abc news

[sportsrancho]

www.abc2news.com/news/health/new-treatment-for-diabetes

[promann]

Great one!

[brotherm1]

Sports you are amazing Nice find again. I've no idea who or what prompted this news station to do this story, but it is certainly great to see Afrezza on TV and at either no cost - or little cost if any - to MNKD

[greg1961]

Great find postaholic

[mnholdem]

I find this report to be a bit depressing, but ONLY because it reminds me that MannKind management has Afrezza over-priced, which means that Afrezza will continue to be reported as a great insulin that is expensive. I'm concerned that management continually ignores what the marketplace is telling them. The other example is the issue which the patient in this report states is important to him: refrigeration is required for injected insulin. Well, duh, refrigeration is also required on the label of Afrezza because in nearly fifteen years management hasn't thought to conduct an inexpensive trial to prove that insulin powder (aka Technosphere) didn't require refrigeration.

It's great how reports like this one (thanks, sportsrancho) help raise awareness of Afrezza, but they also raise awareness of how expensive Afrezza is compared to competing RAA insulin brands.

As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?

Where will that leave Afrezza? Where will that leave shareholders?

It's bad enough that Afrezza must be marketed as merely non-inferior to RAA. I appreciate management's effort to distinguish Afrezza via a new OUTsulin campaign, but it's only used on the Afrezza website for patients. The Afrezza HCP site, unfortunately, continues to expose HCPS to a Sanofi-inspired website with it's over bearing black box warning and information. What's with that?

Management continually ignores the low-hanging fruit to reach for the golden apple. I don't buy Castagna's logic about why MannKind has decided to retain the premium level where Sanofi priced Technosphere insulin. I don't care if other insulin has seen price increases over the past two years. Afrezza is still priced too high and IMO this is a major reason why the new sales force cannot sell it.

Wall Street has priced MNKD where it is because market perception is that nobody wants what MannKind has to offer. Virtually no sales for Afrezza (there are an average 250,000-300,000 prandial prescriptions written weekly in the U.S.) No partners for the Technosphere pipeline. No major data publications in NEJM or AMA. Great posters at ADA-2016... then nothing since. Unless I missed it, there hasn't been a major medical journal article about Afrezza since the FDA approved it in 2014.

So, again, the article is okay, but drives home two points. Afrezza is too expensive and a number of patients want the convenience of not having to carry ice packs to keep their life-saving insulin cool.

Unfortunately, MannKind cannot market Afrezza as not needing refrigeration. They need to fix that ASAP. They also need to lower the price of Afrezza ASAP. Finally, they need to take proactive steps to market why this [currently] non-inferior insulin is different, because if the FDA rejects the application to label Afrezza with a first-in-class classification "ultra fast acting", management will have wasted 10 months to demonstrate why Afrezza will satisfy a medical necessity.

The market is speaking, but is management listening?

[greg1961]

mnholdem = Adam Fraudstein!!!

[uvula]

I didn't realize it wasn't approved for pregnant women. I thought 1 of the fda trial patients was pregnant. Was the tv reporter correct? Either way it was a nice segment.

[madog365]

Nov 22, 2016 8:59:44 GMT -5 mnholdem said:

I find this report to be a bit depressing, but ONLY because it reminds me that MannKind management has Afrezza over-priced, which means that Afrezza will continue to be reported as a great insulin that is expensive. I'm concerned that management continually ignores what the marketplace is telling them. The other example is the issue which the patient in this report states is important to him: refrigeration is required for injected insulin. Well, duh, refrigeration is also required on the label of Afrezza because in nearly fifteen years management hasn't thought to conduct an inexpensive trial to prove that insulin powder (aka Technosphere) didn't require refrigeration.

It's great how reports like this one (thanks, sportsrancho) help raise awareness of Afrezza, but they also raise awareness of how expensive Afrezza is compared to competing RAA insulin brands.

As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?

Where will that leave Afrezza? Where will that leave shareholders?

It's bad enough that Afrezza must be marketed as merely non-inferior to RAA. I appreciate management's effort to distinguish Afrezza via a new OUTsulin campaign, but it's only used on the Afrezza website for patients. The Afrezza HCP site, unfortunately, continues to expose HCPS to a Sanofi-inspired website with it's over bearing black box warning and information. What's with that?

