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EpiCept Corporation (EPCT)
 

EpiCept Corporation (EPCT)

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OneMedForum NY Company Presentation: EpiCept Corporation, a specialty pharmaceutical company, focuses on the development and commercialization of pharmaceutical products for the treatment of cancer . ...

OneMedForum NY Company Presentation: EpiCept Corporation, a specialty pharmaceutical company, focuses on the development and commercialization of pharmaceutical products for the treatment of cancer . Learn More at: http://www.onemedplace.com/database/list/cid/13501

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  • Blaise et al . 2000; Baer et al. JCO 2008; Lange et al. Blood. 2008; Kolitz et al. Blood. 2007; Pautas C et al. Blood. 2007; Willemze et al. Blood , 2009.
  • References: Data Monitor, 2006; Farag et al. Blood . 2006;108:63-73; Pautas C et al. Blood . 2007; Tallman et al. Blood 2005; 106:1154-63; Swedish Leukemia Registry; Farag et al. JCO. 2005; 23:482-493; Byrd et al. Blood. 2002; 100:4325-4336; Rowe et al. Blood. 2005; 106:11 Abstr. 546; Burnett et al. Br J Haematol . 2002; 118:385-400; Breems et al. JCO . 2005; 23:1969-78.

EpiCept Corporation (EPCT) EpiCept Corporation (EPCT) Presentation Transcript

  • Corporate Presentation June 2010
  • Forward-Looking Statements
      • This presentation contains forward looking statements that involve risks and uncertainties regarding the operations and future results of EpiCept. You should review the company's filings with the Securities and Exchange Commission, including without limitation the company's Form 10-K and Forms 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward looking statements. The content of this presentation contains time sensitive information that is accurate only as of the date of the presentation. The company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
      • A specialty pharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain
    Company Description
  • Investment Highlights
      • Ceplene approved in Europe and launched in UK, Germany and Austria
      • NDA filed in US, priority review requested
      • Ceplene is the first efficacious remission maintenance drug for AML
        • Met primary endpoint in 320 patient pivotal Phase III trial
        • 40% of Ceplene treated patients in first remission were leukemia free at 3 years vs. 26% of control patients (p=0.011)
      • Substantial upside retained in European partnership with Meda
      • Market exclusivity for 7 years in US and 10 years in EU
      • Potential for market expansion in MDS and CML
      • NP-1 completed Phase II for pain and Crolibulin in Phase I for solid tumors
      • Azixa partnered with Myriad Pharmaceuticals in Phase II for brain cancer
        • Action Dates
        • Ceplene
        • US NDA filing 2Q 2010
        • European commercial launch 2Q 2010
        • Canadian NDS approval 3Q 2010
        • FDA acceptance of Ceplene NDA / Announced PDUFA Date 3Q 2010
        • ODAC meeting 4Q 2010
        • US approval Q1 2011
        • Pipeline
        • NP-1 partnership 2H 2010
        • Azixa Phase II brain cancer results 2Q 2010
        • Crolibulin Phase Ib combination trial initiation 2Q 2010
    2010 Upcoming Milestones
  • Ceplene ® Reducing the Risk of Relapse in AML
  • Ceplene ® : EU Approved Label “ Ceplene, administered in conjunction with interleukin-2, is indicated for maintenance of remission in adult patients with acute myeloid leukaemia in first remission to prolong the duration of leukaemia free survival.”
