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Santarus and Pharming Announce Presentation of Retrospective Analyses of Data from Clinical Studies of RHUCIN

^{Published on 2011-11-04 11:07:17 - Market Wire}
 

SAN DIEGO & LEIDEN, Netherlands--([ BUSINESS WIRE ])--Specialty biopharmaceutical company [ Santarus, Inc. ] (NASDAQ: SNTS) and biotech company [ Pharming Group NV ] (NYSE Euronext: PHARM) today announced that a retrospective analysis of integrated efficacy data from patients with Hereditary Angioedema (HAE) undergoing treatment with the investigational drug RHUCIN (recombinant human C1 inhibitor, or C1INH) for acute attacks of HAE will be presented in an oral presentation at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, MA on November 6, 2011. The findings of a separate retrospective analysis of immuno-safety data will be presented in the poster sessions at the ACAAI meeting. The data analyzed were derived from placebo-controlled and open-label clinical studies conducted with RHUCIN in patients with HAE.

"We were pleased to have the integrated efficacy data accepted for oral presentation and to have the opportunity to present the poster on immuno-safety of RHUCIN at this major U.S. medical meeting of physicians who treat patients with HAE"

aWe were pleased to have the integrated efficacy data accepted for oral presentation and to have the opportunity to present the poster on immuno-safety of RHUCIN at this major U.S. medical meeting of physicians who treat patients with HAE,a said Rienk Pijpstra, MD, MBA, Chief Medical Officer at Pharming.

The abstract Clinical Efficacy of Recombinant Human C1 Inhibitor in North American Patients with Acute Hereditary Angioedema Attacks (R. Levy, et al) is scheduled for an oral presentation at the ACAAI meeting. This integrated efficacy dataset included 70 HAE patients treated for 179 angioedema attacks with 50 U/kg RHUCIN, including patients treated for repeated attacks. Median time to the primary endpoint of onset of symptom relief was 60 minutes and median time to minimal symptoms was 240 minutes. Abdominal attacks had the fastest onset of relief (36 min), followed by urogenital (56 min), oro-facial-pharyngeal-laryngeal (65 min), and peripheral attacks (84 min). In addition, 96% of attacks (172/179) had a clinical response within 4 hours.

A second abstract Immuno-safety of Recombinant Human C1 Inhibitor in Patients with Hereditary Angioedema: An Integrated Analysis (C. Hack, et al) will be discussed in a poster presentation. Data from 155 patients in the RHUCIN acute treatment studies with 424 administrations of RHUCIN were analyzed. The frequency of anti-C1INH antibodies was low and similar in pre- and post-exposure samples (1.7% and 1.8%, respectively). Occurrence of anti-C1INH antibodies did not correlate with repeated treatment or time since last treatment. No neutralizing antibodies were detected. A total of 5/155 (3%) RHUCIN-treated patients had confirmed anti-host-related impurities (HRI) antibodies, which included one patient with anti-HRI antibodies prior to exposure to RHUCIN. The presence of anti-C1INH and anti-HRI antibodies was not associated with clinical symptoms.

RHUCIN Phase III Study

Pharming is conducting a Phase III clinical study with RHUCIN under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). RHUCIN is being evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-controlled Phase III study at a dosage strength of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. Santarus has licensed certain exclusive rights from Pharming to commercialize RHUCIN in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study. The study is expected to be completed by the third quarter of 2012.

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 Pharmingas proprietary technology in milk of transgenic rabbits and in Europe is approved under the name RUCONESTfor treatment of acute angioedema attacks in patients with HAE. RHUCIN has been granted orphan drug designation in the U.S. 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.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST (RHUCIN in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum. The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, [ www.pharming.com ].

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 physician specialists. The companyas 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 investigational drugs in Phase III clinical programs: UCERIS^a" (budesonide) Tablets 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 travelersa diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available at [ www.santarus.com ].

Santarus and Pharming caution 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 anticipated timing for completion of the RHUCIN Phase III study.The inclusion of forward-looking statements should not be regarded as a representation by Santarus or Pharming 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 and Pharming's businesses, including, without limitation:whether the Phase III study for RHUCIN is completed in a timely manner and provides adequate support for the submission of a BLA and approval of RHUCIN; whether additional clinical studies and/or development programs beyond the Phase III study are required to support submission of a BLA and 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 and Pharming's 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 neither Santarus nor Pharming 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 and UCERIS^a" are trademarks 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.