SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (date of earliest event reported): December 7, 2018 (December 5, 2018)
CUMBERLAND PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
2525 West End Avenue, Suite 950, Nashville, Tennessee 37203
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code:
(Former name or former address, if changed since last report)
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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).
Emerging growth company o
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Item 1.01 Entry into a Material Definitive Agreement
On December 5, 2018, Cumberland Pharmaceuticals Inc. (“Cumberland”) closed its previously announced agreement with GastroEntero-Logic, LLC (“GEL”) to acquire the assets associated with Omeclamox®-Pak (the "Product"), including the Product’s FDA-approved New Drug Application, the domestic and international trademarks and other assets. The closing of this transaction suspends Cumberland’s payments of royalties and manufacturing fees to GEL, and Cumberland assumes responsibility for the maintenance of the Product’s FDA approval and for the oversight of the Product’s manufacturing and packaging. In exchange for the Product’s assets, Cumberland paid GEL approximately $2.3 million.
Omeclamox-Pak, is for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease. This innovative product combines three well-known and widely prescribed medications: omeprazole, clarithromycin, and amoxicillin. Omeclamox-Pak was the first FDA-approved triple therapy combination medication to contain omeprazole as the proton pump inhibitor, which works to decrease the amount of acid the stomach produces. Clarithromycin and amoxicillin are both antibiotic agents which hinder the growth of the H. pylori bacteria. Interaction of these agents allows the stomach lining to heal effectively. The medications are packaged together on convenient daily dosing cards, making it simple to follow the twice a day dosing before meals. In addition, compared to its competitors, Omeclamox-Pak involves the lowest pill burden and fewest days of therapy.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Cumberland Pharmaceuticals Inc.
Dated: December 7, 2018
By: /s/ Michael Bonner
Name: Michael Bonner
Title: Chief Financial Officer