Data from DDW pasted below. To me the drug seems like it has a low risk of failure and it is entering a huge market. Marketing may be tough but all they need is a sliver of market share to be successful. That's my read anyways.
Santarus Announces Presentation of Positive Clinical Data for Rapinex Powder for Oral Suspension 40mg at Digestive Disease Week Annual Meeting
SAN DIEGO, May 19, 2004 (BUSINESS WIRE) -- Santarus, Inc. (SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced the presentation of results from its pivotal Phase III clinical trial evaluating Rapinex (omeprazole) immediate-release powder for oral suspension 40mg (Rapinex 40mg) for the prevention of upper gastrointestinal (GI) bleeding in critically ill patients. The trial results were presented at the Digestive Disease Week (DDW) meeting held May 15-20 in New Orleans. Rapinex 40mg is an immediate-release formulation of the proton pump inhibitor (PPI), omeprazole. Santarus is seeking FDA approval for Rapinex 40mg for the prevention of upper GI bleeding in critically ill patients. No PPI is currently approved for the prevention of upper GI bleeding in this patient population.
The trial results were presented in a poster session on May 16 and in an oral presentation on May 18 during the DDW meeting. The blinded clinical trial compared Rapinex 40mg, administered through a nasogastric tube, with intravenous (IV) cimetidine, an H2-receptor antagonist and the only drug currently approved by the U.S. Food and Drug Administration (FDA) for the prevention of upper GI bleeding in critically ill patients. One group of patients received Rapinex 40mg by nasogastric tube twice on Day 1 and once per day thereafter. Another group of patients received IV cimetidine in a 300mg loading dose and 50mg per hour thereafter. The trial compared the effects of the two treatments in critically ill, mechanically ventilated, intensive care unit patients over a two-week period. The pre-specified analysis of the primary endpoint was statistically significant for both the per protocol and intent-to-treat populations. Using acid-reducing agents, the therapeutic goal in critically ill patients is to raise gastric pH above 4. In the Santarus trial, two hours after the first dose of trial drug, the median gastric pH was 7.8 (7.3, 8.3) for Rapinex-treated patients and 6.4 (4.8, 7.1) for cimetidine-treated patients (p less than 0.001). Failure to control gastric pH (pH less than or equal to 4 on two successive measurements) occurred during the 14-day trial in 58% of cimetidine-treated patients and in 18% of Rapinex-treated patients. These findings led study physicians to increase the cimetidine dose in 53% of patients and the Rapinex dose in just 15% of patients (p less than 0.009). The adverse events in this trial reflected the seriousness of the patients' underlying medical conditions.
"The findings are promising," said one of the study's authors and gastroenterologist Dr. Loren Laine, professor of medicine at the University of Southern California and chief of the GI Section at Los Angeles County USC Medical Center. "Many critically ill patients are at risk for upper GI bleeding and there is currently only one FDA-approved treatment. The possibility of a new treatment option may offer additional benefits for patient care, such as convenient delivery. Rapinex 40mg may be administered once per day through nasogastric or orogastric tubes currently in place, while IV cimetidine is administered by continuous infusion."
Critically ill patients, especially those being mechanically ventilated, are at risk for developing upper GI bleeding. When bleeding occurs, patients may require blood transfusions or surgery, with an increase in morbidity and mortality. While PPIs are approved for many conditions, including symptoms of gastroesophageal reflux disease (GERD), peptic ulcers, and erosive esophagitis, none has been approved for prevention of upper GI bleeding in critically ill patients. Santarus estimates that as many as 4 million critically ill patients may be at risk for upper GI bleeding annually in the U.S., with 1.5 million at highest risk due to the use of ventilators.
"Santarus is delighted that the therapeutic goal of elevating the gastric pH to 4 or greater was met in most patients after the first dose of Rapinex 40mg," said Bonnie Hepburn, M.D., another of the study's authors and senior vice president, drug development and chief medical officer for Santarus.
About PPIs
PPIs are the most common prescription treatment option for upper GI diseases and disorders, including GERD, due to their potent acid suppression, demonstrated safety and once-daily dosing. However, all currently marketed PPIs are available for oral use only in delayed-release formulations. According to IMS Health, total U.S. market sales of PPI products were $12.9 billion in 2003, and prescriptions written in the U.S. for PPI products totaled 95.2 million in 2003, up 10% from 2002. Common side effects of PPIs include headache, diarrhea, abdominal pain and nausea.
About Santarus
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the prevention and treatment of GI diseases and disorders. The company has two NDAs under review by the FDA for its product candidate Rapinex powder for oral suspension 20mg and 40mg and is developing formulations of its Rapinex capsules and Rapinex chewable tablets product candidates for use in pivotal pharmacokinetic/pharmacodynamic clinical trials later this year. The Rapinex product candidates are immediate-release formulations of omeprazole, a widely prescribed PPI. More information about Santarus is available on the company's Web site at www.santarus.com.
About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 15-20, 2004, in New Orleans. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus' business, including, without limitation: the potential for Rapinex powder for oral suspension or Santarus' other product candidates to receive regulatory approval for one or more indications on a timely basis or at all; difficulties or delays in development, testing, manufacturing and marketing of Rapinex powder for oral suspension or Santarus' other product candidates; the progress and timing of clinical trials; unexpected adverse side effects or inadequate therapeutic efficacy of Rapinex powder for oral suspension or Santarus' other product candidates that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for Rapinex powder for oral suspension and Santarus' other product candidates; Santarus' ability to commercialize Rapinex powder for oral suspension and its other product candidates without infringing the patent rights of others; competition from other pharmaceutical or biotechnology companies; Santarus' ability to obtain additional financing to support its operations; and other risks detailed in Santarus' Quarterly Report on Form 10-Q for the quarter ended March 31, 2004, filed with the Securities and Exchange Commission on May 13, 2004.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Santarus(R) and Rapinex(R) are registered trademarks of Santarus, Inc.
SOURCE: Santarus, Inc. |
