Brickell Biotech announces the sale of sofpironium bromide to Botanix Pharmaceuticals

Brickell Biotech announces the sale of sofpironium bromide to Botanix Pharmaceuticals

Brickell Biotech

The deal includes up to $ 9 million in upfront payments and potential near-term regulatory milestones, $ 168 million in potential future regulatory and sales milestones payments, plus tiered payments on net sales to Brickell.

The sale reflects Brickell’s strategic shift in the fields of immunology and inflammation; the proceeds will be used to advance the Company’s pipeline of recently acquired new therapies

BOULDER, Colo., May 3, 2022 (GLOBE NEWSWIRE) – Brickell Biotech, Inc. (Nasdaq: BBI) (“Brickell” or “Company”), a clinical-stage pharmaceutical company striving to transform patients’ lives developing innovative solutions and differentiated prescription drugs for the treatment of autoimmune, inflammatory and other debilitating diseases, today announced that it has signed and entered into a definitive asset purchase agreement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited (ASX : BOT) (“Botanix”), for which Botanix acquired the Company’s rights to sofpironio bromide, a new retrometabolically engineered chemical entity that belongs to a class of drugs called anticholinergics. 15% Sofpironium Bromide Gel is a potential best-in-class topical therapy that recently completed a pivotal Phase 3 clinical program in the United States for the treatment of primary axillary hyperhidrosis or excessive armpit sweating. Brickell was well on his way to filing a new drug application (“NDA”) with the US FDA for 15% sofpyron bromide gel in mid-2022.

Under the terms of the agreement, Botanix acquired all the businesses primarily related to sofironium bromide from Brickell. In return, Brickell will receive upfront payments and potential short-term regulatory milestones over the next 18 months of up to $ 9 million from Botanix. Brickell is also eligible to receive additional success-based sales and regulatory milestone payments of up to $ 168 million and tiered earning payments ranging from high single digits to mid-teens figures on net sales of sofpironio bromide gel. Some 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 Sofpironum Bromide globally. In connection with the sale of sofpyron bromide, Brickell and Botanix have entered into a transition services agreement under which Brickell will provide advisory services to Botanix through the U.S. NDA submission and potential approval for sofpyron bromide gel. , 15%.

“We are delighted to announce the closing of this transaction with Botanix, whose established management team has a solid track record of gaining FDA clearance and successfully commercializing some of the leading brands in medical dermatology and aesthetic medicine,” he said. commented Robert Brown, CEO of Brickell. “This agreement allows us to begin 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 with primary axillary hyperhidrosis without the significant marketing investment required by us “.

Mr. Brown continued: “Today marks a pivotal day in Brickell’s evolution as we now shift our strategic focus to developing new therapies in the fields of immunology and inflammation. Accordingly, we intend to invest the proceeds and potential future economies of this sale to continue to advance our exciting pipeline of new and potential first-class therapies. This includes conducting a first Phase 1 human clinical trial that is well on its way to the start of this quarter for our main DYRK1A inhibitor, BBI-02, and progressing the development of our main STING inhibitor, BBI. -10 and other next-generation kinase inhibitors through the first preclinical studies in 2022 ”.

Further details of the transaction, including agreements and related matters, will be contained in a current report on Form 8-K which will be filed by the Company.

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

Information on sofpironio bromide

Sofpironio bromide is a new chemical entity that belongs to a class of drugs called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system responsible for a variety of bodily functions, including the activation of the sweat glands. Sofpironio bromide was designed retrometabolically. Retrometabolic drugs aim to exert their action locally and are potentially rapidly metabolized to a less active metabolite once absorbed into the blood. Sofpironium bromide gel, 15% have completed a key U.S. Phase 3 clinical program for the treatment of primary axillary hyperhidrosis, and sofpironium bromide gel, 5% are approved in Japan for the same indication under the ECCLOCK brand®.

