uniQure Appoints Alexander Kuta as Senior Vice President of Regulatory Affairs
(Thomson Reuters ONE) -
LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Jan. 25, 2017 (GLOBE NEWSWIRE)
-- 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. www.uniQure.com
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
m.cantor(at)uniQure.com
Tom Malone
Direct: 339-970-7558
Mobile: 339-223-8541
t.malone(at)uniQure.com
Eva M. Mulder
Direct: +31 20 240 6103
Mobile: +31 6 52 33 15 79
e.mulder(at)uniQure.com
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
Datum: 25.01.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 519887
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