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uniQure signs EU commercialization agreement with Chiesi Farmaceutici

By 9 July 2013January 6th, 2023No Comments
Press Release.

 

uniQure signs EU commercialization agreement with Chiesi Farmaceutici for first approved gene therapy treatment, and raises EUR 45 million (USD 59 million)

  • Partnership with Chiesi Farmaceutici for commercialization of Glybera and co-development of hemophilia B gene therapies in  Europe and certain other territories
  • Investment by Coller Capital and other investors

Amsterdam, the Netherlands, July XX, 2013 — uniQure B.V., the leader in human gene therapy, today announced it has successfully raised a total of EUR 45 million, with EUR 31 million from Chiesi Farmaceutici SpA (Parma, Italy), and EUR 14.1 million in an investment led by Coller Capital (London, UK) with participation by existing investors.

uniQure’s agreement with Chiesi Farmaceutici (Chiesi), an international company headquartered in Parma, Italy, gives Chiesi 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) for which there is currently no treatment, as well as for uniQure’s pipeline product for hemophilia B in Europe and selected other countries. Commercial rights for the US, Japan, and parts of Latin America and Asia, and Australasia remain with uniQure. In exchange, uniQure stands to receive high double-digit royalties on sales of both products. Furthermore, Chiesi will fund half of the remaining development costs for uniQure’s hemophilia B program, as well as take an equity stake in uniQure.

Separately, uniQure recently announced a raise of EUR 13.5 million in convertible debt led by Coller Capital, a leading global private equity investor; existing investors Forbion Capital Partners, Gilde Healthcare Partners, Lupus Alpha and Grupo Netco also participated. An additional EUR 0.6 million in equity funding was contributed by staff and other private investors.

“The agreement with Chiesi is a key component of our strategy to rapidly develop and commercialize multiple gene-therapy based treatments as well as being a tremendous validation of our technology platform,”

said Jörn Aldag, CEO of uniQure.

“With its focus on innovative therapeutics, Chiesi is the ideal partner for the commercialization of Glybera in Europe. The additional investment from Coller Capital, supplemented by our existing investors, allows us to continue apace with the development of the richest and most-advanced gene therapy pipeline in the industry. In the next 12-18 months, we anticipate clarifying the path toward an FDA filing for Glybera in the US, reporting results from a Phase I/II study in acute intermittent porphyria, and starting at least two Phase I/II studies for additional pipeline programs.”

About uniQure
uniQure is delivering on the promise of gene therapy, single treatments with potential curative results. We have developed a modular platform to rapidly bring new disease modifying therapies to patients with severe disorders. Our approach is validated by multiple partnerships and the regulatory approval of our lead product Glybera.www.uniqure.com.

About Chiesi Farmaceutici
Founded in 1935 in Parma, Italy, Chiesi Farmaceutici currently has 25 affiliates worldwide and markets its therapeutics in over 60 countries. Chiesi’s manufacturing plants in Parma, Blois (France) and Santana de Parnaiba (Brazil), and R&D centers in Parma, Paris, Rockville (USA) and Chippenham (UK) integrate their efforts to advance the Group’s pre-clinical, clinical and registration programs. At the end of 2012, the Chiesi Group’s total staff stood at over 3,800 people, more than 350 of whom are dedicated to R&D. The main areas of activity are in respiratory therapeutics and specialist medicine areas.

Contacts
Jörn Aldag                           Hans Herklots
CEO                                     Managing Director
uniQure                               Capricorn One
Tel : +31 20 566 8014        Tel: +41 79 598 7149
j.aldag@uniQure.com        capricorn1@bluewin.ch