National Editor

In a market that's still giving heartburn to many when it comes to financing, Santarus Inc. raised $51.4 million through a private placement for the further development of its product candidates for more serious upper gastrointestinal disorders.

"It's our third round of outside money," said Debra Crawford, vice president and chief financial officer of San Diego-based Santarus, and it gives the company a little more than $55 million in cash.

"Our burn rate has been under $2 million per month, so this gives us enough for at least a couple of years," she said.

In Phase III trials Santarus has SAN-05, an immediate-release formulation of omeprazole, a widely used proton pump inhibitor that provides a rapid effect on gastric pH while maintaining the attractive once-a-day dosing schedule of delayed-release PPIs, noted Gerald Proehl, president and CEO of Santarus.

PPIs are the most frequently prescribed drugs for the treatment of many upper GI diseases and disorders including gastroesophageal reflux disease and heartburn.

SAN-05 is a powder. "You mix it up with water and put it in a liquid formulation, and it's put down a nasal gastric tube," Proehl said.

Intended to prevent upper GI bleeding in critically ill adult patients, the drug is expected to yield Phase III data in the third quarter of this year. So far, only intravenous administration of cimetidine, an H2 blocker, has been approved by the FDA for use in such patients, and Santarus estimates that as many as 4 million critically ill patients may be at risk for upper GI bleeding annually in the United States, with 1.5 million critically ill patients at the highest risk due to the use of ventilators.

"The liquid formulation obviously allows us to go after special populations" such as patients in hospitals and others, Proehl told BioWorld Today. "Ultimately, we'd look to do additional clinical work" and add more patients in whom SAN-05 might be useful, he added.

The company also has SAN-15, a chewable tablet version of immediate-release omeprazole, in the final stage of development.

Santarus takes its name from two founders - and current members of the medical advisory board - William Sanborn and Stephen Targan. The "us" portion of the name stands for "and the rest of us."

Proehl said the company's model involves coming up with new formulations of existing drugs or in-licensing product candidates.

"We in-licensed a product from Mayo for Crohn's disease," he said. That drug was a reformulation of azathioprine. "We took it through Phase II, but the data just weren't compelling enough [to continue]," he said.

Santarus also has a potential $100 million licensing deal entered last summer with Lake Forest, Ill.-based TAP Pharmaceutical Products Inc., based on the former's approach to next-generation upper GI therapies. (See BioWorld Today, July 10, 2002.)

New investor S.R. One Limited, of New York and West Conshohocken, Pa., led the most recent financing round, with additional first-time financing provided by Life Sciences Partners, of Amsterdam, the Netherlands, and Munich; Hamilton Apex Technology Ventures, of San Diego; China Development Industrial Bank, of Taipei, Taiwan; New England Partners, of Boston; and others.

Existing investors that took part include St. Paul Venture Capital, of Minneapolis; Advent Venture Partners, of London; Domain Associates LLC, of Princeton, N.J.; JPMorgan Partners, of New York; Windamere Capital Ventures, of San Diego; and Fog City Fund, of San Francisco. Rockport Venture Partners, of Boston, assisted the company with the private placement.