provided statistically significant and clinically meaningful significant and clinically meaningful improvements in the key parameters of glycemic improvements in the key parameters of glycemic control.control.Significantly more patients achieved the HbASignificantly more patients achieved the HbA1C1Ctarget of <7% at week 24 with saxagliptin added to target of <7% at week 24 with saxagliptin added to TZD therapy TZD therapy vsvs TZD monotherapy.TZD monotherapy.Over 24 weeks, the combination of saxagliptin Over 24 weeks, the combination of saxagliptin and TZD was generally well tolerated.and TZD was generally well tolerated.



Saxagliptin AddSaxagliptin Add--on SU Study Design: on SU Study Design: EASD 2008EASD 2008

T2DSU Monotherapy≥2 months

Submaximal SU

HbA1c ≥7.5%–≤10.0%to Enroll

MFPG ≥140 mg/dL or MFWBG ≥131 mg/dL and HbA1c ≥7.0% to Randomize

GLY 7.5 mg o.d. + SAXA 5 mg o.d.†

UP-GLY 10/15 mg* o.d. + PBO†

Superiority

4 Weeks

GLY 7.5 mg +PBO Lead-in

24 Weeks (N=768)

••92% reached maximum allowed dose of Glyburide in the short term 92% reached maximum allowed dose of Glyburide in the short term phase (UPphase (UP--GLY) GLY) -- per the protocol titration per the protocol titration criteriacriteria

†If rescue criteria was met in short-term phase, add metformin 500–2500 mg TDD and enter LTE phase;metformin rescue also available in the LTE phase.

MFPG = mean fasting plasma glucose; MFWBG = mean fasting whole blood glucose; o.d. = once daily.

GLY 7.5 mg o.d. + SAXA 2.5 mg o.d.†

Superiority

GLY 7.5 mg o.d. + SAXA 5 mg o.d.†

UP-GLY 10/15/20 mg* o.d. + PBO†

GLY 7.5 mg o.d. + SAXA 2.5 mg o.d.†

12 Months LTE



-0.5-0.6

+0.1

-0.8

-0.6

-0.4

-0.2

0.0

0.2

DoseDose 2.52.5 55 Pbo + UPPbo + UP--GlyGlyn =n = 246246 250250 264264

8.448.44Baseline MeanBaseline Mean 8.368.36 8.488.48

HbAHbA1C1C Adjusted Mean Change from BaselineAdjusted Mean Change from Baselineat Week 24 (LOCF)at Week 24 (LOCF)

ΔΔ HbAHbA1C 1C (%)(%)with 95% CIwith 95% CI

Saxagliptin (mg) + GlySaxagliptin (mg) + Gly

Sour

ce:

CV

1810

40 –

Figu

re 7

.2.1

A


p <.0001p <.0001

p <.0001p <.0001


Fasting Plasma Glucose Adjusted Mean Fasting Plasma Glucose Adjusted Mean Change from Baseline at Week 24 (LOCF)Change from Baseline at Week 24 (LOCF)

Sour

ce:

CV

1810

40 –

Figu

re 7

.3.1

A

ΔΔ FPG (mg/dL)FPG (mg/dL)withwith 95% CI95% CI

Saxagliptin (mg) + GlySaxagliptin (mg) + GlyDoseDose 2.52.5 55 Pbo + UPPbo + UP--GlyGly

n =n = 247247 252252 265265174.4174.4Baseline Mean (mg/dLBaseline Mean (mg/dL)) 170.1170.1 175.0175.0

-7.1

-9.7

0.7

-15.0

-10.0

-5.0

0.0

5.0


p = .0218p = .0218

p = .0020p = .0020


Postprandial Glucose AUC Adjusted Mean Postprandial Glucose AUC Adjusted Mean Change from Baseline at Week 24 (LOCF)Change from Baseline at Week 24 (LOCF)

CV

1810

40 –

Figu

re 7

.3.3

ΔΔ PPG AUCPPG AUC(mg(mg minmin/dL)/dL)with 95% CIwith 95% CI

-4296-5000

1196

-6500

-4500

-2500

-500

1500

Saxagliptin (mg) + GlySaxagliptin (mg) + GlyDoseDose 2.52.5 55 Pbo + UPPbo + UP--GlyGly

n =n = 190190 195195 20420451801 51801 Baseline MeanBaseline Mean

(mg(mg min/dL)min/dL)4912449124 5034250342


p <.0001p <.0001p <.0001p <.0001


Most Common (Most Common (≥≥5%) Reported Adverse Events 5%) Reported Adverse Events During 24During 24--Week TreatmentWeek Treatment

•• Hypoglycemic events were reported in 13.3% [33/248], 14.6% [37/2Hypoglycemic events were reported in 13.3% [33/248], 14.6% [37/253] of subjects in the 53] of subjects in the SAXA 2.5SAXA 2.5--mg & 5mg & 5--mg treatment groups vs Upmg treatment groups vs Up--Gly (10.1% [27/267]). The differences were Gly (10.1% [27/267]). The differences were not statistically significantnot statistically significant


