Dyax Corp. and Debiopharm S.A. Restructure Development Agreement for DX-890 (Depelestat) in Pulmonary Disorders.CAMBRIDGE, Mass. & LAUSANNE, Switzerland -- Dyax Corp. (Nasdaq: DYAX) and Debiopharm S.A. today announced the restructuring of their long-standing development agreement for DX-890 (Depelestat), a recombinant inhibitor of human neutrophil elastase Neutrophil elastase (or leukocyte elastase) is a type of enzyme that acts as a platelet activator. It consists of five exons. It is one of the two human forms of elastase. The neutrophil form of elastase (EC 3.4.21. (hNE) discovered by Dyax and developed by Debiopharm, for the treatment of pulmonary disorders. Under the terms of the restructured agreement, Debiopharm will have exclusive worldwide rights for the development, manufacture and commercialization of a native form of DX-890 in cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. (CF) and acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. (ARDS Ards District (pop., 2001: 73,244), Northern Ireland. Formerly part of County Down, Ards was established as a district in 1973. Much of its land is devoted to crops and pasture. Newtownards, settled c. 1608 by Scots, is its administrative seat and manufacturing centre. ). Dyax will retain rights to milestones and royalties with respect to Debiopharm's DX-890 programs, as well as the exclusive worldwide rights to extended half-life versions of DX-890 for development, manufacturing and commercialization in other chronic pulmonary indications such as chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. (COPD COPD chronic obstructive pulmonary disease. COPD abbr. chronic obstructive pulmonary disease Chronic obstructive pulmonary disease (COPD) ). Dyax will receive a milestone payment upon execution of the agreement in connection with Debiopharm's recent initiation of Phase I clinical studies in ARDS patients. Other financial details were not disclosed. "This new agreement with Debiopharm is beneficial for both companies, providing Dyax with the ability to seek new development partners for our extended half-life versions of DX-890 in chronic pulmonary disorders, while providing Debiopharm with control of future development activities of the native form of DX-890 for CF and ARDS," said Henry E. Blair, Chairman and Chief Executive Officer of Dyax. "I am happy to conclude this new agreement which provides the structure and facility for DX-890 to be developed and commercialized in the global marketplace," said Rolland-Yves Mauvernay, President and Chief Executive Officer of Debiopharm. About DX-890 (Depelestat) DX-890 is a highly potent and specific inhibitor of human neutrophil elastase (hNE). hNE is an enzyme produced as part of the inflammatory response and is implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in the loss of lung function in patients with CF and other clinical conditions. A drug that can block hNE may control the inflammatory processes early in the course of CF disease, and may limit the damaging effects of excessive inflammation, potentially delaying the progression of pulmonary deterioration and decreasing mortality. DX-890 is currently in a Phase IIb study in children, adolescents and adults to demonstrate clinical benefit and define dosing for a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial. DX-890 is also in a Phase I study in ARDS patients. DX-890 has orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designations in both the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and Europe. About Dyax Dyax Corp. is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on cancer 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. In its joint venture with Genzyme Corporation, Dyax has successfully completed two Phase II trials of DX-88 for the treatment of hereditary angioedema Hereditary angioedema A complement deficiency characterized by lymphatic vessel blockages that cause temporary swelling (edema) of areas of the skin, mucous membranes, and, sometimes, internal organs. Mentioned in: Complement Deficiencies (HAE). A third Phase II trial is nearing completion, and a pivotal Phase III trial has just commenced. Independently, Dyax has successfully completed a Phase I/II trial of DX-88 for the prevention of blood loss during heart surgery (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there procedures) and is in partnering discussions for further development of DX-88 in this indication. DX-88 has orphan drug designation in the US and EU, as well as Fast Track designation in the US for the treatment of HAE. Dyax identified DX-88 and other compounds in its pipeline using Dyax's patented phage display phage display n. A technique using recombinant DNA technology to create bacteriophages with a desired peptide embedded in the surface of their protein shells. technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages its technology broadly with over 75 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. About Debiopharm S.A. Founded in 1979 in Lausanne, Switzerland, Debiopharm is an experienced and competent drug development company that in-licenses compounds with promising in-vivo results to develop for global registration and to out-license to sales and marketing pharmaceutical partners. Debiopharm is part of an established group of five complementary and synergistic companies, namely Debiovision in Canada, Debioinnovation and Debio R.P. in Switzerland and Debioclinic in France. Together, they provide drug development expertise and know-how from the evaluation of early-stage and innovative research, partnering, financing, pre-clinical and clinical trials, to manufacturing and sophisticated drug-delivery systems. Debiopharm has developed and registered three products with combined sales in excess of $1.8bn in 2004: Eloxatin(R), one of sanofi-aventis' leading marketed products; Decapeptyl(R), the leading product of Ipsen; and Trelstar(R) (1-and 3-month), marketed by Watson Pharmaceuticals Watson Pharmaceuticals, Incorporated (NYSE: WPI) is the 5th largest pharmaceutical company in the United States based on number of prescriptions dispensed. Based in Corona, California, Watson's Generics division markets over 150 pharmaceutical product families, including one of the , Inc. For more information on Debiopharm and the Debio companies, please visit: www.debio.com. Dyax Disclaimer This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , including statements regarding the prospects for further clinical trials and commercialization of the native form of DX-890 compound by Debiopharm and Dyax's research and development program for an extended half-life form of DX-890 for indications other than CF and ARDS. 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 further clinical trials and commercialization of the DX-890 compound by Debiopharm and Dyax's research and development program for DX-890 include the following risks: our dependence on the expertise, effort, priorities and contractual obligations of Debiopharm and others in the development, clinical trials, manufacture, marketing, sales and distribution of DX-890; DX-890 may not show 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; DX-890 may not gain market acceptance; Dyax's ability to obtain and maintain intellectual property protection for DX-890; the development of technologies or products superior to DX-890; and other risk factors described or referred to in Dyax's most recent Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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 specifically disclaims responsibility for statements made by Debiopharm and the paragraph of information describing Debiopharm that was provided by Debiopharm. Dyax is headquartered in Cambridge, Massachusetts This article is about the city of Cambridge in Massachusetts. For the English university town, see Cambridge, England. For other places, see Cambridge (disambiguation). Cambridge, Massachusetts is a city in the Greater Boston area of Massachusetts, United States. , and has antibody discovery facilities in Liege liege In European feudal society, an unconditional bond between a man and his overlord. Thus, if a tenant held estates from various overlords, his obligations to his liege lord, to whom he had paid “liege homage,” were greater than his obligations to the other , Belgium. For online information about Dyax Corp., please visit www.dyax.com. Dyax and the Dyax logo are the registered trademarks of Dyax Corp. |
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