Afrezza Will Succeed But Initial Sales Likely To Disappoint
Aug 3, 2015 8:41:44 GMT -5
jpg, babaoriley, and 3 more like this
Post by sla55 on Aug 3, 2015 8:41:44 GMT -5
www.forbes.com/sites/kenkam/2015/02/20/afrezza-will-succeed-but-initial-sales-likely-to-disappoint/
If MannKind (NASDAQ:MNKD) could say Afrezza reduces complications such as hypoglycemic events, weight gain, premature organ failure, etc., Afrezza would be one of the most successful product launches in pharmaceutical history. But, here’s the rub. Since they are not going to be able to make such claims at the launch, investors who think otherwise will be disappointed with initial sales results, even though they may be eventually proven right.
This issue arises because Mannkind presented a slide at the FDA Advisory Committee meeting which showed that Afrezza is metabolized over time, much like insulin produced by non-diabetic individuals, which is very different from the way rapid acting analogues are metabolized.
As a result, many have made the logical conclusion that using Afrezza should result in fewer complications. However, while the logic makes sense, the conclusion is not yet proven, and the sales reps can only market claims that are proven.
On MannKind, Diabetics Have One Up On Wall Street. (Photo credit: istockphoto.com)
What the clinical trials have proven, and what sales reps can say, is that Afrezza is “not inferior” to existing alternatives. This claim alone makes Afrezza attractive for patients who don’t like to inject themselves in public and should lead to a successful launch, even if initial sales disappoint MannKind’s most zealous shareholders.
I’ve reached these conclusions after reviewing the responses that were emailed to me or left as comments to Afrezza Breathes Life Into Mannkind, Diabetics: Use Your Firsthand Experience To Beat Wall Street, and On MannKind, Diabetics Have One Up On Wall Street.
On the question of whether “no needles” alone is enough to make Afrezza successful assuming non-inferiority, these 5 responses are typical of the ones I found compelling. In the interests of privacy, I’m only going to use first names.
www.youtube.com/watch?v=NgN-waVAs8w
www.youtube.com/watch?v=_HGGgaKQDT0
Rick: I have been a type 1 diabetic for almost forty years and one of my brothers, my two sisters, and two of my nephews are also type 1 diabetics. For those on the pump, the inhaled insulin may not be of social benefit, but for those of us using pens and syringes, the social benefit you mention is absolutely correct. My brother and I have always said, “I need to shoot up”. On the same “social note,” when injecting insulin, one might need to untuck a shirt and/or unbuckle belts for site location and this prolongs the event, making it harder to be quick and discrete. When out to dinner with a group, often one excuses themselves to go to the restroom (for privacy) and in reality, it can be less private in there. As a young man and a new diabetic, I was embarrassed and felt “less than,” so I would go out to my car.
Jeff: I am a 25 year diabetic and take 3 insulin shots a day and still have issues. I have not used Afrezza yet, but plan on asking for it as soon as it is available. I travel a lot for business and therefore eat in many restaurants. It is very difficult to use insulin in a public setting.
Brian: I have been a type 1 diabetic now for 16 years… I absolutely hate the shots. You have to keep it (the insulin) refrigerated, can not shake up the vials too much while traveling. The injections are uncomfortable to do in public, they leave bruises, and they hurt, just to name some of the drawbacks.
Ryan: I am a type 1 diabetic diagnosed at age 23. Presently I am 29 and proud to say I am doing very well… I already take insulin shots in public areas. It can be difficult and at times embarrassing, but it’s always worked out fine. I do get the occasional ‘look,’ but no one has ever questioned it. One thing I am shocked about though is how in all my years as an insulin dependent diabetic, I have only seen 1 other person take an insulin shot in public.
Kristen: I have had T1 diabetes for 46 years. I have always been overzealous in my proactive treatment with insulin. Of the 5110+ pricks a year, 2190+ of them are injections-6 to 8 a day with the rest testing myself. I have done the restaurant get-up-from-the-table-to-take-a-shot routine. I have “shot up” at the table with the stares that happen when I do it… I challenge Mr. Pile and other diabetes guru’s to spend a day with me. I challenge all of them to shoot up with an empty syringe everytime I do, no matter where I am. Needle sticks NEVER become “tolerable!” … We “existing patients” will jump on this like a flea on a dog in August. (Nate agrees with you Kristen.)
If you still doubt that “no needles” is an important enough benefit to make Afrezza successful assuming non-inferiority watch these two videos and try to imagine yourself using either an insulin pen or an inhaler in a public place
The reason expectations for initial sales may be too high is because of comments like the following.
Jenny: I used fast acting insulin for over five years. So let me tell you right now, I’m really excited about Afrezza–again not because it is inhaled, but because of the pharmacokinetics you dismissed as not important… The FDA did not let the label state that Afrezza stops hypos, but the people I have heard from who were in the Afrezza trials tell me it stops SEVERE hypos. This makes sense as it stops acting so much earlier than the injected insulins. It takes an hour or two for the severe hypo to come on. Since Afrezza is gone so much faster, it doesn’t have the time to cause those life-threatening deep hypos.
