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Alembic, UCB sign agreement

Staff Correspondent

Alembic to get milestone payments

MUMBAI: Alembic has entered into a licensing agreement with the Brussels-based UCB for its novel drug delivery platform for Keppra XR (Levetiracetam Extended Release tablets).

Under the terms of the agreement, Alembic will receive milestone payments of $11 million and royalty on future worldwide net sales of Keppra XR, subject to necessary legal and regulatory approvals. Phase III clinical trials on Keppra XR, the once daily formulation of Keppra, are in progress and results are expected in the fourth quarter of 2007. Keppra is UCB's leading anti-epileptic drug.

The development of Levetiracetam XR is a milestone for the Alembic's novel drug delivery system (NDDS) programme. According to the company, a few other systems are in advanced stages of development and are protected by suitable patents and will be shortly available for commercialisation. The company's current year's ANDA filings are three and it expected filings at the rate of 12-15 annually in the next three years.

Addressing a press conference here on Wednesday, Chirayu Amin, Chairman and Managing Director, Alembic, said, "we have not yet discussed the launch of Keppra in India as yet with UCB. It depends on the market potential.''

The company's manufacturing facilities are located in Vadodara and Panelav in Gujarat and Baddi in Himachal Pradesh. The Vadodara unit has the largest fermentation capacity in India. In terms of manufacturing capacity, Alembic at present makes one billion capsules annually and this will go up to 1.8 billion in the next few months and reach five billion in the next few years.

"In our international business, we would like to have 10-12 drug master files (DFs) and 20 ANDAs annually. One of our key focus areas is contract development and manufacturing for big pharma players,'' Mr. Amin said.

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