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Intarcia Provides 2019 Corporate Update

Intarcia Provides 2019 Corporate Update

Strong leadership appointments across the medical, regulatory, quality and marketing teams helping to drive momentum into 2019

ITCA 650 NDA resubmission on track for mid 2019

Boston, MA, December 18, 2018 – Intarcia Therapeutics Inc. today provided an update on the company’s progress in 2018 and trajectory for advancement in 2019. In 2018, the company appointed three new members to the leadership team, including the addition of Dr. Fred Fiedorek as Chief Medical Officer and Global Head of Regulatory Affairs, Anders Vinther as Global Head of Quality & Engagement and Thane Wettig as Chief Marketing Officer and Metabolic Franchise Head. Dr. Fiedorek leads all the clinical development and regulatory related functions, including medical affairs, clinical pharmacology, safety, health economics and outcomes (HEOR) and biostatistics for Intarcia. Vinther brings a diverse set of global quality and manufacturing expertise built from nearly 30 years in the industry and has played a critical role in leading our quality and manufacturing efforts at our Hayward, CA, facility. Wettig leads Intarcia’s marketing and metabolic franchise team, while simultaneously spearheading the implementation of the fully integrated launch plan for ITCA 650 and the development of Intarcia’s metabolic assets in the pipeline. “All three senior leaders come to Intarcia with very deep and relevant industry expertise that has already made a meaningful difference in our progress and further strengthened our senior leadership team moving forward in 2019”, said Kurt Graves, Chairman, President and CEO.

“It’s been great to join Intarcia at such an exciting time,” says Dr. Fiedorek. “The growth of the GLP-1 class coupled with the development plan for ITCA 650 and other products in Intarcia’s pipeline present rewarding opportunities.  I’m very inspired to be part of this team and their work to improve patient outcomes for patients living with T2D.”

"Having worked across many disease areas and disciplines of manufacturing, Intarcia has provided an exciting opportunity to apply my expertise and skillsets to their ground-breaking work in the treatment of T2D and other major chronic diseases," said Vinther. "I look forward to playing a continued and active role as our team prepares for both the resubmission of our filing for ITCA 650 and the successful scale up of our manufacturing efforts to deliver this innovative and important new approach to chronic therapy for patients."

“Throughout my career, I’ve been driven by a mission to improve the outcomes of people with diabetes,” commented Wettig on his appointment. “This is a transformative moment in time for the future of type 2 diabetes management, and I believe that Intarcia’s lead product and pipeline have the potential to help shape the future of treatment and real-world outcomes for diabetes. I’m excited to lead a team that is working relentlessly to reinvent the way chronic medicines are delivered to patients in need”.

In 2018, Intarcia has made significant progress towards the resubmission of its New Drug Application (NDA) for ITCA 650, the company’s lead investigational therapy for the treatment of type 2 diabetes (T2D), which it expects to file with the FDA in mid-2019.  After several consultations with the FDA during 2018, the company is preparing a resubmission of its NDA to address each of the deficiencies listed in the complete response letter received last fall.

For additional updates on ITCA 650, pipeline progress and company leadership, please visit the company's website.

About Intarcia Therapeutics, Inc.

Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment and prevention outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines just once- or twice yearly to prevent and/or chronically treat diseases holds potential to improve outcomes by improving effectiveness over time and by addressing real-world unmet needs around poor patient adherence and persistence rates that are high in the majority of chronic diseases. Intarcia is investigating multiple therapies, including combination therapies, for chronic diseases leveraging the convergence of novel medicines and the proprietary Medici Drug Delivery System™. Intarcia is developing a strong pipeline in important therapeutic areas, including: diabetes (ITCA 650), obesity, autoimmune diseases, HIV, and other serious disorders.

Intarcia Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that ITCA 650 may not receive regulatory approval and, if approved, whether ITCA 650 will be commercially successful. No forward-looking statement can be guaranteed. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by federal securities law, Intarcia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.    


Intarcia Therapeutics, Inc.

Investor Contact

James Ahlers
james.ahlers@intarcia.com


Intarcia Therapeutics, Inc.

Media Contact

Seth Goldenberg
seth.goldenberg@intarcia.com


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