Dyax Corp. (NASDAQ:DYAX) today announced that it has launched its newly enhanced product website, www.KALBITOR.com, featuring its comprehensive financial assistance program. KALBITOR® (ecallantide) is approved for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
HAE patients, healthcare professionals and caregivers may contact KALBITOR AccessSM, a one-stop support services program, to learn about comprehensive financial assistance solutions for qualified patients. The KALBITOR Access program also offers reimbursement support services, treatment location coordination and assistance with ordering and shipping KALBITOR. The program team is staffed with dedicated health insurance specialists and nurse case managers to answer questions and to help physicians and their patients ensure that KALBITOR is accessible.
Every patient who enrolls into KALBITOR Access is automatically evaluated for financial assistance with KALBITOR treatment. Based on each patient’s eligibility, they may be eligible for:
- KALBITOR free of charge – For qualified uninsured patients
- Co-payment reduction – For qualified insured patients
- Charitable foundation assistance – To subsidize the cost of health insurance premiums and co-pay assistance
“We are pleased to offer financial assistance solutions for qualified HAE patients in need,” stated Gustav Christensen, President and Chief Executive Officer of Dyax. “Due to the unpredictable nature of HAE, we believe it is important for patients to enroll into KALBITOR Access to ensure that a treatment plan is in place before the next attack occurs. The enhanced product website is part of our continuous commitment to educate patients who are seeking ways to treat acute HAE attacks. KALBITOR.com provides HAE patients, healthcare professionals and caregivers the opportunity to not only gain a better understanding of HAE but also to help determine if KALBITOR is the right treatment for them.”
KALBITOR.com offers comprehensive product information. It also features educational videos on the mechanism of action behind HAE attacks, real patient accounts of life with HAE and information about the risks and benefits of KALBITOR.
“The KALBITOR website is a useful resource for patients interested in learning more about the product or thinking about enrolling into KALBITOR Access,” said Greg, who was diagnosed with HAE over 20 years ago. “The KALBITOR Access team has been very helpful in addressing my specific questions and working with my doctor to make the treatment available at a hospital which is around the corner from my house.”
Important KALBITOR Safety Information
Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. KALBITOR should not be administered to patients with known clinical hypersensitivity to KALBITOR.
For more information about KALBITOR, including full prescribing information, visit www.KALBITOR.com.
KALBITOR HAE Program
The approval of KALBITOR is based on the results of two placebo-controlled Phase 3 clinical studies, known as EDEMA3® and EDEMA4®. Patients having an attack of HAE, at any anatomic location, with at least one moderate or severe symptom, were treated with 30 mg subcutaneous KALBITOR or placebo. Because patients could participate in both trials, a total of 143 unique patients participated. There were 64 patients with abdominal attacks, 55 with peripheral attacks, and 24 with laryngeal attacks. In both trials, the effects of KALBITOR were evaluated using the Mean Symptom Complex Severity (MSCS) score and the Treatment Outcome Score (TOS), two HAE-specific patient-reported outcome endpoints developed by Dyax. These measures evaluated the severity of attack symptoms at all anatomical locations (MSCS score) and response to therapy (TOS). In the EDEMA4 trial at 4 hours, patients treated with KALBITOR demonstrated a greater decrease from baseline in the mean MSCS than placebo (-0.8 vs. -0.4; p = 0.010) and a greater mean TOS (53 vs. 8, p = 0.003). In the EDEMA4 trial at 24 hours, patients treated with KALBITOR also demonstrated a greater decrease from baseline in the mean MSCS than placebo (-1.5 vs. -1.1; p = 0.04) and a greater mean TOS (89 vs. 55, p = 0.03). The results in the EDEMA3 trial were consistent with the EDEMA4 trial results.
Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical studies, 10 patients (3.9%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (2.7%) experienced anaphylaxis. Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension. These reactions occurred within the first hour after dosing. Other adverse reactions indicative of hypersensitivity reactions included pruritis (5.1%), rash (3.1%) and urticaria (2.0%). Patients should be observed for an appropriate period of time after administration of KALBITOR, taking into account the time to onset of anaphylaxis seen in clinical trials.
The most common adverse reactions occurring in ≥3% of KALBITOR-treated patients and greater than placebo were headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.
Patients and healthcare providers can contact KALBITOR AccessSM to receive information and work with program staff to research patient health insurance coverage for KALBITOR. KALBITOR Access is designed as a one-stop point of contact for information about KALBITOR. The program is staffed with dedicated health insurance specialists and nurse case managers who will help coordinate access to KALBITOR. Patients and healthcare providers can call 1-888-4KALBITOR (1-888-452-5248) for information or visit www.KALBITOR.com to learn more.
Hereditary angioedema (HAE) is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in the larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. HAE is estimated to affect 1 in 10,000 to 1 in 50,000 individuals.
Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel biotherapeutics for unmet medical needs. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Our lead product, DX-88, has been approved under the brand name KALBITOR® (ecallantide) in the United States for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.
In June 2010, Dyax announced a strategic partnership with Sigma-Tau to develop and commercialize subcutaneous DX-88 for the treatment of hereditary angioedema (HAE) and other therapeutic indications throughout Europe, North Africa, Middle East and Russia. Dyax and Sigma-Tau will work together with the European Medicines Agency as they review our Marketing Authorization Application for potential approval to market DX-88 in the European Union for HAE.
DX-88 is being investigated for its therapeutic potential in other angioedema indications (acquired and ACE inhibitor-induced angioedemas) and, through a collaboration with Fovea Pharmaceuticals (a subsidiary of sanofi aventis), is in a Phase 1 trial for retinal vein occlusion-induced macular edema.
DX-88 and other compounds in Dyax’s pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
This press release contains forward-looking statements, including statements regarding the prospects for therapeutic benefits and treatment advantages of KALBITOR for HAE and capabilities and success of KALBITOR Access patient services. Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the prospects for therapeutic benefits and treatment advantages of KALBITOR for HAE and prospects of KALBITOR Access patient services include the risks that: others may develop technologies, products or product support services superior to KALBITOR or that are on the market before KALBITOR; KALBITOR may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, marketing, sales and distribution of KALBITOR; and other risk factors described or referred to Item 1A, “Risk Factors” in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
Dyax, the Dyax logo and KALBITOR are registered trademarks and EDEMA3 and EDEMA4 are registered service marks of Dyax Corp. KALBITOR Access is a service mark of Dyax Corp.
Ivana Magovčević-Liebisch, 617-250-5759
Executive Vice President Corporate Development and General Counsel
Nicole Jones, 617-250-5744
Director, Investor Relations and Corporate Communications
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