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Santarus Licenses OTC Rights to Lower Dosage Immediate-Release ZEGERID Products to Schering-Plough.


Conference Call to Begin Today at 10:00 a.m. Eastern Time

SAN DIEGO -- Santarus, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:SNTS SNTS Society for New Testament Studies
SNTS Standalone NMD Training System
), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that it has entered into an agreement with Schering-Plough HealthCare Products, Inc., a subsidiary of Schering-Plough Corporation, granting certain exclusive rights to Schering-Plough to commercialize ZEGERID([R]) branded immediate-release omeprazole products for the over-the-counter (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
) market in the U.S. and Canada.

Schering-Plough will be responsible for the development, manufacturing and commercialization of OTC ZEGERID products with the lower dosage strength of 20 mg of omeprazole for heartburn-related indications. According to A.C. Nielsen, a market research firm, the OTC market for heartburn heartburn, burning sensation beneath the breastbone, also called pyrosis. Heartburn does not indicate heart malfunction but results from nervous tension or overindulgence in food or drink.  products was approximately $1.1 billion for the 12 months ending mid-August 2006. Santarus will continue to manufacture, promote and sell ZEGERID products in both 40 mg and 20 mg dosage strengths of omeprazole for their approved prescription indications in the U.S. prescription market for proton pump inhibitor proton pump inhibitor
n.
A class of drugs that inhibit gastric acid secretion by interfering with the movement of hydrogen ions across cell membranes and are used mainly to treat peptic ulcers, gastroesophageal reflux disease, and esophagitis.
 (PPI (1) (Pixels Per Inch) The measurement of the resolution of a monitor or scanner. For example, a monitor that is 16 inches wide and displays 1600 pixels across its width would have a resolution of 100 ppi (1600 divided by 16). ) products. The U.S. prescription PPI market was approximately $13.4 billion for the 12 months ending July 2006 according to IMS Health, a market research firm.

Under the terms of the agreement, Santarus will receive a $15 million upfront license fee payable following the effective date of the agreement and may receive up to an additional $65 million in milestone payments upon the achievement of certain regulatory and sales milestones. Santarus will also receive a royalty, subject to adjustment in certain circumstances, on net sales Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
 of any ZEGERID OTC products sold by Schering-Plough under the license agreement. A portion of these royalties will be paid to the University of Missouri pursuant to a license agreement between Santarus and the University of Missouri. The terms of the OTC agreement with Schering-Plough are subject to review under the Hart-Scott-Rodino Antitrust Improvements Act The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Public Law 94-435, known commonly as the HSR Act) is a set of amendments to the antitrust laws of the United States, principally the Clayton Antitrust Act. The HSR Act was signed into law by President Gerald R.  (HSR HSR homogeneously staining regions. ), and the parties will seek early termination of the HSR waiting period.

"We are very pleased to enter into this agreement with Schering-Plough, with its longstanding leadership position of successfully commercializing major OTC brands," said Gerald T. Proehl, president and chief executive officer of Santarus. "We believe the development of ZEGERID products appropriate for the OTC market will provide a healthcare benefit to consumers and may have a positive future impact on overall awareness of our prescription ZEGERID products, the significant majority of which are currently prescribed at the higher 40 mg dosage strength."

Conference Call

Santarus has scheduled an investor conference call regarding this announcement at 10:00 a.m. Eastern Time (7:00 a.m. Pacific Time) today, October 18, 2006. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. A telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 9062736. The live conference call also will be available via the Internet by visiting the Investor Relations Investor relations

The process by which the corporation communicates with its investors.
 section of the company's Web site at www.santarus.com, and a recording of the call will be available on the company's Web site for 14 days following the completion of the call.

About Currently Marketed ZEGERID Prescription Products

ZEGERID Capsules and ZEGERID Powder for Oral Suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease gastroesophageal reflux disease (GERD)

Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing.
 (GERD GERD gastroesophageal reflux disease.

GERD
abbr.
gastroesophageal reflux disease


GERD 
), the short-term treatment (four to eight weeks) of erosive e·ro·sive
adj.
Causing erosion.
 esophagitis esophagitis /esoph·a·gi·tis/ (e-sof?ah-ji´tis) inflammation of the esophagus.

chronic peptic esophagitis  reflux e.
 diagnosed by endoscopy endoscopy

Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the
 and active benign gastric ulcers, the short-term treatment of active duodenal ulcers and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months). ZEGERID Powder for Oral Suspension is also indicated for the reduction of risk of upper gastrointestinal bleeding Upper gastrointestinal (GI) bleeding refers to hemorrhage in the upper gastrointestinal tract. The anatomic cut-off for upper GI bleeding is the ligament of Treitz, which connects the fourth portion of the duodenum to the diaphragm near the splenic flexure of the colon.  in critically-ill patients.

ZEGERID offers a distinct pharmacological profile -- rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control, with a median 24-hour gastric pH of greater than 4 ranging from 12.2 hours to 18.6 hours, depending on the strength and dosage form, after repeated once-daily dosing. ZEGERID can be conveniently taken once-a-day on an empty stomach, at least one hour before a meal.

PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs, other than ZEGERID, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression. Unlike delayed-release PPIs, ZEGERID Capsules and Powder for Oral Suspension utilize an antacid antacid, any one of several basic substances that counteract stomach acidity (see stomach). Antacids are used by physicians to treat hyperchlorhydria, i.e., the excessive production of hydrochloric acid by the parietal cells lining the stomach.  in lieu of an enteric coating. The antacid neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption and suppression of gastric acid.

Important Safety Information

ZEGERID (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension contain a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects the omeprazole from acid degradation.

The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with ZEGERID and with the comparator comparator

Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies.
 (acid-controlling) drug. 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 Capsules contain 300 mg of sodium per dose in the form of sodium bicarbonate (1100 mg/13 mEq), and ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq). This should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia Hypocalcemia Definition

Hypocalcemia, a low bood calcium level, occurs when the concentration of free calcium ions in the blood falls below 4.0 mg/dL (dL = one tenth of a liter). The normal concentration of free calcium ions in the blood serum is 4.0-6.
. ZEGERID is contraindicated in patients with known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  to any component of the formulation.

About Santarus

Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that treat gastrointestinal diseases and disorders and enhance the quality of life for patients. The company's products are immediate-release formulations of omeprazole, a widely prescribed PPI. The company's marketed products include ZEGERID Capsules (launched in late March 2006) and ZEGERID Powder for Oral Suspension. Santarus received U.S. Food and Drug (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approval for its third dosage form, ZEGERID with Magnesium Hydroxide Chewable Tablets, in March 2006. 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: risks related to the licensing arrangement with Schering-Plough, including the termination of the waiting period under the HSR Act, the success of Schering-Plough's development, sales and marketing activities, and Schering-Plough's level of commitment and the potential for termination of the arrangement; Santarus' ability to drive increased market demand for, and generate increased sales of, ZEGERID Capsules, ZEGERID Powder for Oral Suspension and any other products that may be marketed; 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; unexpected adverse side effects or inadequate therapeutic efficacy of ZEGERID products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; competition from other pharmaceutical or biotechnology companies; other difficulties or delays relating to the development, testing, manufacturing and marketing of ZEGERID products; Santarus' ability to obtain additional financing as needed to support its operations; 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995.

Santarus([R]) and ZEGERID([R]) are registered trademarks of Santarus, Inc.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Oct 18, 2006
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