Restaurant patron: MannKind must marry top CGM, Y the delay?

[trondisc]

I'm not always proud of being a seafood restaurant manager in the heart of Silicon Valley.  It entails policing the chefs (in some cases older than I am) & servers (younger naiveté & immaturity) from drinking/general shennanigans, ignoring parents who don't parent they're kids because they think the public space is a free-scream playground for unacceptable crawling on floor & running behavior, adults who irresponsibly leave expensive belongings behind in our lost and found (cell phones? cash & credit cards? KEYS? WTF?), and lastly hearing countless & annoying 3rd party solicitation from marketing companies who think they compare to the the great Groupon.  

Once in blue moon when the stars perfectly align the restaurant cosmos suddenly stands still as if it speaks to me specifically.  A brief moment in which I forget that I work for a bunch of ***holes vs. idiots: the following conversation transpired today as we immediately opened for dinner with our happy hour retired folk named Kathy & John.  Kathy & John were bragging about how her husband (23 years with the company Oracle) submitted ideas for the MAKER FAIRE with a backing from GE regarding LED technology advancements.  Kathy chimed in on his update that his LED technology will have a significant positive impact on commercial & residential health.  I started talking about how impressed I am by drone monitoring and wearable health-tech (apple, fit bit, etc.) collecting vital data for research purposes.  Then it happened...

Kathy: I'm so impressed by what technology can do to accommodate patients in the medical field.  Did you know that diabetics now use a device called a CGM to measure & verify the glucose-
Me (/cutting her off): ...like a Dexcom "G5" CGM?
Kathy (/startled from realizing I knew this subject): ...uh well yes.  Anyways companies like this should have some outlet for administering medicine with digital feedback..
Me: Have you heard of Verily, Alphabet's Life Sciences Division?  They were developing a contact lens CGM...
Kathy: Oh right, I had heard about that awhile ago.
Me: Kathy if you don't mind my asking, have you heard of a company called MannKind?
Kathy (/long 6 second pause thinking): You know...I have heard of them.
Me: Inhalable treatments are the future of faster, efficient and less invasive modern medicine I feel.
John (/chiming in abruptly): She's right.  Why hasn't ANY CGM company not worked with MannKind yet?  I feel like the bio-pharma industry is just stalling & threatened.
Me: ...AND wasting time on pivotal progress helping patients?  Couldn't agree more John. 



Reasonable reactions please.  No hate spam ala "this conversation never happened", "LOL, why are you lying trondisc?", etc., etc.  Anyways food for thought.

[prvs]

It seems like the word is getting out trondisc. The pairing of the CGM with Afrezza is a marriage made in heaven. I still suspect that Dwaine DeSisco will be returning to MNKD once the non compete is over in September.

[matt]

I think a lot has to do with the regulatory environment. When you say "pair" CGM with Afrezza you have to be very clear exactly what that relationship involves. If the products are marketed together there is a very good chance that FDA will deem the pair a "combination product" which requires additional clinical trials to test that specific device with that specific drug. A change in either the drug or the device presses the reset button on the label. Given the pace of change in the electronics world this is more of an issue for the device maker than the drug maker.

If I had the leading CGM technology I would not want to have any kind of exclusive relationship with any particular insulin partner. It is better from the device manufacturer's perspective to play the field and let the market dictate which insulins will be most successful commercially and let the monitors flow into those supply chains on a non-exclusive basis. If you are a device company, you want everybody to be your friend and nobody your enemy unless you also own the drug, in which case you use the device to drive demand for a high margin drug. Unfortunately, insulin is not a high margin drug.

[agedhippie]

It would damage Dexcom's relationship and revenue with device manufacturers like JNJ who incorporate the Dexcom G4 into their insulin pumps. If CGM and Afrezza is a natural pairing at this point people will get a Dexcom anyway (the Medtronics is not as accurate) so there is no need for a partnership. Given the difficulty of getting a CGM paid by insurers it's not a big market.

[lennymnkd]

Matt; good point , I just asumed we were the ones in the drivers seat with AFREZZA ... But the cgm companies must be just as selective . Might not be as easy as I thought ! But believe we will prevail .

