Fennec Pharmaceuticals Inc. · NASDAQ:FENC
Fennec Pharmaceuticals — Adherex Technologies — Investor Presentation (April 2013)
22 slides from Fennec Pharmaceuticals's investor presentation, April 2013
Slide 1: Corporate Presentation April 2013
Corporate Presentation April 2013
Slide 2: Safe Harbor Statement
Adherex Technologies Safe Harbor Statement During the course of this presentation we will make statements that constitute forward- looking statements. These statements may include operating expense projections, the initiation, timing and results of pending or future clinical trials, the actions or p
Slide 3: Company Overview
Company Overview Biopharmaceutical Company dedicated to the discovery and development of novel cancer therapeutics 2 late stage clinical products: Eniluracil and STS US based management team Headquarters in Research Triangle Park, NC Ticker: ADHXF – USA, AHX – Toronto Market Cap: $18.3 MM; 25.1 MM s
Slide 4: Investment Highlights
Investment Highlights Lead product Eniluracil is being developed to improve the therapeutic value of 5-FU, a current mainstay of oncology treatment Positive Clinical Data: Eniluracil is active and well tolerated in metastatic breast cancer (MBC) patients. Preliminary Phase II data presented at the 2
Slide 5: Management and Board of Directors
Management and Board of Directors Rosty Raykov – CEO Bear Stearns, Tiedemann Group, John Levin & Co., Alchem and DCML Co. Robert Andrade – CFO Bear Stearns, JP Morgan, CIBC, Caxton Associates, Millennium Partners and DCML Co. Tom Spector, PhD – Chief Scientific Officer 35 years drug research experie
Slide 6: Fluorouracil Market Overview
Fluorouracil Market Overview iv 5-FU Xeloda® (capecitabine) Discovered in 1957, widely available as Oral, prodrug of 5-FU generic On the market since 1998, expected generic Principal uses: colorectal, breast, gastric, in the US by 2013/2014 pancreatic, head and neck, ovarian and Principal uses: colo
Slide 7: Lead Product Candidate: Eniluracil
Lead Product Candidate: Eniluracil Oral Chemotherapy for Solid Tumors • Irreversible inhibitor of DPD, the enzyme responsible for the rapid breakdown of 5-FU • Developed as a potentiator of 5-FU in the 1990s by Burroughs Wellcome and then by GlaxoWellcome (now GSK) 7
Slide 8: 5-FU Metabolic Pathways
5-FU Metabolic Pathways • 5-FU must be activated to kill cancer cells • The enzyme, DPD, prevents activation and degrades 5-FU to F-BAL DPD problems: F-BAL problems: Highly Variable levels >80% of dose = F-BAL Unpredictable 5-FU PK Decreases 5-FU Efficacy 5-FU t1/2 = 10-20 min Neurotoxic 5-FU MTD co
Slide 9: The Solution: EU Inactivates DPD
The Solution: EU Inactivates DPD EU Eliminates DPD & F-BAL Problems 5-FU is not destroyed: F-BAL formation is minimal: Half-life = 5 hr. No interference with efficacy Highly predictable linear PK Minimize neurotoxicity Oral dosing HFS is negligible 9
Slide 10: High EU:5-FU Ratio Decreases Efficacy
High EU:5-FU Ratio Decreases Efficacy In a study of rats with large tumors: EU:5-FU ratio 5:1 <1:5 A high ratio of EU to 5-FU was less effective than a low ratio Data: Spector T, Cao, S. A Possible Cause and Remedy for the Clinical Failure of 5-Fluorouracil plus Eniluracil. Clinical Colorectal Cance
Slide 11: Encouraging Comparison
Encouraging Comparison Dr. Grem’s Phase I Weekly Schedule vs. Xeloda®’s Phase 2 in Advanced Colorectal Cancer Refractory to iv 5-FU/Lv Outcome EU/5-FU/Lv Xeloda® 20mg/29mg/m2/30mg 1,250mg/m2 Treatment weekly every 12 hr for 3 weeks for 14 days Tumor Responses 2/17 0/22 Diarrhea 65 (17) % 74 (26) % t
