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Swedish Orphan Biovitrum

Drug Names(s): Ancestim

Description: Stemgen is a recombinant formulation of (methionyl) stem cell factor (also known as Kit ligand, c-Kit ligand, Steel factor, Mast cell growth factor, and SCF). When used in combination with Neupogen, it can stimulate migration of stem cells from the bone marrow to the periphery (“PBPC,” peripheral blood progenitor cell mobilization). These cells can be collected for use in stem cell transplants. Stemgen is also used in combination with other cytokines, such as epo or GM-CSF, for generation of autologous progenitor cells ex vivo. Cells produced in this manner have restored hematopoiesis (production of blood cells) in cancer patients treated with high-dose chemotherapy.

Therefore, Stemgen can decrease the number of phereses (mechanical, invasive, blood cell collecting methods) required to collect peripheral blood progenitor cells capable of providing rapid multi-lineage (red cell, white cell, platelet) hematopoietic reconstitution following marrow-suppressive or marrow-ablative therapies such as chemotherapy or radiotherapy. The greater the quantity of stem cells available to repopulate the marrow and the peripheral blood, the more intensive are the doses of chemo- or radiotherapy that can be administered. In many clinical settings, peripheral blood stem cells are preferred to bone marrow transplantation.

Stemgen is approved in Canada, Australia, and New Zealand, but Amgen is no longer pursuing approval in the U.S.

Deal Structure: Stemgen was originially developed by Amgen.

In September 2008, Biovitrum AB and Amgen announced that they entered into an agreement under which Biovitrum will acquire Kepivance and Stemgen from Amgen, and will also obtain from Amgen a worldwide exclusive license to Kineret for its current approved indication.

In December 2008, Biovitrum announced the closing of an agreement, signed with Amgen in September 2008, under which Biovitrum has obtained a worldwide exclusive license to Kineret for its current approved indication, and has acquired from Amgen global rights to Kepivance and Stemgen.

After Kineret and Kepivance have reached certain cumulative net sales Biovitrum will pay one-time milestones to Amgen. Biovitrum also has the right to develop a modified anakinra product for use in orphan indications as well as gout and pseudo gout. If Biovitrum develops and commercializes a modified version of anakinra, Amgen will receive single digit percentage royalties.

On...See full deal structure in Biomedtracker

Partners: Amgen, Inc.

Stemgen News

Pink Sheet Amgen Stemgen

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