Human gene therapy company uniQure have announced the appointment of Alexander Kuta as Senior Vice President of Regulatory Affairs.
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.
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 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.”
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, 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.
Before joining industry, he was Chief of the Cytokine and Gene Therapy Branch in the Center for Biologics at FDA. 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.
Kuta holds a Bachelor of Science degree from Saint John's University and a PhD from Chicago Medical School at Rosalind Franklin U-Med and Science. He conducted his post-doctoral studies at the National Cancer Institute/ National Institutes of Health.
In connection with Kuta's offer of employment, uniQure granted 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 Kuta's employment compensation. The inducement grant is being made as an inducement material to 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 Kuta's start date and an additional 6.25% vesting at the end of each subsequent three-month period thereafter, subject to Kuta's continued service with the Company through the applicable vesting dates.