- The Bill & Melinda Gates Foundation is committing up to $140M in grants and equity with the intent to develop the first once- or twice-yearly anti-HIV prophylactic therapy
- The strategic initiative marks the first development of Intarcia's proprietary Medici Drug Delivery System™ to enable the prevention of a major infectious disease
BOSTON, Dec. 29, 2016 /PRNewswire/ -- Intarcia Therapeutics, Inc., today announced it has completed its second major close of the Series EE equity financing, and also entered into a relationship with the Bill & Melinda Gates Foundation to help prevent the spread of HIV in Sub-Saharan Africa and other countries where the HIV epidemic is most severe.
- Following the initial Series EE equity financing in September, Intarcia secures an additional $206M in the second close of the Series EE equity financing. A third and final close is planned in 1Q 2017.
- As part of the Series EE financing, Intarcia also enters into a pioneering relationship with the Bill & Melinda Gates Foundation to develop and advance an anti-HIV prophylactic, as well as planned enhancements to the Medici technology platform itself.
- The relationship with the Gates Foundation will fully leverage Intarcia's innovative Medici Drug Delivery System by developing the first once- or twice-yearly anti-HIV prophylactic therapy that can fit seamlessly into people's lives and enable optimal adherence and effectiveness. Adherence is a critical success factor for effective HIV prevention.
- Intarcia submitted its first NDA for ITCA 650 in type 2 diabetes on November 21st. This milestone triggered a $100M milestone payment linked to the submission; ITCA 650 is a promising investigational therapy for the chronic treatment of type 2 diabetes.
"Thanks to tremendous financing progress, an even stronger shareholder base, our recent NDA submission in type 2 diabetes, and now a groundbreaking relationship with the Bill & Melinda Gates Foundation, Intarcia is poised to open up a totally new category of important once- or twice-yearly treatment and prevention therapies for some of the world's most serious chronic diseases − including those that disproportionately affect people with some of the greatest unmet needs," said Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics, Inc. "Over the last five years we have successfully brought to life the vision and promise of our disruptive Medici technology platform, and an expanding pipeline of novel therapeutics. With Medici, and each of our new once- or twice-yearly therapies, we're aiming to solve some of the biggest unmet needs in the treatment and prevention of major chronic diseases that impact millions and millions of lives every day. We look forward to working with health and regulatory authorities in preparing to bring our first investigational medicine to patients with type 2 diabetes next year. With our new strategic initiative in HIV prevention, we are also tremendously excited and humbled to work with an incredible organization as smart, forward-looking and purpose-based as the Bill & Melinda Gates Foundation."
As a part of its commitment, the Gates Foundation will invest up to $140M; $50M as a program-related investment into the Series EE round, with up to $90M in non-dilutive milestone-based grants tied to the HIV prophylactic program. Assuming success over time, additional grants will be made to ensure access to an important prophylactic for HIV.
"There's a vital need for an HIV/AIDS intervention that allows those at risk to incorporate prevention more easily into their daily lives. We feel optimistic about our partnership with Intarcia and the prospect of an implantable prophylactic device that could make a world of difference for people most in need," said Sue Desmond-Hellmann, CEO of the Bill & Melinda Gates Foundation.
ITCA 650, delivered through the Medici Drug Delivery System, holds the potential to be a disruptive entry into the massive type 2 diabetes market that is still poorly controlled due to the sub-optimal efficacy of pills and injections for the majority of patients in real-world circumstances. With most type 2 diabetes patients failing to achieve and sustain control over time, despite over 40 pills and injections being approved for type 2 diabetes in the last 10 years, Intarcia developed a totally new convergence of medicine and technology designed to deliver medicines just twice-yearly. Once-yearly mini-pumps are also in development. In chronic diseases this should provide a key to successful control over time, which is fundamental to improving clinical outcomes in both therapeutic and preventive medicine.
Morgan Stanley & Co. LLC acted as sole structuring agent to Intarcia on the equity aspects of this important transaction.
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 to provide an optimal user experience
Once a drug is approved, a trained healthcare professional can place the small device in an 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 an 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 other end of the device. Each osmotic mini-pump is designed to hold an appropriate volume of drug to treat a patient for up to a full year.
About ITCA 650
ITCA 650 is designed as a 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 receptor agonist therapy. Once-yearly mini-pumps at the 60mcg/day maintenance dose are also in development.
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.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
Follow us on Twitter @intarcia.
SOURCE Intarcia Therapeutics, Inc.