-Promising first interim phase 3 data for ITCA 650 in type 2 diabetes, combined with robust execution against key milestones and the addition of key talent
-Last two private financings have strengthened Intarcia's position to continue to drive value creation while preserving independence and strategic control of its assets
-New Capital also enables focused efforts and collaborations to build the pipeline
BOSTON, April 1, 2014 -- Intarcia Therapeutics, Inc. today announced the completion of another landmark private round of equity financing for $200 million. Together with the $210 million round of equity and debt financing in November of 2012 the company is very strongly positioned for future milestones and launch preparations. Intarcia is a rapidly emerging biotech company committed to developing and commercializing innovative therapies that merge medicine with technology and have the potential to transform therapeutic outcomes in chronic serious diseases.
"Intarcia has created a remarkably promising diabetes product with the potential to simplify glucose control and be a cost-effective solution with ensured compliance built-in, which would be inconceivable by any other means. We expect this product to be welcomed by patients, physicians, and importantly payors who desperately need new ways to overcome the huge financial burden associated with diabetes," said Peter Kolchinsky, Managing Director of RA Capital, and one of the key new investors in Intarcia. "This financing acknowledges Intarcia's unprecedented accomplishments to date and having a late stage and potential game changing therapy in one of the largest markets in pharmaceuticals. That such a large financing was done in the private markets demonstrates that form follows substance and that knowledgeable investors will support a strong team with great data and the right plan to whatever extent it needs via whatever financing structure is appropriate regardless of the general market conditions. Intarcia has more options than ever for how it will go on to create greater value advancing its wholly-owned lead product and building a pipeline of additional transformational programs," added Kolchinsky.
RA Capital led the round as a new investor and was joined by a top-tier mix of new and prior investors such as Farallon Capital Management, Foresite Capital, Franklin Templeton, LLC, Fred Alger Management, New Leaf Venture Partners, Quilvest, and three additional large top-tier institutional investors that were in the last round.
"This round of financing is a critically important milestone for our Company" said Kurt Graves, Chairman, President and Chief Executive Officer of Intarcia. "When you are innovating and have something truly disruptive in your hands, there are no analogues – not for the product itself, not for how we finance the business, and not for how our products will be commercialized. We embrace having 'no analogues' at Intarcia and it is because we aren't aiming to do any therapies that are similar or incremental - our aim is to open up a whole new way of delivering medicines that have potential to transform outcomes. There is much more to be done but our interim phase 3 data in type two diabetes is an exciting glimpse at the potential we have to make a real difference for many patients, payors and providers alike," added Graves.
Global Phase 3 Execution On Track and Promising First Interim Data
In this latest transaction, Intarcia further retains control of its lead product candidate ITCA 650 - its novel once-yearly GLP-1 for type two diabetes, currently being investigated in a global phase 3 clinical trial program called FREEDOM. First interim results from the FREEDOM program were reported this past January at the JP Morgan Healthcare Conference in San Francisco. The interim data showed a 3.2% mean reduction of HbA1c after 6 months in high unmet need subjects that were failing on diet and exercise and/or standard oral diabetes therapies, and who had a poorly controlled starting baseline HbA1c level of 10.9%. Due to the improvements observed in the interim results, Intarcia immediately decided to extend the study for patients beyond the original 9-month design. This will allow the use of additional 6-month and 12-month mini-pumps to further evaluate safety and some of the most important potential benefits of the therapy related to the built-in compliance and persistency (with either once or twice yearly dosing). More data from this trial will be shared at major medical meetings throughout 2014 and 2015.
Execution of the global FREEDOM phase 3 clinical trial program for ITCA 650 is fully on track with more than 2,300 patients already enrolled out of the 4,000 total patient enrollment planned. Results from the first pivotal clinical trial (FREEDOM 1) will be available at the end of September of this year. Results from the High Base Line (HBL) trial are also expected at the same time. The head-to-head trial vs. sitagliptin and the cardiovascular outcomes trial are also expected to complete enrollment in 2Q and end of year with final results needed to support global regulatory filings by early 2016.
If approved, ITCA 650 would be the first and only once-yearly, injection-free GLP-1 therapy for the treatment of type 2 diabetes. Intarcia oversees the FREEDOM Phase 3 clinical trial program with its strategic development partner Quintiles, Inc., the world's leading biopharmaceutical service provider – and a Company that has helped develop many successful diabetes products.
Additional Key Milestones
Intarcia achieved several additional key milestones in the past year, strengthening its Board of Directors and bringing on new talent to increase the breadth and depth of its Leadership Team and other key positions needed as the company advances. New headquarters were opened in the 3Q of last year at Boston's Innovation Center, while the world-class technology and manufacturing capabilities were scaled up and dramatically strengthened in Hayward, California. Most recently, the Company has begun to differentiate itself by hiring a new officer to create new best-practice standards in training and driving pro-active strategies to ensure optimal Customer Experiences and Outcomes, an area where continuous improvements would be of particular value for consistent optimal use and outcomes for patients, payors and providers using ITCA 650, as well as subsequent Intarcia products.
About ITCA 650
ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia's proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted sub-dermally 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 long extended periods of time.
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 and once weekly self-injection therapy for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia's robust intellectual property portfolio protects ITCA 650 through 2031. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM.
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 (impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG)), 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, eliminating the need for life-long injections, ensuring compliance and persistency over time with up to once-yearly dosing, and by improving the tolerability of drug therapies. Delivering medicines just once or twice yearly virtually ensures patient compliance and persistency, 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 Intarcia's proprietary technology platforms. Intarcia is conducting a Phase 3-stage development program for type 2 diabetes and has additional early development programs ongoing for weight regulation to control obesity. For more information on the Company, please visit www.intarcia.com.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.