Slide 12: Phase 2 Oral 5-FU Regimens
Phase 2 Oral 5-FU Regimens Modified weekly EU/5-FU/Lv schedule (all oral regimen) • Administers a higher EU dose to eliminate all DPD, including DPD in nervous tissue to minimize neurotoxicity. Allows excess EU to be cleared before dosing with 5-FU • Administers 5-FU when the EU:5-FU ratio is very l
Slide 13: Phase 2 Study Design
Phase 2 Study Design Other Reasons Arm 1 80 Subjects EU/ 5-FU / Lv PD X-over Assessment of Randomization: N = 140: first- or second-line Option Primary Endpoint: therapy for MBC patients who had Progression-Free previous treatment with an PD Survival anthracycline and a taxane Arm 2 60 Subjects Xelo
Slide 14: Preliminary Interim Results
Preliminary Interim Results* Main Study: EU/5-FU/Lv vs. Xeloda® Evaluated CR PR SD CR + PR + SD1 Arm patients n (%) n (%) n (%) n (%) Arm 1: EU/5-FU/Lv 68 1 (1) 16 (24) 35 (51) 52 (76) Arm 2: Xeloda® 54 0 (0) 14 (26) 26 (48) 40 (74) Crossover Option: Xeloda® failures who crossed over to take EU/5-FU
Slide 15: Rapid Xeloda Failures
Rapid Xeloda® Failures Arm 2 Patients Who Rapidly Failed Xeloda® and Crossed Over to Take EU/5-FU/Lv in Arm X Adjuvant/Neoadjuvant Patient Arm X Arm 2 5-FU Treatment(s) Best Best PFS1 (Days) PFS (Days) Response Response 1 2322 SD 38 PD No 2 212 SD 41 PD Yes 3 124 PR 41 PD Yes 4 28 PD 41 PD Yes 5 335
Slide 16: Rapid Xeloda Failures - Progression-Free Survival
Rapid Xeloda Failures - Progression-Free Survival 16
Slide 17: Mechanisms for EU/5-FU/Lv clinical benefit
Mechanisms for EU/5-FU/Lv clinical benefit The possible mechanisms for rapid Xeloda® failure and subsequent clinical benefit from EU/5-FU/Lv may include any of the following: 1. Low Xeloda® absorption (highly variable with possible extended lag periods) 2. Low or deficient levels of one or more of t
Slide 18: Clinical Summary
Clinical Summary Preliminary Interim Results – December 2012 • Patients who rapidly failed Xeloda® (N=9) who were subsequently treated with EU/5-FU/Lv experienced the following: 89% had clinical benefit 33% had tumor response Ongoing median progression-free survival of 117 days vs. 42 days whi
Slide 19: Eniluracil US MBC Market Opportunity
Eniluracil US MBC Market Opportunity* Substantial pipeline of opportunities outside initial indication $400 $350 $300 > $250 M $ in Millions $250 > $200 M $200 > $150 M Additional $150 Available Pts. Est. 3-4k > $120 M Halaven (3rd Line) $100 Ixempra (After Xeloda Fail) 11.0% Response $50 Eligible P
Slide 20: STS: Prevention of Platinum Induced Hearing Loss in Pediatric Patients
STS: Prevention of Platinum Induced Hearing Loss in Pediatric Patients Sodium Thiosulfate (STS) Orphan Drug Designation March 2004 • Being developed for prevention of ototoxicity in pediatric patients • STS administered IV over 15 min six hours post Cisplatin • Children treated with Cisplatin and/or
Slide 21: STS: Value Drivers
STS: Value Drivers Path to Approval • Submit COG study as single Phase III trial to support approval • 2,000 eligible patients in US per year Rare Pediatric Disease Priority Review Voucher Incentive Program (“Voucher Program”) • Priority review voucher issued to sponsor of rare pediatric disease pro
Slide 22: Summary
Summary Lead product Eniluracil has the potential to change the treatment paradigm for MBC by making 5-FU more effective and better tolerated • Positive Preliminary Interim Results presented in December 2012 • Final comparative efficacy and safety data to be reported during 2Q/3Q 2013 Large Market O
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