Healthcare Industry News: Integrated BioPharma
News Release - January 11, 2011
Dyax and Sigma-Tau Group Expand Agreement to Commercialize KALBITOR(R) (ecallantide) for Hereditary AngioedemaAdditional Territories Include Australia and New Zealand
CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)-- Dyax Corp. (NASDAQ: DYAX) and Defiante Farmaceutica S.A., an affiliate of the pharmaceutical group Sigma-Tau (Sigma-Tau), announced today the expansion of their partnership to commercialize KALBITOR® (ecallantide) for the treatment of hereditary angioedema (HAE) throughout Australia and New Zealand. Defiante already has rights to KALBITOR for Europe, North Africa, Middle East and Russia, while Dyax retains the rights to develop and commercialize KALBITOR in the U.S. and in other un-partnered territories. KALBITOR was approved by the U.S. Food and Drug Administration (FDA) in December 2009 and is marketed by Dyax for the treatment of acute attacks of HAE in patients 16 years of age and older.
In addition to receiving an upfront payment of $1 million, which includes $500,000 in cash and $500,000 in equity shares at a 50% premium investment, Dyax is eligible for up to $2 million in regulatory and commercialization milestones. Dyax will also receive royalties equal to 41% of net sales of product, less cost of goods sold. Consistent with the previous agreement, Sigma-Tau will pay the costs associated with regulatory approval and commercialization in these additional territories.
“Our growing relationship with Sigma-Tau Group is a testament to their commitment to developing and commercializing KALBITOR,” states Gustav Christensen, President and Chief Executive Officer of Dyax Corp. “Expanding our agreement with Sigma-Tau Group enables us to advance our global commercialization strategy for KALBITOR and to make it available to HAE patients worldwide.”
"Sigma-Tau Group continues in its strategic mission to extend its contribution dedicated to providing drugs to patients suffering from rare and severe diseases, such as hereditary angioedema, even in additional countries with respect to the deal executed last June," said Mr. Ugo Di Francesco, Sigma-Tau Group Executive Vice President and CEO.
"Through the acquisition of KALBITOR rights in Australia and New Zealand, we are pleased and delighted to reconfirm a strong and long-lasting commitment in the 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 and possibly to continue in 2011 by adding additional geography to the strategic alliance with Dyax as to KALBITOR and HAE.
Hereditary angioedema (HAE) is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, gastrointestinal tract, genitalia, and 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 in 10,000 to 1 in 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. 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 has established partnerships worldwide to develop and commercialize ecallantide for the treatment of HAE in key regions including Japan, Europe, North Africa, the Middle East, Russia and Israel. Dyax is also exploring other potential indications for ecallantide, either alone or through partnerships, including drug-induced angioedema and retinal vein occlusion-induced macular edema.
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. As part of its Licensing and Funded Research Program, Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as for affinity separations, diagnostic imaging, and research reagents.
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, Spain, Germany, the UK, USA and India, and in addition the Group operates other production facilities in USA and Spain. 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.
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.
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