Management continually ignores the low-hanging fruit to reach for the golden apple. I don't buy Castagna's logic about why MannKind has decided to retain the premium level where Sanofi priced Technosphere insulin. I don't care if other insulin has seen price increases over the past two years. Afrezza is still priced too high and IMO this is a major reason why the new sales force cannot sell it.

Wall Street has priced MNKD where it is because market perception is that nobody wants what MannKind has to offer. Virtually no sales for Afrezza (there are an average 250,000-300,000 prandial prescriptions written weekly in the U.S.) No partners for the Technosphere pipeline. No major data publications in NEJM or AMA. Great posters at ADA-2016... then nothing since. Unless I missed it, there hasn't been a major medical journal article about Afrezza since the FDA approved it in 2014.

So, again, the article is okay, but drives home two points. Afrezza is too expensive and a number of patients want the convenience of not having to carry ice packs to keep their life-saving insulin cool.

Unfortunately, MannKind cannot market Afrezza as not needing refrigeration. They need to fix that ASAP. They also need to lower the price of Afrezza ASAP. Finally, they need to take proactive steps to market why this [currently] non-inferior insulin is different, because if the FDA rejects the application to label Afrezza with a first-in-class classification "ultra fast acting", management will have wasted 10 months to demonstrate why Afrezza will satisfy a medical necessity.

The market is speaking, but is management listening?

I'm not sure i understand your point about pricing. The reason Afrezza is considered expensive is because many major insurances do not cover it and therefore patients pay larger out of pocket costs. Lowering the cost of afrezza won't solve this problem as they are already priced competitively, they need to get more payers on board which is something Mike has stated they are working on. Do you believe lowering the price further will get Afrezza to tier 1/2 preferred coverage? 

[babaoriley]

Nov 22, 2016 8:59:44 GMT -5 mnholdem said:

I find this report to be a bit depressing, but ONLY because it reminds me that MannKind management has Afrezza over-priced, which means that Afrezza will continue to be reported as a great insulin that is expensive. I'm concerned that management continually ignores what the marketplace is telling them. The other example is the issue which the patient in this report states is important to him: refrigeration is required for injected insulin. Well, duh, refrigeration is also required on the label of Afrezza because in nearly fifteen years management hasn't thought to conduct an inexpensive trial to prove that insulin powder (aka Technosphere) didn't require refrigeration.

It's great how reports like this one (thanks, sportsrancho) help raise awareness of Afrezza, but they also raise awareness of how expensive Afrezza is compared to competing RAA insulin brands.

As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?

Where will that leave Afrezza? Where will that leave shareholders?

It's bad enough that Afrezza must be marketed as merely non-inferior to RAA. I appreciate management's effort to distinguish Afrezza via a new OUTsulin campaign, but it's only used on the Afrezza website for patients. The Afrezza HCP site, unfortunately, continues to expose HCPS to a Sanofi-inspired website with it's over bearing black box warning and information. What's with that?

Management continually ignores the low-hanging fruit to reach for the golden apple. I don't buy Castagna's logic about why MannKind has decided to retain the premium level where Sanofi priced Technosphere insulin. I don't care if other insulin has seen price increases over the past two years. Afrezza is still priced too high and IMO this is a major reason why the new sales force cannot sell it.

Wall Street has priced MNKD where it is because market perception is that nobody wants what MannKind has to offer. Virtually no sales for Afrezza (there are an average 250,000-300,000 prandial prescriptions written weekly in the U.S.) No partners for the Technosphere pipeline. No major data publications in NEJM or AMA. Great posters at ADA-2016... then nothing since. Unless I missed it, there hasn't been a major medical journal article about Afrezza since the FDA approved it in 2014.

So, again, the article is okay, but drives home two points. Afrezza is too expensive and a number of patients want the convenience of not having to carry ice packs to keep their life-saving insulin cool.

Unfortunately, MannKind cannot market Afrezza as not needing refrigeration. They need to fix that ASAP. They also need to lower the price of Afrezza ASAP. Finally, they need to take proactive steps to market why this [currently] non-inferior insulin is different, because if the FDA rejects the application to label Afrezza with a first-in-class classification "ultra fast acting", management will have wasted 10 months to demonstrate why Afrezza will satisfy a medical necessity.

