|CeQur's Paq device--Courtesy CeQur|
CeQur is gearing up to launch its adhesive wearable insulin device that automatically delivers up to three days of insulin to patients with Type 2 diabetes. It's doubling its Marlborough, MA-based facility to add a manufacturing line, clean room and labs. That follows a whopping $100 million Series C that the company disclosed last fall.
It expects the expanded space, which is slated to be complete later this year, will house about 150 employees by the end of the next 24 months--that's up from its current total of 50. But although it's clearly advancing on the manufacturing and financing fronts, CeQur has remained relatively mum on its regulatory pathway and timeline, as well as on clinical data details, for its Paq device.
"Over the past year, we've optimized Paq for high-volume, low-cost manufacturing and continued to amass clinical evidence that demonstrate Paq will offer a safe, simple-to-use and cost-effective alternative to daily insulin injections for people with Type 2 diabetes," said CeQur CEO Doug Lawrence in a statement. "We are excited to be expanding our facilities here in Marlborough in preparation for the market introduction of Paq."
The company plans to file for FDA clearance of Paq later this year. That's an extended timeline from 2013, when it had hoped to secure clearance in 2015. Paq is an all-in-one subcutaneous insulin delivery device that doesn't require programming or infusion sets. It's worn via adhesive on the abdomen and is filled with insulin by the user.
A perusal of Clinicaltrials.gov turns up two 20-patient trials of the device, one completed in November 2015 and the other in September 2012. It also had another trial that was slated to finish in November 2014, but instead it was terminated in order "to allow continued optimization of the product," the record says. A study of 8 patients with Type 2 diabetes dating from early last year showed that 6 of them had an average reduction in HbA1c of 1.8 (+/-0.9%) after 12 weeks of Paq use in lieu of insulin injections.
The company says clinical studies have shown that Paq can be used to replace multiple daily insulin injections, while offering significant improvements in glycemic control and high patient satisfaction. It also says health economics data shows that Paq is a cost-effective alternative to insulin injections.
CeQur's Paq is somewhat similar to existing subcutaneous insulin infusion pumps, such as Medtronic's ($MDT) MiniMed, which can be worn for as long as three days and obviate the need for insulin injections. But Paq could provide a smaller profile option, without a programmer or infusion set, and a less technically complex option to insulin pumps.
Medtronic is gearing up for its own next advance: the launch of an artificial pancreas that will adjust insulin dosage based upon real-time glucose data, which is slated for as early as next spring.
- here is the expanded facility release