Belgian biopharmaceutical company UCB has said its allergy treatment Xyzal (levocetirizine) failed to meet its objectives in a Phase III trial looking at its role in the prevention of asthma.
Xyzal, a follow-up to UCB’s big selling Zyrtec (cetirizine) product, was launched to help offset the threat of generic competition to its forerunner. But with competition in the anti-allergy sector fierce, UCB had been hoping that the asthma prevention data, in very young children with a family history of the disease, would lift Xyzal above the pack.
Xyzal is already on the market in Europe, but is not due to be launched in the USA until 2007. The USA is by fat the most important market for Zyrtec - sales there were $1.04 billion in the first nine months of the year, a 10% increase year-on-year, while the overall antihistamine market decreased by 5%. But Zyrtec is due to lose its US patent protection in December 2007, and UCB needs Xyzal to support the franchise.
The announcement was made as part of a financial update from UCB in which it reiterated its target of 260 million euros in net income for 2005. Sales in 2005 have been better than expected, it said, and will continue to expand in 2006 on the back of strong gains from Keppra (levetiracetam) for epilepsy.
Keppra’s growth will be bolstered by the expected approval of an intravenous formulation in the USA and Europe early next year, as well as an extension of its indications to include primary generalised myoclonic seizures.
Meanwhile, Cimzia (certolizumab pegol), an anti-tumor necrosis factor (TNF) alpha antibody acquired along with UK biotech Celltech, will be filed for approval for Crohn’s disease in the first quarter of 2006. Phase III data in rheumatoid arthritis is expected by the end of that year.
The Belgian company is hoping to position Cimzia as an alternative to Johnson & Johnson's Remicade (infliximab), which remains the only anti-TNF approved to treat Crohn's. While Cimzia can be given by subcutaneous injection, Remicade requires an intravenous infusion.
UCB also said its R&D budget would come in at about 25% of sales in 2006, ahead of the industry average and more than the 480 million euros it had earmarked for 2005.