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An astute investment on its part last year has enabled insulin patch pump specialist CeQur to transition quickly from a development-stage start-up to a company poised for commercial launch. With a new CEO at its helm, the firm is now scaling up its operations - in a "thoughtful and methodical" way - to bring to market the first on-demand insulin patch pump for type 2 diabetes patients.
CeQur has appointed Bradley Paddock CEO, as the insulin patch pump specialist gets ready to launch its first product - PAQ MEAL - in the US and start commercialisation.
Paddock’s experience is focused on commercialising medical devices and has held several sales leadership positions. Before joining CeQur, he was global president of Stryker’s spine division and has led sales and marketing at other multinationals including Bausch + Lomb and Johnson & Johnson. He also spent eight years at Kyphon, the pioneer of kyphoplasty technology for treating vertebral compression fracture, and helped grow the company before it was acquired by Medtronic for $4.2 billion.
The back story
CeQur was founded in 2008 and its focus then was to develop and bring to market PAQ, its three-day wearable patch pump that delivers both basal, as well as on-demand mealtime bolus insulin to type 2 diabetics. The idea, said executive chairman Eric Milledge, was to replace needle injections with a very simple and convenient way for the patient to administer insulin.
"Type 2 diabetes patients consume 80 percent of the world’s insulin and it is them that really needs help because 70 percent are not in control of their blood glucose levels," he said. "There are 70 percent of insulin-dependent type 2 diabetics who never inject insulin outside their home - they have smart pens and other devices [to help make injections more convenient] but it doesn’t change. It is a stubborn number."
PAQ is designed to be a slimline device that attaches to the patient’s skin and worn under clothing - basal insulin is delivered automatically to the patient, while bolus insulin is delivered with a click of a button on the device (and this can be done discreetly by the patient through their clothing).
Milledge told FirstWord MedTech that CeQur had conducted three clinical trials on the original PAQ basal-bolus device and "we got to the point where we had a substantial offer for the company." However, it had "a bit of a glitch around the bolus function" and so the firm worked to resolve this issue and "the bolus function now works beautifully," said Milledge. CeQur is now working towards submitting its 510(k) application in September to get the PAQ basal-bolus device - which has been rebranded called PAQ TOTAL - cleared by the US FDA.
Meanwhile, last year, CeQur acquired exclusive worldwide licence to an FDA-approved, three-day, bolus-only insulin patch pump technology from Calibra Medical, one of Johnson & Johnson’s diabetes care businesses. The device was then called OneTouch Via and CeQur has since rebranded it PAQ Meal; it is this device that will be the key focus of the company’s upcoming commercial activities.
In terms of competition, CeQur looks like it could be enjoying a monopoly for a while. Most insulin pump technologies that are available target type I diabetics and the only disposable insulin patch pump device for type II diabetics that is commercially available is Valeritas’ V-Go. However, while PAQ Meal is for bolus-only insulin delivery, V-Go is a basal-bolus device; while PAQ Meal is worn for three days, V-Go is for 24-hour use only and has to be changed daily. Becton Dickinson has a three-day, basal-bolus insulin patch pump, Swatch, which it said in November last year that it was going to launch at the end of 2019 pending US and EU approvals but the company has not given an update since.
The wider view
Business is often about being at the right place, at the right time, and, of course, having the right connections. Milledge told FirstWord MedTech that when he first read some 18 months ago about Johnson & Johnson divesting its LifeScan blood glucose monitoring business as part of its diabetes device-exit plans, he noticed the absence of any reference to Calibra and its bolus-only patch pump tech. Milledge, having served at Johnson & Johnson for a decade (including seven years at LifeScan), decided to tap into his connections there to ask about Calibra, which subsequently led to what this pivotal deal that has jettisoned CeQur from a development stage company to a growth stage company.
While the financial details were not disclosed, CeQur has saved itself from having to do the regulatory and clinical legwork for PAQ Meal. The technology came to the company FDA-approved and ready to enter the market, and furthermore, Johnson & Johnson had invested in a 62-centre, randomised controlled trial to gather clinical evidence to back the product. The RCT, involving just under 280 patients, evaluated the use of mealtime, bolus-only insulin therapy - delivered either with the PAQ Meal patch or insulin pens - in controlling glycated haemoglobin (HbA1C) levels in type 2 subjects who were unable to achieve their blood glucose goals despite taking moderately high doses of basal insulin. The results showed that the addition of bolus-only insulin therapy at mealtimes was able to significantly decrease HbA1C levels in the study subjects and that this decrease persisted over time.
CeQur plans to build on this clinical evidence with a registry trial that is expected to start in the fourth quarter this year. A lot of payers and clinicians like real-world evidence, said Milledge, and data from both the RCT and registry will help drive adoption of PAQ Meal.
Kickstarting the registry is just one of the many things on new CEO Bradley Paddock’s to-do list, but a key priority is to build out the internal infrastructure to manage CeQur’s transition from a development- to commercial-stage organisation, he said.
With reimbursement being critical, the company is in the process of hiring national account managers to oversee the contracts that Johnson & Johnson had previously sealed for diabetes care products with over 50 percent of the payers in the US. These contracts had lapsed following Johnson & Johnson’s exit from this space and CeQur is re-engaging these payers, as well as hopefully broaden out coverage to other payers in due course.
The company will also be putting feet on the ground and hiring sales reps, as well as building out a customer support group when they start commercialisation in 2020. "As we enter the new year, we will bring on customers in a limited market release and as we move into 2020, we will continue to slowly put the gas down, continue to add sales reps, bring on more customers, continue to build out our customer service center," said Paddock.
He told FirstWord MedTech "I’m planning to really develop a flawless launch, which means taking a very thoughtful and methodical approach to bringing this product to market, establishing reimbursement and ensuring we educate the customer and patient on what we have. We have a game changing device and it is worthwhile taking our time doing it right."
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