Saxa 2.5 mgSaxa 2.5 mg+ Gly+ Gly

N = 248N = 248

Saxa 5 mgSaxa 5 mg+ Gly+ Gly

N = 253N = 253

All Saxa All Saxa + Gly+ Gly

N = 501N = 501

PboPbo+ Up+ Up--GlyGlyN = 267N = 267

Total subjects with AETotal subjects with AE 186 (75.0)186 (75.0) 183 (72.3)183 (72.3) 369 (73.7)369 (73.7)

40 (8.0)40 (8.0)29 (5.8)29 (5.8)

27 (5.4)27 (5.4)

23 (4.6)23 (4.6)DiarrhoeaDiarrhoea 14 (5.6)14 (5.6) 10 (4.0)10 (4.0) 24 (4.8)24 (4.8) 14 (5.2)14 (5.2)Back painBack pain 12 (4.8)12 (4.8) 15 (5.9)15 (5.9) 27 (5.4)27 (5.4) 12 (4.5)12 (4.5)Pain in extremityPain in extremity 11 (4.4)11 (4.4) 9 (3.6)9 (3.6) 20 (4.0)20 (4.0) 15 (5.6)15 (5.6)HeadacheHeadache 19 (7.7)19 (7.7) 19 (7.5)19 (7.5) 38 (7.6)38 (7.6) 15 (5.6)15 (5.6)CoughCough 13 (5.2)13 (5.2) 10 (4.0)10 (4.0) 23 (4.6)23 (4.6) 13 (4.9)13 (4.9)HypertensionHypertension 9 (3.6)9 (3.6) 16 (6.3)16 (6.3) 25 (5.0)25 (5.0) 6 (2.2)6 (2.2)

*Excludes Hypoglycemia*Excludes Hypoglycemia

205 (76.8)205 (76.8)Adverse Events (Adverse Events (≥≥5%)* 5%)*

Urinary tract infectionUrinary tract infection 13 (5.2)13 (5.2) 27 (10.7)27 (10.7) 22 (8.2)22 (8.2)NasopharyngitisNasopharyngitis 14 (5.6)14 (5.6) 15 (5.9)15 (5.9) 18 (6.7)18 (6.7)

InfluenzaInfluenza 13 (5.2)13 (5.2) 10 (4.0)10 (4.0) 16 (6.0)16 (6.0)

Upper respiratory tract Upper respiratory tract infectioninfection 11 (4.4)11 (4.4) 16 (6.3)16 (6.3) 18 (6.7)18 (6.7)


ConclusionsConclusionsIn patients with type 2 diabetes not achieving glycemic control In patients with type 2 diabetes not achieving glycemic control on submaximal doses of glyburide monotherapy, the additionon submaximal doses of glyburide monotherapy, the additionof saxagliptin once daily provided statistically significant andof saxagliptin once daily provided statistically significant andclinically meaningful reductions in the key parameters of clinically meaningful reductions in the key parameters of glycemic control in contrast to upglycemic control in contrast to up--titrated glyburide titrated glyburide monotherapy.monotherapy.More than twice as many patients treated with the combination More than twice as many patients treated with the combination of saxagliptin and submaximal dose of glyburide achieved of saxagliptin and submaximal dose of glyburide achieved target HbA1c <7.0% compared with uptarget HbA1c <7.0% compared with up--titrated glyburide.titrated glyburide.Improvements in glycemic parameters with the addition of Improvements in glycemic parameters with the addition of saxagliptin to a submaximal dose of glyburide were achieved saxagliptin to a submaximal dose of glyburide were achieved without any significant increases in hypoglycemia.without any significant increases in hypoglycemia.The administration of saxagliptin in combination with The administration of saxagliptin in combination with submaximal doses of glyburide for up to 24 weeks was submaximal doses of glyburide for up to 24 weeks was generally well tolerated.generally well tolerated.



Saxagliptin Conclusion Saxagliptin Conclusion –– EASD HighlightsEASD HighlightsClinically Meaningful Reductions inClinically Meaningful Reductions inAll Key Measures of Glucose Control StudiedAll Key Measures of Glucose Control Studied

Given in combination with metformin as an initial therapy, 5mg Given in combination with metformin as an initial therapy, 5mg saxagliptin demonstrated A1c reductions of 2.5% from baseline saxagliptin demonstrated A1c reductions of 2.5% from baseline

–– In patients with very high (In patients with very high (≥≥10%) A1c10%) A1c’’s, saxagliptin 5mg plus s, saxagliptin 5mg plus metformin demonstrated A1c reductions of 3.3% from metformin demonstrated A1c reductions of 3.3% from baselinebaseline

When added to TZD, saxagliptin 5mg demonstrated A1c reduction When added to TZD, saxagliptin 5mg demonstrated A1c reduction of 0.9% from baseline of 0.9% from baseline

When given in combination with an SU, saxagliptin 5mg When given in combination with an SU, saxagliptin 5mg demonstrated A1c reduction of 0.6%demonstrated A1c reduction of 0.6%

–– No statistically significant increase in hypoglycemiaNo statistically significant increase in hypoglycemia

Saxagliptin also produced significant reductions in FPG and PPGSaxagliptin also produced significant reductions in FPG and PPG

Saxagliptin was well tolerated in all usage situationsSaxagliptin was well tolerated in all usage situations


EASD 2008 HighlightsEASD 2008 HighlightsInvestor Teleconference

Sept 9, 2008Investor Teleconference

Sept 9, 2008

Economy & Finance

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