BIO Investor Forum, San Francisco October 18-19...

BIO Investor Forum, San Francisco

October 18-19 2006

2IDM © 2006

This presentation includes forwardThis presentation includes forward--looking statements that reflect management's looking statements that reflect management's current views of future eventscurrent views of future events such as statements about the expected timing of such as statements about the expected timing of milestone events, the potential therapeutic benefits of and expemilestone events, the potential therapeutic benefits of and expected commercial cted commercial plans for our product candidates, and our strategic goals. Actuaplans for our product candidates, and our strategic goals. Actual results may differ l results may differ materially due to a number of important factors, including risksmaterially due to a number of important factors, including risks and uncertainties and uncertainties associated with the timing and cost of clinical development of oassociated with the timing and cost of clinical development of our product ur product candidates, our ability to develop products based on our technolcandidates, our ability to develop products based on our technologies, the ogies, the regulatory review and approval process, the possibility that ourregulatory review and approval process, the possibility that our product candidates product candidates may not show efficacy in clinical testing or may display undesirmay not show efficacy in clinical testing or may display undesirable side effects, able side effects, manufacturing and marketing capabilities, ourmanufacturing and marketing capabilities, our ability to enter into and maintain ability to enter into and maintain collaborations and licenses, dependence upon our collaborators fcollaborations and licenses, dependence upon our collaborators for resources and or resources and product development and commercialization, product development and commercialization, our cash resources and future access our cash resources and future access to capital, and dependence on intellectual property.to capital, and dependence on intellectual property. These and other factors These and other factors are are more fully discussed in IDMmore fully discussed in IDM’’s Quarterly Report on Form 10s Quarterly Report on Form 10--Q filed with the SEC Q filed with the SEC for the second quarter ended June 30, 2006 and other periodic refor the second quarter ended June 30, 2006 and other periodic reports filed with the ports filed with the SEC.SEC. We undertake no obligation to update such forward looking statemWe undertake no obligation to update such forward looking statements except ents except as required by law.as required by law.

Safe Harbor StatementSafe Harbor Statement

3IDM © 2006

MissionMission

IDM is focused on the development of innovative products

that activate the immune system to treat cancer.

Goal: To cure while caring for quality of life

4IDM © 2006

HighlightsHighlights

Lead product completed Phase III in Lead product completed Phase III in OsteosarcomaOsteosarcoma

•• Filing NDA Q4 2006Filing NDA Q4 2006

•• Potential for other indications in oncologyPotential for other indications in oncology

4 additional products in clinical development4 additional products in clinical development

Product and equity partnership with Product and equity partnership with SanofiSanofi--Aventis Aventis

Headquarters in Irvine, CAHeadquarters in Irvine, CA

5IDM © 2006

Fully operational facilities in U.S. and EuropeFully operational facilities in U.S. and Europe

CaliforniaCalifornia FranceFrance

Regulatory certified facilities in Regulatory certified facilities in Irvine and ParisIrvine and Paris

6IDM © 2006

Corporate partnersCorporate partners

7IDM © 2006

Product candidatesProduct candidates

Destroy cancer cells by activating innate immunityPrevent tumor recurrence by triggering a specific adaptive immune response

Two product lines in oncology with the goals to:

8IDM © 2006

To p

reve

nt tu

mor

re

curr

ence

CandidateCandidate IndicationIndication Phase IPhase I Phase IIPhase II Phase IIIPhase III Marketing RightsMarketing Rights

Ph III trial completedJunovan™ Osteosarcoma IDM

Ph II/IIIBexidem® Bladder cancer

IDM

Ph IIUvidem® Melanoma

Ph IIEP-2101 NSC Lung Cancer

IDM

Ph I/ IIColorectal cancer

IDM

(1)

(1) Cambridge Laboratories acquired the distribution rights for UK and Ireland, Genesis Pharma for South East Europe and Medison Pharma for Israel.

