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Hetero Drugs secures Roche sub-licence for Tamiflu — Arrangement offers scope for huge capacities

Our Bureau

Hetero has committed to delivering one million capsules of Oseltamivir to the Indian Government by January 15, 2006 and expects to fulfil orders for least developed and developing countries from January 2006.

Hyderabad , Dec. 23

SWISS pharmaceutical company Roche has granted the Hyderabad-based Hetero Drugs Ltd, a sub-license for the production and marketing of Oseltamivir (generic Tamiflu).

Under the licensing agreement, signed on December 21, Roche has authorised Hetero to manufacture and market both the active pharmaceutical ingredient (API) and finished product of Oseltamivir for supply in India, least developed countries and developing countries.

Hetero has committed to delivering one million capsules of Oseltamivir to the Indian Government by January 15, 2006 and expects to fulfil orders for least developed and developing countries from January 2006.

The Chairman of Hetero group, Dr B. Parthasaradhi Reddy, in a statement said, "Hetero commands Roche's commitment to increasing the availability of Tamiflu for Government pandemic stockpiling. Hetero is capable of fulfilling Roche's objectives of addressing the needs of least developed an developing countries in preparing for a pandemic by increasing supplies of Oseltamivir."

Oseltamivir is considered an effective drug for the treatment of avian influenza in humans. Avian influenza has become a potential global health threat. The sub-licensing agreement between Roche and Hetero aims to increase available supplies of Tamiflu for pandemic use by Governments. This arrangement is first of its kind by a multinational firm with an Indian company, theHetero statement said.

Following the approval from the Indian Government to manufacture and market a generic version of Oseltamivir, Hetero began investing in the manufacture of Oseltamivir two and a half years ago. It is currently the only company that is in the advanced stage of production process for a generic version. This arrangement offers scope for huge capacities that can fulfil requirement of Indian market.

According to Hetero statement, Roche and Gilead Sciences filed patents for Oseltamivir in India of which some have been granted and the remaining process and product patents are currently under evaluation by the patent office in India.

It is said that this is the first instance in which a sub-licence has been granted since the introduction of India's new patent legislation agreed in 2005. This complies with international patent laws.

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