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 1, 2009
SANTARUS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
(State or Other Jurisdiction
of Incorporation or Organization) | | 0-50651
(Commission File Number) | | 33-0734433
(I.R.S. Employer
Identification No.) |
3721 Valley Centre Drive, Suite 400, San Diego, California 92130
(Address of Principal Executive Offices) (Zip Code)
(Registrant’s Telephone Number, Including Area Code)
(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:
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| o | | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| o | | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| o | | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| o | | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On December 1, 2009, Santarus, Inc. (“Santarus”) issued a press release announcing that that the U.S. Food and Drug Administration approved a New Drug Application (“NDA”) submitted by Schering-Plough HealthCare Products, Inc., now part of Merck & Co., for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate). Upon approval of ZEGERID OTC, Santarus earned a $20 million milestone. A press release announcing the approval of the NDA is attached to this report as Exhibit 99.1 and 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 of its 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: the timing for launch of ZEGERID OTC; whether Schering-Plough is able to generate market demand and acceptance for ZEGERID OTC and, in turn, generate sales milestones and royalty payments for Santarus; whether the introduction of ZEGERID OTC increases awareness of the ZEGERID brand; Schering-Plough’s level of commitment, the potential for termination of the licensing arrangement and other risks related to the licensing arrangement; the scope and validity of patent protection for ZEGERID products, including the timing and outcome of the patent infringement lawsuit against Par Pharmaceutical, Inc., and Santarus’ and its strategic partners’ ability to commercialize products without infringing the patent rights of others; 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.
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| Item 9.01. | | Financial Statements and Exhibits. |
(d)Exhibits.
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| | 99.1 | | | Press Release, dated December 1, 2009 |
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 1, 2009 | By: | /s/ Gerald T. Proehl | |
| | Name: | Gerald T. Proehl | |
| | Title: | President and Chief Executive Officer | |
EXHIBIT INDEX
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| Exhibit No. | | Description |
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| | 99.1 | | | Press Release, dated December 1, 2009 |
