KalbitorTreatment for Angioedema
Update: Kalbitor (ecallantide) Now FDA Approved - November 27, 2009
Dyax Announces Completion of BLA for DX-88
Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep 24, 2008 - Dyax Corp. announced today the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax's lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). Dyax has requested Priority Review, which, if granted, would set a target date of six months from receipt of the completed submission for the FDA to take action on the application. Priority designation is intended for those products that address unmet medical needs. DX-88 has previously been granted Orphan Drug designation as well as Fast Track status by the FDA.
The final portion of the BLA, the clinical section, was based primarily on data from two Phase 3 clinical studies, EDEMA3(R) and EDEMA4(R), which together represent the largest placebo-controlled evaluation of any therapy used in the treatment of HAE. In these studies, DX-88 demonstrated statistically significant improvements over placebo in both the primary and secondary endpoints.
"The submission of the DX-88 BLA is a major milestone for Dyax," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working with the FDA to make this important product candidate available to HAE patients as soon as possible."
The recombinant, small protein, DX-88, was discovered utilizing the Company's proprietary phage display technology. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema, and is being evaluated as a subcutaneous therapy for treating acute HAE attacks.
Hereditary Angioedema (HAE) is an acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in potentially life-threatening cases, 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.
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications. Dyax has completed three Phase 2 trials and two Phase 3 trials of DX-88 for the treatment of hereditary angioedema (HAE). The second Phase 3 trial, known as EDEMA4, was conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for the treatment of acute attacks of HAE. Additionally, Dyax has completed a Phase 1/2 trial of DX-88 for the prevention of blood loss during on-pump coronary artery bypass graft (CABG) procedures. In April 2008, Dyax licensed to Cubist Pharmaceuticals the intravenous formulation of DX-88 for surgical indications in North America and Europe. Cubist is responsible for its ongoing development in these indications. Dyax identified DX-88 and other compounds in its pipeline 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 potential administration, dosing, safety and therapeutic benefits and treatment advantages of DX-88 for HAE and the timing and prospects for , review and FDA approval of the BLA for DX-88 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 potential administration, dosing and therapeutic benefits and treatment advantages of DX-88 for HAE, and the timing and prospects for review and FDA approval of the BLA for DX-88 for HAE, include the risks that: DX-88 could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88 or that receive regulatory approval and are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of DX-88; 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 and the Dyax logo are registered trademarks of Dyax Corp. EDEMA3 and EDEMA4 are registered service marks of Dyax.
Ivana Magovcevic-Liebisch, 617-250-5759
Executive Vice President of Administration
and General Counsel
Nicole Jones, 617-250-5744
Director, Investor Relations
Posted: September 2008
- FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older - April 7, 2014
- Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older - December 2, 2009
- Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema - June 8, 2009
- Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema - March 27, 2009
- FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema - February 5, 2009
- Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema - January 13, 2009
- FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema - November 21, 2008