Dyax Announces Final Patient Treated in Second Phase 3 Clinical Trial of DX-88 in Hereditary Angioedema

Business Wire,  June 23, 2008  

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Company's Clinical Research Provider, BattelleCRO, to Shut Down

Completion of Rolling BLA Now Expected in Early Fourth Quarter

CAMBRIDGE, Mass. -- Dyax Corp. (NASDAQ: DYAX) announced today that it has treated the final patient in its second Phase 3, 96-patient trial of DX-88, known as EDEMA4, for the treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare and life-threatening inflammatory condition for which there is no approved therapy in the United States.

The Company also announced today that it was recently notified by its clinical research provider, BattelleCRO, Inc., that Battelle Memorial Institute has decided to shut down BattelleCRO by June 30, 2008. As a consequence, Dyax is required to transfer BattelleCRO's clinical database to another clinical research service, a process which is underway with a global clinical research organization. After completion of the transfer, the newly housed database can be verified, locked and analyzed, and then prepared for filing as part of Dyax's rolling BLA.

This process is expected to move the completion date of the Company's rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration for approval of DX-88 in HAE to the early fourth quarter of 2008. The Company will disclose topline data from the EDEMA4 study prior to completion of the BLA, once the data become available.

"Treatment of the last patient in our EDEMA4 study is another important step in advancing DX-88 for HAE. While we are disappointed by the untimely closure of BatelleCRO, we have taken immediate action to transfer our clinical database and finalize the BLA sequence," commented Henry E. Blair, Chairman, President and Chief Executive Officer. "We expect these final steps to be completed in a timely manner, while making certain that the BLA meets the highest regulatory standards."

Mr. Blair added: "DX-88's clinical program is the largest placebo-controlled clinical program for any therapy studied for the treatment of HAE. We believe that DX-88's unique attributes, including its significant clinical experience in HAE patients, will position it well in the commercial setting over the long-term. The Company appreciates the dedication of all the investigators and patients who contributed to Dyax's HAE program."

About Dyax

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, 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 this indication. 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.

Dyax Disclaimer

This press release contains forward-looking statements, including statements regarding Dyax's clinical trials of DX-88 for HAE, its plans for disclosure of topline results and completion of the BLA for approval of DX-88 in HAE, and the prospects for commercialization in this indication. 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 clinical trials of DX-88 for HAE, plans for disclosure of topline results and completion of the BLA for approval of DX-88 in HAE, and the prospects for commercialization in this indication, include the risks that: DX-88 may not show sufficient therapeutic effect or an acceptable safety profile in clinical trials or 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 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.