Resubmissions Approvals – What it all means

Resubmissions Approvals – What it all means

This morning Intarcia announced that the FDA has accepted the resubmission of their exenatide micropump. Per a company issued press release;

“Intarcia Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s resubmission of its new drug application (NDA) for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus. Intarcia resubmitted the NDA on September 9th, 2019 and the FDA has recently communicated that it considers the NDA resubmission a complete class 2 response, setting the Prescription Drug User Fee Act (PDUFA) target action date of March 9, 2020.”

This resubmission comes shortly after the FDA approved Novo Nordisk orally delivered GLP-1 Rybelsus®. We are confident that come March 9th Intarcia will be doing the happy dance setting up a fierce battle in the expanding GLP-1 market. This resubmission is just one more reason Novo must execute flawlessly with the Rybelsus launch and places more pressure on Lilly to keep the petal to metal with Trulicity.

While it’s far too early to predict how the Intracia system will be accepted the system offers several compelling benefits over both Rybelsus and any of the injectable GLP-1’s. With each iteration of GLP-1 therapy starting with twice daily injections, then once daily followed by once weekly and now orally delivered the GLP-1 market has expanded. Intracia will face the normal reimbursement hurdles fighting for formulary position and will have the additional hurdle of convincing patients and their physicians that the insertion procedure is simple and relatively pain free.

All that being said we do believe the system will be successful as it solves the more pressing issue when it comes to diabetes management, patient adherence. As once inserted the patient does basically nothing but live their lives without having to worry about injections or the complex dosing regimen for Rybelsus. Still Novo and Lilly will fight to protect and/or promote their GLP-1 offerings making this market one to watch closely. We also believe that Intarcia will have another key announcement in the not so distant future as we see an IPO coming.

Also this morning Dexcom announced the FDA has cleared their G6 Pro system, per a press release;

“Dexcom, Inc. (NASDAQ:DXCM) announced today the U.S. Food and Drug Administration (FDA) has cleared the Dexcom G6 Pro Continuous Glucose Monitoring (CGM) System for healthcare professionals to use with their patients, ages two years and up.”

While this approval was anticipated and not really a huge piece of news it does make us wonder what is taking so long with the Libre2 approval. We have heard all sorts of rumors about the Libre2 approval process which leads us to believe the process is bogged down as Abbott seeks an iCGM designation. As we have noted on many occasions, we don’t believe this designation will change anything from a commercial perspective, Abbott is committed to a value strategy with Libre and iCGM or not that won’t change.

However Abbott is somewhat backed into a corner here given their public statements on the iCGM designation. At first the company and their CEO Miles White basically said iCGM was a slam dunk. Statements he has since backed off. Today it’s more like yes, we will get the iCGM or at least we think we will.

Frankly we see far too much emphasis on this whole interoperability thing. From a commercial perspective the ability to mix and match components really won’t have a material impact on sales of any of the components. Yes there is a small percentage of patients who care about such things but for the majority it really doesn’t matter all that much. The reality is Dexcom and Abbott are going to rule the CGM kingdom and eventually all the connected toys, pens and pumps will work with both the Libre and G6. That is with one notable exception, Medtronic as they insist on promoting their own sensor.

The insulin pump companies not named Medtronic would be better off concentrating their efforts on developing new revenue models to combat Medtronic’s formulary advantage and the coming of Tyler. Speaking of which we continue to hear that all the insulin companies are fumbling about like the Keystone Cops when it comes to their versions of a Tyler. Tyler will eventually get here but truth be told he should have been here two years ago, and had it not been for the ineptitude of the insulin companies he would be here. Hence the reason pharma companies should not be in the device business.

Just as the interoperability issue is over blown with insulin pumps it is equally over blown with Tyler. The basic problem is the insulin companies are .. wait for it … just a little greedy. Not being able to see the forest through the trees they want to make money not just from protecting their insulin franchises but the connected pen and CGM sensor. If they were smart, which they aren’t, they’d surrender some of the revenue from pen and sensor sales as selling insulin should be what matters especially with a biosimilar short-acting insulin coming. But no rather than get to the market with Tyler they continue to act like spoiled children kicking sand around in the sandbox.

We suspected that these kids wouldn’t play well together for long and that greed would get in the way of progress. Hence the reason we think a company like Dexcom should hook up with Companion, a company that has an FDA approved connected pen that actually works, and market a Tyler of their very own. Something we thought Abbott might do as their partner Bigfoot is supposed to have connected cap over which is way cool. Too bad it will soon be way dead as the company is running out of money, losing key people and Abbott has now also signed a connected pen deal with Sanofi.

As the old saying goes kids will be kids. Or as Momma Kliff used to say there comes a time for a child to grow into adulthood and begin acting like an adult.