BOSTON, Aug. 5, 2014 /PRNewswire/ -- Intarcia Therapeutics, Inc. today officially announced the appointment of Sunita Zalani, Ph.D., as Vice President and Global Head of Regulatory Affairs and Quality. In her new capacity, Dr. Zalani serves on the Leadership Team and reports directly to Chairman, President & CEO Kurt Graves. The key new hire comes at a time when Intarcia is building out the company and 'rounding the corner' toward its first Phase 3 milestone later this year, with several others to follow in 2015. The role requires a proven leader with the ability to multi-task, to be results-oriented, to know how to avoid unnecessary risks, and the demonstrated ability to build highly productive and trust-based relationships with health authorities, partners, suppliers and other key stakeholders.
"We led a very competitive search for the person who would best meet the steep demands of our global regulatory and quality functions, and I'm delighted Intarcia prevailed as Sunita's choice out of several other simultaneous options she had," said Mr. Graves. "Sunita was our first choice almost immediately because of her proven leadership and operational experience in both large, and more recently, smaller biotech companies. She is a quick study, strategic, and impressively effective in a lean company environment. She gets difficult things done, and she gets them done extremely effectively and reliably. Her track record shows her to be a team leader with a 'gut grasp' of how to succeed in the biotech industry. Sunita also fits with our culture, our values, and the roll-up-your-sleeves energy required to be successful at Intarcia. This compatibility with our 'DNA' is vitally important. I'm confident that she will play a critical role in these exciting times as we move to strengthen the organization and build great relationships with health authorities and key partners in our mission to bring transformative new therapies to market for patients with type 2 diabetes, obesity and other serious diseases."
Just prior to joining Intarcia, Dr. Zalani worked at Onyx Pharmaceuticals as Vice President of Global Regulatory Affairs. Onyx, based in South San Francisco, is a subsidiary of Amgen. Dr. Zalani worked at Amgen's Thousand Oaks facilities in positions of increasing responsibility and importance since 2004. Prior to this, she worked at Eli Lilly and Company in Indianapolis, Indiana, exiting as their Global Regulatory Lead, Regulatory Affairs. During her career to date, Dr. Zalani's work has focused on therapeutic areas including: Endocrinology, Oncology, Nephrology, Cardiovascular, Inflammation, and Osteoporosis. She won numerous awards and distinctions while at Eli Lilly, she is well published, and has presented at industry and academic meetings. Dr. Zalani holds her Ph.D. in Biochemistry from the M.S. University of India, and was a Post-Doctoral Fellow and Research Fellow at the Lineberger Comprehensive Cancer Center at the University of North Carolina.
Mr. Graves added: "In her new role at Intarcia, Sunita will add great breadth and depth of expertise to a mission-critical area as she applies her skills and focused enthusiasm to get going on the numerous and diverse priorities ahead. This begins with the Company's first NDA filing, which is targeted for the end of 2015, and also extends to fully developing our European registration strategies, expediting our 12-month devices, and initiating additional planned studies to optimize our labeling and competitive differentiation. Through strong support and guidance in all of these areas, we believe Sunita can tangibly help make a bigger difference for the most people possible – a core aspiration of the people of Intarcia – which further facilitates our Company's ability to deliver value to all its stakeholders."
About ITCA 650
ITCA 650 (a once- or twice-yearly continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia's proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted sub-dermally to provide continuous and consistent drug therapy, and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time.
Data from Intarcia's ITCA 650 Phase 2 program have demonstrated significant and sustained reductions in HbA1c and body weight over 48 weeks of treatment with a marked reduction in the duration and severity of GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia's robust intellectual property portfolio protects ITCA 650 through 2031. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM, and some of the first available phase 3 results were reported at the JP Morgan conference in January of this year and viewed as very promising. Top-line results from the FREEDOM 1 and HBL phase 3 studies will be reported in September and/or October of this year. Further results will be reported later in 2014 and 2015.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. In addition, delivering medicines just once or twice yearly virtually ensures patient adherence and compliance, which is very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platform. Intarcia is conducting a Phase 3-stage development program for type 2 diabetes and has additional programs ongoing for weight regulation to control obesity. For more information on the Company, please visit www.intarcia.com.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
SOURCE Intarcia Therapeutics, Inc.