News | February 2, 2009

Apotex And Intas Biopharmaceuticals Extend Their Collaborative Development Of Biosimilars To Include Pegfilgrastim

Apotex Inc. of Canada and Intas Biopharmaceuticals Limited (IBPL) of India have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy). Neupeg™, a recombinant pegylated granulocyte colony stimulating factor is already manufactured and marketed in India and other countries by IBPL. Both companies, IBPL and Apotex are eying a significant share of total Peg GCSF market in North America, which is currently estimated to be around $3.5B annually. This collaboration gives Apotex the rights to market the product in North America (US and Canada), Europe and selected other countries. After announcing launch of first GSCF generic for North America in May 2008, the extension of collaboration between the two companies makes IBPL the first Indian biopharmaceutical company to announce the launch of Peg GCSF for North America and European markets.

Apotex, one of the largest generic pharmaceutical companies in the world, has a strong registration, marketing & distribution team while IBPL, being a quality driven organization, offers a unique competitive advantage in terms of R&D and manufacturing of biopharmaceuticals. The deal offers immense growth opportunities for both, Apotex and IBPL, as they look to consolidate their presence in the global biosimilars market. With changing political and diplomatic scenario in US, both the companies expect speedy implementation of legislation related to biosimilars, which is much awaited development from industry fraternity across the globe.

Dr. Jeremy B. Desai, Apotex Executive Vice President, Research & Development said, “This agreement represents an important milestone for Apotex, as it continues to build the organization’s biosimilars pipeline.”

Speaking on the development, Mr. Mani Iyer, Executive Director, Intas Biopharmaceuticals Limited, said, “This agreement is a step forward to the vision that we all work for - to become a global biopharmaceutical company. This will provide accessibility of Neupeg™ to people outside of the subcontinent, who are currently relying heavily on innovator’s brand and other substitutes.”

As far as Pegylated Filgrastim is concerned, IBPL is the only biopharmaceutical company to manufacture it in India and market the same under the brand name Neupeg™. In India, the brand is a blockbuster drug and IBPL is looking to replicate the success of the brand in North America and Europe.

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 80 million prescriptions a year - the largest amount of any pharmaceutical company in this country. In the next 10 years, Apotex will spend $2B in R&D and has presently over 600 products under development.

About Intas Biopharmaceuticals Limited
Intas Biopharmaceuticals Limited 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 and South African Medicines Control Council certification for GMP. Today, Intas Biopharmaceuticals Limited is the sole manufacturer to commercialize pegylated GCSF and markets under the brand name “NEUPEG™”. IBPL has launched four biosimilar products Neukine® (rHu G-CSF), Erykine™ / Epofit™ (rHu EPO), Intalfa™ (rHu IFN Alfa-2b) and Neupeg™ (rHu Peg GCSF) and marketing in India and international markets. The company is working on seven more biosimilar products, which will be launched in next 3 years in various markets.

SOURCE: Apotex Inc.& Intas Biopharmaceuticals Limited