Intarcia Completes First Close of a Major Equity Financing; Poised for ITCA 650 NDA Filing for Type 2 Diabetes, Commercial Readiness and Pipeline Progression
- First close secured subscriptions of $215 million, a second larger close is expected in 4Q; Company pleased with solid support from existing investors and ability to attract new long-term institutional investors and other permanent capital type investors from the U.S., Europe and Asia.
- Total proceeds from this financing, as well as more than $500M in major milestones expected over the next 2-3 years, position the company very well through the first full year of launch for ITCA 650, as well as the planned progression of several pipeline programs into the clinic.
- Following a positive and constructive pre-NDA meeting, the Company expects to submit the NDA for ITCA 650 to U.S. regulatory authorities within the next 30-60 days. Upon U.S. NDA submission, Intarcia will also receive the 3rd and final $100M milestone payment from the $300M royalty/equity convert financing it completed last year.
BOSTON, Sept. 15, 2016 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced the first closing of a major equity financing that puts the company in a strong strategic and financial position over the next 2-3 years as it prepares for the potential approval and launch of ITCA 650 late next year, and the parallel progression of several novel pipeline programs in major chronic diseases like diabetes, obesity and auto-immune/inflammation. The first close of $215M financing includes subscriptions from new world-class institutional investors, family offices, and our first large and long-term oriented VC/PE fund* located in China – where type 2 diabetes already impacts well over one hundred million patients. The first close also includes support from existing investors that have come into the company over the last 5-6 years. The Company expects a larger second close with additional top-tier investors in 4Q.
"Intarcia remains focused on building an innovative and important company in the chronic disease space – one dedicated to addressing serious unmet needs by disrupting the shortcomings of the pill and injection model in chronic disease management," said Kurt Graves, Chairman, President and CEO of Intarcia. "Ultimately, our goal is to open up a new pathway of delivering once or twice yearly medicines that fundamentally hold the potential to transform therapeutic and economic outcomes over time for millions of patients, and the healthcare system overall. At our core, our proprietary Medici Drug Delivery System™ does this by stabilizing and optimizing the potential of the medicines we develop, enabling the medicine to be delivered just once or twice yearly, and by addressing the massive behavioral challenge of non-adherence with pills and injections that currently impacts the majority of patients in every chronic disease we face," added Graves. "It's an exciting prospect to create a potentially critical new pathway of delivering important medicines for some of the largest and costliest chronic diseases in the world, where very little progress in overall outcomes has been made. We're thrilled with the quality and strength of the shareholder base we're continuing to build for our future, and the ability we collectively have to deliver on our purpose and our mission – improving the lives of millions of patients."
Morgan Stanley & Co. LLC acted as sole structuring agent to Intarcia on this important transaction.
About ITCA 650
ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed as a once or twice-yearly therapy for the chronic treatment of type 2 diabetes. The investigational therapy employs Intarcia's innovative technology platform, the Medici Drug Delivery System™. In its Phase 3 clinical trials for type 2 diabetes, ITCA 650 was evaluated while delivering a continuous and consistent drug therapy in a three-month initiation dose, followed by consecutive six-month doses. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. If approved, ITCA 650 would be the first and only injection-free GLP-1 therapy. Intarcia Therapeutics successfully completed its FREEDOM global Phase 3 clinical trial program for ITCA 650, with each of the four studies meeting their clinical endpoints.
About the Medici Drug Delivery System™
Intarcia's novel technology platform, the Medici Drug Delivery System, is a proprietary subcutaneous delivery system comprised of three unique technologies:
- A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more
- A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication
- A placement technology including proprietary tools designed for a simple, quick and highly reliable user experience
Once trained, physicians, physician's assistants, or nurse practitioners can quickly and simply place the small device in a comfortable in-office procedure. Once in place under the skin, water from the extracellular fluid enters the pump device at one end – by diffusing through a semi-permeable membrane directly into a salt osmotic engine – that expands to drive a piston at a controlled rate. This allows the drug within the pump to be released in a steady, consistent fashion at the distal end of the device. Each osmotic mini-pump is designed to hold an appropriate volume of either mono or combination therapy, to treat a patient for up to a full year and beyond.
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. Delivering medicines for six-month periods of time, and potentially for up to a year and beyond, may improve outcomes by addressing patient adherence and persistence issues with prescribed drug therapies, which are very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are brought to life within the Medici Drug Delivery System, the innovative science and technology platform from which Intarcia plans to launch its pipeline of disruptively innovative drugs. Intarcia continues to research and develop treatments utilizing the Medici Drug Delivery System for major chronic disorders such as diabetes, obesity, autoimmune, and other serious diseases. For more information on the Company, please visit www.intarcia.com.
* Lucion Venture Capital Group, Ltd is the only publicly traded VC/PE company in China that is listed on the Shanghai Stock Exchange. Its investment style focuses on series C or later rounds of financing for growing companies. It currently manages 29 VC funds with more than $4.7B to be invested across China, in Hong Kong and Europe, and is in process to set up an investment fund in the US. Lucion Venture Capital Group's parent company, Lucion Investment Holdings Group, Ltd is one of the largest asset management companies in China. At the end of 2015, Lucion Group had self-owned and entrusted assets of $45.3B.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Intarcia Therapeutics, Inc.
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SOURCE Intarcia Therapeutics, Inc.
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