Sigma-Tau SpA is paying Dyax $2.5 million in cash and will make a $2.5 million equity investment in the firm as part of a partnership to develop and commercialize Dyax’ subcutaneous DX-88 for the treatment of hereditary angioedema (HAE) and other indications. Dyax could receive over $100 million in development and sales milestones as well as royalties equating to 41% of net sales.
The $2.5 million share purchase is priced at a 50% premium above market value, Dyax states. The deal, between Dyax and Sigma-Tau’s Defiante Farmaceutica (www.defiante.com) subsidiary, gives the latter rights to subcutaneous DX-88 in Europe, North Africa, the Middle East, and Russia. Dyax retains its rights to the drug in other territories including the U.S. where DX-88 has been cleared by FDA, trade-named Kalbitor®, for the treatment of acute attacks of HAE in patients aged 16 years and over.
Sigma-Tau will in addition have responsibility for regulatory and commercialization costs within its licensed territories for the HAE indication. The firms will then share costs associated with developing the drug for other indications. DX-88 is already in either Phase I or Phase II development for the treatment of ACE inhibitor-induced angioedema, acquired angioedema, and retinal vein occlusion-induced macular edema.
Dyax claims Sigma-Tau’s strong track record in developing and marketing licensed drugs in its licensed territories will help boost its global commercial initiatives for the drug in HAE and potentially other indications.
“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”, comments Gustav Christensen, Dyax president and CEO.
Kalbitor was approved in the U.S. in December 2009. The drug is a selective and reversible plasma kallikrein inhibitor, which Dyax claims is the first subcutaneous HAE treatment approved in the U.S. Kalbitor was commercially launched in the U.S. at the start of February and made sales of $1.2 million between launch and March 31.
In 2008, Cubist Pharmaceuticals in-licensed development and commercialization rights to DX-88 for surgical indications in the U.S. and the EU. The firm terminated its agreement at the end of March due to poor results from two Phase II trials investigating the drug’s potential to reduce blood loss in patients undergoing cardiac surgery using cardiopulmonary bypass.