UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 20, 2011
SANTARUS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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| Delaware | | 0-50651 | | 33-0734433 |
(State or Other Jurisdiction of Incorporation or Organization) | | (Commission File Number) | | (I.R.S. Employer Identification No.) |
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3721 Valley Centre Drive, Suite 400, San Diego, California 92130
(Address of Principal Executive Offices) (Zip Code)
(858) 314-5700
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
On December 20, 2011, Santarus, Inc. (“Santarus”) announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking market approval for Uceris™ (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis. Uceris, a locally acting, nonsystemic corticosteroid in a novel, patented, oral tablet formulation, utilizes proprietary MMX® multi-matrix system technology that is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Uceris is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Forward-Looking Statements
Santarus cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any plans or objectives will be achieved. Actual results may differ materially from those set forth in this report due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus’ ability to successfully develop its Uceris 9 mg and other product candidates in a timely manner or at all; whether Santarus is able to obtain regulatory approval for Uceris 9 mg and its other product candidates in a timely manner or at all, including whether the FDA agrees with the statistical analysis plan for the Uceris phase III studies, the clinical interpretation of the results and the conduct of the studies and whether the extended use study, which evaluated Uceris 6 mg, will provide adequate data to support approval of Uceris 9 mg; risks associated with the collaboration with Cosmo relating to the MMX product candidates, including the potential for termination of the collaboration; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates and other risks detailed in Santarus’ prior public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits.
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| 99.1 | | Press Release, dated December 20, 2011 |
SIGNATURE
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.
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| | SANTARUS, INC. |
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| Date: December 20, 2011 | | | | By: | | /s/ Debra P. Crawford |
| | | | Name: | | Debra P. Crawford |
| | | | Title: | | SVP and Chief Financial Officer |
EXHIBIT INDEX
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Exhibit No. | | Description |
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| 99.1 | | Press Release, dated December 20, 2011 |
