25
th
Annual JPMorgan Healthcare Conference
January 10, 2007
Forward Looking Statements
Except for
historical information, the matters contained in this slide presentation may
constitute forward-looking statements that involve risks and uncertainties,
including uncertainties related to product development and clinical trials,
unforeseen safety issues resulting from the administration of antibody
products in patients, uncertainties related to the need for regulatory and
other government approvals, dependence on patents and proprietary technology,
the need for additional capital, uncertainty of market acceptance of
Medarex’s product candidates, the receipt of future payments, the
continuation of business partnerships and other risks detailed from time to
time in Medarex’s filings with the Securities and Exchange Commission (SEC).
All forward-looking statements included in this slide presentation are
based on information available to us as of January 10, 2007. We do not assume
any obligation to update any information contained in these materials. Our
actual results may differ materially from the results discussed in the
forward-looking statements.
Accomplishments in 2006
7 Corporate Partnerships
Ongoing
Vaccine Combo Trial under SPA Fast Track designation Ipilimumab Monotherapy Trial – Enrollment Completion Clinical and
preclinical data Ipilimumab data (multiple settings) at ASCO, EORTC,
ASH 2006 MDX-066 Phase I for C.
difficile at DDW 2006 Valortim™ at IDSA 2006 Multiple Clinical Trial Initiations 7 IND Filings 2 proprietary
(MDX-1388, MDX-1106) 5 from partners (Amgen, ImClone Systems, NovImmune,
Undisclosed) Initiation of Chemotherapy Combo Trial under SPA Initiation of
Monotherapy Trial under SPA Advancing
ipilimumab toward commercialization
P
P
P
P
P
P
P
P
P
P
P
P
* Source: “2006
Industry Dynamics: Lessons to be Learned” report (Decision Resources,
December 2006).
Antibody Appeal “Many monoclonal antibodies are as good as gold – the technology
is hot and will remain so in the foreseeable future” *
Antibody Appeal – Estimated Worldwide 2006 Sales Over $18 Billion
Sources: Worldwide antibody sales estimate from “2006 Industry
Dynamics: Lessons to be Learned” report (Decision Resources, December 2006).
Antibody statistics from internal company research.
>350 Antibody-based Therapeutics in
Clinical Development ~16% are Fully Human Antibody-based Therapeutics
~10% are from Medarex UltiMAb
®
Technology ~60% of all Fully Human
Antibody-based Therapeutics
The Business Model: Turning Antibodies into Cash Flow
Maximizing the Technology Output
Increasing Stream of New Products Creating Potential Market Opportunities
Proprietary Products
Equity Ownerships
(17% Genmab A/S, 19% IDM Pharma, 60% Celldex)
Cash and Carry Partnerships
Medarex Pipeline: Creating Potential Market Opportunities
22
Phase I Products
6
Phase II or Phase I/II Products
1 Co-Promote and Profit-Share
Phase III Phase III Phase III Phase III
2 Cash & Carry
Milestones / Royalties
2 Double-Digit Royalties* 2 Equity
Interest
* Double-digit royalties on Pfizer
CP-675,206. Up to double-digit royalties ex-North America on Genmab
HuMax-CD4, in addition to equity interest in Genmab.