  • Meda Partnership
    • Leading international specialty pharmaceutical company
        • Sales and marketing organization of about 1,200 people throughout Europe
        • Established sales organizations in the US and more than 40 other countries
        • Annual revenues of approximately $1.8 billion
        • Oncology/hematology presence with several products , including Onsolis TM indicated for breakthrough pain in cancer patients
    • Up to $40 million in upfront payments and milestones, plus escalating double digit royalty
    • EpiCept is responsible for Ceplene's commercial supply
    • Territory includes Europe, Japan, China, Australia and selected Asian countries
    • Selective EU launches underway
  • Changing the AML Treatment Paradigm
    • 90 – 95% mortality at 5 years
    • Median survival 6 - 9 months
    • 40% Ceplene+IL-2 patients reach LFS at 3 years vs. 26% of SOC patients
    • Median improvement of 64 weeks in overall survival
    • If successful it is a true cure
    • High procedural mortality rate
    Induction and Consolidation Therapy Complete Remission (70%) Bone Marrow Transplant Remission Maintenance: Ceplene+IL-2 Remission Maintenance: Current SOC (no treatment) (>80% Relapse) No Remission (30%)
  • Rationale for the Use of Ceplene with IL-2 IL-2 Activates and expands T and NK cells Ceplene (HDC) Protects T and NK cells against inactivation and apoptosis Elimination of leukemic cells and protection against relapse - T cells and NK cells can attack and eliminate AML blasts - T and NK cell functions determine relapse risk in AML NK NK AML blast
  • Ceplene: Mechanism of Action in AML NKp46 Activating Receptors Myeloid Cell NK Cell H 2 receptor Cytotoxicity O 2 AML Blasts NKG2D NADPH oxidase Response to IL-2 Apoptosis
  • Ceplene: Mechanism of Action in AML Lysed NKp46 Activating Receptors Myeloid Cell NK Cell H 2 receptor Cytotoxicity Ceplene (HDC) NKG2D NADPH oxidase Response to IL-2
  • Pivotal Phase III Study Design, Trial Endpoints and Analyses
    • Primary endpoint: Leukemia-free survival (LFS) after 3 years
    • Secondary endpoints:
      • Overall survival (OS)
      • LFS in CR1 and CR>1 subgroups
      • LFS rates at 6, 12, 18, 24 and 36 months
      • Safety and quality-of-life (QLQ-C30)
    AML Remissions (n=320) 18 Months 18 Months Endpoint Analysis Ceplene+IL-2 (n=160) 10 cycles over 18 months followed by 18 months of observation Randomized
    • Key prognostic variables tested by multivariate analyses
    • Additional follow-up at 5 and 6 years
    Standard of Care (No Treatment) (n=160)
  • Results of the Pivotal Phase III Study: Leukemia-Free Survival Overall Population CR1 Population
  • Results of the Pivotal Phase III Study: Overall Survival Overall Population CR1 Population
  • Summary: Clinical Benefit of Ceplene+IL-2
    • Phase III study met primary endpoint of LFS rate at 3 years
    Overall Population CR1 Population 3 Year LFS Log Rank Treatment: 34% Control: 24% p = 0.008 Treatment: 40% Control: 26% p = 0.011 5 Year LFS Log Rank Treatment: 30% Control: 21% p = 0.017 Treatment: 34% Control: 22% p = 0.025 3 Year OS Log Rank Treatment: 48% Control: 44% p = 0.161 Median Improvement: 24 weeks Treatment: 55% Control: 46% p = 0.118 Median Improvement: 64 weeks
  • Ceplene: US Regulatory Status
    • Pre-NDA meeting completed
    • NDA filed June, 2010
    • 82% concurrence of FDA and EMEA approvals since 2006 (1)
    • Key issues to be addressed:
      • Approval based on single pivotal trial
      • Acceptability of Leukemia Free Survival as primary endpoint
      • Trial design - Isolation of Ceplene’s contribution to efficacy vs. IL-2
    (1) Source: FDA – Center for Drug Evaluation & Research, New Drug Review: 2009 (FDA/CMS Summit December 3, 2009), includes New Molecular Entities only
  • FDA Issue 1: Single Pivotal Trial
      • Robust statistical outcome of pivotal study (p<0.008)
      • Significant unmet medical need
      • Orphan indication
      • Numerous precedents for approval based on a single randomized pivotal trial for orphan indications and/or high unmet medical need if the data demonstrates substantial evidence of efficacy (Folotyn, Istodax, Velcade)
  • FDA Issue 2: Acceptability of LFS as Appropriate Primary Endpoint
      • Data supports LFS as a surrogate marker for survival
      • Median improvement of 64 weeks on overall survival
      • No adverse effect seen on survival
      • Numerous precedents in oncology for accelerated approval based on response rate, progression free survival, time to progression (Gleevec, etc.)
