G-BA's Glybera assessment in line with uniQure's expectations

Germany's Federal Joint Committee (G-BA) issued a final benefit assessment stating that the additional benefit was not quantifiable from gene therapy Glybera alipogene tiparvovec from uniQure N.V. (NASDAQ:QURE) to treat lipoprotein lipase ( LPL) deficiency. uniQure chief commercial officer Hans Rohde told BioCentury the decision was in line with the benefit assessment that uniQure had requested and will allow the company to proceed with pricing negotiations in Germany, which are expected to last three to six months. G-BA had postponed its assessment of Glybera earlier this month (see BioCentury Extra, May 7).

"This is what had been requested based on the number of patients we had and the lack of statistically significant data we could provide," he said, adding that uniQure believes the decision will not negatively affect pricing negotiations. ...