uniQure N.V. (NASDAQ:QURE) Files An 8-K Termination of a Material Definitive Agreement
Item 1.02. Termination of Material Definitive Agreement.
On April19, 2017, uniQure N.V. (the Company), through its
subsidiary uniQure biopharma B.V., and Chiesi Farmaceutici S.p.A.
(Chiesi) entered into an agreement to terminate in its entirety
the Commercialization Agreement dated April29, 2013 (and as
amended on December15, 2014) with respect to the
commercialization and manufacture of Glybera (the Termination
Agreement). In connection with the Termination Agreement, the
Company will use its best efforts to withdraw marketing
authorization in the European Union for Glybera by October25,
2017. Certain provisions of the Commercialization Agreement will
terminate with immediate effect; the Commercialization Agreement
will terminate in its entirety effective October 25, 2017.
to the Termination Agreement, the Company will make certain
payments to Chiesi, and will be solely responsible for, and bear
all costs associated with, terminating the ongoing patient
registry, Phase IV post-approval study and related winding-down
costs. The Company will continue to make agreed quantities of
Glybera available to Chiesi to treat any patients approved for
treatment prior to October25, 2017. The financial obligations
under the Termination Agreement, in the aggregate, are not
material to the Company.
Item 8.01. Other Events
On April20, 2017, the Company issued a press release, a copy of
which is attached as Exhibit99.1 and is incorporated herein by
reference, announcing that it will not be pursuing renewal of
marketing authorization for Glybera in Europe.
Item 9.01 Financial Statements and
Exhibits
(d) Exhibits
|
99.1 |
Press release dated April20, 2017, announcing that uniQure |
About uniQure N.V. (NASDAQ:QURE)
uniQure N.V. (uniQure) is a gene therapy company. The Company is engaged in developing single treatments with curative results for patients suffering from genetic and other severe diseases. The Company is advancing a focused pipeline of gene therapies that have been developed both internally and through partnerships. The Company’s product candidates include AMT-060 for Hemophilia B, AMT-130 for Huntington’s disease, S100A1 for congestive heart failure and Glybera for lipoprotein lipase deficiency (LPLD). uniQure has established clinical proof-of-concept in its lead indication, hemophilia B and has achieved pre-clinical, proof-of-concept in Huntington’s disease. The Company, through its collaboration with Bristol Myers-Squibb (BMS), is focused on building a portfolio of gene therapies led by the S100A1 program for congestive heart failure. uniQure N.V. (NASDAQ:QURE) Recent Trading Information
uniQure N.V. (NASDAQ:QURE) closed its last trading session down -0.14 at 5.42 with 40,267 shares trading hands.