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Medarex Inc – ‘8-K’ for 1/10/07 – EX-99.1

On:  Wednesday, 1/10/07, at 5:02pm ET   ·   For:  1/10/07   ·   Accession #:  1104659-7-1893   ·   File #:  0-19312

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  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

 1/10/07  Medarex Inc                       8-K:7,9     1/10/07    2:2.5M                                   Merrill Corp-MD/FA

Current Report   —   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Current Report of Material Events or Corporate      HTML     20K 
                          Changes                                                
 2: EX-99.1     Miscellaneous Exhibit                               HTML     51K 


EX-99.1   —   Miscellaneous Exhibit


This exhibit is an HTML Document rendered as filed.  [ Alternative Formats ]



Exhibit 99.1

 

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25th Annual JPMorgan Healthcare Conference January 10, 2007

 


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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.

 


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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 PPPPPPPPPPPP

 


* 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

 


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The Business Model: Turning Antibodies into Cash Flow Maximizing the Technology Output Increasing Stream of New Products Creating Potential Market Opportunities Proprietary ProductsEquity Ownerships (17% Genmab A/S, 19% IDM Pharma, 60% Celldex) Cash and Carry Partnerships

 


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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.

 


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Advancing Towards Commercialization: Phase III Products in Development Target Medarex Interest Medarex Cost Partner or Licensee Product Ipilimumab (MDX-010)BMS 45% U.S. Profit Ticilimumab (CP-675,206)Pfizer Double Digit Royalties Golimumab (CNTO 148)J&J/Centocor “Cash & Carry” Royalties CNTO 1275Zanolimumab (HuMax-CD4)Genmab/Serono < Double Digit Royalties ex-N.Am.* J&J/Centocor “Cash & Carry” Royalties CTLA-4 CTLA-4 TNFa IL12/IL23 CD4 * Plus ~17% equity ownership in Genmab Ofatumumab (HuMax-CD20) Genmab Equity Interest CD20 35% 0% 0% 0% 0% 0% Zalutumumab (HuMax-EGFR) Genmab Equity Interest EGFR 0%

 


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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

 


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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

 


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FDA Cancer Monotherapy Approvals in 2nd/3rd 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

 


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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

 


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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

 


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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

 


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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)

 


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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.


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Ipilimumab (MDX-010): Multiple Commercial Opportunities Melanoma Monotherapy – 2nd line Melanoma Chemo Combo – 1st line Melanoma Vaccine Combo – 2nd 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

 


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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.

 


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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.

 


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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

 


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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

 


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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

 


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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

 


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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 051015202502505007501000125015001750daysmedian tumor volumemm3

 


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.

 


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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

 


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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 CancerNVS 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 CancerCancerIND 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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707 State Road Princeton, NJ 08540 T: +1-609-430-2880 F: +1-609-430-2850 www.medarex.com

 


Dates Referenced Herein   and   Documents Incorporated by Reference

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