Washington Editor

Santarus Inc. stands to gain up to $100 million through a licensing agreement announced Tuesday with TAP Pharmaceutical Products Inc. aimed at developing a next-generation therapy for upper gastrointestinal diseases.

Santarus, a private company based in San Diego, already has two products in the clinic based on the technology, which is designed to cover a combination of proton pump inhibitors (PPI) plus antacids. Santarus initially licensed the technology from the University of Missouri in an agreement that extends until mid-2016.

Financial terms of the deal call for TAP, of Lake Forest Ill., to pay Santarus an $8 million initial fee, plus potential milestones of up to $100 million if a product is successfully developed and marketed. Santarus also would get sales royalties. TAP gains the North American rights to manufacture and sell products resulting from the technology, while Santarus retains rights to use its intellectual property to develop and commercialize related products.

"We think this agreement validates our technology approach. That is, the combination of immediate-release PPI with the antacid will give us an advance over what's currently out there in the marketplace," Gerry Proehl, president and CEO of Santarus, told BioWorld Today. "This allows us to go after new indications and new dosage formulations that have a much more rapid onset of action. We believe our partner thinks the same thing, and that is why they signed the agreement with us."

Kim Modory, a spokeswoman for TAP, was unable to discuss specific products TAP will develop using the new technology. However, she told BioWorld Today that Santarus' technology "fits into our long-term plans and needs."

In a prepared statement, Rich Masterson, TAP's vice president of licensing, said, "TAP is excited about the opportunity to develop improved product offerings through the application of Santarus' intellectual property. The signing of this agreement is another example of TAP's continuing commitment to growing our presence in the U.S. market through the development and commercialization of innovative, patented products."

Santarus' two products developed using the technology are named Acitrel and Rapinex.

Acitrel, the lead drug, is a liquid that combines omeprazole with sodium bicarbonate in an immediate-release formulation. In June, Santarus initiated a Phase III trial of Acitrel in the prevention of upper GI bleeding in critically ill adults. A month before that, the company started a pharmacokinetic/pharmacodynamic trial comparing blood levels and pH control of Acitrel vs. Prilosec (AstraZeneca plc, of London). A pediatric Phase III trial, also for prevention of upper GI bleeding, is planned for late 2002 or early 2003.

Most products on the market for gastrointestinal diseases are "delayed release," said Proehl, who added that not only will Santarus' products provide "immediate release," but they also likely will provide sustainability over 24 hours.

Proehl said he hopes to file the new drug application for Acitrel in the third or fourth quarter of 2003. Meanwhile, he expects to file the investigational new drug application later this quarter for Rapinex, a chewable drug that also combines omeprazole with an antacid complex for immediate-release formulation. Rapinex also will be tested against Prilosec, and will be the subject of a Phase III trial for the prevention and/or treatment of heartburn and other symptoms associated with gastroesophageal reflux disease.

Founded in 1996, Santarus has raised $38 million in three rounds of financing. Proehl said the company has about $23 million in cash and is preparing for a fourth financing. The burn rate is about $120,000 per month and is expected to increase once Rapinex enters Phase III in 2003, Proehl said.

TAP Pharmaceutical Products was founded in 1977 as a joint venture between Abbott Laboratories Inc., of Abbott Park, Ill., and Takeda Chemical Industries Ltd., of Osaka, Japan. TAP markets Prevacid, an acid-suppressing agent; Lupron Depot, primarily used for prostate cancer; and Spectracef, a cephalosporin antibiotic.