ACRUX PRESENTS AT BIOSHARES BIOTECH SUMMIT

Transcription

1 ACRUX (ACR) - ASX ANNOUNCEMENT 24 JULY 2017 ACRUX PRESENTS AT BIOSHARES BIOTECH SUMMIT Acrux (ASX: ACR) today announced that CEO and Managing Director, Michael Kotsanis presented at the 2017 Bioshares Biotech Summit on 22 July The presentation follows this announcement. For further information, contact Michael Kotsanis, CEO and Managing Director: About Acrux Acrux (ASX: ACR) is a pharmaceutical company dedicated to developing and commercialising specialty and generic topical pharmaceuticals. Incorporated in 1998 and using in house facilities and capabilities, Acrux has successfully developed and commercialised through licensees a number of pharmaceutical products in the US and Europe using the Patchless Patch, a fastdrying and invisible topical application technology. Marketed products include Axiron, Evamist and Lenzetto. More recently, in addition to specialty products, Acrux has identified and initiated development of a range of generic products. Acrux is leveraging its on-site laboratories, GMP manufacturing suite, clinical and commercial experience to bring more products to market. Acrux encourages collaboration and is well positioned to discuss partnering and product development. For further information on Acrux, visit

2 Generics affordable medicine Michael Kotsanis CEO and Managing Director, Acrux Ltd 2017 Bioshares Biotech Summit 22 July, 2017

3 Forward looking statements This presentation includes forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks andimportant factors that may cause the actual results, performance or achievements of Acrux to be materially different from the statements in this presentation. Actual results could differ materially depending on factors such as the availability of resources, the results of clinical studies, the timing and effects of regulatory actions, the strength of competition, the outcome of legal proceedings and the effectiveness of patent protection. 2

4 Agenda About generics Generic facts, figures and impact Generic market evolution The Acrux opportunity 3

5 What is a generic drug? According to the FDA: Generic drugs are just as safe and just as effective as their brand-name counterparts, and they are a cost effective way of achieving substantial savings. A generic drug is identical or bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. According to the American Medical Association (AMA): One of the primary ways physicians can practice cost-effective prescribing is by offering patients a generic medicine when one is available. What is a generic medicine? Generic drugs contain the same active ingredients, in the very same strength, as brand-name drugs. When a medicine is first developed, the pharmaceutical company that discovers and markets it receives a patent on its new drug. The patent usually lasts for 20 years, to give the originating company a chance to recoup its research investment. After the patent expires, a generic version of the drug may become available. Generics are marketed under the drug's chemical, or "generic," name and meet the same FDA quality and effectiveness standards as the original. Source: 4

6 Agenda About generics Generic facts, figures and impact Generic market evolution The Acrux opportunity 5

7 Healthcare spending on pharmaceuticals United States Figure 1: National healthcare expenditure Figure 2. United States generic and branded volume and sales Pharmaceuticals 10% 11% 89% Dispensed prescription volume Generic market >$90 Billion 26% Dispensed prescription cost 74% United States national healthcare expenditure was 17.8% of GDP in 2015 Sources: Figure 1. Data from Centers for Medicare & Medicaid Services. National Health Expenditure Fact Sheet Figure 2. QuintilesIMS MIDAS Q3 2016; QuintilesIMS GPHA February 2017 Brands Generics (branded and unbranded) 6

8 US$ Billion The US healthcare system has saved $1.46 trillion in the last ten years due to the availability of low cost generics Cumulative savings from older and newer generics ($Billions) $1,456 Bn $626 Bn $829 Bn older generics launched pre 2006 newer generics launched Source: QuintilesIMS GPHA February

9 Impact of generics in Europe Up to 17% R&D investment of turnover Billion less spending through generic competition Over 350 manufacturing sites European generic market 22% of pharmaceutical expenditure 160,000 employees in sector Over 56% of dispensed medicines INCREASED PATIENT ACCESS VALUE FOR PATIENTS IMPROVED ECONOMIC VALUE Source: European Generics Association / Medicines For Europe 8

10 Value of generic medicines European Generics Association Health Economics Study INCREASED PATIENT ACCESS VALUE FOR PATIENTS IMPROVED ECONOMIC VALUE IMPROVED MEDICATION ADHERENCE BETTER PATIENT HEALTH OUTCOMES HYPERTENSION BREAST CANCER DEPRESSION MORE PATIENTS TREATED with SAME EXPENDITURE SAME NUMBER OF PATIENTS TREATED with LESS EXPENDITURE MORE PATIENTS TREATED with SMALL EXPENDITURE INCREASE Source: European Generics Association / Medicines For Europe 9

11 Timelines for development of originator or generic drugs Originator drugs High development cost High development risk Clinical trials Target discovery/validation Phase 1 Phase 2 Phase 3 Market Access YEARS Lead optimisation Pre-clinical testing FDA review Commercialisation Generic drugs YEARS Project selection Product development Clinical trials Bioequivalence Stability Exhibit batch manufacture FDA review Low development cost Low development risk Commercialisation Drug development timelines for generics are substantially shorter than originator drug development 10

12 Agenda About generics Generic facts, figures and impact Generic market evolution The Acrux opportunity 11

13 $ Billion Generic company opportunities - over $50 billion of branded sales facing loss of exclusivity in coming years Small molecule patent expiry exposure in the United States ($ Billion) Source: QuintilesIMS, National Sales Perspectives, Sep 2016 Sales in year prior to expiry used for years ; sales in MAT Sep 2016 used for years

14 Changing landscape - United States pricing trends for generics Oral Topical Injection Ophthalmic INCREASED PRICING PRESSURE IN COMMODITISED SEGMENTS Source: Government Accountability Office (GAO) analysis of Medicare Part D prescription drug event data 13

15 United States market sales by dosage form $ Billion Dosage proportion based on sales Oral 14 Generic Injectable 12 Liquids 10 Topical Aerosol $130 billion $200 billion 8 6 Brands Powders 4 Other 2 0 Market size for topically applied drugs Topically applied drugs generate almost $18 billion in sales in the United States Acrux pipeline is focussed on the development of generic topical/transdermal products Source: US market by dosage form, IMS Q2, 2015 MAT. US market sales. US$. Market for topically applied drugs IMS Q1, 2017 MAT US$ 14

16 Agenda About generics Generic facts, figures and impact Generic market evolution The Acrux opportunity 15

17 $ Billion $ Million The Acrux market opportunity Acrux generic pipeline addressable market value 14 Generic Brands Market size for topically applied drugs 0 Jun-17 Acrux has 7 generic products in active development Acrux expects to increase this to 12 generic products in active development by end FY18 Source: Acrux analysis. IMS Q1, 2017 MAT. US market sales. US$ 16

18 Acrux opportunities and challenges ahead Opportunities Low project risk for generic pipeline compared to branded products Considered project selection including products with biowaiver potential or Paragraph IV opportunity Avoid commoditised market segments with significant pricing pressure Commercialise a diversified broad topical generic portfolio FDA costs lower for ANDAs compared to 505(b)(2) or NDA submissions Challenges Undisclosed pipelines for generic companies Acrux plans to file ANDA regulatory submissions mid 2018 for its initial generic products 17

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