|Intarcia's implantable drug delivery system for Type 2 diabetes--Courtesy of Intarcia|
Intarcia has wrapped up data for the last of its four major pivotal trials for its implantable drug delivery system to treat Type 2 diabetes. Known as ITCA 650, it combines a version of exenatide with a micropump to offer a GLP-1 agonist that can be implanted subcutaneously only once or twice yearly.
Now, the company expects to submit to the FDA for ITCA 650 next quarter--and it's raised an additional $75 million in debt to scale-up manufacturing and inventory in anticipation of a global launch. Most recently prior to that, Intarcia bumped up a synthetic royalty and equity convertible financing to $300 million last June. That financing valued Intarcia at $5.5 billion--putting it solidly within the elusive 'unicorn' category of startups valued at $1 billion or more.
The new credit facility is from MidCap Financial and Silicon Valley Bank and comes just as the company announces top-line results from a more than 4,000 patient cardiovascular safety trial (FREEDOM-CVO).
"The completion of our FREEDOM-CVO safety trial is the most recent of four consecutive and successful clinical milestones for Intarcia, marking the end of our large pivotal Phase 3 trials required for the regulatory submissions for ITCA 650," said Intarcia's Diabetes CMO Dr. Michelle Baron in a statement. "The FREEDOM-CVO trial was designed to test CV safety in a pre-approval setting, and we are pleased that it has achieved all of its clinical endpoints and was completed on time."
GLP-1 agonists, including exenatide, are a major segment within diabetes treatment--with a market that's anticipated to reach $8 billion by 2020. Novo Nordisk ($NVO) dominates GLP-1 agonists with its once-daily injectable Victoza; it's also starting Phase III trials of an oral version that could launch by 2020.
ITCA 650 is a combination of a matchstick-size, miniature osmotic pump that is implanted sub-dermally to dispense the company's formulation of exenatide, which remains stable at temperatures above that of the human body for long periods of time.
It "represents the first and only once or twice-yearly GLP-1 in development: a totally differentiated approach for chronic medicine delivery that we aim to show can bring important potential benefits to patients, payers and providers who seek earlier and better control of type 2 diabetes, dramatically improved medication adherence and control rates over time, and an important alternative to life-long self-injections of GLP-1s and pills that the vast majority of patients with diabetes struggle to persist with after just six months of initiating therapy," said Intarcia chairman, President and CEO Kurt Graves.
- here is the announcement