-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, J4pDXN8rFD3UVjDbsXiaKAaHFPunckHQFdHiWT5yUApJ8KikQc4jDfH0NSV55XxQ VkJlNE4zzF45nVX1ySqpIg== 0000950134-08-010230.txt : 20080527 0000950134-08-010230.hdr.sgml : 20080526 20080527060103 ACCESSION NUMBER: 0000950134-08-010230 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080527 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080527 DATE AS OF CHANGE: 20080527 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SANTARUS INC CENTRAL INDEX KEY: 0001172480 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330734433 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50651 FILM NUMBER: 08859361 BUSINESS ADDRESS: STREET 1: 3721 VALLEY CENTRE DRIVE STREET 2: STE 400 CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: 8583145700 MAIL ADDRESS: STREET 1: 3721 VALLEY CENTRE DRIVE STREET 2: STE 400 CITY: SAN DIEGO STATE: CA ZIP: 92130 8-K 1 a41107e8vk.htm FORM 8-K e8vk
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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)
 
         
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
Item 9.01. Financial Statements and Exhibits
SIGNATURE
EXHIBIT INDEX
EXHIBIT 99.1


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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

 


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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

 


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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.
             
    SANTARUS, INC.    
 
           
Date: May 27, 2008
  By:     /s/ Gerald T. Proehl
 
   
    Name:  Gerald T. Proehl    
    Title:  President and Chief Executive Officer    

 


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EXHIBIT INDEX
     
Exhibit No.   Description
 
99.1
  Press Release, dated May 27, 2008

 

EX-99.1 2 a41107exv99w1.htm EXHIBIT 99.1 exv99w1
Exhibit 99.1
(SANTARUS INC. LOGO)
     
COMPANY CONTACT:
  INVESTOR CONTACT:
Martha L. Hough
  Lippert/Heilshorn & Associates, Inc.
VP Finance & Investor Relations
  Jody Cain (jcain@lhai.com)
(858) 314-5824
  Bruce Voss (bvoss@lhai.com)
Debra P. Crawford
  (310) 691-7100
Chief Financial Officer
   
(858) 314-5708
   
For Immediate Release
SANTARUS ACHIEVES $2.5 MILLION REGULATORY MILESTONE
UNDER OTC LICENSE AGREEMENT WITH SCHERING-PLOUGH
SAN DIEGO (May 27, 2008) – Santarus, Inc. (NASDAQ: SNTS), a specialty pharmaceutical company, today 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. Santarus expects to receive the $2.5 million payment within the next two weeks. Schering-Plough is seeking U.S. Food and Drug Administration (FDA) approval to sell a ZEGERID® branded omeprazole/sodium bicarbonate OTC product. The OTC heartburn market in 2007 was estimated at $1.6 billion in the U.S. based on data from external market research sources and Santarus estimates.
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 proton pump inhibitor (PPI) products.
Product Description
ZEGERID (omeprazole/sodium bicarbonate) contains omeprazole, a PPI, and sodium bicarbonate, which raises the gastric pH and thus protects omeprazole from acid degradation.
Important Safety Information about ZEGERID Branded OTC Products
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
ZEGERID contains sodium bicarbonate. This should be taken into consideration for patients on a sodium-restricted diet.
ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
About Santarus
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company’s current marketing efforts are primarily focused on ZEGERID Capsules and Powder for Oral

 


 

Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI. More information about Santarus is available on the company’s Web site at www.santarus.com.
Santarus cautions you that statements included in this press release 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 release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: whether the FDA ultimately approves the Schering-Plough 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 press releases as well as in 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 news release 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.
Santarus® and ZEGERID® are registered trademarks of Santarus, Inc.
# # #

 

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