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SNTS > SEC Filings for SNTS > Form 8-K on 7-Nov-2012All Recent SEC Filings

Show all filings for SANTARUS INC

Form 8-K for SANTARUS INC


7-Nov-2012

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events.

On November 7, 2012, Santarus, Inc. ("Santarus" or the "Company") issued a press release announcing positive top-line results from the phase III clinical study to evaluate the safety and efficacy of the investigational drug Ruconest® (recombinant human C1 esterase inhibitor) for the treatment of acute attacks of angioedema in patients with hereditary angioedema, or HAE. 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 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: risks related to the timing for submission of the biologics license application, or BLA, and whether the U.S. Food and Drug Administration, or FDA, will accept the BLA for review following submission and ultimately approve it; whether the FDA will concur with the clinical interpretation of the phase III study results or the conduct of the study; whether the FDA ultimately will require additional clinical studies or other development programs before accepting the Ruconest BLA or approving Ruconest; risks related to Santarus' dependence on Pharming for many functions related to Ruconest, and Pharming's ability to continue to perform these functions based on its limited financial resources; risks related to the license and supply arrangements between Santarus and Pharming, including the potential for termination of the arrangements; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus' products; 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.

99.1 Press Release, dated November 7, 2012


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