Santarus 8-K 2009
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 6, 2009
(Exact Name of Registrant as Specified in Its Charter)
3721 Valley Centre Drive, Suite 400, San Diego, California 92130
(Address of Principal Executive Offices) (Zip Code)
(Registrants 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:
TABLE OF CONTENTS
Item 8.01. Other Events.
On April 6, 2009, Santarus, Inc. (Santarus) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for a new tablet formulation to add to its Zegerid® family of branded prescription pharmaceutical products. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the NDA by December 4, 2009.
The NDA was submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In connection with the FDAs acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec® (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
A copy of the press release announcing the acceptance for filing of the NDA is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
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: whether the FDA completes its review and approves the NDA for the new tablet product in a timely matter or at all; the timing for commercial availability of the new tablet product and potential for delays associated with the regulatory approval process; whether, subject to receipt of FDA approval, Santarus is able to generate market demand and acceptance for the new tablet product; the scope and validity of patent protection for the new tablet product and Santarus other Zegerid products, including the outcome and duration of the pending patent infringement lawsuit against Par Pharmaceutical, Inc., and Santarus ability to commercialize the new tablet product and its other Zegerid products without infringing the patent rights of others; 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.
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.