Zegerid new formulation filed; OTC switch of original still in play

SAN DIEGO Santarus, a specialty pharmaceutical company, on Monday announced that the Food and Drug Administration has accepted for filing the company’s drug application for a new tablet formulation to add to its Zegerid (omeprazole/sodium bicarbonate) family of branded prescription pharmaceutical products.

“In late January, we submitted to the FDA an NDA for an immediate release tablet formulation of Zegerid, which combines omeprazole with a mix of buffers,” Gerald Proehl, Santarus president and CEO, told analysts last month. “We believe this new tablet has the potential to provide features and benefits that … will be important to physicians and their patients with GERD. Our objectives [are] to have the new Zegerid tablet product commercially available in the United States in the fourth quarter of 2009.”

Pursuant to Prescription Drug User Fee Act guidelines, Santarus expects the FDA will complete its review or otherwise respond to the NDA by Dec. 4.

In connection with the FDA’s acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.

On a separate front, Schering-Plough, in partnership with Santarus, is currently seeking to switch the current Zegerid formulation (20-mg) from prescription-only to over-the-counter. Schering-Plough HealthCare Products received a Complete Response Letter regarding that switch application in January.

“Santarus believes that the response will be based on further analysis of existing data,” Proehl said. “While we can't predict with certainty what the FDA will require if the analysis of the existing data is acceptable to the FDA, Santarus does not believe there will be a need for any additional clinical study.”