Potpourri

Being fans of Jeopardy, and honestly who isn’t a fan, we loved the category potpourri as it was a catch all for a wide range of questions. We also like the phrase as we used the title Mixed Bag after Insulet reported yesterday. Listen it’s not easy coming up with creative headlines when you write as often as we do. So with that being said let’s have at it.

1. The FDA concluded their inspection of the Biocon insulin manufacturing facility in Malaysia as the company prepares to launch along with their partner Mylan yet another biosimilar version of Lantus. According to Biocon the inspection noted three issues which they are addressing “expeditiously.”

A couple of observations here, first we need another biosimilar Lantus about as much as we need more snow here in Chicago. Second, the inspection shows that not just anyone can make insulin and the importance of having quality manufacturing processes. Third, it’s another reason Sanofi who has lots of insulin manufacturing experience should complete their exit from diabetes by selling their diabetes franchise which would include these facilities.

Now that insulin has become a commodity the ability to manufacture insulin cheaply has become paramount. Sanofi has already stripped their diabetes franchise to the bare bones and has no real reason to remain in the market. Hence selling the franchise along with their existing infrastructure is the next logical move.

2. This morning Oramed announced results from their phase 2b trial for their version of orally delivered insulin. Per a company issued press release;

“Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced positive topline data from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, at lower dose regimens. ORMD-0801 has the potential to be the first commercially available oral insulin capsule for the treatment of diabetes.”

It has long been a dream to have an orally delivered version of insulin as many believe the reason more patients don’t use insulin is fear of injections. We have never felt this way as the reason more patients don’t use insulin is because they aren’t afraid of injections, they are afraid of insulin. As we noted recently transitioning to insulin therapy is also viewed as personal failure by the patient, which is another reason, they don’t adopt insulin therapy.

Still this belief exists which is why so many companies have sought alternate non-injectable forms of insulin. None of which by the way have become commercially viable. About the closet we’ve come is Afrezza from MannKind and while doing better than it was, we cannot yet call Afrezza a commercial success.

Perhaps one day someone will actually listen to the patient and instead of developing new ways to administer insulin develop programs that educate the patient about the benefits of insulin therapy. Of course this is a commonsense approach and we can’t have any of that can we?

3. This isn’t directly diabetes related but JNJ and Apple are launching a 150,000 patient virtual study to test its ECG smartwatch. According to a post on the FireceBiotech web site;

“Johnson & Johnson launched a new, virtual clinical study to gauge whether Apple’s iPhone and ECG-enabled smartwatch can help reduce a person’s risk of stroke and detect earlier, hidden cases of atrial fibrillation.

Conducted entirely through the companies’ Heartline Study smartphone app, J&J and its Janssen division have begun enrolling adults age 65 and older and covered by Medicare—with the goal of building a 150,000-person cohort. The program was developed in collaboration with Apple and the research data firm Evidation Health.”

As we all know Apple is partnered with Dexcom and many believe that one day the Apple Watch will also serve as a wearable CGM. And contrary to what’s been widely reported in the press Apple does not have a non-invasive CGM under development, they tried and like so many they failed.

The issue here with all these health-related efforts going on with the Apple Watch and other wearables is will the FDA step in and require that an Apple Watch go through the rigors of a clinical trial. Gathering information as they are doing with JNJ is one thing, however having the watch also serve as the patients CGM is quite another.

4. Lilly made some news when the FDA approved their once-weekly GLP-1 Trulicity to reduce the risk of cardiovascular events in Type 2 diabetes patients with—or without—established CV disease. Some see this as giving Lilly an edge over Ozempic the once-weekly GLP-1 from Novo Nordisk, we don’t.

First the GLP-1 market continues to expand. Second while there are some differences between Trulicity and Ozempic they do basically the same thing the same way producing similar results. Which of course means that just as insulin became a commodity GLP-1’s are progressing down this path. Which in turn means this is becoming a battle for … wait for it …. Formulary position.

5. Some may have noticed that shares of Senseonics have been trending upward. The question becomes is this a dead cat bounce or a sustained move upward? Nothing against the good folk at Senseonics but this has all the earmarks of a dead cat bounce.

As we have said from the beginning there is nothing wrong with their sensor which works quite nicely. The problem isn’t with the product, the problem is the business model which in today’s expanding CGM universe just doesn’t work very well. The company can issue all the press releases they want about positive coverage decisions or the impact CGM has on patients.

However in the real world these events don’t translate into what the company needs most, more patients. Now running low on funds the company has a limited set of options. They could of course find a buyer, but we see this as a very remote possibility. A more likely scenario would be to pull a Tandem and majorly dilute the stock to raise desperately needed capital.

Even if they can pull this off, we don’t see a Tandem like turnaround. The fact is yes there is place for an implantable sensor the problem however it’s a niche not mass market. Simply put there just aren’t enough patients to make this a viable business.