About Brickell

Brickell Biotech, Inc. is a clinical-stage pharmaceutical company that strives to transform patients’ lives by developing innovative and differentiated prescribed therapies for the treatment of autoimmune, inflammatory and other debilitating diseases. Brickell’s pipeline consists of several candidates under development and a state-of-the-art platform with broad potential in autoimmune and inflammatory disorders. This includes BBI-02, a Phase 1-ready oral DYRK1A inhibitor, potential first-in-class with strong preclinical validation for the treatment of autoimmune and inflammatory diseases, such as atopic dermatitis, rheumatoid arthritis and type 1 diabetes, BBI-10 , a novel preclinical oral STING inhibitor that demonstrated dose-dependent reduction of cytokines in non-clinical studies providing evidence of the mechanism for the treatment of autoinflammatory and rare genetic conditions and a platform of kinase inhibitors DYRK, CLK, LRRK2 and Next generation TTK with the potential to produce treatments for autoimmune, inflammatory and other debilitating conditions. Brickell’s executive management team and board of directors have extensive experience in product development and global marketing, having held leadership roles in large global pharmaceutical and biotech companies that have developed and / or launched successful products, including many first class and / or achieved iconic status, such as Cialis®Valtz®Gemzar®Prozac®Cymbalta®and Juvederm®. Brickell’s strategy is to leverage this experience to license, acquire, develop and commercialize innovative pharmaceutical products that Brickell believes can significantly benefit patients suffering from chronic and debilitating diseases who are underserved by available therapies. For more information, visit https://www.brickellbio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements made in this press release relating to future financial, commercial and / or research and clinical performance, conditions, plans, prospects, trends or strategies and other similar matters, including without limitation Brickell’s strategy; future operations; future financial position; future liquidity; future income; expected expenses; results of operations; the anticipated timeframe, scope, design, progress, results and / or data disclosure of ongoing and future clinical and non-clinical studies; intellectual property rights, including their validity, duration and enforceability; the expected timing and / or results of regulatory submissions and approvals; and the prospects for marketing any of Brickell’s candidate products, or the research collaborations or actions of its partners, including Japan, South Korea, the United States, or any other country are forward-looking statements under the US Private Securities Litigation Reform Act of 1995. Also, when or if used in this press release, the words “announce”, “may”, “could”, “should”, “could”, “anticipate”, “reflect”, “believe”, “estimate “,” Expect “,” I mean “,” plan “,” foresee “,” potential “,” will “, evaluate”, “advance”, “excited”, “aim”, “strive”, “help”, ” progress “,” select “,” start “,” look ahead “,” promise “and similar expressions and variations thereof, as they refer to Brickell or any of Brickell’s partners or to third parties, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time, often rapidly and in unexpected ways. Important factors that could cause actual results to differ materially from the results discussed in forward-looking statements or historical experience include risks and uncertainties, including but not limited to research results and data that do not meet objectives, expectations or regulatory approval requirements. ; ability to obtain adequate funding for product development, regulatory submissions and any commercialization; ability to maintain and enforce intellectual property rights; potential delays or alterations in product development, testing of any kind and regulatory submissions and reviews; changes in law or policy; litigation, feedback or requests from regulatory agencies; supply chain disruptions; unexpected requests for cash resources; disruptions and negative effects related to the COVID-19 pandemic and the conflict in Ukraine; interruptions, interruptions or inability by Brickell or its partners to obtain or supply research material, raw materials and / or products anywhere in the world; efforts to obtain and maintain adequate prices and adequate reimbursements and other insurance coverage for Brickell products; the result of Brickell’s current and planned preclinical and clinical studies in his portfolio; Botanix’s inability to realize the regulatory and sales events, and therefore Brickell has not received any additional payments, under his agreement with them; and other risks associated with developing and obtaining regulatory approval for and marketing candidate products.

Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in the filings by Brickell with the United States Securities and Exchange Commission, available at https://www.sec.gov (or at https://www.brickellbio.com). Forward-looking statements represent only Brickell’s estimates as of the date of this document. Brickell expressly disclaims any obligation or obligation to update any forward-looking statements.

Brickell Investor Contact:
Dan Ferry
LifeSci Consultants
(617) 430-7576
daniel@lifesciadvisors.com

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