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Our Bureau

For epilepsy drug Keppra

Mumbai May 23 Alembic Ltd has entered into a licensing agreement with Belgian drugmaker UCB for its Novel Drug Delivery Platform for epilepsy drug Keppra XR (Levetiracetam extended release tablets).

As per the terms of the agreement, Alembic will provide the technology to reduce the dosage for the twice-a-day Keppra drug to make it a once-a-day tablet. The tablet will then be sold in dosages of 500 mg, 1000 mg and 1500 mg and will be called Keppra XR.

Milestone Payment

Alembic would receive milestone payments of $11 million and additionally get royalty payments on future worldwide net sales of the Keppra drug, subject to necessary legal and regulatory approvals.

Phase III clinical trials on Keppra XR (Levetiracetam Extended Release tablets) are ongoing and results are expected in the fourth quarter of 2007, said the company in a statement to the BSE.

Keppra is UCB's leading anti-epileptic drug, which realised sales of 761 million ($1 billion) in 2006, it added. "We will get the milestone payment from the deal starting immediately and over the next three years till 2009," said Mr R.K. Baheti, Director and President of Finance, at the sidelines of a press conference.

USFDA approval

According to Mr Pranav Amin, Head of Business Development at Alembic, the drug is likely to get approval from the US Food and Drug Administration by 2009.

UCB is a global biopharmaceutical company that is dedicated to the research, development and commercialisation of pharmaceutical and biotechnology products in the fields of central nervous system disorders. In 2006, it achieved a turnover of 2.5 billion. "Keppra is UCB's leading anti-epileptic drug. In 2006, the drug had realised sales of $1 billion globally," said Mr Chirayu R. Amin, Chairman and Managing Director. Shares of Alembic closed 12.53 per cent higher on the BSE at Rs 65.10.

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