European Intention to Grant on applicator patent makes Sofdra® more attractive for ex-US commercialisation
JMM
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European Patent Office has issued an Intention to Grant for a patent covering the proprietary applicator technology used with sofpironium topical gel, 12.45% (branded Sofdra® in the US)
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Following formal grant and validation in selected European countries, the patent is expected to provide protection into May 2039
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The decision strengthens Botanix's European IP position and is expected to enhance the Company's value proposition for potential ex-US commercialisation pathways
Botanix Pharmaceuticals Limited (ASX:BOT, "Botanix" or "the Company") announces that the European Patent Office ("EPO") has issued an Intention to Grant for European patent application EP 19799730.7, ‘Applicator and System for Pharmaceutical Preparation and Method of Use.’ The application covers proprietary applicator technology used with sofpironium topical gel, 12.45%, the drug product branded as Sofdra® in the United States.
The patent application covers commercially relevant aspects of the applicator device, including features designed to support controlled topical administration and patient use. Following completion of the formal grant process and validation in selected European countries, protection is expected to extend into May 2039.
Sofdra is currently only commercialised in the US. Securing patent protection in Europe before commercialising there is a forward-looking, strategic move. Botanix is proactively securing the IP runway needed to enhance the Botanix value proposition for potential ex-US commercialisation.
Dr Howie McKibbon, Chief Executive Officer of Botanix, welcomed the decision, noting it further strengthens the Company's intellectual property estate surrounding the delivery and administration of sofpironium topical gel. He added that physicians have identified the applicator, which helps limit unwanted drug contact to the hands, as one of the key reasons they prescribe Sofdra®.
About us:
Botanix Pharmaceuticals Limited (ASX:BOT) is a dermatology company based in Philadelphia and Phoenix (US), which has received FDA approval for Sofdra, its product for the treatment of primary axillary hyperhidrosis. Sofdra is the first and only new chemical entity approved by FDA to treat primary axillary hyperhidrosis and presents a novel, safe and effective solution for patients who have lacked treatment options for this socially challenging medical condition. To learn more, please visit: http://www.botanixpharma.com/
Contact details:
Investor and Media Relations, Jane Morgan Management Wilamina Russo M: +61 450 646 609 [email protected]
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Sofdra Bottle Applicator Cap (1).jpg
Thoughtful design of bottle and applicator proves valuable to Sofdra®.
