HAYWARD, Calif., Oct. 21, 2011 /PRNewswire/ --Intarcia Therapeutics, Inc. today announced the signing ofa letter of intent with Quintiles, the world's leading biopharmaceutical services company, to collaborate on the global Phase 3 program for Intarcia's ITCA 650 (DUROS® subcutaneous continuous delivery of exenatide). The program aims to demonstrate multiple advancements in GLP-1 therapy to better address the unmet needs of the almost 350 million people worldwide suffering from Type 2 diabetes a debilitating and deadly disease. ITCA 650 utilizes a matchstick-size, subcutaneous mini-pump that allows smooth continuous delivery of exenatide from a once-yearly placement. This novel delivery of GLP-1 therapy has been shown to improve HbA1c, weight loss, tolerability and also virtually ensures patient compliance and adherence. By improving the clinical profile and removing the self-injection barrier to use, ITCA 650 would also hold promising potential for use in earlier lines of therapy.
Upon execution of the definitive agreement, Quintiles will initiate a global Phase 3 program including the six clinical studies that will form the basis of international regulatory submissions. This alliance is the first of a planned two-step partnering strategy, as Intarcia finalizes its late-stage discussions with global pharma companies in the diabetes field. This will form a unique and powerful three-way alliance dedicated to the development and commercialization of ITCA 650 around the world.
"The prospect of a once-yearly, improved GLP-1 therapy could be a game-changer in one of the industry's largest and most rapidly growing therapeutic categories," said Kurt Graves, Executive Chairman of Intarcia's Board of Directors. "Patients, physicians and payors alike have responded very favorably to the potential for a once-yearly therapy that may provide enhanced glucose control, weight loss and ensured compliance without the need for regular self-injections."
Mr. Graves further explained, "We couldn't be more pleased to attract and partner with a world-class organization like Quintiles a global leader in its field with great depth and breadth of expertise in Type 2 diabetes. The Quintiles team working with us shares our enthusiasm for ITCA 650; this was the catalyst to form an innovative collaboration model about which we are both very excited."
The design of the Phase 3 program was discussed with the U.S. Food and Drug Administration earlier this year at an end-of-Phase 2 meeting. As currently planned, the ITCA 650 global registration program will involve a total of five Phase 3 studies and a cardiovascular outcomes study (to be listed on Clinicaltrials.gov).
Treatment algorithms endorsed by the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) recommend GLP-1 agonist therapies like exenatide as a treatment option when blood sugar goals are not met or maintained with lifestyle adjustments and metformin. However, use of currently available GLP-1 therapies has been limited to third- or fourth-line use by the need for frequent self-injections and injection-related side effects. Upon approval, Intarcia believes ITCA 650 could significantly expand the use of a GLP-1 therapy for the treatment of Type 2 diabetes.
About ITCA 650
ITCA 650 (DUROS® subcutaneous continuous 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 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 2011Lancet 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 patient adherence and improving the efficacy, convenience and tolerability of drug therapies. 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.
SOURCE Intarcia Therapeutics, Inc.