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news.Dyax Corporation and Defiante Farmaceutica, a subsidiary of the pharmaceutical company Sigma-Tau, have formed a strategic partnership to develop and commercialise subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.
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Dyax will retain its rights to subcutaneous DX-88 in other territories, including the US, where DX-88 has been approved by the FDA and is marketed as Kalbitor (ecallantide) for the treatment of acute attacks of HAE in patients 16 years of age and older.
As per the terms of the agreement, Sigma Tau is expected to make a $2.5m upfront payment to Dyax and will purchase $2.5m in equity shares at a 50% premium above market value.
Additionally, Dyax will also be eligible to receive over $100m 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 commercialisation 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.
Gustav Christensen, president and CEO of Dyax, said: “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.”
Ugo Di Francesco, group executive vice president and CEO of Sigma-Tau, said: “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.
“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.”