Bangalore, May 6, 2008: India’s Intas Biopharmaceuticals has signed business agreement with Canada’s Apotex for co-development and supplying Filgrastim brand— Neukine— in North America.

 

European pharmaceutical major Kwizda Pharma—that is working with IBPL to develop G-CSF for the European market— has transferred all of its rights in IBPL’s G-CSF to Apotex. Both, Apotex and IBPL launch Neukine in the US.

 

Mani Iyer, Executive Director, IBPL, said, “This business deal brings together two companies having respective expertise in niche areas of operations. IBPL and Apotex have complementary strengths, which will help in launching the first GCSF generic in North America.

 

IBPL along with its partner is eyeing a significant share of total G-CSF market in North America and Europe, which is currently estimated to be around $1.4 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, a prepared company release said.

 

For Intas, North America and Europe are ideal markets to serve the goal of developing innovative research technologies/new molecules related to biopharmaceuticals; evaluate technology platforms; identify partnership opportunities, in-licensable Intellectual Properties, and to build up Novel Drug Delivery System. Intas and Apotex are keen to explore prospective business opportunities for more biosimilar products in the coming years.

 

 Dr. Jeremy B Desai, Executive Vice President, Research & Development, Apotex says, “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”.

 

According to Dr. Helmut Brunar, VP Research and Business Development, Kwizda Pharma, “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.”