The FINANCIAL — Dyax Corp. (NASDAQ: DYAX) and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA (Sigma-Tau), announced on June 21 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(R) (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," Dyax Corp. says.
"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."