ChemGenex, Hospira, Announce Agreement to License, Develop and Commercialize Leukemia Drug in Europe
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ChemGenex Pharmaceuticals Limited and Hospira, Inc. have announced that they have entered into an exclusive agreement to license, develop and commercialize ChemGenex’s product candidate omacetaxine mepesuccinate, a novel targeted cytotoxic pharmaceutical product, in Europe, the Middle East and parts of Africa (the Territory).
Applications for marketing approval of the product have been accepted for regulatory review in both the United States and Europe for treatment of patients with chronic myeloid leukemia (CML) who have failed to respond to the current standard of care treatment, imatinib mesylate, and who have the Bcr-Abl T315I mutation.
Under the terms of the agreement, Hospira will make an initial payment of €11.1 million (A$ 17.8 million), with the potential for up to an additional €74.1 million (A$ 119.4 million), in performance milestone payments based on the successful development and commercialization of omacetaxine. In addition, following successful commercialization, Hospira will pay ChemGenex a royalty on product sales in the Territory.
ChemGenex will complete registration of omacetaxine in its initial indication with the European Medicines Agency (EMEA), while Hospira and ChemGenex will collaborate to explore future applications in a variety of hematological malignancies. Hospira will have responsibility for commercializing omacetaxine in the Territory.
"We are very excited by the promise omacetaxine holds to improve outcomes for seriously ill patients who have stopped responding to other treatments available for their condition," said Michael Kotsanis, President Europe, Middle East and Africa, Hospira, Inc. "This agreement is a further step in Hospira's strategy to build upon our strong portfolio of oncology and hematology products."
"We are very pleased to announce this important agreement, in keeping with our corporate strategy of partnering in Europe and other parts of the world, as we prepare for the launch of omacetaxine in the U.S., if approved," said Greg Collier, CEO and Managing Director ChemGenex. "We look forward to working with the Hospira team to realize omacetaxine’s potential in the hematology-oncology space in Europe."
Applications for marketing approval of the product have been accepted for regulatory review in both the United States and Europe for treatment of patients with chronic myeloid leukemia (CML) who have failed to respond to the current standard of care treatment, imatinib mesylate, and who have the Bcr-Abl T315I mutation.
Under the terms of the agreement, Hospira will make an initial payment of €11.1 million (A$ 17.8 million), with the potential for up to an additional €74.1 million (A$ 119.4 million), in performance milestone payments based on the successful development and commercialization of omacetaxine. In addition, following successful commercialization, Hospira will pay ChemGenex a royalty on product sales in the Territory.
ChemGenex will complete registration of omacetaxine in its initial indication with the European Medicines Agency (EMEA), while Hospira and ChemGenex will collaborate to explore future applications in a variety of hematological malignancies. Hospira will have responsibility for commercializing omacetaxine in the Territory.
"We are very excited by the promise omacetaxine holds to improve outcomes for seriously ill patients who have stopped responding to other treatments available for their condition," said Michael Kotsanis, President Europe, Middle East and Africa, Hospira, Inc. "This agreement is a further step in Hospira's strategy to build upon our strong portfolio of oncology and hematology products."
"We are very pleased to announce this important agreement, in keeping with our corporate strategy of partnering in Europe and other parts of the world, as we prepare for the launch of omacetaxine in the U.S., if approved," said Greg Collier, CEO and Managing Director ChemGenex. "We look forward to working with the Hospira team to realize omacetaxine’s potential in the hematology-oncology space in Europe."
