Zegerid Study Shows Benefits For Immediate-Release PPI/Antacid

Santarus announces positive clinical trial results for its prescription Zegerid proton pump inhibitor/antacid as it pursues an OTC switch application for a lower-dose version of the combination product.

An open-label, randomized, crossover study of 51 patients evaluated the effects of morning dosing of three PPI products on 24-hour gastric acid control by measuring the percentage of time that gastric pH was greater than 4, Santarus said Jan. 7.

A morning dosing of immediate-release Zegerid (omeprazole 40 mg/sodium bicarbonate 1,100 mg) maintained gastric pH at a level greater than 4 for patients with symptoms of gastroesophageal reflux disease 43 percent longer than patients treated with Wyeth's Protonix delayed-release tablets (pantoprazole sodium), Santarus said.

The immediate-release PPI/antacid product also kept gastric acid greater than level 4 for 22 percent longer than TAP Pharmaceutical's Prevacid delayed-release tablets (lansoprazole), the San Diego-based firm said.

"We believe these positive clinical results, together with the favorable results of our previously conducted studies, support the benefits of treating GERD patients with Zegerid for both daytime and nighttime acid control," Santarus President and CEO Gerald T. Proehl says in a release.

The firm announced plans in October 2006 to switch Zegerid 20 mg omeprazole to OTC status through a licensing agreement with Schering-Plough (¹ (Also see "Zegerid May Bring Quick Heartburn Relief To Market Under Santarus/S-P deal" - Pink Sheet, 23 Oct, 2006.), p. 3).

Santarus and Schering-Plough expect Zegerid's immediate-release delivery could differentiate the product from Procter & Gamble's Prilosec OTC .

Meanwhile, that market is becoming more competitive. FDA in December approved Dexcel Pharma Technologies' application for a generic Prilosec OTC. Perrigo is the exclusive marketer of Dexcel's product and expects to begin distribution in the first quarter (² (Also see "Perrigo Expects To Launch Private Label Prilosec OTC In Early 2008" - Pink Sheet, 5 Nov, 2007.), p. 10).

Schering-Plough would develop, manufacture and commercialize OTC Zegerid under the licensing agreement.

Both firms declined to comment on the status of the Zegerid switch application.

The deal added another unique product to Schering-Plough's OTC switch portfolio, which includes the antihistamine Claritin and Braintree Laboratories' MiraLAX first-in-class hyperosmotic laxative approved in December 2006 (³ (Also see "S-P Brings New Laxative Class To OTC Market Under Braintree Licensing Deal" - Pink Sheet, 11 Dec, 2006.), p. 7).

GSK Has Zegerid International Rights

Santarus recently entered into agreements granting exclusive rights to GlaxoSmithKline to commercialize prescription and OTC versions of Zegerid in more than 100 countries in GSK's international region, which includes Africa, Asia, the Middle-East and Central and South America.

GSK will develop, manufacture and commercialize the Zegerid products in up to 114 countries, excluding the U.S., Europe, Australia, Japan and Canada, Santarus said in December.

The agreements also grant GSK rights to distribute and sell prescription Zegerid products in Puerto Rico and the U.S. Virgin Islands beginning in the first quarter of 2008, according to the firm.

GSK will pay Santarus $11.5 million in an upfront fee and tiered double-digit royalties on the net sales of the products sold under the license and distribution agreements.

The license agreement will continue as long as GSK is obligated to pay royalties and the distribution agreement will continue as long as GSK sells the products, according to a release.

Additionally, GSK can make a buy-out payment 20 years after the agreements go into effect, which would end the royalty payments, the firm said.

Santarus also will waive the first $2.5 million of aggregate royalties, which GSK is supposed to pay under the agreements, to support GSK's initial launch costs, the firm said.

- Jessica Lake ([email protected])