rapinex

SAN DIEGO, April 29, 2004 -- Santarus, Inc., a specialty pharmaceutical companyfocused on therapies for gastrointestinal diseases and disorders, today announcedthat the U.S rapinex. Food and Drug Administration (FDA) has accepted for filing thecompany's New Drug Application (NDA) for Rapinex powder for oral suspension40mg (Rapinex 40mg) rapinex. This product is an immediate-release formulation of theproton pump inhibitor (PPI) omeprazole rapinex. The Rapinex 40mg NDA seeks approvalfor the treatment of gastric ulcers and the prevention of upper gastrointestinal(GI) bleeding in critically ill patients rapinex. No PPI is currently approved for theprevention of upper GI bleeding in this patient population.

Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expectsthe FDA will complete its review or otherwise respond to the Rapinex 40mg NDAby December 26, 2004 rapinex. The company submitted the NDA for Rapinex 40mg in February2004 rapinex. In August 2003, Santarus submitted an NDA for Rapinex powder for oralsuspension 20mg, seeking approval for treatment of heartburn and other symptomsrelated to gastroesophageal reflux disease (GERD), treatment and maintenanceof healing of erosive esophagitis and treatment of duodenal ulcer, and expectsFDA review or other response under PDUFA by June 15, 2004.

"The FDA's acceptance of this NDA marks an important milestone as we moveto commercialize products for the prevention and treatment of GI diseases anddisorders," said Gerald T rapinex. Proehl, president and chief executive officer rapinex. "This is the second NDA filing of a product based on our powder for oralsuspension formulation, which may be desirable for hospitalized patients andthe elderly, who may prefer or require a liquid formulation."

The NDA for Rapinex 40mg contained data from a pivotal Phase III clinical trialwith 359 critically ill patients rapinex. Given the serious medical condition of thepatient population, the blinded clinical trial compared Rapinex 40mg, administeredthrough a nasogastric tube, with intravenous (IV) cimetidine, an H2-receptorantagonist, rather than with a placebo rapinex. IV cimetidine is the only drug currentlyapproved by the FDA for the prevention of upper GI bleeding in critically illpatients rapinex. The primary endpoint of the Rapinex 40mg Phase III trial, the occurrenceof clinically significant bleeding, was the same as that seen in the IV cimetidinetrial that led to its approval rapinex. Santarus also conducted an open-label clinicaltrial treating 243 patients, including 97 patients with gastric ulcers, to collectsafety data related to Rapinex 40mg over an 8-week treatment period, and hasprovided that data to the FDA as additional support for the product candidate'sapproval.

In connection with the filing of the Rapinex 40mg NDA, Santarus provided noticeto the NDA holder for Prilosec(R) delayed-release capsules and related patentholders that Rapinex 40mg does not infringe the patents listed in the OrangeBook for Prilosec or that those patents are invalid.

About PPIs
PPIs are the most common prescription treatment option for upper GI diseasesand disorders, including GERD, due to their potent acid suppression, demonstratedsafety and once-daily dosing rapinex. However, all currently marketed PPIs are availablefor oral use only in delayed-release formulations rapinex. According to IMS Health totalU.S rapinex. market sales of PPI products were $12.9 billion in 2003, and prescriptionswritten in the U.S rapinex. for PPI products totaled 95.2 million in 2003, up 10% from2002.

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