Intarcia Therapeutics
The business, the turning points, and the decisions behind them.
01 / WHAT IT BUILT
What the company did
Intarcia Therapeutics was a Boston-based biotech company that developed drug-device combinations for type 2 diabetes. Its lead product, ITCA 650, was a matchstick-sized osmotic minipump implanted under the skin that delivered the GLP-1 agonist exenatide continuously for six months through its Medici Drug Delivery System. Once valued at more than $5 billion and backed by over $1 billion in venture capital, Intarcia pitched the implant as a replacement for twice-daily or weekly injections. After years of FDA rejections, its diabetes-treating assets were acquired by i2o Therapeutics, under which the company now operates as a business unit.
02 / Intarcia Therapeutics FAILURE REASONS
Failure reasons
The FDA issued Complete Response Letters for ITCA 650 in 2017 and again in 2020, citing clinical deficiencies, manufacturing issues, and device/product quality problems. After the company resubmitted and disputed the decisions, the FDA published a rare public notice stating the trial data showed ITCA 650 causes acute kidney injury, sometimes leading to prolonged hospitalization, dialysis or death. An FDA advisory panel unanimously voted against approval, and Intarcia's final request for a hearing was denied. Executives departed and the company's assets were acquired by i2o Therapeutics.
03 / EVENT HISTORY
Events in the structured record
- Liquidation
28 Dec 2020 reporting Luxin Venture Capital Group statement: Intarcia Therapeutics embarking on bankruptcy liquidation and retained a third party to dispose of assets and liquidate; firm 'lacks the wherewithal to keep operating' after FDA rejection. Mergr/PitchBook also list Nov 2020 bankruptcy/liquidation exit.
04 / CONTEMPORARY REBUILD ASSESSMENT
Difficulty of rebuilding this project today
Material for this section is being gathered and checked. It will appear here once ready.
Overall assessment: Not completed
05 / CAUSAL CHAIN
How the factors connect
- 01
Intarcia raised more than $1 billion in venture capital over several rounds and was valued at over $5 billion at its peak.
- 02
Following the FDA's repeated rejections, the company's diabetes-treating assets were acquired and integrated by i2o Therapeutics; i2o said it raised a $46 million Series A to continue developing the implant. No asset-sale price was disclosed.