The market is speaking, but is management listening?

Wow, a very baba-like post, MN!  What's up with that?  Are you into the holiday depression mode?  Understandable if so.  I had to watch it twice, so I could focus on the news ribbon below around the time the doctor was on - so was the burglar naked or was the pizza shop that he burglarized a "clothing optional" establishment?  That what leapt out at me.  

[mnholdem]

Take a look at what's been happening throughout the industry in regard to rapid-acting analog (RAA) insulin. Many 3rd party payers have RAA insulin tiered high (Tier 3) while others are dropping coverage for certain brands of RAA insulin altogether. Lowering the price of Afrezza may or may not be sufficient to get preferred coverage, but it certainly WILL lower out-of-pocket cost to the patient, regardless of coverage. MannKind is operating in a hostile environment and must act accordingly, IMO.

In 10 months, a brand new classification of Ultra Fast-Acting for Afrezza would likely be considered to be a home run for brand marketing, but that achievement would not guarantee that Preferred tier status will be the result. PBM's are making deals with deep-pocketed pharmaceutical giants and giving them the nod for preferred status.

The battle must be fought in the consumer arena. As you are aware, I post coverage for Afrezza for all five of the formulary channels for every state in the USA and the data clearly confirms what management stated at the earnings call that there is currently about 70% coverage for Afrezza. So why isn't Afrezza selling? Perhaps one of the reasons, which didn't get mentioned, was that the copays for patients who use Afrezza are still outrageously high.

Just so you understand, I am thrilled with the news that MannKind has submitted Afrezza for reclassification. Also, I am absolutely elated that they announced progress on the pediatric trial. I believe Matt or Ray promised that they would be announcing a timeline for this all-important trial. IMO, pediatric approval is worth more than the designation "Ultra-Fast". Regardless, the FDA should be publishing the resumed trial when it starts. Just keep in mind that the FDA has been extremely harsh with Afrezza in the past and the competitors will be lobbying hard for the FDA to NOT introduce a new classification of rapid-acting insulin.

There are some things I see as definite progress for Afrezza. I stated recently that I wholeheartedly believed that Afrezza could break 3,000 scripts per week by EOY if they commenced effective DTC/DTP marketing of Afrezza beginning in September. Nothing has happened. CCO Michael Castagna has performed admirably and continues to perform well, considering what he has to work with.

I'm also convinced that Afrezza will become a blockbuster one day and I remain a fervent supporter of this company. It's hardly all gloom and doom for me, but it's infuriating to watch how this 2nd launch - or is it the 3rd? - has languished.

[mannmade]

Mn, For what its worth regarding the below quote I lift from you above post, I recall Ray saying they were expecting to hear approval of label change (not a decision on label change) from the FDA in 4th Q 2017 as I recall. I actually posted about this as I thought it was either a slip or a very confident prognosis. They are in communication with FDA about the label change which has now been submitted so perhaps the strategy is to maintain price while they wait for the label change which puts AFREZZA in the class by itself that it deserves. Just a thought as I do not know more than this.

As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?

[lennymnkd]

Hey maybe more expensive is better , the old saying / if you can't sell something raise the price . Perceive to be that much better !!!!

[madog365]

thanks for the detailed response. 

So just to be clear your solution is...Lower price of afrezza --> patients pays less but still out of pocket --> more sales of afrezza

i am by no means an expert on payer coverage so my question is even though Afrezza has 70% coverage, it's not tier 2 or preferred coverage therefore the patient is paying significant costs out of pocket where as competitive products are covered (preferred) with less cost out of pocket? How does lowering the cost even if it's by 50% fix this problem. The competitive drugs will still be less expensive bottom line for patient that is paying through insurance and not out of pocket. 

[sportsrancho]

I'm going to pass this on the best I can:
I was just working out with Tom, ( dad of the kids on Afrezza ). I let him read this thread...He says it's only 20 dollars more per month for Afrezza. ( copay ). He doesn't see that as a problem. What he does see as a problem is that there are not Doctors willing to write scripts if you are not their patient!! ( He says MNKD needs to hire a few.:-) That people will be coming from all over to go to Vdex and get a script because you can just walk in!

[Deleted]

When does Vdex open?