News

Feb 25, 2013

Dyax Presents DX-2930 Data at the 2013 American Academy of Allergy, Asthma and Immunology Annual Meeting

DX-2930 is a Potent, Highly Specific, and Potentially Long-Acting Antibody Inhibitor of Plasma Kallikrein

BURLINGTON, Mass.–(BUSINESS WIRE)– Dyax Corp. (NASDAQ:DYAX) today announced results from a preclinical study of DX-2930, their internally developed, fully human monoclonal antibody inhibitor of plasma kallikrein, at the 2013 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting which is taking place February 22-26, 2013 in San Antonio, TX.

The poster, titled “Discovery and characterization of a fully human monoclonal antibody inhibitor of plasma kallikrein for the treatment of plasma kallikrein-mediated edema,” (poster #116) highlighted results of preclinical work that was designed to evaluate the activity of DX-2930 as a long-acting inhibitor of plasma kallikrein (pKal). Dyax currently markets KALBITOR^® (ecallantide), a specific pKal inhibitor, for treatment of acute hereditary angioedema (HAE) attacks in patients 16 years of age and older. The Company is exploring DX-2930 as a subcutaneous, long-acting, prophylactic treatment for HAE.

Data demonstrate that DX-2930 is a potent antibody inhibitor of pKal (Ki=0.14 nM) that does not bind prekallikrein or any other serine protease tested. In a preclinical model, DX-2930 reduced carrageenan-induced edema. Pharmacokinetic properties following subcutaneous injection indicate that the antibody is bioavailable (66%) and has a half-life of 12.5 days in non-human primates.

“These data are significant because they indicate that DX-2930 is a potent, highly specific, potentially long-acting antibody inhibitor of plasma kallikrein,” said Burt Adelman M.D., Chief Medical Officer and Executive Vice President at Dyax. “DX-2930 may be a viable prophylactic treatment option for hereditary angioedema and other plasma kallikrein-mediated (PKM) diseases. Our focus is on plasma kallikrein inhibition because we think it is the most logical strategy to both treat and prevent HAE attacks.”

Gustav Christensen, President and CEO of Dyax added: “The findings presented today represent an important step for Dyax as we move toward our goal of expanding our angioedema portfolio to offer a preventative treatment option for those suffering from HAE and other PKM diseases.”

Based upon the attributes of selectivity, specificity and long half-life Dyax has chosen to develop DX-2930 as a self-administered, subcutaneous injection for chronic prevention of HAE attacks. The Company plans to file an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) by the end of the second quarter of 2013 and expects to initiate Phase 1 clinical studies in the second half of 2013.

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Jan 09, 2013

CSL Behring Launches Its First Co-Pay Assistance Program to Ease Financial Burden of Treating Hereditary Angioedema

Berinert^® Co-Pay BENefit covers up to $12,000 of patient’s yearly out-of-pocket expenses

King of Prussia, PA – January 2, 2013 – CSL Behring announced today the launch of a financial assistance program designed to cover patients’ out-of-pocket expenses for Berinert^®, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute laryngeal, facial and abdominal attacks of hereditary angioedema (HAE). HAE is a rare and potentially fatal genetic disorder. Berinert Co-Pay BENefit is the most recent addition to the Berinert Expert Network (B.E.N.^®), a full-service support program for healthcare providers and HAE patients and their caregivers. Berinert is available through specialty pharmacies and distributors in the United States.

Berinert Co-Pay BENefit assists with co-pay costs related to a patient’s prescription for Berinert. On behalf of program participants, CSL Behring will coordinate with the patient’s specialty pharmacy to cover the patient’s out-of-pocket co-pay costs up to $12,000 in eligible expenses per year. The program is available to new or existing Berinert patients, age 12 or older, who are U.S. residents insured in the U.S. and who receive product through a specialty pharmacy. Patients covered by state- or federally- funded programs, such as Medicare, Medicaid and Veterans Health Insurance, are not eligible.

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Nov 16, 2012

Dyax Corp. Announces Presentation of KALBITOR® (ecallantide) Pediatric and Abdominal Attack Data at the American College of Allergy, Asthma and Immunology Annual Meeting (ACAAI)

BURLINGTON, Mass.–(BUSINESS WIRE)– Dyax Corp. (NASDAQ: DYAX) announced today that two poster presentations featuring updated KALBITOR® (ecallantide) data in pediatric patients with hereditary angioedema (HAE) and HAE patients with abdominal attacks were presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2012 Annual Scientific Meeting, held November 8-13, at the Anaheim Convention Center in Anaheim, CA. Both presentations pooled results from patients enrolled in four different clinical trials of ecallantide for the treatment of acute HAE attacks: DX-88/19, an open-label continuation study; EDEMA2®, an open-label, Phase 2 dose-ranging, repeat-dosing study; and EDEMA3® and EDEMA4®, two Phase 3 double-blind, placebo-controlled studies. KALBITOR is indicated for the treatment of acute attacks of HAE in patients 16 years of age and older.

