FDA Approves ZEGERID OTC(TM) For Over-the-Counter Treatment Of Frequent Heartburn

Main Category: Acid Reflux / GERD
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 02 Dec 2009 - 1:00 PDT

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Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ZEGERID OTC(TM) (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), for over-the-counter treatment of frequent heartburn. ZEGERID OTC will be marketed over-the-counter by Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc. Schering-Plough and Merck merged on November 3, 2009.

ZEGERID OTC is a proton pump inhibitor (PPI), the strongest and most effective class of acid-reducing medications available for frequent heartburn. ZEGERID OTC treats frequent heartburn by controlling and suppressing acid for a full 24 hours, all day and all night.

ZEGERID OTC contains a patented dual-ingredient formulation that combines the leading prescription acid reducing medicine (omeprazole) with sodium bicarbonate, which protects the omeprazole from acid in the stomach. ZEGERID OTC capsules will be available in their original prescription formula, and are expected to be available at drug stores, grocery stores, mass merchandisers and club stores in the first half of 2010.

The approval provides a new and unique over-the-counter option for the estimated 50 million American adults who experience symptoms associated with frequent heartburn -- defined by symptoms occurring more than 2 times per week -- with up to 25 million Americans experiencing heartburn on a daily basis.(1)

"ZEGERID OTC is another demonstration of our commitment to bringing innovative treatments to consumers," said Stan Barshay, executive vice president and president, Schering-Plough HealthCare Products. "For millions of Americans dealing with frequent heartburn, the availability of prescription-strength ZEGERID OTC is important news and we're pleased to offer this unique, dual-ingredient, over-the-counter product."

ZEGERID OTC(TM) is a 14-day course of treatment taken once per day to treat frequent heartburn as directed.

ZEGERID OTC capsules add to the Schering-Plough HealthCare Products, Inc. expanding portfolio of gastrointestinal OTC products such as MiraLAX® laxative, which was launched in 2007 for the treatment of occasional constipation. ZEGERID OTC(TM) is the most recent example of the Schering-Plough HealthCare Products, Inc. legacy of successful switches of medications from prescription to over-the-counter status. This portfolio of products includes brands such as CLARITIN®, MiraLAX®, LOTRIMIN®, AFRIN®, CORICIDIN®, TINACTIN®, and DRIXORAL®. Many of these products are market-leading brands in their respective category.

Under an agreement with Santarus, a specialty pharmaceutical company that developed and currently markets prescription ZEGERID®, Schering-Plough HealthCare Products is responsible for the development, manufacturing and commercialization of ZEGERID OTC products for heartburn-related indications in the U.S. and Canada. Santarus will continue to manufacture, promote and sell its ZEGERID (omeprazole/sodium bicarbonate) products in both 20 mg and 40 mg dosage strengths in the U.S.

About Schering-Plough Consumer HealthCare Products, Inc.

Today's Merck is working to help the world be well. Schering-Plough Consumer HealthCare Products, Inc. is the over-the-counter division of Merck. Each day, millions count on one or more of our industry-leading brands that help prevent or treat various common conditions. These include household names such as CLARITIN for allergies, COPPERTONE for sun care, DR. SCHOLL'S for foot care, and many more. Merck. Be well.

Forward-Looking Statement

This communication includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site

(1) Source: National Heartburn Alliance

Source: Merck & Co., Inc

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