William: I am a type 2 diabetic who was a participant in one of the last trials before Afrezza was approved by the FDA. Although the ease of use, comfort, and distaste for carrying needle-tipped injection devices to use several times per day, hopefully in some searched-for private place is more than obvious, I feel comfortable in disputing the opinion there are no medical benefits to Afrezza’s small, convenient, inhaling device, the insulin to the lungs is faster entering the blood stream and faster exiting. This should result in fewer/lower spikes and conversely fewer potentially dangerous low blood sugar (hypoglycemic) episodes.
Kathleen: You say you have seen the PK slide, but have you actually looked at the data in the document submitted to the FDA and to the doctors on the AdCom panel? If you look thoroughly enough, you will see data showing a STATISTICALLY SIGNIFICANT REDUCTION IN HYPOS In Afrezza Users. This was a study done with real people using Afrezza. It boggles my mind that you cannot accept this PROVEN fact and include it in your assessment.
I did look at the data and I asked several people whether it was a proven fact that Afrezza users had fewer hypoglycemic events. The best response came from a doctor, who I’ll refer to as Doc to protect his privacy.
Doc: The data obtained from small studies is interesting and possibly relevant, but the truth is only until large numbers of patients are using this drug, will we realize the full implications of this new approach to insulin therapy. Will there be a significant drop in ER visits by diabetics? Will there be less weight gain associated? What will be the CV benefit? Will there be less premature end organ failure? Really, the list goes on and on. Focusing on any one parameter at this moment seems premature, time will tell the story.
My Take: To solve an unmet medical need, a new drug has to prove itself to be superior than the current standard of care. Afrezza’s clinical trials were designed to show non-inferiority, not superiority, to existing alternatives. At the launch, Afrezza will be marketed as a non-inferior alternative to insulin pens to control blood sugar without needles. I think there are enough patients who value “no needles” to make Afrezza successful.
It may take a few years before doctors will gain enough clinical experience with Afrezza’s PK profile to know whether it results in fewer complications. In the next 6 months, however, initial sales will likely disappoint those who think this is already a proven fact. I wouldn’t bet the farm on MannKind, but if I had a portfolio of 10 stocks with the same risk-reward profile, I would bet the farm on that portfolio.
Next Steps: To understand how difficult the initial launch will be, we need to get some feedback from diabetics who don’t already know about Afrezza which I suspect is the overwhelming majority of potential customers. Will these patients take the initiative to consult with their doctors, or will they wait for their doctors to contact them about Afrezza?
Vincent DeRobertis, Senior Vice President of Global Healthcare at Research Now, has offered to use their diabetes panel get us this feedback. I’ll report the results next week.
If MannKind (NASDAQ:MNKD) could say Afrezza reduces complications such as hypoglycemic events, weight gain, premature organ failure, etc., Afrezza would be one of the most successful product launches in pharmaceutical history. But, here’s the rub. Since they are not going to be able to make such claims at the launch, investors who think otherwise will be disappointed with initial sales results, even though they may be eventually proven right.
This issue arises because Mannkind presented a slide at the FDA Advisory Committee meeting which showed that Afrezza is metabolized over time, much like insulin produced by non-diabetic individuals, which is very different from the way rapid acting analogues are metabolized.
As a result, many have made the logical conclusion that using Afrezza should result in fewer complications. However, while the logic makes sense, the conclusion is not yet proven, and the sales reps can only market claims that are proven.
On MannKind, Diabetics Have One Up On Wall Street. (Photo credit: istockphoto.com)
What the clinical trials have proven, and what sales reps can say, is that Afrezza is “not inferior” to existing alternatives. This claim alone makes Afrezza attractive for patients who don’t like to inject themselves in public and should lead to a successful launch, even if initial sales disappoint MannKind’s most zealous shareholders.
I’ve reached these conclusions after reviewing the responses that were emailed to me or left as comments to Afrezza Breathes Life Into Mannkind, Diabetics: Use Your Firsthand Experience To Beat Wall Street, and On MannKind, Diabetics Have One Up On Wall Street.
On the question of whether “no needles” alone is enough to make Afrezza successful assuming non-inferiority, these 5 responses are typical of the ones I found compelling. In the interests of privacy, I’m only going to use first names.
www.youtube.com/watch?v=NgN-waVAs8w
www.youtube.com/watch?v=_HGGgaKQDT0
Rick: I have been a type 1 diabetic for almost forty years and one of my brothers, my two sisters, and two of my nephews are also type 1 diabetics. For those on the pump, the inhaled insulin may not be of social benefit, but for those of us using pens and syringes, the social benefit you mention is absolutely correct. My brother and I have always said, “I need to shoot up”. On the same “social note,” when injecting insulin, one might need to untuck a shirt and/or unbuckle belts for site location and this prolongs the event, making it harder to be quick and discrete. When out to dinner with a group, often one excuses themselves to go to the restroom (for privacy) and in reality, it can be less private in there. As a young man and a new diabetic, I was embarrassed and felt “less than,” so I would go out to my car.
