CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA (Sigma-Tau), announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other therapeutic indications throughout Europe, North Africa, Middle East and Russia. Dyax retains its rights to subcutaneous DX-88 in other territories, including the U.S., where DX-88 has been approved by the U.S. Food and Drug Administration (FDA) and is marketed as KALBITOR® (ecallantide) for the treatment of acute attacks of HAE in patients 16 years of age and older.
Under the terms of the agreement, Sigma Tau will make a $2.5 million upfront payment to Dyax and will purchase $2.5 million in equity shares at a 50% premium above market value. Dyax will also be eligible to receive over $100 million in development and sales milestones related to DX-88 and royalties equal to 41% of net sales of product. Sigma-Tau will pay the costs associated with regulatory approval and commercialization in the territories licensed to Sigma Tau. Additionally, Dyax and Sigma-Tau will share equally the costs for all development activities for future indications developed in partnership with Sigma-Tau.
“Sigma-Tau’s strong track record of developing and marketing licensed drugs in these geographic regions brings an important capability to our global commercial and clinical initiatives for KALBITOR in HAE and other potential indications,” announced Gustav Christensen, President and Chief Executive Officer of Dyax. “The strategic considerations under this partnership, including clinical development cost sharing, will enable Dyax to further leverage its resources to fund and develop new indications for DX-88.”
“This represents another important milestone in the strategic mission of our Group, just a few months after the acquisition of Enzon Pharmaceutical products and business. With KALBITOR, Sigma-Tau continues its strategic mission dedicated to providing novel therapeutics approaches and drugs to patients suffering from rare and severe diseases, such as hereditary angioedema, and other unmet medical needs,” said Mr. Ugo Di Francesco, Sigma-Tau Group Executive Vice President and CEO.
“Through the acquisition of KALBITOR rights in a vast number of countries, such as, all of Europe, Middle East, and North Africa, we will increase our presence in the field of the specialty pharmaceutical business and rare diseases with a product of great value which is a result of an outstanding research activity and a very successful interaction with Dyax. Sigma-Tau is fully determined to continue Dyax’s excellent work in the field of rare diseases which aims at tackling life-threatening conditions. We believe that the recent history of Sigma-Tau’s commitments in rare diseases represents a specific and tangible value added for KALBITOR’s success.”
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. Learn more at www.HAEHope.com.
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® (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 www.dyax.com.
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.
Sigma-Tau is part of a leading, international, pharmaceutical group with a wholly Italian-owned capital that invests in the research, development and marketing of innovative and effective treatments to improve patient well-being and quality of life. Sigma-Tau has its headquarters in Pomezia (Rome, Italy), and subsidiaries in France, Switzerland, Belgium, the Netherlands, Portugal, Germany, the UK, USA and India, as well as in Spain where the Group operates another production facility. It has over 2500 employees and an extensive network of licensees worldwide. Sigma-Tau was founded in Italy in 1957 and achieved a global turnover of € 615 million (about $ 909 million) in 2009. Sigma-Tau consistently invests approximately 16% of its annual turnover in R&D. Sigma-Tau’s R&D staff of approximately 400 people is currently running over 40 R&D projects. A total of 12 NCEs and 12 known molecular entities in 35 different indications are at various stages of development. Among them, several are aimed at rare diseases. Therapeutic areas in which the company’s research and development are focused include metabolism, neurology, cardiovascular, oncology and immunology. Sigma-Tau website: www.sigma-tau.it.
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