Commenting on the study “Clinical Trial Experience of Pediatric Patients Treated with Ecallantide for Acute Attacks of Hereditary Angioedema,” Andrew MacGinnitie, MD, PhD, Associate Clinical Director, Division of Immunology at Boston Children’s Hospital, and lead investigator of the study, stated: “In order to provide patients with effective relief from the disease’s often debilitating, acute attacks, it is important that pediatric and other specialist communities learn to diagnose and treat HAE as early as possible.”

“Our clinical studies of KALBITOR reinforce its demonstrated ability to effectively treat various patient populations and attack locations,” commented Dr. Burt Adelman, Executive Vice President and Chief Medical Officer at Dyax Corp. “The presentation of these data is part of our ongoing effort to educate the healthcare community about hereditary angioedema and novel treatments such as KALBITOR. Dyax remains committed to providing an HAE support, education and treatment awareness program that is second to none.”

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Nov 13, 2012

Santarus And Pharming Announce Positive Top-Line Phase III Results For Ruconest In Acute Hereditary Angioedema

Statistically significant results for primary endpoint of time to beginning of symptom relief

SAN DIEGO and LEIDEN, The Netherlands (November 7, 2012) – Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.

A statistically significant difference in the time to beginning of symptom relief was observed in the intent-to-treat population (n=75) between RUCONEST and placebo (p=0.031, log-rank test); the median time to beginning of symptom relief was 90 minutes for RUCONEST patients (n=44) and 152 minutes for placebo patients (n=31). The time to beginning of symptom relief was defined as the time from the beginning of infusion of study medication (RUCONEST or placebo) until the beginning of a persistent beneficial effect, based on the patient’s responses to a Treatment Effect Questionnaire for the primary attack location.

RUCONEST was generally well tolerated in this Phase III clinical study and the frequency of patients experiencing at least one treatment emergent adverse event in the RUCONEST treated group was less than in the placebo group. Within 72 hours of the completion of infusion of study medication, four RUCONEST patients (7%) experienced six adverse events: sneezing, procedural headache, back pain, skin burning sensation, an increase in fibrin D-dimer and lipoma. Within the 72 hour period four placebo patients (22%) experienced four adverse events: sinus congestion, vasomotor rhinitis, diarrhea and dyspepsia. Thromboembolic events, anaphylaxis, or neutralizing antibodies to C1 inhibitor were not observed in any patient. There was one patient in the RUCONEST group that experienced a serious adverse event (abdominal hernia at Day 79) that was assessed by the investigator as not related to the study drug.

“These positive results are consistent with the efficacy data previously reported from two smaller randomized, controlled clinical studies with RUCONEST in patients with HAE, and we believe the results provide strong support for our proposed dosing regimen of 50 U/kg in treating acute attacks of HAE,” said Wendell Wierenga, Ph.D., executive vice president of research and development of Santarus.

“We are very pleased with these pivotal study results and look forward to working with our colleagues at Santarus to prepare and submit the Biologics License Application (BLA) for RUCONEST to the FDA in the first half of 2013,” said Bruno Giannetti, M.D., Ph.D., chief operations officer of Pharming. “We anticipate that additional data from this Phase III study will be presented at an appropriate medical meeting in 2013.”

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Sep 21, 2012

ViroPharma And Halozyme Provide Update On Clinical Development Of Subcutaneous Cinryze® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20)

EXTON, Pa. and SAN DIEGO, Sept. 21, 2012 /PRNewswire/ – ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced today that the U.S. Food & Drug Administration (FDA) has provided guidance enabling ViroPharma to resume clinical studies of the subcutaneous administration of Cinryze in combination with rHuPH20. The FDA informed ViroPharma that based upon their ongoing assessment, the FDA believes the potential safety signals regarding antibodies to rHuPH20 that were detected in the clinical development program of another company’s product are limited to that specific program. According to Halozyme, the detected antibodies were non-neutralizing and not associated with any clinical adverse events. The FDA has advised ViroPharma to amend the study protocol, allowing for increased laboratory sampling to monitor rHuPH20 antibody levels, and keep the Agency informed of elevated antibody levels during the treatment phase of the study.

ViroPharma intends to provide additional commentary on next steps and timing at ViroPharma’s analyst day event scheduled to begin at 9:00 A.M. E.T. today. To access the webcast of ViroPharma’s analyst day, please visit www.viropharma.com.

About Cinryze® (C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. In the E.U., the product is approved by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. Cinryze is for intravenous use only.

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