Alembic seals epilepsy drug delivery deal
heavyweight UCB to apply the company's novel drug delivery system
for a once-a-day version of UCB's market leading epilepsy drug.
The extended release version of UCB's Keppra (levetiracetam) is currently in Phase III trials with results expected by the end of this year, and promises to offer a full 24 hours of protection to epileptics when it hits the market towards late 2008/early 2009. The current Keppra product is the leading epilepsy drug in both the EU and US markets, but patients must take the drug two to three times a day to keep seizures at bay. While the standard formulation comes in strengths of 250mg, 500mg and 750mg, the new extended release version the companies have been developing - Keppra XR - will be available in 500mg, 1,000mg and 1,500mg formulations. The 24 hour version is likely to prove an attractive option for some epilepsy sufferers who find that they are most susceptible to seizures upon waking in the mornings - i.e. when the effect of the previous dose taken the night before has completely worn off. The new product, that would deliver therapeutic levels of the drug for a full 24 hours, would combat this problem. Alembic has been working on the novel drug delivery platform for some time, but was unable to disclose any further details regarding the technology due to confidentiality agreements. However, this first licensing deal for the technology is a good sign, showing UCB's evident confidence in the platform and its potential for other applications. "[So far] the drug delivery technology has been tried and tested on the levetiracetam [extended release] formulation only," Pranav Amin, director at Alembic told in-PharmaTechnologist.com, but the platform could presumably also be applied to the delivery of other drugs as well. UCB has high hopes for its new extended release product, but is realistic in terms of how it could initially be received once it is out on the market: "The epilepsy market is very difficult and there can be a lot of resistance to change," explained Jean-Christophe Donck of UCB. This could largely be put down to the fact that as up to one third of epilepsy patients have to put up with 'unsatisfactory' treatments, once they find a reasonable product they're unlikely to swap. As such, Donck said that company doesn't see itself employing a 'switch strategy' by which it will try and convert current Keppra users to the new extended release version, but envisions the successful Keppra name helping fuel uptake of Keppra XR. As for Alembic, this is by now means the only iron it has in the fire, with a novel drug delivery system development programme in place and currently working on half a dozen molecules, according to Amin. The system for levetiracetam was one of the most developed projects and as such is the first to be licensed out. With milestone payments of $11m (€8.2m) and low to mid single-digit royalties on worldwide sales of the new Keppra product to be paid to Alembic through the licensing agreement, the deal may seem a drop in the ocean to heavyweight UCB (whose 2006 revenue hit €2.5bn) but is much more significant for the Indian firm. Alembic achieved revenues of around €132m in 2006, eight per cent up on the previous year but still much smaller numbers than UCB is used to dealing with. Sales of Keppra alone (UCB's main growth product) generated €761m in revenue for the company during 2006. However, despite the apparent size mismatch between the two parties, Donck pointed out that UCB needed access to expertise and know-how to push ahead with the Keppra XR development plans, and Alembic is the company that appears to have delivered.
