LEIDEN, Netherlands and SAN DIEGO, Nov. 8, 2013 (GLOBE NEWSWIRE) --
Pharming Group NV (NYSEEuronext: PHARM) and Santarus, Inc. (NASDAQ: SNTS) announced that new data froman open-label extension of the pivotal Phase III clinical study with RUCONEST(®)(recombinant human C1 esterase inhibitor, or rhC1INH) will be featured in aposter presentation on November 9 & 10, 2013 at the 2013 American College ofAllergy, Asthma & Immunology Annual Scientific Meeting at the Convention Centerin Baltimore, Maryland.  The poster is titled, Efficacy and Safety ofRecombinant Human C1 Esterase Inhibitor for Acute Attacks of HereditaryAngioedema:  An Open-Label Study.RUCONEST was administered for the treatment of 224 repeat acute angioedemaattacks in 44 patients with hereditary angioedema (HAE) following initialtreatment in the pivotal randomized controlled clinical study.   RUCONEST is aninvestigational drug in the U.S. and has been granted orphan drug designation bythe U.S. Food and Drug Administration (FDA) for the treatment of acute attacksof HAE."The results from this clinical trial are consistent with findings from previousstudies supporting that RUCONEST  reduces time to symptom relief when used forrepeat HAE attacks," said H. Henry Li, M.D., Ph.D., Director of Chevy ChaseClinical Research, Institute for Asthma and Allergy, Chevy Chase, Maryland.  "Inaddition, it is important clinically to evaluate the safety findings from thesemultiple exposures."The median time in minutes (95% confidence interval [CI]) to onset of symptomrelief following treatment as measured by patient responses to a TreatmentEffect Questionnaire (TEQ) for the first five repeat attacks ranged from 62.5(48, 90) to 134.0 (75, 150) and across all attacks was a median of 75.0 (69,89).  The median (95% CI) time in minutes to minimal symptoms (first threeattacks per patient) as measured by a TEQ ranged from 243 (76, 1440) to 304(150, 719) and for all assessed attacks was 303 (211, 367).Exposure and Safety Information  * Only one dose of RUCONEST was administered for 96% of the 224 attacks.  * 12 of 44 (27%) patients experienced at least one treatment emergent adverse    event (TEAE) within 72 hours of completion of RUCONEST infusion.      * TEAEs occurring in 5% of patients were nasopharyngitis, cough, fibrin D-        dimer increase, and headache      * The percentage of patients experiencing TEAEs did not increase with        RUCONEST treatments for repeat attacks.  * There were no discontinuations due to adverse events, no thrombotic or    anaphylactic events, and no neutralizing anti-C1INH antibodies observed with    repeat RUCONEST treatment.Santarus and Pharming are seeking U.S. marketing approval of RUCONEST for thetreatment of acute angioedema attacks in patients with HAE.  The BiologicsLicense Application (BLA) filing for RUCONESTis under review by the U.S. Foodand Drug Administration (FDA) with a response expected by April 16, 2014. RUCONEST is approved in Europe for the treatment of acute angioedema attacks inpatients with HAE and is an investigational drug in the U.S. that has beengranted orphan drug designation by the FDA.About RUCONEST and Hereditary AngioedemaRUCONEST (INN conestat alfa) is a recombinant version of the human protein C1esterase inhibitor, and is produced with Pharming's proprietary transgenictechnology. RUCONEST is approved in Europe for the treatment of acute angioedemaattacks in patients with HAE, a genetic disorder in which the patient isdeficient in or lacks a functional plasma protein C1 esterase inhibitor,resulting in unpredictable and debilitating episodes of intense swelling. Theswelling may occur in one or more anatomical areas, including the extremities,face, trunk, genitals, abdomen and upper airway. The frequency and severity ofHAE attacks vary and are most serious when they involve laryngeal edema, whichcan close the upper airway and cause death by asphyxiation. According to theU.S. Hereditary Angioedema Association, epidemiological estimates for HAE rangefrom one in 10,000 to one in 50,000 individuals.About Pharming Group NVPharming Group NV is developing innovative products for the treatment of unmetmedical needs. RUCONEST(®) is a recombinant human C1 esterase inhibitor approvedfor the treatment of angioedema attacks in patients with HAE in all 27 EUcountries plus Norway, Iceland and Liechtenstein, and is distributed in the EUby Swedish Orphan Biovitrum. RUCONEST(®) is partnered with Santarus, Inc.(NASDAQ: SNTS) in North America and a Biologics License Application for RUCONESTis under review by the U.S. Food and Drug Administration. The product is alsobeing evaluated for various follow-on indications.  