Dyax Corp. (NASDAQ: DYAX) today announced five HAE Allies honorees chosen as the first to be recognized by the program for their contributions in supporting those with hereditary angioedema (HAE) to live life to the fullest. By drawing from the inspiring stories of individuals nationwide, the HAE Allies program hopes to underscore the value of support for those living with this potentially life-threatening condition, which is characterized by spontaneous episodes of edema, or swelling, in the face, feet, hands, throat and abdomen. The honorees were selected by a multi-disciplinary council of HAE experts organized by Dyax, the developer and marketer of KALBITOR® (ecallantide) for the treatment of sudden attacks of HAE in patients 16 years of age and older. Ranging from health care providers to loved ones to community members working to educate the public about HAE, the 2013 honorees are:
- Douglas Jones, MD of Salt Lake City, Utah
- Barbara Mathews, RN of Frisco, Texas
- Justin Wright of Washington, Utah
- Ernie Seawright of Decatur, Georgia
- Chief Donald Sayre (retired) of Tarpon Springs, Florida
“A support network is essential to those living with HAE,” stated Gustav Christensen, President and Chief Executive Officer of Dyax. “These honorees truly exemplify the meaningful difference individuals can make for someone struggling with a rare disease.”In addition to recognizing a group of honorees who have demonstrated extraordinary commitment to a specific HAE patient or the HAE community in general, the goal of the HAE Allies program is to utilize insights from the submissions to empower more patients to seek and receive the support they need from their healthcare providers, families and communities. “As a nurse for over 35 years, I have dedicated my life to helping people get the treatment and support they need to manage illness. HAE presents unique challenges because of the unpredictability of attacks and the lack of awareness of the condition,” said Barbara Mathews, RN and HAE Allies honoree. “In my role as a nurse I’ve had the privilege to partner with patients to help navigate some of these hurdles, hopefully enabling them to more easily work, travel, or participate in activities they enjoy. I have been truly awed by the optimism and tenacity of those facing this condition.” About HAE Hereditary angioedema (HAE) is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, gastrointestinal tract, genitalia, and 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 up to 1 in 50,000 individuals. Learn more at www.HAEHope.com/HAEAllies. About KALBITOR KALBITOR is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. KALBITOR, which was discovered and developed by Dyax, is the first subcutaneous treatment available in the U.S. for treating acute HAE attacks.
Important KALBITOR Safety InformationAnaphylaxis 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.As part of product approval, Dyax has implemented a Risk Evaluation and Mitigation Strategy (REMS) program. The goal of the REMS is to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms. For more information about KALBITOR, including full prescribing information, visit www.KALBITOR.com . About Dyax Dyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company's key value drivers are the KALBITOR \ business, DX-2930 and the Licensing and Funded Research Program (LFRP). Dyax developed KALBITOR on its own and, since February 2010, has been selling it in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older. Outside the United States, the Company has established partnerships to obtain regulatory approval and commercialize KALBITOR in certain markets and is evaluating opportunities in others. The Company is developing products to expand its angioedema portfolio, including a therapeutic candidate, DX-2930, for the prophylactic treatment of HAE and a biomarker assay to identify plasma- kallikrein-mediated disorders. In August 2013, Dyax began a Phase 1 clinical study evaluating the safety and tolerability of single subcutaneous administration of DX-2930 in healthy subjects. KALBITOR and DX-2930 were identified using Dyax's patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly through the LFRP. This program has provided the Company a portfolio of product candidates being developed by its licensees, which currently includes 13 revenue eligible product candidates in various stages of clinical development, including three in Phase 3 trials.
For additional information about Dyax, please visit www.dyax.com.DisclaimerThis press release contains forward-looking statements. 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 future performance include the risks that: DX-2930 may not show sufficient therapeutic effect or an acceptable safety profile in clinical trials or could take longer to gain regulatory approval than Dyax expects or may never gain approval; others may develop products superior to KALBITOR or DX-2930; KALBITOR and/or DX-2930 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 DX-2930; and other risk factors described or referred to in 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 marks of Dyax Corp.