Collidem®

To d

estr

oy

canc

er c

ells

Product candidate pipelineProduct candidate pipeline

9IDM © 2006

To p

reve

nt tu

mor

re

curre

nce

First line of products to destroy cancer cellsFirst line of products to destroy cancer cells




IDM



IDM


IDM

(1)


Collidem®

To d

estr

oy

canc

er c

ells

10IDM © 2006

Junovan: Completed Phase III in Junovan: Completed Phase III in osteosarcomaosteosarcoma

Fully synthetic compound Fully synthetic compound

Targeting Targeting osteosarcomaosteosarcoma, , bone cancer in adolescents bone cancer in adolescents

Orphan drug status in EU & U.S. Orphan drug status in EU & U.S.

11IDM © 2006

MuramylMuramyl TripeptideTripeptide--PhosphatidylPhosphatidyl EthanolamineEthanolamine(MTP(MTP--PE)PE)

MTP

PE

JunovanJunovan chemical entitychemical entity

12IDM © 2006

Electron microscopy picture of Electron microscopy picture of a a multilamellarmultilamellar liposome liposome

The The lipophiliclipophilic molecule MTPmolecule MTP--PE is intercalated in the lipid PE is intercalated in the lipid bilayersbilayers at a MTPat a MTP--PE PE phospholipidphospholipid ratio of 1:250ratio of 1:250

JunovanJunovan formulation: formulation: LiposomalLiposomal MTPMTP--PEPE

Nardin A. et al, Current Cancer Drug Targets, 6:561-571, 2006

L-MTP-PE

13IDM © 2006

Junovan activates antiJunovan activates anti--tumor function of tumor function of macrophages through NOD2 receptormacrophages through NOD2 receptor

NOD2Plasma membrane

Cytosol

MDP

Macrophage

TNFa

IL- 1

IL- 8IL- 6

Strober W., Nature Rev Immunol, 6:9-20, 2006

L-MTP-PE

L-MTP-PE

L-MTP-PE

L-MTP-PE

Signaling pathway of NOD2 intracellular receptor1. Junovan (L-MTP-PE) enters into macrophage

2. MTP-P is degraded in MDP (Muramyl Di Peptide)

3. MDP binds to NOD2 receptor,

4. leading to NF-kB release through RICK activation,

5. and secretion of inflammatory cytokines: TNFa, IL- 6, IL- 8, IL- 1

14IDM © 2006

Macrophage ability to kill a tumor cellMacrophage ability to kill a tumor cell

1 hr1 hr

30 min30 min

macrophagemacrophage

tumor celltumor cell

6 hr6 hr

tumor cell debristumor cell debris

15IDM © 2006

LL--MTPMTP--PE PE BiodistributionBiodistribution at 5hoursat 5hours

spleenlungs

nasopharynx

liver

Murray et al., J. Clin. Murray et al., J. Clin. OncolOncol., 1989., 1989

16IDM © 2006

Junovan (Junovan (LL--MTPMTP--PEPE) as single ) as single agent injected IV after agent injected IV after surgical resection of lung surgical resection of lung metastasesmetastases

Limited side effectsLimited side effects

JunovanJunovan: Phase II results in relapsed : Phase II results in relapsed osteosarcomaosteosarcomawith lung metastaseswith lung metastases

0 10 20 30 40 50 60 70 80 90 100 110 120 130 10 20 30 40 50 60 70 80 90 100 110 120 130 140 1500 140 150

1.01.0

0.90.9

0.80.8

0.70.7

0.60.6

0.50.5

0.40.4

0.30.3

0.20.2

0.10.1

0.00.0

Dis

ease

Dis

ease

-- Fre

e Su

rviv

alFr

ee S

urvi

val

MonthsMonths

KleinermanKleinerman ES et al, ES et al, Am.JAm.J. . ClinClin. . OncOnc. 18:93, 1995. 18:93, 1995

17IDM © 2006

Junovan: Phase III Junovan: Phase III osteosarcomaosteosarcoma results results

Overall Survival

Years

Pro

porti

on s

urvi

ving

0 1 2 3 4 5 60.0

0.2

0.4

0.6

0.8

1.0

- Junovan+ Junovan

Disease-Free Survival

Years

Pro

porti

on s

urvi

ving

rela

pse

free

0 1 2 3 4 5 60.0

0.2

0.4

0.6

0.8

1.0

- Junovan+ Junovan

In 664 patients with nonIn 664 patients with non--metastaticmetastatic resectableresectable disease at diagnosisdisease at diagnosis

