Kiadis Pharma, a biopharmaceutical company based in The Netherlands, announced that it has entered into a licensing agreement with Hospira, Inc., a global specialty pharmaceutical company, to develop and commercialize Kiadis Pharma's ATIR.
ATIR is a personalized haematology product designed for blood cancer patients in need of allogeneic bone marrow transplantation who cannot locate a matched donor. The product will enable a mismatched family member to act as donor and is being developed to reduce transplant related mortality caused by infections and graft-versus-host disease.
Under the terms of the agreement, Hospira is granted exclusive marketing rights to ATIR for Europe, the Middle East, Africa, Australia, Japan and parts of Asia. Kiadis Pharma maintains all rights to ATIR for the rest of the world. The financial terms include an undisclosed upfront payment and partial funding of the ATIR registration clinical trial currently ongoing in Europe and North America. Upon successful development and commercialization of ATIR in the European market, Kiadis Pharma can receive additional milestone payments and is entitled to royalties on product sales.
"We are very pleased to have Hospira as a partner bringing extensive pharmaceutical development expertise into the ATIR development program. Hospira's commitment to commercialize ATIR will ultimately accelerate making this lifesaving product available for patients," says Manja Bouman, CEO of Kiadis Pharma.
"Hospira is excited about the lifesaving potential of this innovative haematology product," said Andrew Robbins, vice president, corporate development and proprietary pharmaceutical marketing, "Following approval, ATIR will fit nicely within our strong portfolio of oncology products, including biosimilars Nivestim and Retacrit, in Europe and Asia."
ATIR is an innovative therapy of donor T-lymphocytes depleted of alloreactive T-cells and is infused after a patient receives a mismatched haematopoietic stem cell transplantation to reduce transplant related mortality. ATIR is designed to prevent severe acute graft-versus-host disease while providing an early immune reconstitution to fight infections and remaining tumour cells, thereby reducing transplant related mortality and improving overall and disease free survival. Moreover, it enables the use of a mismatched, related (haplo-identical) donor, thus providing virtually everyone with an immediately available donor, addressing an urgent unmet medical need. Today patients eligible for allogeneic transplantation, but without a matched donor, have no treatment options. ATIR can be considered a truly personalized medicine because it is prepared specifically for each patient.
Patients are currently being enrolled in a multinational, registration clinical trial of ATIR, with sites in Europe and North America. The trial is expected to be completely enrolled in the first part of 2011. ATIR has orphan drug designations from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Kiadis Pharma is an oncology focused biopharmaceutical development company with cell based products in clinical development. The company develops products that offer novel treatment options for terminally ill cancer patients and address significant unmet medical needs. The key focus indication for Kiadis Pharma is limitations and complications of bone marrow transplantation procedures.
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions.