Santarus Announces Presentation of RHUCIN Clinical Data at 7th C1 Inhibitor Deficiency Workshop
SAN DIEGO--(BUSINESS WIRE)--May 23, 2011 - Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that new data from open-label studies evaluating the efficacy and safety of the investigational drug RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) were presented at the 7th C1 Inhibitor Deficiency Workshop on May 20 - 22, 2011 in Budapest, Hungary.
New data from 194 treatments with RHUCIN in 57 patients with acute HAE attacks were presented at a satellite symposium at the Workshop. The data were from an open-label extension study from one of two randomized controlled studies that formed the basis for regulatory approval in Europe. The median time to beginning of relief of symptoms across treatments for repeat attacks was approximately 60 minutes with an overall response rate of 87% and no relapses. No product-related adverse reactions were observed during this study. This data from the European open-label study is consistent with previously announced results from an open-label extension study conducted in North America. The safety dataset of RHUCIN now includes a total of 714 administrations in 190 subjects.
Additional new open-label data from 34 patients who were treated with RHUCIN for 53 severe acute angioedema attacks involving the upper airways were also presented in a poster session at the Workshop. The median time to beginning of relief of symptoms for these upper airway attacks was 76 minutes (95% confidence interval, 62; 120 min). These results are consistent with previously reported results with RHUCIN for other anatomical locations. The overall response rate in treating these severe and potentially life threatening attacks was 100%; there were no treatment failures and no relapses were reported. In the overall safety analysis of all attacks, including the upper airway attacks, RHUCIN was generally safe and well-tolerated.
“The open-label experience with RHUCIN provides additional data evaluating the safety and efficacy of the drug for the treatment of acute attacks of angioedema in patients with HAE,” said Mark C. Totoritis, M.D., Santarus senior vice president, clinical research.
Santarus has licensed certain exclusive rights from Pharming Group NV to commercialize RHUCIN in North America for the treatment of acute attacks of HAE and other future indications. Pharming is currently conducting a placebo-controlled, double-blind, Phase III clinical study with RHUCIN for the treatment of acute attacks of angioedema in patients with HAE in support of a Biologics License Application in the U.S.
About RHUCIN (RUCONEST in European countries) and Hereditary Angioedema
RHUCIN (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RHUCIN is produced through Pharming's proprietary technology in milk of transgenic rabbits and in Europe is approved under the name RUCONEST™ for treatment of acute angioedema attacks in patients with HAE. RHUCIN was granted orphan drug designation for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Santarus also has a diverse development pipeline, including three product candidates in Phase III clinical programs: budesonide MMX® for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers' diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available on the company's website 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. 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' businesses, including, without limitation: whether the ongoing Phase III study for RHUCIN is completed in a timely manner and provides adequate support for the approval of RHUCIN; whether additional clinical studies and/or development programs beyond the ongoing Phase III study are required to support approval of RHUCIN; risks related to the license and supply arrangements between Santarus and Pharming, including the potential for termination of the arrangements; 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 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 any 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® is a trademark of Santarus, Inc. GLUMETZA® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a trademark of VeroScience LLC. MMX® is a trademark of Cosmo Technologies Limited. RHUCIN® and RUCONEST™ are trademarks of Pharming Group NV.
Contact: Company Contact:
Martha L. Hough
VP Finance & Investor Relations
Debra P. Crawford
Chief Financial Officer
Lippert/Heilshorn & Associates, Inc.
Jody Cain or Bruce Voss, 310-691-7100
Posted: May 2011