Chiesi and uniQure delay Glybera launch to add data

Netherlands-based venture capital backed human gene therapy firm uniQure and privately-held Italian drugmaker Chiesi Farmaceutici have provided an update on preparations relating to the launch of Glybera (alipogene tiparvovec).

Expanding on the original launch strategy, Chiesi and uniQure decided to include in the pricing and reimbursement applications for launch, the six-year follow-up pancreatitis data from the study AMT 011-05, announced June 3. As a consequence, Chiesi now expects to launch Glybera in the fourth quarter of 2014/first quarter of 2015.

Chiesi has exclusive rights to commercialize Glybera, the first gene therapy product approved in the European Union, for the treatment of the orphan disease lipoprotein lipase deficiency (LPLD), in the EU and selected additional territories.