Brickell Biotech and its subsidiary announced the company and Bodor Laboratories and Dr. Nicholas S. Bodor have entered into a settlement agreement and an amended license agreement. This resolves the previously disclosed dispute related to the sofpironium bromide license agreement and allows the Company to continue its efforts to develop sofpironium bromide for the treatment of hyperhidrosis, a life-altering medical condition with an estimated 15 million sufferers in the United States.
Pursuant to the settlement, the parties agreed to dismiss the related litigation and arbitration with prejudice. As part of the settlement and amended license agreement, Brickell agreed to make an upfront payment to Bodor of $1.0 million in cash and pay future amounts, up to $1.0 million in cash and $1.5 million in common stock, upon the achievement of specified milestones (with shares to be valued at the closing price on the day preceding each such issuance). Additionally, Brickell agreed to pay Bodor a low single-digit royalty related to a newly filed provisional patent application and modified the percentage of certain sub-licensing income that Bodor may receive in the future.
“Resolving the dispute with Bodor at this time is, on balance, in the best interest of our stockholders as it permits Brickell to continue to advance our lead product candidate without the cloud of litigation,” said Robert Brown, Brickell’s Chief Executive Officer. “We look forward to focusing on the development of sofpironium bromide, including sharing top-line results from our Phase 3 long-term safety study in the second quarter of this year.”
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Sofpironium bromide is a proprietary new molecular entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a considerably less active metabolite once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor, Ph.D., D.Sc., d.h.c. (multi), HoF.
Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States, are believed to suffer from hyperhidrosis. Axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common occurrence of hyperhidrosis, affecting an estimated 65% of patients in the United States or 10 million individuals.