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): May 27, 2008
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.) |
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
TABLE OF CONTENTS
Item 8.01. Other Events.
Santarus, Inc. (“Santarus”) announced that it has achieved a $2.5 million regulatory milestone under its over-the-counter (“OTC”) license agreement with Schering-Plough Healthcare Products, Inc. (“Schering-Plough”). Santarus expects to receive the $2.5 million payment within the next two weeks. The regulatory milestone was earned upon U.S. Food and Drug Administration (“FDA”) acceptance for filing of a New Drug Application (“NDA”) submitted by Schering-Plough for a Zegerid® branded omeprazole/sodium bicarbonate OTC product in a 20 mg dosage strength of omeprazole. The OTC division of the FDA follows the Prescription Drug User Fee Act timelines for review of regulatory submissions. Based on available FDA data for the years 2002 to 2006, the median FDA approval times for standard NDAs have ranged from 12.9 months to 15.4 months.
The Schering-Plough NDA was submitted under the terms of an OTC license agreement signed in October 2006 for OTC proton pump inhibitor (“PPI”) products using Santarus’ proprietary technology. In addition to the $2.5 million milestone for the acceptance for filing of the NDA, Santarus is entitled to receive a $20 million milestone upon achievement of an additional regulatory milestone. Schering-Plough is seeking FDA approval to sell the product in the OTC heartburn market, which in 2007 was estimated at $1.6 billion in the U.S., based on data from external market research sources and company estimates.
Santarus previously received from Schering-Plough a $15 million upfront license fee in 2006 and a $5 million milestone payment in 2007 relating to progress on clinical product development strategy. Santarus will also be entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any OTC products sold by Schering-Plough under the license agreement and may receive up to an additional $37.5 million in sales milestones. Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products.
Under the agreement, Schering-Plough is responsible for the development, manufacturing and commercialization of Zegerid branded OTC products with the dosage strength of 20 mg of omeprazole for heartburn-related indications in the U.S. and Canada. Santarus is continuing to manufacture, promote and sell its Zegerid (omeprazole/sodium bicarbonate) prescription products in both 20 mg and 40 mg dosage strengths of omeprazole in the U.S. prescription market for PPI products.
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 of its 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
ultimately approves Schering-Plough’s NDA in a timely manner or at all; whether, subject to receipt of FDA approval, Schering-Plough is able to generate market demand and acceptance for Zegerid branded OTC products and, in turn, generate sales milestones and royalty payments for Santarus; 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 and Santarus’ and Schering-Plough’s ability to commercialize Zegerid 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.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits.
99.1 Press Release, dated May 27, 2008
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. | | |
| | | | | | | |
| Date: May 27, 2008 | | By: | | /s/ Gerald T. Proehl | | |
| | | Name: Gerald T. Proehl | | |
| | | Title: President and Chief Executive Officer | | |
EXHIBIT INDEX
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| Exhibit No. | | Description |
| |
| 99.1 | | Press Release, dated May 27, 2008 |
