Invion Ltd. · ASX:IVX
Invion — Investor Presentation (July 2015)
10 slides from Invion's investor presentation, Jul 27, 2015
Slide 1: INV104 (zafirlukast)
For personal use only INV104 (zafirlukast) Target: a novel inhaled non-steroidal anti-inflammatory treatment for asthma
Slide 2: Target: an inhaled reformulation of a successful oral therapeutic for asthma
Target: an inhaled reformulation of a successful oral therapeutic for asthma For personal use only INV104 (zafirlukast): > Leukotriene-receptor antagonist (LTRA) or “anti-leukotriene” that reduces inflammation, constriction of the airways, and the build-up of mucus in the lungs > Approved worldwide
Slide 3: Inhaled zafirlukast an anti-leukotriene: background and rationale
Inhaled zafirlukast an anti-leukotriene: background and rationale For personal use only Defined safety Defined CMC profile Airway & nasal Full toxicology 200mcg demonstrated secretions are rich in package completed 12 hour protection LTC4, D4 and E4 Excellent flow using CFC-based Single and multiple
Slide 4: FDA pre-IND established framework for reformulation of zafirlukast
FDA pre-IND established framework for reformulation of zafirlukast Agreement reached with FDA on: For personal use only > chemistry manufacturing and controls (GMP) > active pharmaceutical ingredient (API) with drug master file (DMF) > formulation: dry powder inhaler (DPI) approved for development >
Slide 5: Inhaled Product Rationale
Inhaled Product Rationale Oral Inhaled For personal use only Forms Form Risk of neuropsychiatric/suicide ideation events? Risk of liver toxicity ? Greater efficacy due to higher airway concentrations Potential for once a day dosing ? Singulair Potential for expanded EIB claims ? Prevention Only Rapi
Slide 6: Hovione CMC collaboration mitigates major risk of inhaled zafirlukast development
Hovione CMC collaboration mitigates major risk of inhaled zafirlukast development Formulation & device partner, Hovione For personal use only > Invion will collaborate with Hovione to develop the proprietary novel technology – a dry powder formulation of zafirlukast and the accompanying inhalational
Slide 7: About Hovione and the XCaps inhaler
About Hovione and the XCaps inhaler For personal use only > International company with over 50 years’ experience in the development and compliant manufacture of active pharmaceutical ingredients and drug product intermediates > With four FDA inspected sites in the U.S., China, Ireland, and Portugal,
Slide 8: Expected placement of inhaled zafirlukast in treatment regimes
Expected placement of inhaled zafirlukast in treatment regimes > As many as 334 million people have For personal use only asthma which occurs in people of all ages. Wheeze is the most common symptom and the burden of disability is high. > In 2007 the U.S. spent over $56 billion on asthma care, of wh
Slide 9: Inhaled zafirlukast program: progress and clinical development strategy
Inhaled zafirlukast program: progress and clinical development strategy For personal use only Clinical benefits FDA approved as an oral asthma therapy Proof of concept previously conducted using inhaled drug Non-steroidal Higher local concentrations without systemic exposure (decreased risk
Slide 10: Disclaimer
For personal use only Disclaimer • The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Invion Limited ACN 094 730 4