Pharming has a unique GMPcompliant, validated platform for the production of recombinant human proteinsthat has proven capable of producing industrial volumes of high qualityrecombinant human protein in a more economical way compared to current cellbased technologies. In July 2013, the Platform was partnered with ShanghaiInstitute for Pharmaceutical Industry (SIPI), a Sinopharm Company, for jointglobal development of new products. Pre- clinical development and manufacturingwill take place at SIPI and are funded by SIPI. Pharming and SIPI initially planto utilise this platform for the development of rhFVIII for the treatment ofHaemophilia A.  Additional information is available on the Pharming website, SantarusSantarus, Inc. is a specialty biopharmaceutical company focused on acquiring,developing and commercializing proprietary products that address the needs ofpatients treated by physician specialists. The company's current commercialefforts are focused on five products.  UCERIS(®)(budesonide) extended releasetablets for the induction of remission in patients with active, mild to moderateulcerative colitis and ZEGERID(®) (omeprazole/sodium bicarbonate) for thetreatment of certain upper gastrointestinal disorders are promoted togastroenterologists. GLUMETZA(®) (metformin hydrochloride extended releasetablets) and CYCLOSET(®) (bromocriptine mesylate) tablets, which are indicatedas adjuncts to diet and exercise to improve glycemic control in adults with type2 diabetes, and FENOGLIDE(®) (fenofibrate) tablets, which is indicated as anadjunct to diet to reduce high cholesterol, are promoted to endocrinologists andother physicians who treat patients with type 2 diabetes.  Full prescribing andsafety information for Santarus' products is available at or bycontacting Santarus at 1-888-778-0887.Santarus' product development pipeline includes the investigational drugRUCONEST(® )(recombinant human C1 esterase inhibitor).  A Biologics LicenseApplication for RUCONEST for the treatment of acute angioedema attacks inpatients with hereditary angioedema is under review by the U.S. Food and DrugAdministration with a response expected in April 2014.  Santarus is alsodeveloping rifamycin SV MMX(®), which is in Phase III clinical testing for thetreatment of travelers' diarrhea.  In addition, the company has completed aPhase I clinical program with SAN-300, an investigational monoclonal antibody.More information about Santarus is available at and Pharming caution you that statements included in this press releasethat are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as arepresentation by Santarus or Pharming that any of its plans or objectives willbe achieved. Actual results may differ materially from those set forth in thisrelease due to the risks and uncertainties inherent in Santarus and Pharming'sbusinesses, including, without limitation:  whether the FDA will approve theRUCONEST BLA in a timely manner or at all; whether the FDA will concur with theclinical interpretation of the Phase III study results or the conduct of thestudy; whether the FDA ultimately will require additional clinical studies orother development programs before approving RUCONEST; risks related to Santarus'dependence on Pharming for many functions related to RUCONEST, and Pharming'sability to continue to perform these functions based on its limited financialresources; risks related to the license and supply arrangements between Santarusand Pharming, including the potential for termination of the arrangements; otherdifficulties or delays in development, testing, manufacturing and marketing of,and obtaining and maintaining regulatory approvals for, Santarus and Pharming'sproducts; and other risks detailed in prior press releases as well as in publicperiodic filings with the Securities and Exchange Commission, includingSantarus' Quarterly Report on Form 10-Q for the quarter ended September30, 2013.You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. All forward-lookingstatements are qualified in their entirety by this cautionary statement andneither Santarus nor Pharming undertakes any obligation to revise or update thisnews release to reflect events or circumstances after the date hereof, except asmay be required by law. This caution is made under the safe harbor provisions ofSection 21E of the Private Securities Litigation Reform Act of 1995.Santarus(®), FENOGLIDE(®), UCERIS(®), and ZEGERID(®) are registered trademarksof Santarus, Inc. GLUMETZA(®) is a trademark of Biovail LaboratoriesInternational S.r.l. licensed exclusively in the United States to Depomed, Inc.CYCLOSET(®) is a trademark of VeroScience LLC. MMX(® )is a trademark of CosmoTechnologies Limited. RUCONEST(®) is a trademark of Pharming Group N.V.SANTARUS CONTACTS:                                      PHARMING CONTACTS:Martha L. Hough, VP Finance & Investor Relations        Sijmen de Vries, CEO+1 (858) 314-5824                                                       Tel:+31 (0)71 524 7400Debra P. Crawford, Chief Financial Officer+1 (858) 314-5708Westwicke Partners, LLC        FTI ConsultingStefan Loren, Ph.D. (        Julia Phillips/John Dineen+1 (858) 356-5930                                                Tel: +44 (0)207269 7193Robert Uhl ( (858) 356-5932[HUG#1741731]