Germany’s Bayer is to take a charge of over 150 million euros and has suffered a major blow with the news that its best-selling drug Betaferon does not work any better at a higher dose.
Bayer has announced results from the BEYOND study of patients with relapsing-remitting multiple sclerosis which investigated the efficacy, tolerability and safety of a 500mcg dose of Betaferon (interferon beta-1b) compared to the standard 250mcg Betaferon dose and the rival drug Copaxone (glatiramer acetate), produced by Teva. However the trial did not show statistically significant superiority of the 500mcg dose and the risk for relapses, the primary end point, was similar in all three study arms, unlike in other studies.
The results are bad news for Bayer as it was hoping to market the higher dose at some stage but the data from BEYOND do not support a regulatory filing. As a result, the Leverkusen-based based firm will take an impairment charge of 152 million euros for the third quarter, full results from which will be announced next Tuesday. Its Bayer Schering Pharma division is expecting sales of Betaferon, acquired through the Schering AG purchase last year, to grow range of 7%-9% for this year and 2007 and 2008, which would push this year’s sales over the billion euro mark.
Bayer put a brave face on proceedings, saying that its “continued investment in lifecycle management programmes, including enhancing the Betaferon application system as well as ongoing long term follow-up programs will further enhance the product”. Nevertheless, at 10am this morning, the firm’s shares had already slipped nearly 1.3% to 57.55 euros.