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Uniqure N.V.. (1/25/17). "Press Release: Uniqure Appoints Alexander Kuta as Senior Vice President of Regulatory Affairs". Lexington, MA & Amsterdam.

Organisations Organisation Uniqure N.V. (Nasdaq: QURE)
  Group Uniqure (Group)
  Organisation 2 EMD Serono Inc.
  Group Merck (DE) (Group)
Products Product gene therapy
  Product 2 regulatory services
Persons Person Kuta, Alexander (Uniqure 201701– SVP Regulatory Affairs before EMD Serono + Lantheus Medical Imaging + AMAG + Genzyme)
  Person 2 Kapusta, Matthew (Matt) (Uniqure 201612– CEO before interim CEO before CFO before AngioDynamics + Smith & Nephew)

uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced the appointment of Alexander Kuta, Ph.D., as Senior Vice President of Regulatory Affairs. Dr. Kuta has more than 25 years of regulatory experience within the industry, having previously held leadership positions at Genzyme Corporation, EMD Serono, AMAG Pharmaceuticals and Lantheus Medical Imaging. Dr. Kuta will be responsible for leading all global regulatory affairs for uniQure's gene therapies. He will report to Matt Kapusta, Chief Executive Officer of uniQure, and will be based in the Company's Lexington, Massachusetts facility.

"Alex has an accomplished track record of working closely with the FDA on behalf of both large and small companies to achieve regulatory results," said Mr. Kapusta. "Advancing our hemophilia B program into late-stage clinical development is a key priority at uniQure, along with progressing our pipeline programs in Huntington's and cardiovascular diseases. Alex's vast experience will be instrumental in helping to deliver our gene therapy candidates to patients."

"I am very pleased to be joining uniQure at this important and exciting time for the company," stated Dr. Kuta. "There are tremendous opportunities ahead, and I look forward to working with Matt and the leadership team to further develop our relationship with regulatory authorities and to deliver on our corporate objectives for 2017."

Dr. Kuta was most recently with EMD Serono as Vice President of Research & Development Global Regulatory Affairs and a member of the U.S. Leadership Team. In this role, he was responsible for driving the strategic direction of EMD Serono's regulatory efforts in immune-mediated diseases, oncology and regulatory CMC, as well as strengthening interactions with the U.S. Food and Drug Administration (FDA).

Prior to joining EMD Serono, Dr. Kuta was Vice President of Global Regulatory Affairs and a member of the Executive Leadership Team at Lantheus Medical Imaging. His previous experience includes senior roles at AMAG Pharmaceuticals and at Genzyme Corporation, where he served for 15 years in regulatory leadership positions of increasing responsibility. Prior to joining industry, he was Chief of the Cytokine and Gene Therapy Branch in the Center for Biologics at FDA. Dr. Kuta has also served as a member of the BIO Regulatory Affairs Leadership Committee, Cell and Gene Therapy Working Group and the ICH Gene Therapy Working Group.

Dr. Kuta holds a Bachelor of Science degree from Saint John's University and a Ph.D. from Chicago Medical School at Rosalind Franklin U-Med & Science. He conducted his post-doctoral studies at the National Cancer Institute/ National Institutes of Health.

In connection with Dr. Kuta's offer of employment, uniQure granted Dr. Kuta non-qualified stock options to purchase 150,000 ordinary shares. The award has been made pursuant to the NASDAQ inducement grant exception as a component of Dr. Kuta's employment compensation. The inducement grant is being made as an inducement material to Dr. Kuta's acceptance of employment with the Company in accordance with NASDAQ listing Rule 5635(c)(4).

The options have an exercise price of $5.31 per ordinary share, the closing price of uniQure's common stock on January 23, 2017. The options have a 10-year term and vest over four years, with 25% of the original number of ordinary shares vesting on the first anniversary of Dr. Kuta's start date and an additional 6.25% vesting at the end of each subsequent three-month period thereafter, subject to Dr. Kuta's continued service with the Company through the applicable vesting dates.

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 CNS, liver/metabolic and cardiovascular diseases.

uniQure Forward-Looking Statement

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 development of our gene therapy product candidates, including the future development of AMT-060, 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 our and our collaborators' clinical development activities, collaboration arrangements, corporate reorganizations and strategic shifts, 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 2015 Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2016. 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 Direct: 339-970-7536 Mobile: 617-680-9452
Tom Malone Direct: 339-970-7558 Mobile: 339-223-8541
Eva M. Mulder Direct: +31 20 240 6103 Mobile: +31 6 52 33 15 79

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: uniQure N.V. via Globenewswire

Record changed: 2023-06-05


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