Parma, 20 April 2017 - Chiesi Farmaceutici Spa (“Chiesi”) acknowledges that uniQure biopharma B.V (uniQure), have taken the decision to withdraw the ongoing application for the Marketing Authorization Renewal of Glybera, for which Chiesi holds commercialization rights for Europe and other selected countries. This request for withdrawal, which is taken unilaterally by uniQure, has not been triggered by grounds on quality, safety and\or efficacy of the product but it is associated with uniQure’s own economic considerations.
In this specific circumstance, Chiesi wishes to reinforce its commitment to continue fulfilling its obligations toward patients and is available to treat the eligible and consented ones within the timeframe of the existing Marketing Authorization, expiring on October 25, 2017, and up to the availability of the approved product in uniQure’s stock. Under the terms of the agreement between uniQure and Chiesi, uniQure will continue to make product available to Chiesi to treat any patients that are approved for treatment prior to October 25, 2017 at a nominal price.
Glybera is a one time, single-administration gene therapy, which introduces copies of natural LPL gene to produce functional LPL enzyme, providing a long-term therapeutic effect, currently documented up to six years from administration.
Chiesi Group has exclusive rights for the commercialization of Glybera in Europe and other selected countries, as well as for the co-development and commercialization of a gene therapy for haemophilia B.
About Chiesi Farmaceutici
Headquartered in Parma, Italy, Chiesi Farmaceutici is an international research-focused Healthcare group, with over 80 years of experience in the pharmaceutical industry, present in 26 countries. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare diseases areas. Its R&D organization is headquartered in Parma (Italy), and integrated with other 6 key R&D groups in France, USA, UK, Sweden and Denmark to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi employs nearly 5,000 people.