8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  April 19, 2017

uniQure N.V.

(Exact Name of Registrant as Specified in Charter)

The Netherlands	001-36294	N/A
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

Paasheuvelweg 25a, 1105 BP Amsterdam, The Netherlands	N/A
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: +31-20-566-7394

Meibergdreef 61, 1105BA Amsterdam, The Netherlands

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o         Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o         Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o         Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o         Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

Item 1.02. Termination of Material Definitive Agreement.

On April 19, 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 April 29, 2013 (and as amended on December 15, 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 October 25, 2017. Certain provisions of the Commercialization Agreement will terminate with immediate effect; the Commercialization Agreement will terminate in its entirety effective October 25, 2017.

Pursuant 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 October 25, 2017. The financial obligations under the Termination Agreement, in the aggregate, are not material to the Company.

Item 8.01. Other Events

On April 20, 2017, the Company issued a press release, a copy of which is attached as Exhibit 99.1 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 April 20, 2017, announcing that uniQure N.V. will not be pursuing renewal of marketing authorization for Glybera in Europe.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	UNIQURE N.V.
Date: April 20, 2017
	By:	/s/ MATTHEW KAPUSTA
		Name:	Matthew Kapusta
		Title:	Chief Executive Officer and
		Interim Chief Financial Officer

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EXHIBIT INDEX

Exhibit No.	Desciption
99.1	Press release dated April 20, 2017, announcing that uniQure N.V. will not be pursuing renewal of marketing authorization for Glybera in Europe.

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EX-99.1

Exhibit 99.1

uniQure Announces It Will Not Seek Marketing Authorization Renewal

for Glybera in Europe

— Marketing Authorization for Glybera® to Expire on October 25, 2017—

— Company Maintains Focus on Core Programs in Hemophilia B, Huntington’s Disease

and Congestive Heart Failure —

Lexington, MA and Amsterdam, the Netherlands, April 20, 2017 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it will not pursue the renewal of the Glybera® (alipogene tiparvovec) marketing authorization in Europe when it is scheduled to expire on October 25, 2017.

“The decision to not pursue marketing authorization renewal of Glybera in Europe involved a thoughtful and careful evaluation of patient needs and the clinical use of the therapy, and is not related to any risk-benefit concern,” stated Matthew Kapusta, chief executive officer of uniQure.  “Glybera’s usage has been extremely limited and we do not envision patient demand increasing materially in the years ahead.”

Mr. Kapusta added, “In line with our previously announced strategy, we will focus our resources on advancing our hemophilia B program into a pivotal trial, moving our Huntington’s disease program into a clinical proof-of-concept trial, and progressing our research and development collaboration with Bristol-Myers Squibb.”

In October 2012, the European Commission granted a five-year marketing authorization for Glybera under exceptional circumstances as a treatment for a small subset of patients with familial lipoprotein lipase deficiency (LPLD), an ultra-rare genetic disorder. As part of Glybera’s approval, uniQure was required to establish a global registry for the long-term surveillance of patients, conduct a post-approval clinical study, submit for annual regulatory reassessments and implement additional risk management procedures.  All of these activities required a significant infrastructure for uniQure that included the Company bearing the full costs of maintaining commercial manufacturing capabilities, managing development and validation of numerous assays and supporting regulatory interactions and inspections.

uniQure has initiated discussions with the European Medicines Agency (EMA) to discuss steps to wind down these various activities and review plans for ongoing patient monitoring.

Under the terms of the agreement between uniQure and Chiesi Group, which has exclusive rights for the commercialization of Glybera in Europe and other selected countries, uniQure will continue to make product available to Chiesi to treat any patients that are approved for treatment prior to October 25, 2017, and will also be responsible for terminating the Phase IV post-approval study.

As a result of the withdrawal of Glybera, uniQure expects to reduce future expenses related to the product by approximately $2 million annually, beginning in 2018 and net of any payments to Chiesi.  These cost savings will be in addition to those previously announced by the Company related to the consolidation of manufacturing into the Company’s Lexington facility.  uniQure continues to expect its existing cash resources will be sufficient to fund operations into 2019.

About Glybera:

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 hemophilia B.

About uniQure

uniQure is delivering on the promise of gene therapy — single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with hemophilia, Huntington’s disease and cardiovascular diseases. www.uniQure.com

uniQure Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the winding down of our Glybera program, the development of our other gene therapy product candidates, the success of our collaborations and the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with corporate reorganizations and strategic shifts, collaboration arrangements, our and our collaborators’ clinical development activities, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading “Risk Factors” in uniQure’s 2016 Annual Report on Form 10-K filed on March 15, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

uniQure Contacts:
Maria E. Cantor	Tom Malone
Direct: 339-970-7536	Direct: 339-970-7558
Mobile: 617-680-9452	Mobile: 339-223-8541
m.cantor@uniQure.com	t.malone@uniQure.com
Eva M. Mulder
Direct: +31 20 240 6103
Mobile: +31 6 52 33 15 79
e.mulder@uniQure.com