Healthcare Industry News:  Biovail 

Biopharmaceuticals Drug Delivery Gastroenterology

 News Release - March 25, 2010

Santarus Announces Completion of Enrollment in U.S. Phase III Clinical Study for Budesonide MMX

SAN DIEGO--(HSMN NewsFeed)--Santarus, Inc. (NASDAQ: SNTS ), a specialty biopharmaceutical company, today announced the completion of enrollment of 510 patients in a U.S. Phase III clinical study to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis. This is the second Phase III clinical study being conducted in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), as part of the budesonide MMX Phase III clinical program for U.S. registration. Enrollment in a European Phase III clinical study was completed in December 2009.

“Completing enrollment in the U.S. Phase III clinical study marks another major clinical milestone for budesonide MMX in our advancement toward U.S. registration,” said E. David Ballard, II, senior vice president, clinical research and medical affairs of Santarus. “We currently expect to announce top-line results from the European Phase III study late in the second quarter of 2010 and results from the U.S. study in the second half of 2010.”

As previously reported, the U.S. Food and Drug Administration (FDA) requested that the results from an additional 12-month extended use study be included in the Phase III clinical program to support a U.S. regulatory submission. Up to approximately 150 patients from the Phase III clinical studies in the U.S. and Europe are being enrolled in this double-blind, placebo-controlled extended use study, which will evaluate the long-term safety and tolerability of budesonide MMX 6 mg and collect data on the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo. Assuming successful and timely completion of the budesonide MMX Phase III clinical program, Santarus plans to submit a New Drug Application (NDA) for budesonide MMX to the FDA in the second half of 2011.

Budesonide MMX Phase III Clinical Program

Budesonide MMX is being evaluated for the treatment of mild or moderate active ulcerative colitis in two Phase III clinical studies, both of which are intended to support U.S. regulatory submission. The primary endpoint is the achievement of clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment.

Each clinical study is a double-blind, placebo-controlled, four-arm study.
  • The European Phase III clinical study is comparing a single tablet of budesonide MMX 6 mg or budesonide MMX 9 mg dosed once daily to placebo and to a reference arm using three Entocort EC® (budesonide) 3 mg capsules dosed once daily (9 mg).
  • The U.S. Phase III clinical study is comparing a single tablet of budesonide MMX 6 mg or budesonide MMX 9 mg dosed once daily to placebo and to a reference arm using two Asacol® (mesalamine) 400 mg delayed-release tablets dosed three times daily (2.4 grams).
The European and U.S. clinical studies are powered to show a statistical difference between budesonide MMX and placebo. The reference arms using Entocort EC in the European study and Asacol in the U.S. study are not powered to show statistical differences versus budesonide MMX.

In addition, the FDA requested that the results from the 12-month extended use study be included in the Phase III clinical program to support a U.S. regulatory submission.

The protocols for the budesonide MMX Phase III clinical program were reviewed and approved by the FDA under Special Protocol Assessments.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists, endocrinologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX® and rifamycin SV MMX®, for the U.S. market. Budesonide MMX is being investigated in a Phase III clinical program for the induction of remission of mild or moderate active ulcerative colitis. Santarus expects to begin Phase III clinical testing of rifamycin SV MMX in patients with travelers’ diarrhea in the second quarter of 2010. More information about Santarus is available on the company’s Web site at www.santarus.com.

Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding the timing for reporting top-line data from the Phase III clinical studies for the budesonide MMX product candidate and the timing of a U.S. NDA submission. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives 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: Santarus’ ability to successfully develop (including timely and successful completion of the ongoing and planned Phase III clinical program) and obtain regulatory approval for the budesonide MMX and rifamycin SV MMX product candidates in a timely manner or at all; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of the MMX product candidates; the scope and validity of patent protection for the MMX product candidates; and risks associated with the collaboration with Cosmo relating to the MMX product candidates, including the potential for termination of the collaboration; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; and other risks detailed in Santarus’ prior press releases as well as in public periodic filings with the Securities and Exchange Commission.

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. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus® and ZEGERID® are registered trademarks of Santarus, Inc. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. MMX® is a registered trademark of Cosmo Technologies Limited.



Source: Santarus

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