Wex Pharma - Investor Presentation


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Wex Pharma - Investor Presentation

  1. 1. a new class of non-opioid analgesic in Phase 3 WEX Pharmaceuticals Inc. Bin Huang, President & CEO April 2010
  2. 2. Forward looking Statement This presentation contains forward-looking statements which involve known and unknown risks, uncertainties and other facts which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward- looking statements. The Company does not expect to update forward- looking statements continually as conditions change. Investors are referred to the full discussion of risk factors associated with the Company’s business contained in the Company’s Annual Information Form filed with securities regulatory authorities dated February 15, 2010. 2
  3. 3. $7B opioids* the Gold Standard for moderate to severe pain relief *2005 global sales 3
  4. 4. But opioids have limitations • Side effects – Respiratory – GI RISKS with prescribing, administering – CNS – Others & taking opioids: • Ineffective • Tolerance • Addiction 4
  5. 5. Cancer pain is a vivid example 1 in of all cancer patients require opioids to manage pain 1 in 4 fail opioid therapy 4 5
  6. 6. there is no good alternative to opioids! 6
  7. 7. Reformulation is not the answer • MS Contin® • OxyContin® • DURAGESIC® All the same concerns remain: • Remoxy® • FENTORA® a reformulated opioid is • AVINZA® still an opioid! • Actiq® 7
  8. 8. Tetrodotoxin: a NEW class of NON opioid analgesic 8
  9. 9. Tetrodotoxin (TTX) • >80 issued and pending • No opioid-like side effects patents – Non addictive – No tolerance • Blocks VGSC (voltage gated sodium channels) on • Long duration of action neurons associated with – 2-3 weeks persistent pain • Rapid onset of pain relief • 2000x more potent than – 20 minutes morphine • Significant activity in • Highly specific to pain fibers neuropathic pain • Safe and well-tolerated 9
  10. 10. TTX is safe • >200 patients treated to date in Canadian trials • 5 trials completed • Well-tolerated in single and multiple doses (up to 4X per day, 4-7 days of treatment) • Mild, short lasting side effects (numbness, tingling) • Intramuscular administration comparable to subcutaneous 10
  11. 11. TTX efficacy signals in cancer pain Phase IIa Phase IIb • Open label, dose escalation, • Randomized, double-blind placebo multicentre trial controlled, multicentre trial • 24 patients • 77 patients • Severe cancer pain inadequately • Moderate to severe unrelieved cancer controlled with opioids pain despite best available treatment • Primary endpoint: proportion of patients achieving >30% pain intensity reduction 55% of treatments resulted in pain reduction Trial terminated at interim analysis 8-15 day duration 42% treated vs. 31% placebo (not statistically significant) 11
  12. 12. Phase IIb Phase IIb CTA Submitted IMMPACT paper Interim Results 2004 2005 2006 “Physical and emotional functioning and participant reports of global improvements should also be included among the six core domains” - IMMPACT paper 12
  13. 13. Strong efficacy signal using IMMPACT guidelines Original Endpoint TTX=38 42% >30% decrease in pain intensity Placebo=39 31% p=0.425 Non statistically significant trend Composite Endpoint based on IMMPACT guidelines TTX=38 45% >30% decrease in pain intensity OR Placebo=39 21% p=0.043 >50% decrease in opioid use AND Robust analgesic effect >30% increase in quality of life 13
  14. 14. Ongoing Phase III trial • Multicentre, randomized, double-blind, placebo-controlled trial • Moderate to severe inadequately controlled cancer-related pain • 120 patients planned • Primary endpoint: Composite endpoint based on IMMPACT guidelines • Interim results expected Q3 2010 Screening Follow up/ Randomization Baseline Treatment Follow up Open label -28 to -7 days -7 to 0 days 1 to 4 days 5, 8, 15 days >15 days 14
  15. 15. Strong efficacy signals in neuropathic pain Composite Endpoint Robust analgesic effect based on IMMPACT guidelines TTX=22 44% Neuropathic pain subset analysis Placebo=28 18% 15
  16. 16. Phase II trial in planning • Chemotherapy-induced neuropathic pain • Common following combined What is treatment with a platinum and neuropathic pain? a taxane • Shooting, burning pain • Health Canada – no objection letter March 2009 • Limits dosing of chemotherapy • File U.S. protocol Q4 2010 16
  17. 17. Multiple data events Clarity Events Data Events Phase III Cancer-related Q3 10 H2 11 pain Interim Final results analysis Phase II Chemotherapy- Q4 10 Q3 11 Q2 12 induced Submit U.S. Interim Final results neuropathic pain protocol analysis 17
  18. 18. TTX in the cancer pain landscape 18
  19. 19. Tetrodotoxin manufacturing • API manufactured by wholly-owned Chinese subsidiary • Finished product manufactured by Sandoz Canada Source: Pufferfish 19
  20. 20. Financial Highlight Symbol WXI Cash (January 2010) $39M Monthly burn rate $800,000 Shares o/s 442 million Major shareholder (89%) CK Life Sciences Int’l., Inc. 20
  21. 21. CK Life Sciences International Hong Kong Stock Exchange Stock Code: 00775 $20M Private Placement, October 2007 Investment in WEX $34M as part of Rights Offering, January 2010 Business areas Pharmaceutical / Nutraceutical / Agriculture Revenue USD350M (2009) TTX is the most advanced drug candidate in CKLS’ pipeline of pharmaceutical products 21
  22. 22. Management and Clinical Investigators Bin Huang, PhD, MBA Neil Hagen MD, FRCPC President and CEO Lead Investigator Former CEO of GeneHarbor (HK) and Cytovax, Division Chief, Division of Palliative Medicine, VP BD Monsanto Canada Calgary; Professor, Faculty of Medicine, University of Calgary Kwong Choo, CGA CFO, VP Finance & Admin Bernard Lapointe, MD, FRCPC 20 years international experience in finance and Co-lead Investigator accounting Associate Professor, Oncology, McGill (Jewish General Hospital); 2007 Canadian Hospice Larry Gontovnick, PhD Palliative Care Award of Excellence Vice President, R&D Over 20 years experience in drug development; Patrick du Souich, MD, PhD Former Sr. Director clinical development, GSK Medical Monitor Professor and Chairman, Dept of Pharmacology, Anh Ho Ngoc, PhD Faculty of Medicine, University of Montreal; Director, Regulatory Affairs Chairman, Division of Clinical Pharmacology of Over 20 years pharma industry IUPHAR experience; 3 years at Health Canada 22
  23. 23. No narcotic How large side effects? would the $7B opioid market be with… Less risk of tolerance or addiction? 23
  24. 24. 700,000 chemo-induced 1,420,000 neuropathic pain cancer pain (700,000*) (350,000*) 368,000 painful diabetic neuropathy 130,000 post herpetic neuralgia Tetrodotoxin *WEX’s target market Initial indication prevalence in North America 24 Follow on indication prevalence in North America
  25. 25. a new class of non-opioid analgesic in Phase 3 WEX Pharmaceuticals Inc. Corporate Presentation April 2010