      • Cooperative group studies use LFS as primary endpoint for AML
  • FDA Issue 3: Trial Design - I solation of Ceplene’s Contribution to Efficacy vs. IL-2
      • Only Ceplene+IL-2 pivotal trial successful for remission maintenance
      • Six separate IL-2 monotherapy AML trials have failed to demonstrate IL-2 benefit
      • Meta and Bayesian analysis of background IL-2 monotherapy “contribution” concluded incremental contribution of Ceplene beyond IL-2 background at p<0.05
  • IL-2 Monotherapy Trials vs. Ceplene+IL-2 Trial N Age (years) Monthly IL-2 Dose MIU/m 2 P-values Blaise et al. 78 <50 120 0.54 CALGB 9720 163 ≥ 60 81 0.47 CCG-2961 289 ≤ 21 52 0.49 CALGB 19808 214 <60 91 0.13 ALFA 9801 161 50-70 25 0.88 EORTC/GIMEMA 288 <61 12 - 24 0.57 Ceplene+IL-2 Phase III Study 320 18-84 15 0.01
  • IL-2 Monotherapy vs. Standard of Care Note: Kaplan analysis curve for EORTC/GIMEMA trial not yet published 100 80 60 Standard of care IL-2 IL-2 No treatment P =0.88 Months from IL-2 randomization Disease-free survival Overall survival Blaise et al. CALGB 9720 ALFA 9801 Years from IL-2 randomization CALGB 19808 CCG 2961
  • Ceplene: Market Opportunity (1) National Cancer Institute (2) European LeukemiaNet (ELN) US Prevalence 38,000 New Patients/Year 13,000 (1) Complete Remissions Achieved (70%) 9,100 Less Bone Marrow Transplants (20-25%) (2,275) Annual New Patient Candidates 6,825 Median Annual Cost/Patient $ 35-40K Ceplene Peak Market Potential $235-270 MM
  • Ceplene US Commercialization Strategy
    • Orphan protection granted, 7 years market exclusivity
    • First and only product to prevent AML relapse
    • No competing products in late stage development
    • Continue targeting top KoLs through symposia, conferences, etc.
    • Initiate pre-launch Ceplene experience program
    • Outreach to patient advocate groups
    • Planning self launch in US with 20-25 MSLs/sales representatives
    • Target audience 1500 hematologists
    • Target top 200 US hospitals
    • Gain inclusion of Ceplene+IL-2 in AML treatment guidelines
  • Ceplene Summary
    • Ceplene+IL-2 is first and only therapeutic regimen to prevent relapse and prolong LFS in AML patients in remission
    • Ceplene+IL-2 LFS rate at 3 years of 40% vs. 26% for control (p=0.011) is clinically relevant for AML patients in first remission
    • Cycles of daily Ceplene+IL-2 s.c. injections at home are well-tolerated and are not an impediment to AML patients’ QoL or functional status
    • No competing therapy in Phase II or III clinical development
    • European partnership established, launches underway
    • Pursuing North American regulatory approvals
    • Orphan drug designation provides 7 years market exclusivity in US and 10 in EU
  • EpiCept™ NP-1: Product Profile
        • Phase III ready topical cream for the relief of pain associated with post- herpetic neuropathy (PHN), diabetic neuropathy and chemotherapy
        • 4% amitriptyline plus 2% ketamine combination provides pain relief equivalent to current therapies
        • Over 1,300 patients treated in seven clinical trials
        • Effective and well-tolerated in chronic use
        • Better side effect profile than oral therapies
        • Skin irritation is infrequent; fatigue and drowsiness are rare and mild
        • NP-1 represents a large, low risk commercial opportunity
  • EpiCept™ NP-1: PHN Clinical Data
      • Efficacy vs. placebo tested in 150 PHN patients in dose response trial
      • Dose-response trial met primary endpoint; p=0.026
      • Strong analgesic effect
