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News Release - October 5, 2010
RHUCIN Clinical Trial Data Published in the Journal of Allergy and Clinical ImmunologySAN DIEGO--(Healthcare Sales & Marketing Network)-- Santarus, Inc. (NASDAQ:SNTS ), a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN® (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI). The studies were conducted to evaluate the efficacy and safety of two dosage strengths of RHUCIN, an investigational drug, for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in an overreaction of the immune system.
In the JACI publication, Zuraw et al reported the pooled results of two similar but independent, randomized, placebo-controlled studies in 70 HAE patients. As advised by the respective Independent Data Monitoring Committees, both of the studies were halted when predefined interim analyses revealed statistically significant results for the primary and secondary endpoints with no apparent adverse safety findings.
RHUCIN significantly reduced the time to beginning of relief of symptoms for all anatomical locations studied at both dosage strengths compared to placebo. The mean overall score on the visual analogue scale for both RHUCIN groups decreased more rapidly than that of the placebo group. Treatment with RHUCIN 100 U/kg (n=29) and 50 U/kg (n=12) achieved the primary endpoint with significant reduction in time to beginning of relief of symptoms, with a median 66 [61 to 122, 95% CI] minutes at the 100 U/kg dose, and 122 [72 to 136] minutes at the 50 U/kg dose, compared with placebo (n=29) with a median 495 [245 to 520] minutes, p<0.001 and p=0.013, respectively.
RHUCIN treatment was well tolerated in the studies. No patient was discontinued due to an adverse reaction. Adverse events occurred less frequently in the RHUCIN groups (27 adverse events in 7 patients treated with 100 U/kg and 6 adverse events in 4 patients of the 50 U/kg group) than in the placebo group (33 adverse events in 14 patients). Adverse events that were assessed as related to study treatment for patients exposed to RHUCIN included headache and vertigo; adverse events that were assessed as related to patients receiving placebo were headache, injection site swelling, epistaxis and hypotension. One serious adverse event occurred in the 100 U/kg (31 days following treatment) and three in the placebo group. None of the serious adverse events were considered by the investigator to be possibly, probably or definitely related to study drug.
Lead author Bruce Zuraw, M.D., said, “The publication of the results from these randomized controlled trials is an important step in educating the medical community about recombinant human C1INH for HAE patients with acute angioedema.” Dr. Zuraw is a leading authority on HAE and is Professor of Medicine and Chief, Section of Allergy & Immunology in the Department of Medicine, University of California, San Diego and Research Scientist at the Veterans Medical Research Foundation, San Diego, CA.
Santarus recently licensed exclusive rights from Pharming Group NV to commercialize RHUCIN in North America for the treatment of acute attacks of angioedema in patients with HAE and other future indications.
HAE is characterized by unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway, which may last up to five days when untreated. In addition to the life-threatening nature of the disease in case of laryngeal attacks, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals (1:10,000 – 1:50,000) suffers from HAE with an average of approximately eight acute attacks per year.
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by specialists, including gastroenterologists, endocrinologists, allergists, immunologists and rheumatologists. 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. The company expects to commercially launch CYCLOSET in November 2010.
Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: budesonide MMX® for induction of remission of active ulcerative colitis, rifamycin SV MMX® for treatment of travelers’ diarrhea and RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema. In addition, Santarus plans to initiate a Phase I clinical study in the first half of 2011 with its anti-VLA-1 antibody that the company expects to investigate for the treatment of rheumatoid arthritis. 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, including statements regarding expected timing for launch of CYCLOSET and for initiation of a Phase I clinical study for Santarus’ anti-VLA-1 antibody. 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 its product candidates, including RHUCIN, in a timely manner or at all; whether the clinical study results for RHUCIN are indicative of results that may be obtained in future clinical studies; risks associated with the collaboration with Pharming relating to RHUCIN, including the potential for termination of the collaboration; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; 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® is a registered trademark of Santarus, Inc. RHUCIN® is a registered trademark of Pharming Group NV. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a registered trademark of VeroScience LLC. MMX® is a registered trademark of Cosmo Technologies Limited.
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