- Intarcia selects Quintiles as worldwide development partner; companies strike strategic alliance incorporating equity and product investments aligned with Phase 3 success
- Pivotal head-to-head superiority trials planned vs. oral standard-of-care medicines; ITCA 650 would be the first once-yearly, injection-free GLP-1 therapy upon approval
- Intarcia-Quintiles deal is first of two-step alliance process; Intarcia expects to sign a global pharma partner with significant diabetes expertise prior to Phase 3 start
HAYWARD, CA and RESEARCH TRIANGLE PARK, N.C. – December 13, 2011 – To speed development of a potential ground-breaking therapy for Type 2 diabetes – a debilitating and deadly disease that currently affects almost 350 million people worldwide – Intarcia Therapeutics, Inc., and Quintiles today announced the signing of definitive agreements whereby Quintiles will become a financial and strategic partner for the global clinical development of Intarcia’s ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide).
Contingent upon successful development and approval, ITCA 650 would be the first and only once-yearly injection-free GLP-1 therapy for the treatment of Type 2 diabetes, enabling a broader patient population to benefit from the glycemic control, weight loss and improved adherence and tolerability observed in clinical studies to date with DUROS continuous delivery of exenatide. This alliance is the first of Intarcia’s two-step plan: first, to have a development partner, Quintiles, that delivers high-quality operational excellence in running multiple Phase 3 studies in parallel; second, to finalize and capture the global power, reach and skill of a top-tier, diabetes-focused pharmaceutical company.
Through this innovative alliance, Quintiles will support the accelerated development of ITCA 650 by its Capital Solutions group providing a combination of equity, product, and operational investments. Intarcia is currently in negotiations to select a global pharmaceutical partner to contribute funding for the clinical development and commercialization of ITCA 650.
“We believe this innovative collaboration strengthens our organization and will speed startup, with the goal of accelerated time-to-market for our game-changing injection-free GLP-1 therapy,” said Kurt Graves, Executive Chairman of Intarcia Therapeutics. “Quintiles’ commitment and intellectual contributions in crafting this development alliance, plus their strategic investments in Intarcia, reflect our vision for ITCA 650 to reshape the way Type 2 diabetes is treated and to deliver significant treatment outcome advantages to patients, payors and providers. In addition, with once-yearly administration, ITCA 650 virtually ensures the adherence and compliance that payors, providers and patients really need.
“We are confident that the promise of ITCA 650, combined with Quintiles’ world-class development experience in diabetes and the knowledge and presence of a global pharma leader, will form a powerful and effective three-way alliance.”
Dennis Gillings, CBE, Quintiles’ founder, Chairman and Chief Executive Officer, said: “This alliance illustrates Quintiles’ ability to bring financial, human and intellectual capital together to address a customer’s complex strategic challenges, and accelerate development of a potential therapy that could make very positive difference for those suffering from Type 2 diabetes.”
Quintiles has dedicated a world-class team to manage and execute the global ITCA 650 program involving multiple Phase 3 studies. Start-up activities have begun and Quintiles is working toward initiating patient enrollment in first quarter 2012.
About ITCA 650
ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide) is being developed for the treatment of Type 2 diabetes. The investigational therapy comprises Intarcia’s DUROS delivery device, a matchstick-size, miniature osmotic pump that is inserted subcutaneously 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. The DUROS technology can deliver up to a full year of therapy from a single ITCA 650 placement.
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 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 a twice-daily self-injection therapy for Type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver up to a full year of treatment from a single placement. Intarcia’s robust intellectual property portfolio protects ITCA 650 through 2027.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and presents when the body either does not produce enough insulin or becomes resistant to insulin, resulting in high levels of blood sugar. According to a June 2011 Lancet publication by Danaei and colleagues, an estimated 347 million adults worldwide suffered from Type 2 diabetes in 2008; that number is expected to rise to 472 million by 2030. It is estimated that pre-diabetes, or impaired glucose tolerance (IGT), a condition that often leads to diabetes, affects a population roughly twice the size of the current diabetes population. The World Health Organization estimates deaths resulting from diabetes will double between 2005 and 2030 and estimates the global cost of diabetes to have exceeded $400 billion in 2010. United Healthcare expects spending on diabetes and diabetes-related care to reach $500 billion by 2020 in the U.S. alone, and projects the cumulative cost of diabetes care will reach $3.4 trillion over the next decade.
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 the proprietary DUROS® drug delivery platform. Intarcia is pursuing a Phase 3-stage development program for Type 2 diabetes and has additional programs ongoing for weight regulation to control obesity. For more information, please visit www.intarcia.com.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc. DUROS is a registered trademark of ALZA Corporation licensed to Intarcia Therapeutics, Inc. in certain fields.
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.