We are a Company of action, not words. When we commit to opening a totally new pathway of delivering medicines and creating potentially game-changing new standards of care in major chronic diseases, we follow through. Our new acquisition of Phoundry Pharmaceuticals in Research Triangle Park, NC, is another definitive action to advance our vision of progress in chronic diseases. After looking for one of the very best peptide discovery engines in the world to build our pipeline, we made the unequivocal determination that Phoundry was the perfect and complementary fit for us. That belief was quickly reciprocated by Phoundry co-founders Paul Feldman, CEO, and Andrew Young, Chief Science Officer.
Phoundry’s peptide library, innovative science, IP, and deeply experienced team are so well suited and matched to our own disruptive delivery technologies that you might wonder if it had developed with just our strategic combination in mind. The new possibilities for “NextGen” peptides and peptide combinations with ITCA 650 in our once or twice yearly mini-pumps are very exciting in diabetes and obesity. Additionally, other disruptive product possibilities beyond diabetes and obesity are now within our reach for our mid and longer-term pipeline.
Taken in context with our other pipeline collaboration with Swiss-based Numab AG, which provides us multiple antibody fragments of interest, our pipeline is now fueled by two world-class discovery engines: One with expertise in optimized peptides, and the other with expertise in both mono and multi-specific antibody fragments. Both our pipeline deals this year have all the hallmarks of driving the disruptive innovation that is at the heart of our corporate vision.
Phoundry’s team brings over 120 years of combined experience in peptide drug discovery and translational medicine insights that are invaluable to us in our target markets, and their team has a proven track record of producing medicines. Phoundry was recently spun out of GlaxoSmithKline’s Enteroendocrine Discovery Performance Unit after years of work developing multiple novel peptides, with a core focus on diabetes and obesity. However, their library of optimized peptides covers other chronic diseases as well. This is where our continuous, zero order delivery platforms become the ideal method for the optimal administration of these peptides. There is perfect harmony taking Phoundry’s highly potent, stable and selective peptides and combining them with Intarcia’s proprietary technologies to:
This should set the stage for a number of disruptively innovative medicines that hold the promise to fundamentally change the standard of care and dramatically improve long-term outcomes.
Intarcia has retained all Phoundry employees as well as a presence in Research Triangle Park, NC. We expect to double the headcount there within the next 18 months, delivering continued progress for our highest priority metabolic projects that we aim to move into the clinic in 2017 and 2018. In the same time period, Intarcia will greatly expand our headquarters in Boston to accommodate our high growth trajectory for the potential commercialization of ITCA 650 anticipated in 2017. Accordingly, we will be moving our headquarters to a larger facility within the same Innovation District of Boston. With our world-class manufacturing center in Hayward, CA, Intarcia is now a three-site corporate entity, with its headquarters clearly established in Boston.
Our late-stage investigational type 2 diabetes therapy, ITCA 650, has now delivered consistent success through three Phase 3 trials, showing incredible promise in type 2 diabetes by addressing key unmet needs: better glycemic control, better weight reduction, freedom from regular self-injections, very low rates of hypoglycemia, and more assured patient compliance and adherence with therapy. Our projected regulatory filings in the U.S. and EU are on schedule for 2016. This progress, along with our two pipeline deals this year, have transformed the strategic outlook for Intarcia, and put us in a position to build on ITCA 650 and advance a potentially leading portfolio of disruptive once or twice yearly combination therapies in diabetes and obesity. Our vision is to create combination therapies of optimized peptides that have the potential to mimic and extend the metabolic benefits and weight loss potential associated with bariatric surgery − all potentially delivered in our proprietary once or twice yearly mini-pumps.
With very recent data published in JAMA showing up to 52% of the U.S. population now having type 2 diabetes or pre-diabetes, and the incidence of obesity rising over 35% in many areas of the U.S., there is an urgent and growing need for game changing therapies that truly disrupt these epidemic trends, as well as their devastating human and economic consequences.
There has been and will continue to be interesting news as our industry’s current and emerging pipeline of products to treat type 2 diabetes evolves. But with all that new information, ITCA 650 firmly holds its position as a vitally important and disruptive potential therapy demonstrating well differentiated attributes that address pressing unmet needs. And now, with the prospects of “NextGen” ITCA 650 combo products, the potential future clinical progress is exponentially heightened.
Our vision continues, uninterrupted. Our team is growing rapidly and our allies and partners are increasing. Our commitment to do what is right and what will do the most good for all parties, beginning always with patients, is what drives us every day at our jobs. Our pace and our sense of urgency only increases, and the impressive range of possibilities now before us is a reflection of our passion and tenacity to win on behalf of patients, and the rest of our stakeholders.
I want to thank our investors for their steadfast support and commitment, and a specific shout-out for the intense and brilliant efforts to organize and complete the Phoundry acquisition made by our internal Business Development and cross-functional team dedicated to making this deal happen for a better future for us, and so many others.
Chairman, President and CEO
Intarcia Therapeutics, Inc.