bbi-20200925

Delaware

000-21088

93-0948554

(State or Other Jurisdiction
of Incorporation)

(Commission File
Number)

(IRS Employer
Identification No.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Common stock, par value $0.01 per share

BBI

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

On September 25, 2020, Brickell Biotech, Inc. (the “Company”) issued a press release, which is furnished as Exhibit 99.1 to this report, announcing that its Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”), received approval to manufacture and market sofpironium bromide gel, 5% in Japan for the treatment of primary axillary (underarm) hyperhidrosis.

The information in this Item 7.01, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.

On September 25, 2020, the Company announced that its Japanese development partner, Kaken, received approval to manufacture and market sofpironium bromide gel, 5% under the brand name ECCLOCK® in Japan for the treatment of primary axillary (underarm) hyperhidrosis.

This regulatory approval is based on the results of the Japanese Phase 3 pivotal registration study of sofpironium bromide gel, 5% in 281 patients with primary axillary hyperhidrosis, in which all primary and secondary efficacy endpoints demonstrated statistically significant differences between sofpironium bromide gel and vehicle (placebo). In addition, sofpironium bromide gel was deemed to be safe and generally well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan.

Under the sublicense agreement with Kaken, the Company is entitled to receive sales-based milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide gel in Japan.

Sofpironium bromide is currently being developed by the Company in the U.S. for the treatment of primary axillary hyperhidrosis. The Company intends to initiate its pivotal Phase 3 program in the U.S. for sofpironium bromide gel, 15% during the fourth quarter of 2020, which will ultimately be comprised of two pivotal Phase 3 trials to evaluate sofpironium bromide gel compared to vehicle in approximately 350 subjects (per trial) with primary axillary hyperhidrosis.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: September 25, 2020

Brickell Biotech, Inc.

By:

/s/ Robert B. Brown

Name:

Robert B. Brown

Title:

Chief Executive Officer