      • Additive to or can replace standard of care
      • Effective in persistent pain
      • Supports advancement to Phase III
    NP-1 (n=32) Placebo (n=46) Baseline (mean) 6.47 + 1.65 6.5 + 1.60 Day 21(mean) 3.28 + 2.1 4.35 + 2.2 Mean Change 3.19 + 2.0 p=0.026 2.15 + 1.8
  • EpiCept™ NP-1: PHN Clinical Data
      • Phase II, Non-inferiority design, vs. gabapentin and placebo in PHN for 4 weeks
      • Met primary endpoint:
        • Efficacy superior to placebo, p =.044
        • Not inferior to gabapentin, p =.84
      • Results indicate at least equivalent efficacy to unit market leader
      • Better side effect profile
      • Supports advancement to Phase III
    ITT Population Primary Endpoint: Mean pain score NP-1 n=135 Placebo n=76 Gabapentin n=138 Baseline 6.04 ± 1.25 6.37 ± 1.32 6.32 ± 1.17 At the end of week 4 3.54 ± 1.98 4.22 ± 2.30 3.55 ± 1.93 Mean difference in pain score 2.42 ± 0.18 p =.044 1.88 ± 0.23 2.47 ± 0.18
  • EpiCept™ NP-1: Market Opportunity
      • 2008 US market size: 4.7 million patients, $2.6 billion in sales
      • 2018 est. US market size: 6.1 million patients; $5.1 billion in sales
      • Key market drivers: aging population and unmet medical need due to ineffective therapy
      • Competing products: gabapentin (generic), Lyrica (Pfizer), Cymbalta (Eli Lilly), Lidoderm (Endo)
        • No current therapy effective in more than 50% of patients
        • Oral therapies have CNS side effects
        • Lidoderm patch not convenient for many areas prone to pain
      • May be used in combination with other therapies
      • Patent protection to 2021 plus US orphan drug designation in PHN
  • Crolibulin
    • Small molecule, vascular disruption agent (VDA), disrupts newly formed vascular cells and blood flow to tumor
    • Superior anti-tumor (apoptotic) activity compared to other VDAs
    • Enhanced efficacy in combination with Cisplatin or other chemotherapeutics
    • Active on multi-drug resistant cells
    • DLT/MTD identified
    • Activity in resistant hepatocellular carcinoma
    • Objective evidence of anti-tumor response by CT perfusion
    • Combination trial to be initiated Q2 2010
    • Strong intellectual property position
  • Azixa ™ ( MPC-6827): Myriad Pharmaceuticals
    • Small molecule, apoptosis inducer with VDA activity, concentrates in the CNS
    • Two Phase I studies completed in brain cancer: primary and metastatic
    • Treatment schedule: Once a week for 3 weeks on 28 day cycle
    • Reported Phase I results
      • Reached Maximum Tolerated Dose (MTD)
      • Signs of efficacy: measurable reduction in tumor size in primary glioblastoma and patients with secondary metastases
    • Myriad Pharmaceuticals conducting Phase II trials dosing in primary and metastatic brain cancer
  • Investment Highlights
      • Ceplene approved in Europe and launched in UK, Germany and Austria
      • NDA filed in US, priority review requested
      • Ceplene is the first efficacious remission maintenance drug for AML
        • Met primary endpoint in 320 patient pivotal Phase III trial
        • 40% of Ceplene treated patients in first remission were leukemia free at 3 years vs. 26% of control patients (p=0.011)
      • Substantial upside retained in European partnership with Meda
      • Market exclusivity for 7 years in US and 10 years in EU
      • Potential for market expansion in MDS and CML
      • NP-1 completed Phase II for pain and Crolibulin in Phase I for solid tumors
      • Azixa partnered with Myriad Pharmaceuticals in Phase II for brain cancer
  •