The Burrill Report

Intarcia Therapeutics has raised another $200 million in private financing, which together with the $210 million round of equity and debt financing in November of 2012, puts the company in a strong position to complete a late-stage clinical trial and prepare to launch its once yearly diabetes treatment, and to build its pipeline.

The financing was led by new investors RA Capital, with participation by Farallon Capital Management, Foresite Capital, Franklin Templeton, Fred Alger Management, New Leaf Venture Partners, Quilvest, and three additional large top-tier institutional investors that were in the last round.

“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 payers who desperately need new ways to overcome the huge financial burden associated with diabetes,” says Peter Kolchinsky, managing director of RA Capital.

Intarcia’s therapy has some significant selling points: it is an optimized version of an already approved drug that is not likely to be rejected by regulators; it targets the substantial type 2 diabetes market with 400 million worldwide affected by the disease; and it has a management team experience in drug development. Chairman and CEO Kurt Graves has held executive positions at a number of leading biotechs and large pharmaceutical companies including Vertex Pharmaceuticals and Novartis, and has sat on numerous boards of directors.

The Hayward, California-based biotech’s lead candidate ITCA 650 is a continuous subcutaneous delivery of exenatide, which, if approved, would be the first and only once-yearly injection-free GLP-1 therapy for the treatment of type 2 diabetes. Intarcia plans to keep total control of ITCA 650 and avoid partnering with a big pharmaceutical company.

“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,” says Graves. “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.”

Intarcia’s focus is to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. It has developed a method of delivery that involves a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy. In addition, Intarcia’s proprietary formulation technology maintains the stability of therapeutic proteins and peptides at human body temperatures for long extended periods of time.

Intarcia expects that patients are more likely to stick with medications that are taken just once or twice yearly. Amylin, now owned by AstraZeneca, markets injectable versions of exenatide under the brands Byetta and Bydureon. Bydureon was approved in early 2012. But neither Amylin, nor its early partner Eli Lilly, hold a composition of matter patent on the exenatide molecule. Byetta loses patent protection in 2016.

ITCA 650 is currently being investigated in a global late-stage clinical trial with a final total enrollment of 4,000 patients. Interim results of the treatment on 2,300 patients, reported in January, showed a 3.2 percent 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 percent. Based on these improvements, Intarcia decided to extend the study beyond the original 9-month design to 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.

“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, payers and providers alike,” Graves says.


April 04, 2014
http://www.burrillreport.com/article-intarcia_lands_200m_for_disruptive_drug_delivery.html