Phase III trial demonstratedPhase III trial demonstrated relative reduction in the risk of relative reduction in the risk of recurrence of 25% and risk of death of 30%recurrence of 25% and risk of death of 30%

p = 0.030 P = 0.039

Anderson P., Future Oncol.2(3):333Anderson P., Future Oncol.2(3):333--343, 2006, and JCO 23:6437, 2005343, 2006, and JCO 23:6437, 2005

18IDM © 2006

Junovan: Product status Junovan: Product status

Expect to file NDA in 2006, launch anticipated in 2007

Exclusive worldwide sales and marketing rights in U.S. and major part of Europe

Orphan drug designation provides 7 year marketingexclusivity in the U.S. and 10 years in Europe upon approval

Potential for development in other cancer indicationsPotential for development in other cancer indications

19IDM © 2006

Other potential cancer indications Other potential cancer indications

Cancer originating in kidney, breast, ovarian, prostate, colon and melanoma are susceptible to metastasize in lung

Junovan’s mechanism of action provides a rationale for potential benefit in treating patients with lung metastases regardless of the site of the primary tumor

20IDM © 2006

Junovan market potential in Junovan market potential in osteosarcomaosteosarcoma

Approximately 1,000 new patients per year in North America and 1,000 in EU

Increase in survival: 10% at 6 years (from 67.5% to 77.2%)*

Osteosarcoma develops in children and young adolescents; if cured, they can hope to have a normal life expectancy

Pricing and reimbursement will be based on pharmaeconomic analysis

* Nardin A. et al, Current Cancer Drug Targets, 6:561-571, 2006

21IDM © 2006

Thiounn N. et al, J. Urology 168:2373-76, 2002

Bexidem

Product containing activated macrophagesProduct containing activated macrophages

Targeting bladder cancerTargeting bladder cancer

Addresses unmet medical needsAddresses unmet medical needs•• TumorTumor removal, local chemo and BCG removal, local chemo and BCG

therapy of limited benefittherapy of limited benefit

Phase I/II clinical trial completedPhase I/II clinical trial completed

•• TumorTumor occurrences for 17 patients occurrences for 17 patients decreased to 8 from 34 in first year decreased to 8 from 34 in first year afterafter treatmenttreatment

•• No serious side effectsNo serious side effects

BexidemBexidem: Phase II/III clinical trial initiated: Phase II/III clinical trial initiated

22IDM © 2006

Bexidem: Product status Bexidem: Product status

Ongoing Phase II/III clinical trial in Europe

FDA Special Protocol Assessment in June 2006

Interim data analysis expected early 2007

Exclusive worldwide sales and marketing rights

Opportunity to partner with large pharma

More than 60,000 new cases of bladder cancer per year in the U.S.*

* American Cancer Society

23IDM © 2006

To p

reve

nt tu

mor

re

curre

nce




IDM



IDM


IDM

(1)


Collidem®

To d

estr

oy

canc

er c

ells

Second line of products to prevent Second line of products to prevent tumortumor recurrencerecurrence

24IDM © 2006

DendriticDendritic cells induce T cell responsescells induce T cell responses

Lymphoid organ

B

B

TT

T

T

T

T

T T

Lymphocyteactivation

MATUREDendritic cells

T

T

Peripheral tissue

Pathogen

25IDM © 2006

IDM Cell Drug therapy IDM Cell Drug therapy -- an efficient processan efficient process

Outpatient apheresis

Apheresisproduct

Ship Elutriation Purified dendriticcells or MAK

20 doses from 20 doses from one one apheresisapheresis

Ship

Outpatient treatment

Culture with cytokines

7 Days

Proprietary IDM Proprietary IDM ProcessProcess

Wash & concentrate and freeze cells

26IDM © 2006

UvidemUvidem: Partnered with : Partnered with SanofiSanofi--AventisAventis

Cell Drug: Cell Drug: DendriticDendritic cells loaded with melanoma cell cells loaded with melanoma cell lysateslysates

Targeting melanoma Targeting melanoma –– the most deadly form of skin cancerthe most deadly form of skin cancer

