Dyax Corp. and Defiante Farmaceutica SA, an affiliate of the pharmaceutical group Sigma-Tau, announced 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 US and in other un-partnered territories. Kalbitor was approved by the US 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 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.

Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel bio-therapeutics 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.

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.