Chiesi and uniQure Provide Update on Glybera(r) Launch
GlobeNewswire
uniQure 5 hours ago
AMSTERDAM, the Netherlands, and PARMA, Italy, Aug. 4, 2014 (GLOBE NEWSWIRE) -- uniQure N.V. (QURE), a leader in human gene therapy, and Chiesi Farmaceutici S.p.A. ("Chiesi"), a leading international pharmaceutical company, today provided an update on preparations relating to the launch of Glybera(R) (alipogen tiparvovec), the first gene therapy product approved in the European Union, for the treatment of the orphan disease lipoprotein lipase deficiency (LPLD). Chiesi has exclusive rights to commercialize Glybera in the EU and selected additional territories. 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, 2014. As a consequence, Chiesi now expects to launch Glybera in the fourth quarter of 2014/first quarter of 2015.
"We are fully supportive of Chiesi's approach to include additional data demonstrating multiyear benefit for a one time treatment in our pricing and reimbursement documentation. Adding long-term data will significantly strengthen the quality of the application," said Jorn Aldag, CEO of uniQure.
Chiesi CEO Ugo Di Francesco added: "Whilst pricing and reimbursement discussions are on-going, Chiesi has commenced the setup of a number of expert treatment centres which will be able to offer Glybera for the appropriate patients and manage them post treatment."
Developed by uniQure, Glybera was approved by the European Commission in October 2012 under exceptional circumstances for the treatment of a subset of patients with LPLD, a potentially life-threatening, orphan metabolic disease. Glybera currently is not approved for use outside of the European Union.
Glybera is indicated for the treatment of adult patients diagnosed with familial LPLD confirmed by genetic testing and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. LPLD results in hyper-chylomicronemia, or dramatic and potentially life-threatening increases in the level of large fat-carrying particles, called chylomicrons, in the blood after eating. In many cases, LPLD and the associated elevated levels of chylomicrons can cause acute and potentially life-threatening inflammation of the pancreas, known as pancreatitis, thus leading to frequent hospitalizations. Recurrent pancreatitis can lead to chronic abdominal pain, pancreatic insufficiency - which is an inability to properly digest food due to a lack of digestive enzymes made by the pancreas -, and diabetes. There is no other approved treatment for LPLD.