Ipilimumab (MDX-010) in Melanoma: Broad Registrational Program
Monotherapy (second line) – Fully
Enrolled – DTIC Combination (first line) Vaccine Combination (second line)
BLA submission opportunities beginning
in 2007
Ipilimumab (MDX-010): Monotherapy Second-Line Registrational Study in
Melanoma
150 patient single-arm study in
metastatic melanoma Dosing: 10.0mg/kg every 3 weeks x4, then every 3 months
thereafter Endpoints: best objective response rate (primary); progression and
survival Initiated under SPA – March 2006 Enrollment completed – December
2006
FDA Cancer Monotherapy Approvals in 2
nd
/3
rd
Line Patients
106 6.3 months 25.5% RCC Sutent
145 9.2 months 13.8% Ovarian Doxil
111 4.2 months 10.8% CRC Erbitux*
428 n/a 18.7% Breast Faslodex 5.1
months 11.7 months n/a 17.8 months n/a n/a
Response Duration
283 9.1% NSCLC Alimta 366
15.0% Breast Aromasin 129
15.5% Breast Abraxane Breast
Astrocytoma Breast
Indication
43 54 222
# Patients Treated
22% Temodar 25.6%
Xeloda 14% Herceptin
Overall Response Rate Drug
Sources: Respective product labels. * Approved as monotherapy
for patients intolerant to irinotecan
Ipilimumab (MDX-010): Monotherapy Second-Line Supportive Study in
Melanoma
210 patients with metastatic melanoma
Dosing: 0.3, 3.0 and 10.0mg/kg every 3 weeks x4, then every 3 months
thereafter Endpoints: response rate, response duration, progression-free
survival, survival Enrollment completion expected in 2007
Ipilimumab (MDX-010): Additional Studies in Melanoma
Phase II randomized, double-blind, placebo-controlled with or
without prophylactic oral budesonide
100 patients
expected with metastatic melanoma Endpoints: rate of grade 2,3,4 diarrhea;
assess at week 24 best objective response, disease control rate,
progression-free survival and overall survival
Randomized biomarker study in melanoma
80 patients expected with metastatic melanoma into 3.0 or 10.0
mg/kg groups Endpoints: safety and efficacy; biopsy and immune response
Ipilimumab (MDX-010): DTIC Combination First-Line Registrational Study
in Melanoma
500 patients expected with
metastatic melanoma Dosing: 10.0mg/kg every 3 weeks x4 with DTIC, then
10.0mg/kg ipilimumab every 3 months; or DTIC alone Endpoints: overall
progression-free survival (primary); ongoing analysis for survival Initiated
under SPA – June 2006
Ipilimumab (MDX-010): DTIC Combination Phase II Trial Overall Survival
Data
Censored
data
100% 50% 25%
75% 0%
MDX-010+DTIC
(Median Survival14.8 months) Months after Randomization 0 6 12 18 24
MDX-010 + DTIC
Sources: Abstract #7525, ASCO 2005. Historical DTIC data from
FDA CDER Oncologic Drugs Advisory Committee May 3-4, 2004
Historical DTIC
Historical DTIC
(Median Survival 7.8 months)
Ipilimumab (MDX-010): ASCO 2006 Data Summary
>50% decrease in PSA responses with combination (GVAX,
GM-CSF, chemotherapy) treatments and monotherapy in hormone refractory
prostate cancer
GVAX Phase I
Combo: 5 of 6 at therapeutic doses GM-CSF Phase I Combo: 2 of 3 at
therapeutic dose ± Chemotherapy Phase II: 6 of 44
Prostate:
Evidence of tolerable immune activation (12 months dosing) in
adjuvant setting in resected Stage IIIc or Stage IV melanoma
24 of 25 patients were still alive with 18 months median
follow-up*
Melanoma
Adjuvant:
* Data updated at EORTC-AACR-NCI
Meeting, November 2006.
Bone Scan Improvement in Patient with Partial Response from Prostate
Phase I Trial Combination with GVAX
Ipilimumab (MDX-010): ASCO 2006 Data in Prostate Center
Source: Abstract #2500, ASCO 2006.
15Sept05 29Mar06
Patient with Partial Response from Prostate Phase I Trial Combination
with GVAX
Ipilimumab
(MDX-010): ASCO 2006 Data in Prostate Cancer
Source: Abstract #2500, ASCO 2006.
Ipilimumab (MDX-010): Multiple Commercial Opportunities
Melanoma Monotherapy – 2
nd
line Melanoma Chemo Combo – 1
st
line Melanoma Vaccine Combo – 2
nd
line Melanoma (various) Renal Breast
Pancreatic Prostate (various) Ovarian Lymphoma (various) Additional
Pilot/Investigator Trials
(colon, bladder,
leukemia, NSCLC, others)
BLA Filing Phase III/ Registrational Phase II Phase I
2007
Melanoma – Adjuvant Setting Prostate
Lung Ongoing Studies Expected New Studies in 2007
Golimumab (CNTO
148) –
“The future of anti-TNF therapy”*
Next generation Remicade developed for $5 billion anti-TNF
market “Best-in-class” product – monthly, subcutaneous or IV dosing BLA
filing expected 2007/8
Near-Term Value from Milestones/Royalties: Centocor Phase III Programs
CNTO 1275 – “Outstanding efficacy in psoriasis”**
Anti-IL12/IL23 antibody developed for $1.5 billion psoriasis
market Potential “First-in-Class” product – dosing convenience, subcutaneous
BLA filing expected 2007 * Johnson & Johnson R&D Review Day Webcast
(7/18/06), presentation by Joseph Scodari, Worldwide Chairman,
Pharmaceuticals. Anti-TNF market sales for rheumatoid arthritis from company
press releases. ** Johnson & Johnson R&D Review Day Webcast
(5/26/05); presentation by Jay P. Siegel, President of Centocor Research and
Development, Inc. Psoriasis market sales from Decision Resources Psoriasis
report, September 2006.
