ACRUX (ACR) - ASX ANNOUNCEMENT
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`2 NOVEMBER 2016
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`ACRUX FILES NEW INTELLECTUAL PROPERTY APPLICATION
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`FOR ONYCHOMYCOSIS PRODUCT
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`Acrux (ASX: ACR) today announced that it had filed a new provisional patent
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`application covering its pipeline product ACR-065 which is targeting fungal
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`infection of the nail bed in toes and fingers (onychomycosis).
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`The lodgment of this new patent application is an important step in progressing
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`Acrux’ product development pipeline, including onychomycosis.
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`ACR-065 is an improved formulation of the most effective and leading topically
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`applied treatment on the market for onychomycosis, ]ublia®, which contains the
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`antifungal agent efinaconazole. Acrux is progressing development and expects to
`initiate clinical trials in the second half of 2017.
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`For further information, contact
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`Michael Kotsanis, CEO and Managing Director: 03 8379 0100
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`About Onychomycosis
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`Onychomycosis is a fungal infection of the nail. Fungal infections of the nail are common
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`and difficult to successfully treat. Onychomycosis often causes fingernails or toenails to
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`thicken, discolor, disfigure, and split. Without treatment, the toenails can become so thick
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`that they press against the inside of the shoes, causing pressure, irritation, and pain. Half
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`of all nail disorders are caused by onychomycosis, and it is the most common nail disease
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`in adults. Toenails are much more likely to be infected than fingernails.
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`In the United States alone over 30 million people are affected by onychomycosis, with
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`approximately 3.5 million prescriptions written annually for these patients} Company
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`reported sales of ]ublia - the market leading topically applied product were US$338 million
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`in 2015.1 Over the next 10 years, market research estimates anticipate the total
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`onychomycosis market to reach total revenue sales of over $3 billion in 2022.2
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`jublia contains the active ingredient efinaconazole, an azole antifungal indicated for the
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`topical treatment of onychomycosis of the toenail[s) due to Trichophyton rubrum and
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`Trichophyton mentagrophytes.
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`1. Company sales reports and presentation data for Iublia
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`2. Dermatophytic Onychomycosis (D0) — Global Data. US Drug Forecast and Market Analysis to 2022. lune 2013
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`Iublia is a trademark ofValeant Pharmaceuticals International, Inc. or its alfiliates.
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`Kaken Exhibit 2022
`Acrux V. Kaken
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`IPR2017-00190
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`Kaken Exhibit 2022
`Acrux v. Kaken
`IPR2017-00190
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`About Acrux
`is a pharmaceutical company dedicated to developing and
`Acrux (ASX: ACR)
`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 fast-drying 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.
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`For further information on Acrux, visit www.acrux.com.au
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