Canadian firm join hands with IBPL to develop Biosimilar G-CSF

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Submitted by lucky_pharmacist on Sat, 05/03/2008 - 10:58.
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A biosimilar protein that can be used to treat neutropenia (a side effect of cancer chemotherapy) is to be developed by Apotex of Canada in collaboration with Intas Biopharmaceuticals Limited (IBPL) of India.

Neukine, a recombinant granulocyte colony stimulating factor (G-CSF) is already manufactured and marketed in India and other countries by IBPL. Kwizda Pharma of Austria had been working with IBPL to develop G-CSF for the European market for some time. Effective immediately, Kwizda Pharma has transferred all of its rights in IBPL's G-CSF to Apotex. Apotex and IBPL have concurrently agreed to extend the collaboration to development of G-CSF for North America (US and Canada).

Dr Helmut Brunar, VP Research and Business Development of Kwizda Pharma said, "It is part of Kwizda Pharma's current business strategy to work together with non-European pharmaceutical companies to break into the European market. That is why we worked with IBPL to successfully complete a phase I clinical trial and have transferred our rights in IBPL's G-CSF to Apotex including initiation of a phase III trial for the approval of G-CSF in Europe."
Dr Jeremy B Desai, Executive Vice President, Research & Development, Apotex said, "This agreement represents an important milestone for Apotex, as it strengthens the organization's development in Europe and will offer support for entering this important market with future biosimilar products currently in the Apotex development pipeline."
Mr Mani Iyer, Executive Director, IBPL, said, "This business deal brings together two companies having respective expertise in niche areas of operations. IBPL and Apotex are eying a significant share of total G-CSF market in North America and Europe, which is currently estimated to be around CDN$1.4 billion (US $ 1.37 billion) annually. Although guidelines for biosimilar product registration in North America are not yet finalized, the companies anticipate that there would be a clear pathway for biotech companies, once the legislation is in place. IBPL and Apotex are keen to explore prospective business opportunities for more biosimilar products in the coming years."