Near-Term Value from Equity Ownership: Genmab Phase III Programs
Zanolimumab (HuMax-CD4) in CTCL
Phase III data expected 1H07
Ofatumumab (HuMax-CD20) in CLL and NHL
Phase III data in CLL and NHL expected 2H07 Phase III initiation
in RA expected 2007
Zalutumumab
(HuMax-EGFR) in Head and Neck
Phase III data
(survival study) expected in 2008 Sources: Genmab Research, Development and
Business Update webcast, dated 10/18/06, and company press releases.
Emerging
epidemic in North America*: >300,000 in-patient cases per year of C. difficile acquired diarrhea
(CDAD) Phase II combination initiation – September 2006
Randomized, blinded, placebo-controlled study in 200 patients
Single dose of anti-Toxin A and anti-Toxin B antibodies in combination with
standard of care (SOC) antibiotics vs. SOC Assess acute symptoms and
recurrence of CDAD; duration and severity of symptoms, safety and
tolerability
50:50 partnership with
Massachusetts Biologic Laboratories (MBL) Phase II completion expected 2007
* Sources: McDonald et
al. NEJM. 2005 Dec; 353:2433-2441; Warny et al. Lancet. 2005; 366:1079-1084. Mylonakis et al. Arch Int Med. 2001;
161:525-533.
Strong
& Diversified Pipeline: MDX-066 and MDX-1388 C. difficile HuMAbs
MDX-060 Phase
II gemcitabine combination in ~60 patients with Hodgkin’s disease (HD)
Data expected in 2H07/1H08
MDX-1401 second-generation antibody with enhanced effector
function (ADCC) for Hodgkin’s disease
Nonfucosylation
with BioWa Potelligent™ technology
MDX-1401 Phase
I dose-escalation in up to 36 patients with Hodgkin’s disease
IND filed – January 2007
Strong & Diversified Pipeline: Anti-CD30 HuMAb Program
MDX-060 MDX-1401 Isotype control MAb
MDX-1401 Mediates Enhanced ADCC
Activity Compared to First-Generation Antibody (MDX-060)
Enhanced Efficacy & Potency
Karpas 299 target cells
PD-1
(programmed death-1) is a T cell receptor involved in evasion of immune
surveillance
High expression indicative of T
cell exhaustion in HIV infection
Phase I
underway in solid tumors – Phase II initiation expected 2H07 New potential
opportunities in multiple settings
Infectious
disease (HIV, HCV) – IND filing expected 1H07 Synergistic activity with
anti-CTLA-4 antibody
50:50 partnership
with Ono Pharmaceuticals
Strong & Diversified Pipeline: MDX-1106 anti-PD-1 HuMAb
Synergistic Activity with Anti-PD-1 and Anti-CTLA-4 Antibodies
Control aCTLA-4 MAb aPD-1 MAb
Combination aPD-1 + aCTLA-4
Dosing
Combination
of Sub-Efficacious Doses of anti-PD1 and anti-CTLA-4 Antibodies is
Efficacious in Mouse Model
0
5
10
15
20
25
0
250
500
750
1000
1250
1500
1750
days
median
tumor volume
mm3
Medarex option
to co-develop, co-promote and share profits in US for interferon antibodies
for lupus (SLE) MEDI-545 (anti-IFNa) Phase I initiation – April 2006
Dose-escalation in 45 patients with SLE Data expected 1H07
MEDI-545 new trial initiations in 2007
Lupus Phase II trials (IV multi-dose; subcutaneous single and
multi-dose) Psoriasis Phase I (IV single-dose) Idiopathic inflammatory
myositis Phase II (IV multi-dose)
MDX-1333
(MEDI-546) – anti-IFNAR1 HuMAb IND filing expected 2007
Strong & Diversified Pipeline:
Anti-IFN HuMAbs – MedImmune
Source:
MedImmune Analyst Day webcast, dated 12/6/06.
