The Hyderabad-based Zenotech Labs, a biotech-based specialty injectables company, will commence clinical trials for a new biological entity, a monoclonal antibody in oncology sector soon. The company would be the first to develop such an entity in the country.
Almost 85 per cent of the receptor, developed in the in-house facility of the company at Hyderabad, currently has a therapeutic nature for head and neck cancer. The treatment area of the receptor would be specific only after a few more stages of development. The company is planning to hold the phase I and II trials in India while the phase III trials would be conducted worldwide, according to Dr Jayaram Chigrupati, chief executive officer, Zenotech Laboratories Ltd.
Addressing a press conference, Chigrupati added that the company has plans to have a total of 40 ANDAs for specialty injectables. Among these, 14 ANDAs will be developed under the agreement signed with Ranbaxy for G-CSF (filgrastim) development and marketing, signed early this month. Normally, each ANDAs would require an investment of around Rs 3 crore apart from the basic facility and infrastructure for development.
The company is also looking into co-development and marketing opportunities for bio similar apart from its pact with Ranbaxy. The company is also in talks with some big pharma companies for developing and marketing Erythropoietin, though the details are under wrap. There are also plans to enter into gynaecology segment with products developed in its in-house facility, by 2008, Jayaram said.
Company's recent agreement with the pharma major Ranbaxy is to develop and market G-CSF worldwide, targeting European Union and then US market. The agreement will be exclusive in EU, where Ranbaxy will lead the product and semi-exclusive elsewhere with marketing rights for both the companies. The pact also involves upfront licensing fees and profit sharing after launch.
The company is awaiting DCGI approval for clinical trials on generic rituximab in India, while four other generic monoclonal antibodies and three generic biologicals are under development. Currently, the company has 10 injectables in oncology and 5 in anaesthesiology in its product portfolio.
Zenotech have its direct marketing presence in Brazil, Russia, India, Mexico and South Africa (BRIMS) and complementary countries and enjoys its marketing and sales operations in India, Vietnam, Nigeria, Kenya and Philippines.
Established in 2003, Zenotech has two R&D facilities, one in Hyderabad, India and the other in Princeton, NJ, USA. The company also has two US FDA approvable manufacturing facilities, one for biologics and regular injectables and the other for oncology products.