Addresses unmet medical needAddresses unmet medical need

Phase I/II trial completed Phase I/II trial completed •• 15 patients with 15 patients with metastaticmetastatic melanomamelanoma

stage III and IVstage III and IV

•• Product wellProduct well--tolerated with notolerated with nomajor associated toxicitymajor associated toxicity

•• Preliminary indications ofPreliminary indications ofeffectiveness observed:effectiveness observed:

11/14 immune responses to vaccine11/14 immune responses to vaccine

2/9 clinical responses with one complete response2/9 clinical responses with one complete response

DC-MEL-01 Pilot Trial

before after

Patient #02Patient #02

Salcedo M. et al, Cancer Immunol Immunother, 2005

27IDM © 2006

Uvidem: Product status Uvidem: Product status

Phase II data in late stage patients presented at ASCO, May 2005

Phase II trial in earlier stage patients ongoing in U.S.

Phase II combination trial in EU started in 2005

Phase III in U.S. and EU expected to start in 2007

Close to 60,000 new melanoma diagnosed in the U.S. per year*

Partnered with Sanofi-Aventis

* American Cancer Society

28IDM © 2006

Key partnership with Key partnership with SanofiSanofi--AventisAventis

SanofiSanofi--Aventis has an option for exclusive worldwide rights Aventis has an option for exclusive worldwide rights on selected products on selected products

IDM receives milestones payments and reimbursement of IDM receives milestones payments and reimbursement of clinical expensesclinical expenses

Manufacturing at IDM and transfer price including royaltiesManufacturing at IDM and transfer price including royalties

First product selected: First product selected: UvidemUvidem, in Phase II for treatment of , in Phase II for treatment of melanomamelanoma

Equity investment of Equity investment of €€20 million in 2002 and 20 million in 2002 and €€10 million in 10 million in December 2004December 2004

29IDM © 2006

CollidemCollidem::DendriticDendritic cells + peptidescells + peptidesTargeting colorectal cancer Targeting colorectal cancer -- the the third most common cause of death third most common cause of death from cancer in the U.S.from cancer in the U.S.Phase I/II clinical trial in the U.S. Phase I/II clinical trial in the U.S. to evaluate immune and clinical to evaluate immune and clinical responses in addition to safety in responses in addition to safety in patients with patients with metastaticmetastaticcolorectalcolorectal cancercancerEnrollment of patients completed, Enrollment of patients completed, results presented at ASCOresults presented at ASCO--GI and GI and ISCT in 2006ISCT in 2006

MultiMulti--epitopeepitope cancer vaccinescancer vaccines

EPEP--2101:2101:Synthetic adjuvant + peptidesSynthetic adjuvant + peptidesTargeting Non Small Cell Lung Targeting Non Small Cell Lung cancercancerOpenOpen--label phase II study; stage label phase II study; stage IIIB, IV or recurrent disease IIIB, IV or recurrent disease Primary endpoint: Safety and Primary endpoint: Safety and overall survivaloverall survivalSecondary endpoint: ProgressionSecondary endpoint: Progression--free survival (tumor response) and free survival (tumor response) and TT--cell responses in patients cell responses in patients

30IDM © 2006

MultiMulti--epitopeepitope product candidate pipelineproduct candidate pipeline

Colorectal (Collidem)

Ovarian Prostate

Breast

Lung (EP2101)

31IDM © 2006

Financial dataFinancial data

Year Ended 6 months ended Year Ended 6 months ended Statement of OperationsStatement of Operations December 31, 2005December 31, 2005 June 30, 2006 June 30, 2006

(Thousands except loss per share)(Thousands except loss per share)Total revenuesTotal revenues $ 8,540$ 8,540 $ 3,141$ 3,141Loss from operationsLoss from operations (40,044)(40,044) (10,349)(10,349)Net lossNet loss (39,209)(39,209) (9,322)(9,322)Loss per shareLoss per share $3.84$3.84 $1.11$1.11

Balance Sheet Balance Sheet As of December 31, 2005As of December 31, 2005 As of June 30, 2006 As of June 30, 2006 (Thousands)(Thousands)

Cash and cash equivalentsCash and cash equivalents $ 26,702$ 26,702 $ 15,941$ 15,941Total assetsTotal assets 42,88742,887 31,87031,870LongLong--term obligationsterm obligations 3,6293,629 3,7113,711Total stockholdersTotal stockholders’’ equityequity 28,74428,744 18,18718,187

