Some Key Approvals

Some Key Approvals

Late Friday we received word that the FDA finally approved Tresiba and Ryzodeg from Novo Nordisk (NYSE:NVO). According to a company issued press release;

“Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).”

It will be interesting to see how Sanofi (NYSE:SNY) responds to this news as they continue to struggle with the launch of Toujeo. A drug which needed to be heavily discounted to make its way onto formulary. A drug which is just incrementally better than Lantus, the drug it was designed to replace.

And let’s not forget about Lilly (NYSE:LLY) whose biosimilar version of Lantus is waiting in the wings.

Given what’s at stake here for all involved it appears the price war that no one wanted is about to become a reality. That for all the talk about how these long-acting insulin’s differ from each other, the fact is these slight performance differences between the drugs cannot overcome one simple fact; the long-acting insulin market is just one step closer to commodization. That this market like so many others in the diabetes drug world the story isn’t about performance. The story is about market share and the only weapon Novo, Sanofi and Lilly have to gain share is price.

Also this morning Merck (NYSE:MRK) announced that Marizev®, the once weekly version of the blockbuster Januvia was approved in Japan. Japan is the first country to approve the drug which is scheduled to be submitted to the FDA by the end of this year.

Yet to Diabetic Investor it’s unclear just how well Marizev will do in the marketplace. The biggest plus for the drug is its once-weekly dosing.  As we have stated many times with patient compliance being a major issue; when it comes to diabetes medications less is more. However being a DPP4, Marizev could be a victim of bad timing as it is coming to market on the heels of the Jardiance cardiovascular data. Many diabetes experts see the DPP4 category being adversely impacted as physicians will turn to a SGLT2 rather than a DPP4 when it comes time to add medications to the patient’s therapy regimen.

And let’s not forget the biggest obstacle of all making sure Marizev receives favorable formulary position and reimbursement when it arrives in the US.

Finally this morning Medtronic (NYSE:MDT) launched MiniMed Connect, which according to a company issued press release is “the first and only product to enable people with diabetes to discreetly and conveniently view their insulin pump and continuous glucose monitoring (CGM) information on a smartphone.”

As valuable as this system may be patients who want the Connect will pay a pretty penny for this whiz bang way cool technology, $199 according to the Medtronic website. Naturally the system only works with the way cool equally whiz bang iPhone which basically means for the 65% or so of patients using an Android phone they are SOL. Yes the Connect will eventually work with an Android phone but it truly burns our butt that these companies think the world lives and dies with anything Apple, when market share numbers clearly indicate that Android is the more popular system. But we digress.

We also question why Medtronic is making patients pay $199. The fact is it won’t be that long before all insulin pumps transmit data to the patient’s smartphone, that this will be just one more feature on the pump. Now if Medtronic was smart, which they weren’t here, they would have either given this technology away for free or at minimum priced it at cost or lower. The goal is to get the damn data to the cloud, to make this as easy as possible. With pumps costing upwards of $7,000 and annual supply pump supply costs running at $3,000+ asking the patient to pay another $200 seems just a little over the top.

Still the launch of the system confirms what we’ve been saying all along the days of interconnected diabetes management are here to stay. That this is no longer a story about way cool whiz bang technology. This is a story about what to do with all this data once it gets to the cloud, how to turn all this data into patient relevant, understandable and actionable information. Something that isn’t helped when you’re whacking patients $200 for what should be a standard feature. Just saying.