global biopharmaceutical company, Abraxis BioScience Inc,
has signed an agreement to acquire licensing rights from
Biocon to develop its bio similar version of G-CSF (granulocyte-colony
stimulating factor) in North America and the European
Union, for an undisclosed amount.
the terms of the agreement, Biocon will receive an upfront
licensing fee and, following approval in the licensed
territories, royalties from Abraxis BioScience.
is a haematopoietic growth factor that works by encouraging
the bone marrow to produce more white blood cells. Therapeutic
G-CSF is primarily used for the treatment of neutropenia,
the lowering of the white blood cells that fight infections.
has received regulatory approval from the Indian DCGI
for the treatment of neutropenia in cancer patients and
intends to launch the product in India through its Oncotherapeutics
Bioscience is an ideal partner for Biocon as we increase
our focus on oncology. We are confident that both partners
will realise success in attaining market leadership for
G-CSF in their respective markets", said Kiran Mazumdar-Shaw,
chairman and managing director of the Company. "The
present licensing arrangements will certainly pave the
way to other opportunities in the foreseeable future."
biological activity of the Company''s G-CSF used in clinical
trials was evaluated by NIBSC (National Institute of Biological
Standards and Control), UK, which provides independent
testing of biological medicines. The NIBSC found that
the potency of the Company''s drug met the necessary requirements
of a biosimilar G-CSF.