Pharma Focus Asia

Brickell Biotech Announces Sale of Sofpironium Bromide to Botanix Pharmaceuticals

Thursday, May 05, 2022

Brickell Biotech, Inc., a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, announced today that it has signed and closed a definitive asset purchase agreement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited (ASX: BOT) (“Botanix”), whereby Botanix has acquired the Company’s rights to sofpironium bromide, a retrometabolically-designed new chemical entity that belongs to a class of medications called anticholinergics. Sofpironium bromide gel, 15% is a potential best-in-class topical therapy that recently completed a U.S. Phase 3 pivotal clinical program for the treatment of primary axillary hyperhidrosis, or excessive underarm sweating. Brickell was on track to submit a New Drug Application (“NDA”) to the U.S. FDA for sofpironium bromide gel, 15% in mid-2022.

Under the terms of the agreement, Botanix has acquired from Brickell all assets primarily related to sofpironium bromide. In exchange, Brickell will receive upfront and potential near-term regulatory milestone payments over the next 18 months of up to $9 million from Botanix. Brickell also is eligible to receive additional success-based regulatory and sales milestone payments of up to $168 million and tiered earn out payments ranging from high-single digits to mid-teen digits on net sales of sofpironium bromide gel. Certain of these amounts are subject to payments by Brickell to its former licensor. Botanix will be responsible for all further research, development, and commercialization of sofpironium bromide globally. In connection with the sale of sofpironium bromide, Brickell and Botanix entered into a transition services agreement whereby Brickell will provide consulting services to Botanix through submission and potential approval of the U.S. NDA for sofpironium bromide gel, 15%.

“We are pleased to announce the closing of this transaction with Botanix, whose established leadership team has a strong track record of gaining FDA approval for, and successfully commercializing, some of the leading brands in medical dermatology and aesthetic medicine,” commented Robert Brown, Chief Executive Officer of Brickell. “This deal allows us to start unlocking the value of sofpironium bromide by providing an optimal pathway for sofpironium bromide gel, 15% to become a potential best-in-class treatment for the millions of patients suffering from primary axillary hyperhidrosis without the significant investment for commercialization required on our part.”

Mr. Brown continued, “Today marks a pivotal day in Brickell’s evolution, as we now shift our strategic focus to developing novel therapeutics in the immunology and inflammatory fields. Accordingly, we intend to invest the proceeds and potential future economics from this sale to continue advancing our exciting pipeline of novel, potential first-in-class therapies. This includes conducting a first-in-human Phase 1 clinical study that is on track to start this quarter for our lead DYRK1A inhibitor, BBI-02, and progressing the development of our lead STING inhibitor, BBI-10, and other next-generation kinase inhibitors through early preclinical stage studies in 2022.”

Additional details of the transaction, including related agreements and matters, will be contained in a Current Report on Form 8-K to be filed by the Company.

Oganesson, LLC served as transaction advisor and Faegre Drinker Biddle & Reath, LLP served as legal counsel to Brickell in connection with the transaction. MTS Health Partners, LP served as transaction advisor and Troutman Pepper Hamilton Sanders, LLP served as legal counsel to Botanix in connection with the transaction.

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