32IDM © 2006

Management teamManagement team

HervHervéé Duchesne de Duchesne de LamotteLamotte, MBA, MBAVP, Finance and VP, Finance and

General manager FranceGeneral manager FranceMIT, AT KearneyMIT, AT Kearney

Bonnie Mills, PhDBonnie Mills, PhDVP, Clinical Operations and VP, Clinical Operations and General Manager, U.S. General Manager, U.S. NexellNexell, Baxter, Baxter

JeanJean--Loup Loup RometRomet--LemonneLemonne, MD, MDFounder & CEOFounder & CEOHarvard University,Harvard University,Transfusion Transfusion MerieuxMerieux InnovationInnovation

James Bender, PhDJames Bender, PhD Director Product Development Director Product Development NexellNexell, Baxter, Baxter

Rena Rena JuliarJuliar Director Manufacturing Director Manufacturing NexellNexell, Baxter, Medtronic, Baxter, Medtronic

TungTung KohKoh Senior Senior DirectorDirector, , RegulatoryRegulatory OperationOperation NexellNexell, , EndomedixEndomedix, Baxter, Baxter

Jacques Jacques BartholeynsBartholeyns , PhD, PhD Scientific Director Scientific Director Rockefeller University, Merrell Dow Rockefeller University, Merrell Dow PharmaPharma

33IDM © 2006

Experienced nonExperienced non--executive board membersexecutive board members

Robert Beck, Robert Beck, MDMD VP of Fox Chase Cancer VP of Fox Chase Cancer CenterCenter

Jean Jean DeleageDeleage, , PhDPhD Managing general partner, Alta PartnersManaging general partner, Alta Partners

Don Don DrakemanDrakeman, , JD, PhDJD, PhD CEO of CEO of MedarexMedarex Inc.Inc.

Mike Grey Mike Grey CEO of SGX Pharmaceuticals, Inc.CEO of SGX Pharmaceuticals, Inc.

Sylvie Sylvie GregoireGregoire, , PharmPharm DD Former Former BiogenBiogen Inc. ExecutiveInc. ExecutiveExecutive ChairmanExecutive Chairman and CEO of and CEO of GlycofiGlycofi Inc.Inc.

David David HaselkornHaselkorn, , PhDPhD Former CEO of Former CEO of ClalClal BiotechnologyBiotechnology

John John McKearnMcKearn, , PhDPhD CEO of CEO of KalypsysKalypsys Inc.Inc.

34IDM © 2006

OwnershipOwnership

Directors and Officers

3%Sanofi-Aventis15%

Other62%

Medarex20%

(Direct ownership only, excludes beneficial ownership)

(Including 19% held by Alta Partners, Atlas, Apax, CLAL, Schroders and Sofinnova combined)

35IDM © 2006

Junovan Junovan -- FDA/EMEA NDA filingFDA/EMEA NDA filing

Bexidem Bexidem -- Special Protocol Assessment for Phase II/III Special Protocol Assessment for Phase II/III

Uvidem Uvidem -- complete enrolment of complete enrolment of melanomamelanoma Phase II trial in Phase II trial in Europe Europe

Uvidem Uvidem -- complete enrolment of melanoma Phase II in U.S.complete enrolment of melanoma Phase II in U.S.

CollidemCollidem -- Phase I/II trial results in colorectal cancerPhase I/II trial results in colorectal cancer

EPEP--2101 2101 -- complete Phase II trial enrollment in lung cancercomplete Phase II trial enrollment in lung cancer

2006 expected milestones2006 expected milestones

V

V

V

36IDM © 2006

SummarySummary

Colorectal-Collidem

Ovarian Prostate

Breast

Lung EP2101

CandidateCandidate IndicationIndication Phase Phase II

Phase Phase IIII

Phase IIIPhase III

Ph III trial completedJunovan™ Osteosarcoma



Ph I/IICollidem® Colorectal cancer

Ph I/IIEP-2101 NSC Lung Cancer

www.idm-pharma.comNASDAQ: IDMI

BIO Investor Forum, San Francisco October 18-19...

Documents

Transcript of BIO Investor Forum, San Francisco October 18-19...