New players to enter antacid aisle

NEW YORK —As heartburn sales experience their traditional annual spike in sales between Thanksgiving and the New Year, thanks in large part to overindulgence, there soon may be two new players vying for position on the antacid shelf—Schering-Plough’s Zegerid and Perrigo’s generic omeprazole.

Schering-Plough is in the process of switching a low-dose version of Santarus’ Zegerid, a prescription-only proton-pump inhibitor. Schering-Plough earlier this year paid out a $5 million milestone payment to Santarus. “We believe that the receipt of this milestone [payment] indicates that Schering-Plough is continuing to make progress under our OTC license agreement,” stated Santarus president and chief executive officer Gerry Proehl.

Schering-Plough in October 2006 entered into an agreement with Santarus to market Zegerid, an immediate-release over-the-counter omeprazole. The deal, which includes a $15 million up-front payment and this $5 million milestone, could be valued as high as $80 million if all regulatory and sales milestones are reached.

One year into the agreement, Schering-Plough and Santarus have reached their first clinical testing milestone in preparation for the filing of a new-drug application to the FDA.

Perrigo’s store-brand version of omeprazole (to be placed alongside Prilosec OTC) is expected to hit shelves in early 2008, pending Food and Drug Administration approval. “Omeprazole…is the latest new product we are bringing to the market [and] the largest opportunity in our 120-year history of Perrigo,” stated Joe Papa, Perrigo president and chief executive officer.

“Our partner, Dexcel, settled a lawsuit with AstraZeneca on Sept. 27,” he said in a conference call with analysts last month. “Perrigo will [market] this product exclusively, offering a high-quality, affordable product that can save consumers up to $150 million per year. Brand sales of Prilosec OTC are estimated to be $750 million and growing. Our partner has not yet received final approval, but we expect to launch by the end of [the first quarter] calendar year 2008 or just a few months from now. We have just begun working with our customers to start [marketing] efforts for this important product.”

Perrigo also is working toward introducing a private-label version of Johnson & Johnson’s Pepcid Complete in the coming year.