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United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new US patent covering the drug substance technology used in the commercial manufacture of Sofdra®(sofpironium)
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Upon issuance, the patent is expected to add to existing patent protections against unauthorised commercial manufacturing of Sofdra®'s drug substance into May 2040
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The allowance further expands Botanix's US patent portfolio protecting its FDA-approved treatment for primary axillary hyperhidrosis
Botanix Pharmaceuticals Limited (ASX:BOT, "Botanix" or "the Company") is pleased to announce that the United States Patent and Trademark Office ("USPTO") has issued a Notice of Allowance for US patent application Serial No. 17/611,158, "Crystalline Form of Sofpironium Bromide and Preparation Method Thereof." The application covers commercially relevant intellectual property protecting the drug substance underpinning Sofdra® (sofpironium), Botanix's FDA-approved treatment for primary axillary hyperhidrosis in adults and paediatric patients aged nine and older.
The allowed claims relate to proprietary aspects of the sofpironium drug substance technology used in Sofdra®'s commercial manufacture. Once issued, the patent is expected to strengthen Botanix's intellectual property protection surrounding Sofdra® in the United States, protecting against unauthorised commercial manufacturing of the drug substance into May 2040.
The actual chemical entity itself (in this case, the crystalline form of sofpironium bromide), is generally considered the hardest to design around. That's why this type of patent is highly valued by companies and investors alike.
Dr Howie McKibbon, Chief Executive Officer of Botanix, said strengthening the company's intellectual property estate around Sofdra® remained an important strategic priority, and that the Notice of Allowance further expanded its US patent portfolio, supporting the long-term commercial opportunity for Sofdra® out to 2040.
Having multiple issued patents providing protection to 2040 gives Botanix a long window of market exclusivity for Sofdra®, which supports long-term revenue, makes the asset more attractive for potential licensing or partnership deals, and reduces the risk profile for investors.
Botanix is committed to protecting the innovations underpinning its lead commercial product as it continues to build out its US dermatology offering.
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: [email protected]