Jeff: I am a 25 year diabetic and take 3 insulin shots a day and still have issues. I have not used Afrezza yet, but plan on asking for it as soon as it is available. I travel a lot for business and therefore eat in many restaurants. It is very difficult to use insulin in a public setting.
Brian: I have been a type 1 diabetic now for 16 years… I absolutely hate the shots. You have to keep it (the insulin) refrigerated, can not shake up the vials too much while traveling. The injections are uncomfortable to do in public, they leave bruises, and they hurt, just to name some of the drawbacks.
Ryan: I am a type 1 diabetic diagnosed at age 23. Presently I am 29 and proud to say I am doing very well… I already take insulin shots in public areas. It can be difficult and at times embarrassing, but it’s always worked out fine. I do get the occasional ‘look,’ but no one has ever questioned it. One thing I am shocked about though is how in all my years as an insulin dependent diabetic, I have only seen 1 other person take an insulin shot in public.
Kristen: I have had T1 diabetes for 46 years. I have always been overzealous in my proactive treatment with insulin. Of the 5110+ pricks a year, 2190+ of them are injections-6 to 8 a day with the rest testing myself. I have done the restaurant get-up-from-the-table-to-take-a-shot routine. I have “shot up” at the table with the stares that happen when I do it… I challenge Mr. Pile and other diabetes guru’s to spend a day with me. I challenge all of them to shoot up with an empty syringe everytime I do, no matter where I am. Needle sticks NEVER become “tolerable!” … We “existing patients” will jump on this like a flea on a dog in August. (Nate agrees with you Kristen.)
If you still doubt that “no needles” is an important enough benefit to make Afrezza successful assuming non-inferiority watch these two videos and try to imagine yourself using either an insulin pen or an inhaler in a public place
The reason expectations for initial sales may be too high is because of comments like the following.
Jenny: I used fast acting insulin for over five years. So let me tell you right now, I’m really excited about Afrezza–again not because it is inhaled, but because of the pharmacokinetics you dismissed as not important… The FDA did not let the label state that Afrezza stops hypos, but the people I have heard from who were in the Afrezza trials tell me it stops SEVERE hypos. This makes sense as it stops acting so much earlier than the injected insulins. It takes an hour or two for the severe hypo to come on. Since Afrezza is gone so much faster, it doesn’t have the time to cause those life-threatening deep hypos.
William: I am a type 2 diabetic who was a participant in one of the last trials before Afrezza was approved by the FDA. Although the ease of use, comfort, and distaste for carrying needle-tipped injection devices to use several times per day, hopefully in some searched-for private place is more than obvious, I feel comfortable in disputing the opinion there are no medical benefits to Afrezza’s small, convenient, inhaling device, the insulin to the lungs is faster entering the blood stream and faster exiting. This should result in fewer/lower spikes and conversely fewer potentially dangerous low blood sugar (hypoglycemic) episodes.
Kathleen: You say you have seen the PK slide, but have you actually looked at the data in the document submitted to the FDA and to the doctors on the AdCom panel? If you look thoroughly enough, you will see data showing a STATISTICALLY SIGNIFICANT REDUCTION IN HYPOS In Afrezza Users. This was a study done with real people using Afrezza. It boggles my mind that you cannot accept this PROVEN fact and include it in your assessment.
I did look at the data and I asked several people whether it was a proven fact that Afrezza users had fewer hypoglycemic events. The best response came from a doctor, who I’ll refer to as Doc to protect his privacy.
Doc: The data obtained from small studies is interesting and possibly relevant, but the truth is only until large numbers of patients are using this drug, will we realize the full implications of this new approach to insulin therapy. Will there be a significant drop in ER visits by diabetics? Will there be less weight gain associated? What will be the CV benefit? Will there be less premature end organ failure? Really, the list goes on and on. Focusing on any one parameter at this moment seems premature, time will tell the story.
My Take: To solve an unmet medical need, a new drug has to prove itself to be superior than the current standard of care. Afrezza’s clinical trials were designed to show non-inferiority, not superiority, to existing alternatives. At the launch, Afrezza will be marketed as a non-inferior alternative to insulin pens to control blood sugar without needles. I think there are enough patients who value “no needles” to make Afrezza successful.
It may take a few years before doctors will gain enough clinical experience with Afrezza’s PK profile to know whether it results in fewer complications. In the next 6 months, however, initial sales will likely disappoint those who think this is already a proven fact. I wouldn’t bet the farm on MannKind, but if I had a portfolio of 10 stocks with the same risk-reward profile, I would bet the farm on that portfolio.
Next Steps: To understand how difficult the initial launch will be, we need to get some feedback from diabetics who don’t already know about Afrezza which I suspect is the overwhelming majority of potential customers. Will these patients take the initiative to consult with their doctors, or will they wait for their doctors to contact them about Afrezza?
Vincent DeRobertis, Senior Vice President of Global Healthcare at Research Now, has offered to use their diabetes panel get us this feedback. I’ll report the results next week.
I don't take it personally at All ! I just want others to be Aware . This has happened to me twice now . Like I said some are getting desperate & it's not me . I sleep just fine 
I thought you just played one on TV, like Coco.