Chiesi Farmaceutici S.p.A (Parma, Italy) has filed a pricing dossier for Glybera alipogene tiparvovec with Germany's Federal Joint Committee (G-BA) that pegs the price of the gene therapy at over EUR 1 million. Chiesi has commercial rights to Glybera in Europe from uniQure N.V. (NASDAQ:QURE).
In the dossier, Chiesi seeks a retail price of EUR 53,000 ($65,625) per vial, or about EUR 1.1 million ($1.4 million) for a 62.5 kg patient who would require 21 vials.
Glybera is an adeno-associated virus (AAV) vector encoding the lipoprotein lipase (LPL) gene that was approved in Europe in 2012 to treat LPL deficiency in patients with recurring, acute pancreatitis, a rare disorder.
At the time of approval, uniQure said it planned to price the drug at EUR 250,000 ($322,625) per year of duration of clinical benefit, which was estimated at five years. The company also said it was considering a longer-term annuity pricing model, with an upfront payment followed by annual installments based on the duration of benefit.
However, under the subsequent 2013 deal, Chiesi is responsible for setting the price in Europe. Chiesi also has commercialization rights in Brazil, Mexico, Pakistan, Turkey, the Commonwealth of Independent States (CIS) and China. It did not reply to requests for comment in time for publication (see BioCentury, Sept. 2 , 2013).
uniQure shares jumped $2.32 (19%) to $14.82 on Friday.