wex pharma - investor presentation

25
WEX Pharmaceuticals Inc. Bin Huang, President & CEO April 2010 a new class of non-opioid analgesic in Phase 3

Upload: wex-pharma

Post on 03-Jun-2015

1.251 views

Category:

Investor Relations


1 download

TRANSCRIPT

Page 1: Wex Pharma - Investor Presentation

WEX Pharmaceuticals Inc.

Bin Huang, President & CEO April 2010

a new class of non-opioid analgesic in Phase 3

Page 2: Wex Pharma - Investor Presentation

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.

Page 3: Wex Pharma - Investor Presentation

3

the Gold Standard for moderate to severe pain relief

$7B

*2005 global sales

opioids*

3

Page 4: Wex Pharma - Investor Presentation

4

RISKSwith prescribing, administering

& taking opioids:

But opioids have limitations

• Side effects

– Respiratory

– GI

– CNS

– Others

• Ineffective

• Tolerance

• Addiction

4

Page 5: Wex Pharma - Investor Presentation

5

1fail opioid therapy

Cancer pain is a vivid example

in

4

of all cancer patients require opioids to manage pain

1in

4

Page 6: Wex Pharma - Investor Presentation

there is no good alternative to

opioids!

6

Page 7: Wex Pharma - Investor Presentation

7

• MS Contin®

• OxyContin®

• DURAGESIC®

• Remoxy®

• FENTORA®

• AVINZA®

• Actiq®

Reformulation is not the answer

7

All the same concerns remain:

a reformulated opioid is

still an opioid!

Page 8: Wex Pharma - Investor Presentation

Tetrodotoxin:a NEW class of NON opioid analgesic

8

Page 9: Wex Pharma - Investor Presentation

99

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

Page 10: Wex Pharma - Investor Presentation

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

Page 11: Wex Pharma - Investor Presentation

11

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)

Page 12: Wex Pharma - Investor Presentation

12

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

12

Page 13: Wex Pharma - Investor Presentation

13

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

Page 14: Wex Pharma - Investor Presentation

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

Follow up/

Open labelFollow upTreatment

Screening

Randomization

>15 days5, 8, 15 days1 to 4 days-7 to 0 days-28 to -7 days

Baseline

Page 15: Wex Pharma - Investor Presentation

15

Composite Endpoint

based on IMMPACT guidelinesRobust analgesic effect

Neuropathic pain subset analysis

Strong efficacy signals in neuropathic pain

44%

18%

TTX=22

Placebo=28

Page 16: Wex Pharma - Investor Presentation

1616

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

Page 17: Wex Pharma - Investor Presentation

17

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

17

Page 18: Wex Pharma - Investor Presentation

18

TTX in the cancer pain landscape

Page 19: Wex Pharma - Investor Presentation

19

Source: Pufferfish

• API manufactured

by wholly-owned

Chinese subsidiary

• Finished product

manufactured by

Sandoz Canada

Tetrodotoxin manufacturing

19

Page 20: Wex Pharma - Investor Presentation

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.

Page 21: Wex Pharma - Investor Presentation

21

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)

Page 22: Wex Pharma - Investor Presentation

2222

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

Page 23: Wex Pharma - Investor Presentation

23

Less risk of tolerance or addiction?

No narcoticside effects?

opioid market be with…

$7BHow large would the

23

Page 24: Wex Pharma - Investor Presentation

24

Tetrodotoxin

368,000

painful diabetic

neuropathy130,000

post herpetic neuralgia

24

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

Page 25: Wex Pharma - Investor Presentation

WEX Pharmaceuticals Inc.

Corporate Presentation April 2010

a new class of non-opioid analgesic in Phase 3