invion limited (asx:ivx) -...
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Invion Limited (ASX:IVX)
Clinical-stage drug development company targeting chronic inflammation
William Garner, M.D. February | 2013
Disclaimer This presentation has been prepared by Invion Limited (Invion or the Company) solely for its use at presentations to
be made by the Company. The information contained in this presentation is an overview and does not contain all
information necessary to make investment decisions. Although reasonable care has been taken to ensure that facts
stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation,
expressed or implied, is made as to the fairness, accuracy, completeness or correctness of the information and
opinions contained in this presentation and no reliance should be placed on such information or opinions. This
presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or
sale of any security in the Company nor does it constitute financial advice nor take into consideration your investment
objectives. This presentation contains or may contain forward-looking statements that are based on management’s
belief, assumptions and expectations and on information currently available to management. All statements that are
not historical, including those statements that address future operating performance and events of developments that
we expect or anticipate will occur in the future, are forward looking statements. Although management believes these
forward looking statements are fair and reasonable you should not place undue reliance on these statements.
Experienced leadership team
William J. Garner MD, CEO
> EGB Advisors, Roche, Co-Founder DelMar Pharmaceuticals
> Successful corporate founder and executive
Mitchell Glass MD, EVP R&D and CMO
> 25 year veteran of Pharma (AZ, GSK) and Biotech (AGIX)
> Managed more than 40 drug developments including “first in class”
> 5 approved drugs (Accolate® /asthma, Coreg®/ heart failure, AVANDIA)
Ralph Craven, B Eng PhD, Chairman of the Board
> Broad experience as company director, respected member of international energy industry
> Ergon Energy, Arrow Energy, Tully Sugar
James Campbell, PhD MBA, Executive Director
> Senior biotechnology executive with 20+ years experience in research, research management, advisory
> COO and CFO, ChemGenex Pharmaceuticals; Principal, Gemini Biotechnology
Brett Heading, BCom LLB (Hons), Non-executive Director
> Experienced corporate lawyer/ company director across property, agribusiness & life sciences sectors
> Chairman of Partners, McCullough Robertson Lawyers
Warren Brown, B Eng, Non-executive Director
> Experienced in corporate strategy and project management
> Background in consulting engineering and contract negotiation
Current pipeline
Preclinical Phase I Phase II
INV102 (oral)
INV103 (ala-Cpn10)
NCE development
Smoking cessation
Asthma
Lupus (SLE)
INV102 (inhaled)
Chronic bronchitis
Cystic fibrosis
NIH funded (US$4.4m non-dilutive funding)
Academic alliance Beta-2 adrenergic inverse agonist
INV102 (nadolol): overview
> Nadolol is a beta adrenergic inverse agonist (beta blocker) used in the treatment of high blood pressure, chest pain and migraine
> IVX is repurposing the drug for treatment of chronic obstructive pulmonary disease (COPD)
> IVX development strategy follows the medical, regulatory and commercial precedent of beta blockers for the treatment of chronic heart failure (CHF) = mitigated risk
> Phase II trials conducted to date have demonstrated safety and dose-related activity in airways
> An existing drug (generic) it has been used in over 10 million patients* to date = safety database
> Two phase II trials in 2013:
> Smoking cessation
> Asthma
* Company estimates
Medical, regulatory and commercial precedent
Chronic Heart Failure
(CHF)
Beta-Agonist
Beta-Inverse Agonist
e.g. carvedilol
(contraindicated
for >25 years)
Acutely
Beneficial
Acutely
Detrimental
Chronically
Detrimental
Chronic carvedilol
Mortality reduction
Standard of care
Chronic Obstructive Pulmonary Disease
(COPD)
Beta-Agonist
Beta-Inverse Agonist
e.g. nadolol
(contraindicated
for >25 years)
Acutely
Beneficial
Acutely
Detrimental
Chronically
Detrimental/
not helpful
Chronic INV102
(nadolol) for COPD
(asthma &
chronic cough)
AC
UT
E
CH
RO
NIC
After careful titration beta blockers for the treatment of CHF go from contraindicated to standard of care.
Medical, regulatory and commercial precedent for INV102 (nadolol) strategy established.
Airway healing: effect of oral INV102
Control lung tissue Lung tissue of asthmatic mice
treated with INV102 for 28
days: restored epithelium
Lung tissue of ‘asthmatic’ mice -
epithelial cells have been
converted to mucus-producing
goblet cells. No effect of
alprenolol.