[avichen]

Mannkind is now "playing hard to get" and the CGM is "acting don't care"... that's why the marriage doesn't happen

[forlife]

I believe Mike C. is very familiar with "the dance"... also, with the fact that the dancers could be dancing off into the sunset if the competition catches up and overtakes.  

Hopefully, the full management team will align and together take the lead to make this happen... an epic response for the long-suffering diabetic patients (and long-suffering investors)!

[Deleted]

Aug 4, 2016 6:46:03 GMT -5 matt said:

I think a lot has to do with the regulatory environment. When you say "pair" CGM with Afrezza you have to be very clear exactly what that relationship involves. If the products are marketed together there is a very good chance that FDA will deem the pair a "combination product" which requires additional clinical trials to test that specific device with that specific drug. A change in either the drug or the device presses the reset button on the label. Given the pace of change in the electronics world this is more of an issue for the device maker than the drug maker.

If I had the leading CGM technology I would not want to have any kind of exclusive relationship with any particular insulin partner. It is better from the device manufacturer's perspective to play the field and let the market dictate which insulins will be most successful commercially and let the monitors flow into those supply chains on a non-exclusive basis. If you are a device company, you want everybody to be your friend and nobody your enemy unless you also own the drug, in which case you use the device to drive demand for a high margin drug. Unfortunately, insulin is not a high margin drug.

Marketed as a pair, yes FDA hurdles BUT, the G5 sends data directly to patients smartphone.  At some point, patient data will get auto uploaded into the Google cloud.  Once enough data comes in, it will become apparent that diabetics using Afrezza have lower blood glucose levels, less volatility in their blood glucose levels (volatility is the true culprit for long term health complications) and then the payors have to decide based on clinical performance which is the best options for their patients and shareholders.  If the data gets out, patients can also try to demand products that improve their health and threaten legal action to payors who act in a way that is harmful to patients.  

[Deleted]

Aug 4, 2016 6:50:59 GMT -5 agedhippie said:

It would damage Dexcom's relationship and revenue with device manufacturers like JNJ who incorporate the Dexcom G4 into their insulin pumps. If CGM and Afrezza is a natural pairing at this point people will get a Dexcom anyway (the Medtronics is not as accurate) so there is no need for a partnership. Given the difficulty of getting a CGM paid by insurers it's not a big market.

Not to be critical of your post but JNJ is rapidly becoming a non-entity in the pump space.  MDT dominates with around 75% share followed by Insulet and in order for JNJ to remain in the space they are going to have to make some acquisitions or get out of diabetes all together.  

[mannmade]

Like an arranged marriage I personally don't think the marriage works for either side. The free market (consumer's choice) must make the marriage at the alter of the insurance companies. To do otherwise removes choice from the consumer on both sides as choice is removed in an arranged marriage most.

[prvs]

Aug 4, 2016 6:46:03 GMT -5 matt said:

I think a lot has to do with the regulatory environment. When you say "pair" CGM with Afrezza you have to be very clear exactly what that relationship involves. If the products are marketed together there is a very good chance that FDA will deem the pair a "combination product" which requires additional clinical trials to test that specific device with that specific drug. A change in either the drug or the device presses the reset button on the label. Given the pace of change in the electronics world this is more of an issue for the device maker than the drug maker.

If I had the leading CGM technology I would not want to have any kind of exclusive relationship with any particular insulin partner. It is better from the device manufacturer's perspective to play the field and let the market dictate which insulins will be most successful commercially and let the monitors flow into those supply chains on a non-exclusive basis. If you are a device company, you want everybody to be your friend and nobody your enemy unless you also own the drug, in which case you use the device to drive demand for a high margin drug. Unfortunately, insulin is not a high margin drug.

Good point matt. I was thinking along the lines of how well they work together. Mike C. asked us to get insurance companies to cover CGMs used with rapid acting insulin right? I went on the site and voted as a family member. Not sure how the details will be worked out, just glad this "pairing" helps diabetics get better control.