Biosimilar G-CSF: cooperation on three continents

Moraiya, Ahmedabad, (PresseBox) - A biosimilar protein that can be used to treat neutropenia (a side effect of cancer chemotherapy) is to be developed by Apotex Inc. of Canada in collaboration with Intas Biopharmaceuticals Limited (IBPL). Neukine (R), a recombinant granulocyte colony stimulating factor (G-CSF) is already manufactured and marketed in India by IBPL. Kwizda Pharma of Austria had been working with IBPL to develop G-CSF for the European market for some time. Effectively 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 explains the mutual benefits of the agreement: "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, Apotex Executive Vice President, Research & Development adds "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".

Speaking on the development, Shri 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 1.4 billion dollars 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."

About Kwizda GmbH

Kwizda GmbH is a privately owned group of companies and has been operating since 1853 (pharmaceutical division). Kwizda Pharma is a leading Austrian manufacturer and wholesaler of proprietary, in-licensed and third-party pharmaceuticals, OTC drugs and hospital infusions. In 2007, the company recorded sales of approximately EUR 50 million.

About Apotex Inc.

Apotex Inc. is the largest Canadian-owned pharmaceutical company, employing over 6,800 people in research, development, manufacturing and distribution facilities world-wide. Apotex produces more than 300 generic molecules in a variety of different presentations which, in Canada, are used to fill over 75 million prescriptions a year - the largest amount of any pharmaceutical company in this country. In the next 10 years, Apotex will spend 2 Billion Dollars in R&D and has presently over 600 products under development.

Intas Biopharmaceuticals Ltd.

Since launch of biotechnology operations in May 2000, Research & Development, Manufacturing and Marketing of biopharmaceutical products, with a special focus on Oncology (Cancer), are major thrust areas for IBPL. The company is India's first and only biopharmaceuticals manufacturing company to receive European Union - Good Manufacturing Practice (EU-GMP) certification. Today, Intas Biopharmaceuticals Limited is the sole manufacturer of Pegylated GCSF in India and markets under the brand name "NEUPEG".

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