Dyax Announces Marketing Authorization Application for DX-88 (ecallantide) Validated by European Medicines Agency
CAMBRIDGE, Mass., Jul 06, 2010 (BUSINESS WIRE) -- Dyax Corp. (NASDAQ: DYAX) announced today that the European Medicines Agency (EMA) has completed its validation process for the Marketing Authorization Application (MAA) for potential approval to market DX-88 (ecallantide) in the European Union (EU). The completion of this validation process signifies that the formal scientific review of the MAA has begun. DX-88 (ecallantide) has been approved by the U.S. Food and Drug Administration (FDA) and is marketed as KALBITOR(R) (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
The EMA's review of the application will follow the centralized marketing authorization procedure. If approved, DX-88 (ecallantide) will receive marketing authorization in 27 EU member states.
"Starting the formal scientific review process with the EMA represents another step towards our global strategy of treating HAE patients outside of the United States," commented Gustav Christensen, President and Chief Executive Officer of Dyax. "Dyax, along with our new strategic partner Sigma-Tau, looks forward to working with the EMA during this process as we seek approval in Europe."
About HAE
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 1:10,000 to 1:50,000 individuals.
About Dyax
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(R) (ecallantide) in the United States for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.
In addition to its approved commercial use, DX-88 is also being evaluated 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 http://www.dyax.com/index.html.
Dyax Disclaimer
This press release contains forward-looking statements, including statements regarding the prospects for therapeutic benefits and treatment advantages of KALBITOR for HAE. 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 include the risks that: others may develop technologies or products 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 of Dyax Corp.
SOURCE: Dyax Corp.
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