- Intarcia Therapeutics Inc. has cut its staff by 60 people in a restructuring that followed after a Complete Response Letter from the FDA on its lead drug candidate, CEO Kurt Graves told the Boston Business Journal. The company has also ended two late-stage studies of its exenatide drug-device combo, ITCA 650, according to clinicaltrials.gov.
- Despite the cuts, coming in headquarters and manufacturing, Intarcia is still recruiting and doesn't expect its overall headcount to shift significantly.
- The biotech said it is still working toward resubmission with the Food and Drug Administration.
In a fairy-tale beginning, Intarcia was celebrated as a unicorn — a startup company valued at over $1 billion.
But some of that magic fizzled in September when the Food and Drug Administration issued a Complete Response Letter for the biotech's Type 2 diabetes drug-device combo ITCA 650, which incorporates exenatide in a subcutaneous osmotic pump that releases the drug over a number of months. ITCA 650 was submitted for approval in November 2016, triggering a $100 million milestone payment from the $300 million royalty financing put in place in the second quarter of 2015.
According to the website clinicaltrials.gov, Intarcia has terminated an open label study of ITCA 650 in patients with high baseline HbA1c, and a comparison of ITCA 650 to empagliflozin and glimepiride as add-on to metformin; no Intarcia studies for the product are listed as active. The Graves interview with the Boston Business Journal suggests the moves stem from an FDA hold on the studies, after issues arose concerning the stability and sterility of the pump. These issues are not related with the CRL, and resubmission is planned for mid-2018.
In a statement to BioPharma Dive confirming the layoffs, the company said the headcount changes are expected to be "relatively neutral over the course of the year."
The statement continued: "A holistic assessment of the organization was conducted and the decision was made to restructure and reshape the company to focus on our critical priorities. The restructuring and reshaping involves roughly 60 positions that were reduced across various functions, however, it also involves ongoing hiring in key areas of the company that support our 2018 priorities."