Belgian biopharma company UCB has predicted that patent expiry will strongly affect its European growth in 2012.

While UCB’s blockbuster epilepsy drug Keppra faced little generic competition in Europe following its patent expiry in 2011, the company predicts a 50% sales fall for the product in 2012.

However, the company’s CEO said its focus on severe diseases of the immune system and CNS has helped to insulate it against economic austerity.

UCB saw its revenues rise by 1% to €3.25bn in 2011, but predicts a fall of nearly 5% to €3.1bn in 2012.

According to a UCB spokesman, Keppra faces competition from more than 100 generic substitutes in 2012, and its European sales can be expected to fall by 50%.

Delays in the launch of generic alternatives protected Keppra in 2011, when its global sales increased by 3% despite its patent expiry.

UCB’s CEO, Roch Doliveux, said that its commitment to therapy areas such as epilepsy and immunology had shielded the company from the impact of European austerity: “We still have the means in Europe for many years to come to pay for severe healthcare issues, and that’s what we’re addressing.”

Last year, UCB benefited from increased sales of three products: Vimpat for epilepsy, Neupro for Parkinson’s disease and restless legs syndrome, and Cimzia for Crohn’s disease and rheumatoid arthritis (RA).

Doliveux also argued that value-based pricing – due to be adopted by the NHS in 2014 – is not a good model to support innovation. He argued that the current PPRS system is “a very robust system that a lot of countries have tried to copy, and PPRS works well.”

Among non-UK companies, UCB is the leading non-British investor in UK pharmaceutical R&D.

The CHMP has recommended that Vimpat syrup should no longer be marketed after a quality defect in certain batches lead to the uneven distribution of the active substance lacosamide.

The decision follows a review of the 15mg/ml medicine which concluded the benefit no longer outweighs the risk and that patients may receive either too much or too little of the substance.

The EMA says doctors should contact patients currently using the syrup as soon as possible and switch their prescription to Vimpat film-coated tablets where possible.

For patients unable to take the tablets, the EMA says it may be possible to obtain the US-approved Vimpat liquid formation – which does not have a quality defect. The liquid formation is currently under review by the CHMP after a marketing authorisation application was submitted in August 2011.

The review began in July this year after the EMA was informed by the marketing authorisation holder that a ‘flake-like’ precipitate had been observed in bottles of the medication.

Further analysis then showed that lacosamide was not evenly distributed and may lead to patients receiving varying doses of the substance. Although no cases of adverse reactions were noted, the CHMP agreed to a proposal from the application holder to recall the product from the supply chain as a precautionary measure.

Vimpat has been authorised in the European Union since 2008 and is used to treat epileptic seizures as an add-on treatment to other antiepileptic medicines in patients aged 16 years and older.