Zenotech announces global entry into Biosimilars with Ranbaxy Targets EU markets first

Zenotech Laboratories Ltd on February 07, 2007 has announced the signing of a global clinical development & marketing agreement with Ranbaxy Laboratories Ltd for its first biosimilar product, G-CSF (filgrastim). The agreement involves unfront licensing fees and profit sharing after launch.

G-CSF is used to prevent infections from cancer chemotherapy-induced neutropenia (decrease in the number of a type of white-blood cells). The worldwide market for neutropenia treatment is in excess of $ 4 Billion, while the global G-CSF market is about $ 1.6 billion.

Ranbaxy has taken a strategic decision to commit resources to introduce the G-CSF product for global marketing beginning with markets in the EU where regulations for biosimilars are in place.

Dr. Jayaram Chigurupati, CEO, of the Company said, "My team and I, are proud to associate with Ranbaxy for development of G-CSF for the European Union and eventually for the US market, G-CSF will lead the way for the development of other biosimilar molecules within the Zenotech portfolio. These products will be manufactured in Zenotech's US FDA / EU approvable biologics facility in Hyderabad".

Biosimilars are generic versions of biotherapeutics using recombinant DNA technology. So far, no Indian biosimilar product has been launched in the EU due to the substantial investments involved in clinical trials and the regulatory expertise required. Both these aspects pose significant barriers to entry.

The Company is a specialty generic injectables Company with strong expertise in the area of bio-technology. The Company’s predominantly high value injectables product portfolios serve niche therapy ares like oncology, anesthesiology, gynecology, and neurology. The Company has research and development facilities in India and in the U.S. Its oncology and biologics manufacturing facilities are located near Hyderabad, India.

Source : Equity Bulls

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