Proof of concept has been achieved in pre-clinical studies with inhaled INV102
Chronic Exposure to Beta-Blockers Attenuates Inflammation and Mucin Content in a Murine Asthma Model. Nguyen et al. Am J
Respir Cell Mol Biol. 2008 Mar;38(3):256-62. See also. β-Adrenoceptor signaling is required for the development of an asthma
phenotype in a murine model. Nguyen et al. Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2435-40.
Chronic cough and failure to quit smoking*
6,000,000
Americans attempt to quit smoking annually
3,000,000
50% fail to quit at 6 months
1,500,000
50% fail to quit early (first 2-4 weeks)
375,000
25% of early failures due to
inadequate NRT or anxiety
750,000
Up to 50% of early failures due to
cough associated with excess mucus
Enriched with COPD patients
* Company estimates
Oral INV102 development strategy
Smoking cessation
> INV102 can treat underlying cause of chronic cough and
mucus secretion which are a major barrier to smoking
cessation and cause of peri-operative complications in
patients with COPD
> Phase II trial in smoking cessation to initiate 1Q 2013
> Total treatment period less than 5 months
> Titration doses (novel) provide IVX market exclusivity
Asthma
> NIH funding phase II study ($4.4 million)
> Initiated: 2013
> Expected trial end: 2015
Respiratory Inflammation market $64B+1.
> Smoking-Cessation Drug Market worth $2.4B in 20122.
> Large COPD /Asthma drug market, valued at ~$34B1.
> Advair Diskus ®, approved for asthma and COPD, ($8.1B peak annual
sales)3.
> Singulair ®, approved for asthma ($5.5B peak annual sales)4.
> Symbicort ®, approved for asthma and COPD ($3.1B worldwide sales)1.
> FDA sanctions on Long-Acting Beta Agonists (LABAs)
> Drugs associated with excess mortality
> Black box warning on all LABAs and LABA/Steroid combinations, including
Advair Diskus® and Symbicort ® : increased risk of death
1. Respiratory and Inflammation, AstraZeneca Annual Report, 2011
2. Smoking Cessation Drugs: World Market Prospects 2012-2022, Visiongain Reports 2012
3. Healthcare Finance, Bloomberg Brief, 13 August 2012
4. Full-Year and Fourth-Quarter 2011 Financial Results, Merck & Co
INV103 (ala-Cpn10): overview
> Potential new anti-inflammatory biologic therapeutic
> Modified version of a naturally occurring human protein,
chaperonin10
> Strong patent position covering composition of matter
> Novel mechanism: effect on inflammatory markers is
different to current leading therapies, i.e. immune response
is dampened not ablated
> Target indication: systemic lupus erythematosus (“lupus”)
> Under-served market: only 1 drug approved in 50 years
Development plan
> Strong pre-clinical data
> improved kidney function, resolved cutaneous lupus, reduced renal and
circulating levels of inflammatory markers TNF-α and IL-6
> Signals of biological activity in clinical trials to date
> Strong safety profile in >250 patients (9 trials)
> Adequate cGMP material and toxicology coverage to support human clinical trial
> Pre-IND meeting with FDA held 14 December 2012
> Rapid, cost-effective means of determining clinical potential
> Phase II trial expected to initiate in 1Q13, data in 2013
Corporate snapshot
Sector Biotechnology
Principal activities Clinical-stage pharmaceutical drug development
Intellectual Property assets 2 drug candidates
Pipeline status 3 phase II clinical programs
ASX code IVX
Last trade (12-Feb-13) $0.068 (6.8 cents)
Shares on issue 384,531,941
Market cap (12-Feb-13) $26 million
Cash at bank (31-Dec-12) $3.43 million
IVX: potential with mitigated risk
> Management team with significant FDA experience
> 5 NDAs
> Significant value drivers in 2013
> phase II data
> Submission of first NDA possible in less than three years
> INV102 (nadolol) in smoking cessation
> Strong patent position on both assets
William Garner, M.D. [email protected]
Invion Limited 2/120 Bluestone Circuit
Seventeen Mile Rocks
QLD 4073 Australia
P: +61 7 3295 0500
F: +61 7 3295 0599
W: www.invion.com.au
Managing Director and CEO
William Garner, M.D.
Investor and Media Relations
Buchan Consulting