CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX) announced today an update on KALBITOR’s international regulatory status.
Dyax and Defiante Farmaceutica S.A. (Defiante), an affiliate of the pharmaceutical group Sigma-Tau, have reached a joint decision to withdraw the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) for KALBITOR (ecallantide) in the treatment of hereditary angioedema (HAE). This decision was made following discussions with the EMA’s Committee for Medicinal Products for Human Use (CHMP) and the Rapporteurs’ Day 181 Joint Assessment Report indicating the information provided was not deemed sufficient to demonstrate a positive benefit-risk balance. Based on the availability of supportive data, in particular from an ongoing bioequivalence study using a 1mL, high-strength formulation of KALBITOR, the Companies will consider a resubmission to the EMA.
The withdrawal does not impact the marketing status of KALBITOR in the United States nor any efforts to seek regulatory approvals in other important markets around the world. To that end, Dyax and Defiante continue to proceed toward marketing applications and regulatory approvals in other international territories, including Australia, the Middle East and Latin America.
“Dyax and Defiante continue to believe that the robust data package supporting FDA approval demonstrate a favorable benefit-risk profile for KALBITOR in HAE,” stated Gustav Christensen, President and Chief Executive Officer of Dyax Corp. “We look forward to working with our partner to deliver this important treatment option to patients throughout the world.”
Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel biotherapeutics for unmet medical needs. The Company’s lead product, ecallantide, has been approved under the brand name KALBITOR® in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
Dyax is commercializing KALBITOR in the United States independently, and establishing strategic partnerships to develop and commercialize ecallantide for the treatment of HAE in key regions worldwide. Currently, Dyax has partnership agreements for regions including Europe, Japan, Russia, the Middle East, Israel, North Africa, Australia, New Zealand, Latin America (excluding Mexico) and the Caribbean. The Company is also exploring other potential indications for ecallantide, either alone or through partnerships, including drug-induced angioedema.
Ecallantide 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 through the Licensing and Funded Research Program (LFRP), which has approximately 75 revenue generating licenses and collaborations for therapeutic discovery, as well as for affinity separations, diagnostic imaging, and research reagents. The success of the Company’s LFRP royalty portfolio is illustrated by the program’s advanced licensee pipeline that includes 17 candidates in clinical development. Of those candidates, four are in Phase 3 clinical trials, four are in Phase 2 and nine are in Phase 1.
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, KALBITOR and KALBITOR Access are registered trademarks of Dyax Corp.