Download - Wex Pharma - Investor Presentation
WEX Pharmaceuticals Inc.
Bin Huang, President & CEO April 2010
a new class of non-opioid analgesic in Phase 3
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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.
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the Gold Standard for moderate to severe pain relief
$7B
*2005 global sales
opioids*
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RISKSwith prescribing, administering
& taking opioids:
But opioids have limitations
• Side effects
– Respiratory
– GI
– CNS
– Others
• Ineffective
• Tolerance
• Addiction
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1fail opioid therapy
Cancer pain is a vivid example
in
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of all cancer patients require opioids to manage pain
1in
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there is no good alternative to
opioids!
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• MS Contin®
• OxyContin®
• DURAGESIC®
• Remoxy®
• FENTORA®
• AVINZA®
• Actiq®
Reformulation is not the answer
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All the same concerns remain:
a reformulated opioid is
still an opioid!
Tetrodotoxin:a NEW class of NON opioid analgesic
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Tetrodotoxin (TTX)
• >80 issued and pending
patents
• Blocks VGSC (voltage gated
sodium channels) on
neurons associated with
persistent pain
• 2000x more potent than
morphine
• Highly specific to pain fibers
• No opioid-like side effects
– Non addictive
– No tolerance
• Long duration of action
– 2-3 weeks
• Rapid onset of pain relief
– 20 minutes
• Significant activity in neuropathic pain
• Safe and well-tolerated
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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
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Phase IIa Phase IIb
TTX efficacy signals in cancer pain
• Open label, dose escalation,
multicentre trial
• 24 patients
• Severe cancer pain inadequately
controlled with opioids
• Randomized, double-blind placebo
controlled, multicentre trial
• 77 patients
• Moderate to severe unrelieved cancer
pain despite best available treatment
• Primary endpoint: proportion of patients
achieving >30% pain intensity reduction
55% of treatments resulted in pain reduction
8-15 day duration
Trial terminated at interim analysis
42% treated vs. 31% placebo
(not statistically significant)
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2004
Phase IIb
CTA Submitted
2006
IMMPACT paper
Phase IIb
Interim Results
2005
“Physical and emotional functioning
and participant reports of global
improvements should also be included
among the six core domains”
- IMMPACT paper
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Original Endpoint
Composite Endpoint
based on IMMPACT guidelines
>30% decrease in pain intensity
OR
>50% decrease in opioid use
AND
>30% increase in quality of life
>30% decrease in pain intensity
Non statistically significant trend
Robust analgesic effect
Strong efficacy signal using IMMPACT guidelines
p=0.425
p=0.043
42%
31%
TTX=38
Placebo=39
45%
21%
TTX=38
Placebo=39
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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
Follow up/
Open labelFollow upTreatment
Screening
Randomization
>15 days5, 8, 15 days1 to 4 days-7 to 0 days-28 to -7 days
Baseline
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Composite Endpoint
based on IMMPACT guidelinesRobust analgesic effect
Neuropathic pain subset analysis
Strong efficacy signals in neuropathic pain
44%
18%
TTX=22
Placebo=28
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Phase II trial in planning
• Chemotherapy-induced neuropathic pain
• Common following combined treatment with a platinum and a taxane
• Health Canada – no objection letter March 2009
• File U.S. protocol Q4 2010
What is
neuropathic pain?
• Shooting, burning pain
• Limits dosing of
chemotherapy
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Q4 10
Phase II
Chemotherapy-
induced
neuropathic pain
Phase III
Cancer-related
pain
Submit U.S.
protocol
H2 11
Final results
Q3 10
Interim
analysis
Q3 11
Interim
analysis
Q2 12
Final results
Data EventsClarity Events
Multiple data events
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TTX in the cancer pain landscape
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Source: Pufferfish
• API manufactured
by wholly-owned
Chinese subsidiary
• Finished product
manufactured by
Sandoz Canada
Tetrodotoxin manufacturing
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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.
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TTX is the most advanced drug candidate
in CKLS’ pipeline of pharmaceutical products
CK Life Sciences International
Hong Kong Stock
Exchange Stock Code: 00775
Investment in WEX$20M Private Placement, October 2007
$34M as part of Rights Offering, January 2010
Business areas Pharmaceutical / Nutraceutical / Agriculture
Revenue USD350M (2009)
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Management and Clinical Investigators
Bin Huang, PhD, MBA
President and CEO
Former CEO of GeneHarbor (HK) and Cytovax,
VP BD Monsanto Canada
Kwong Choo, CGA
CFO, VP Finance & Admin
20 years international experience in finance and
accounting
Larry Gontovnick, PhD
Vice President, R&D
Over 20 years experience in drug development;
Former Sr. Director clinical development, GSK
Anh Ho Ngoc, PhD
Director, Regulatory Affairs
Over 20 years pharma industry
experience; 3 years at Health Canada
Neil Hagen MD, FRCPC
Lead Investigator
Division Chief, Division of Palliative Medicine,
Calgary; Professor, Faculty of Medicine,
University of Calgary
Bernard Lapointe, MD, FRCPC
Co-lead Investigator
Associate Professor, Oncology, McGill
(Jewish General Hospital); 2007 Canadian Hospice
Palliative Care Award of Excellence
Patrick du Souich, MD, PhD
Medical Monitor
Professor and Chairman, Dept of Pharmacology,
Faculty of Medicine, University of Montreal;
Chairman, Division of Clinical Pharmacology of
IUPHAR
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Less risk of tolerance or addiction?
No narcoticside effects?
opioid market be with…
$7BHow large would the
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Tetrodotoxin
368,000
painful diabetic
neuropathy130,000
post herpetic neuralgia
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1,420,000cancer pain
(350,000*)
700,000chemo-induced
neuropathic pain
(700,000*)
Initial indication prevalence in North America
Follow on indication prevalence in North America
*WEX’s target market
WEX Pharmaceuticals Inc.
Corporate Presentation April 2010
a new class of non-opioid analgesic in Phase 3