Strong & Diversified Pipeline: Potential IND Filings 2007
MDX-1401 (anti-CD30) enhanced for ADCC
IND filed for Phase I in Hodgkin’s disease – January 2007
MDX-1342 (anti-CD19) – Expected 2H07
Targets B-cell cancers (CLL, ALL) and autoimmune diseases
MDX-1411 (anti-CD70) – Expected 2H07
Targets renal cell carcinoma and lymphomas
PacMAb Antibody
Anti-cancer
antibody in partnership with PacMab Limited
P
MDX-010 – MEDX/BMS
Other Cancers MDX-066/MDX-1388 – MBL C. Difficile
Disease MDX-060 Hodgkin’s
Disease, ALCL
Broad
Clinical Pipeline – Medarex and Partners
MDX-018 – Genmab
Undisclosed CNTO 148 –
Centocor Inflammation CNTO
1275 – Centocor Inflammation HuMax-CD20
– Genmab Lymphoma HuMax-EGFR –
Genmab Head and Neck Cancer
MDX-1307 MEDI-545 – MedImmune
Cancer Lupus MDX-1100 MDX-1106 – Ono Ulcerative
Colitis Cancer MDX-1303 –PharmAthene
MDX-1401 Anthrax CD30 Lymphomas
MDX-010 – MEDX/BMS
Melanoma
Proprietary products (dark blue) /
Technology Licensing Products or Equity Interest (light blue) / Products with
Potential for Double-Digit Royalties (yellow)
Phase I Phase I/II – Phase II Phase
III AMGN Ab #1 – Amgen
Undisclosed CNTO 95 – Centocor Cancer HuMax-CD4 – Genmab Lymphoma CP 675,206 – Pfizer Cancer
NVS Ab #1 – Novartis Roche Ab – Genmab
Auotimmune Disease Undisclosed NVS Ab #2 – Novartis Undisclosed –
Undisclosed Autoimmune Disease Undisclosed AMGN Ab #2 – Amgen NI-0401 – NovImmune Undisclosed Autoimmune
Disease AMGN Ab #3 – Amgen IMCL Ab –
ImClone Systems Undisclosed Cancer FG-3019 – Fibrogen Undisclosed – Undisclosed Idiopathic
Pulmonary Fibrosis Undisclosed HGS-TR2J
– Kirin AMGN Ab #4 – Amgen Cancer Undisclosed LLY Ab – Eli Lilly AMG 714 – Genmab Undisclosed Rheumatoid
Arthritis BMS-66513 – BMS IMC-3G3 –
ImClone Systems Cancer Cancer MDX-1333
– MedImmune MDX-1411 (aCD70) MDX-1342 (aCD19) aSDF-1– Ono Lupus Cancer
Cancer Multiple indications aB7H4
aPtk7 PacMab Ab UPT Toxin Programs Cancer CancerCancer
IND
Prep
Resources
~$340 million
in cash, cash equivalents and marketable securities as of 12/31/06 ~$445
million in equity interests* 2006 operating cash burn consistent with
previous guidance ~490 employees as of 12/31/06 Projected 2007 operating cash
burn ~$13 million/month
* As of 1/8/07.
Near-Term and Future Value Catalysts
Ipilimumab BLA filing expected – 2007 Additional potential BLA
filings and/or Phase III data expected*
Centocor Golimumab (CNTO-148) Centocor CNTO-1275 Pfizer
Ticilimumab (CP-675-206) Genmab Zanolimumab (HuMax-CD4) Genmab Ofatumumab
(HuMax-CD20)
Ipilimumab program expansion
Phase III initiation in melanoma adjuvant Phase III initiation
in prostate Phase II initiation in lung * Expectations from company materials
(webcasts, press releases, etc.).
Near-Term and Future Value Catalysts
Other clinical data and milestones
MDX-066/MDX-1388 (anti-C.
difficile) Phase II completion – YE07 MDX-060 (anti-CD30) +
chemotherapy Phase II data – 2H07/1H08 MDX-1100 (anti-IP-10) Phase II
initiation in inflammation – 2H07 MDX-1106 Phase II initiation in cancer–
2H07 =
3 IND filings (proprietary and
partners) Corporate partnerships
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