ADA June 22 - 26, 2018

[peppy]

professional.diabetes.org/meeting/scientific-sessions/78th-scientific-sessions
The STAT. 
clinicaltrials.gov/ct2/show/NCT03143816
This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life study where patients will continue their routine diabetes care and use post-meal correction dosages as deemed necessary for normalizing PPBG as per the protocol.
This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.
All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at every clinic visit on a secured computer. The data will be analyzed after the study for different primary and secondary end points. All patients will be allowed to keep the CGM after the study is over for their day-to-day diabetes care.

[peppy]

Mike C: On CC

"Coming into this quarterly call, I've conducted 10 listening sessions with several key members of our team around the country, in California, Texas, New York, as well as met with about 70% of the -- payers who make up about 70% of their lives, really sharing with them where the company is going, getting insights into the data coming out of ADA, and building our level of confidence as we continue to go forward to hit this year's guidance.

We continue to make progress on our prescriptions, our new writers, our new member patients coming into the brand, as well as the pipeline and international expansion. The buildup of the scientific story is something that we believe has been missing on Afrezza since day one. And I'm really proud with David Kendall here, over the last 12 weeks we've gotten several key data abstracts submitted, accepted, as well as publications that David will walk you through. And when people say when will you launch Afrezza, where you're going to make a difference, I think you're really going to start to see the scientific agenda come out for the brand starting at ADA.

What that means is we can have evening symposiums, we can have CME events that we can sponsor, we can have booths at all the key conferences, and really [indiscernible] on that scientific chatter around the brand that's been missing since day of launch. So that will give the air coverage to the sales force. We'll continue to bring thought leaders onboard, and David will share the direction we're going in that environment."

" The STAT study results are accepted for ADA, we announced that during Q1. That will be an oral presentation as well as a poster presentation. And just to remind you, that study was looking at using Dexcom's CGM looking at timing range and post-perennial controls of one to four hours. We believe this is really important as we've not had data to share in a head-to-head study against a meal-time injectable insulin. For the first time we'll have that data out there, and can reinforce what we've seen on social media and people showing their charts."

"And then the last thing I'll mention is we had an ADA late-breaking poster accepted around hypoglycemia and really demonstrating the differences of Afrezza versus other meal time insulin options. We believe the complete dataset when you look at the hypoglycemia plus STAT plus the history of the safety and efficacy of this product across the 65 trials, we start to educate the physicians on all the data we have, and they're very responsive."

Dr Kendall:
"You see here our planning for the American Diabetes Association's scientific sessions that will be held in Orlando, at the end of June of this coming year. As was noted by Pat, he and his team will have a commercial presence. We will have a medical presence, and have a number of executive encounters with professional organizations including the American Diabetes Association and organizations around the world.

We had previously announced the acceptance of both an oral presentation and a poster presentation from the so-called STAT study, a study that was first developed in collaboration with Satish Garg and colleagues at the Barbara Davis Diabetes Center looking at continuous glucose monitoring. And these results will be available in the poster sessions beginning on Saturday of the scientific sessions with an oral presentation being presented on Monday of the scientific sessions. I'm also very pleased to announce that a team here within our medical group took the opportunity to look at data performed from a trial in Type 1 diabetes and assess not just the rates of hypoglycemia, but adjusted total and severe hypoglycemia rates comparing Technosphere Insulin with Insulin Aspart. And these data will be presented as one of approximately 100 late-breaking poster presentations at the American Diabetes Association.

We also are supporting, through an independent educational grant, MannKind is supporting a discussion on the approach to post-prandial blood glucose control to inhale or inject to hope to try to share scientific information with colleagues at the meeting to understand the clinical use of inhaled insulin, comparing it to the 95-year history of injected insulin.

The next slide, please. While I've emphasized our presence at the American Diabetes Association, this is by no means the only scientific presence that our medical team is investing in, in 2018. In just two weeks time we will have both a scientific and commercial presence at the American Association of Clinical Endocrinology to be held in Boston in the middle of May. The American Diabetes Association's scientific sessions we've already discussed. MannKind has been actively involved in the keystone diabetes meetings sponsored by the Barbara Davis Diabetes Center in July of this year. And will be active both with a commercial and medical presence at the American Association of Diabetes Educator Meeting in Baltimore, in August, and the European Association for the Study of Diabetes to be held in Berlin, in October of this year.

We have scientific information being presented at the ADA. We hope to have additional scientific information presented at each of these meetings, and many of the abstracts that have been developed by our medical team are currently under review, and we hope will be accepted for presentation at these upcoming meetings. So the scientific chatter is growing, and we believe
making this scientific information available to clinicians to understand dosing, the effectiveness, safety and appropriate use can do nothing but support the commercial efforts that Pat and his team have put forth to better serve the diabetes population will require more effective meal time insulin therapy."

Operator
I apologize for the interruption.

Michael Castagna
Can you still hear me? I hope you're still here. So, sorry about that, you can't make this up.

seekingalpha.com/article/4171963-mannkinds-mnkd-ceo-michael-castagna-q1-2018-results-earnings-call-transcript?part=single

[golfeveryday]

May 11, 2018 9:26:37 GMT -5 peppy said:

Mike C: On CC

"Coming into this quarterly call, I've conducted 10 listening sessions with several key members of our team around the country, in California, Texas, New York, as well as met with about 70% of the -- payers who make up about 70% of their lives, really sharing with them where the company is going, getting insights into the data coming out of ADA, and building our level of confidence as we continue to go forward to hit this year's guidance.

We continue to make progress on our prescriptions, our new writers, our new member patients coming into the brand, as well as the pipeline and international expansion. The buildup of the scientific story is something that we believe has been missing on Afrezza since day one. And I'm really proud with David Kendall here, over the last 12 weeks we've gotten several key data abstracts submitted, accepted, as well as publications that David will walk you through. And when people say when will you launch Afrezza, where you're going to make a difference, I think you're really going to start to see the scientific agenda come out for the brand starting at ADA.

What that means is we can have evening symposiums, we can have CME events that we can sponsor, we can have booths at all the key conferences, and really [indiscernible] on that scientific chatter around the brand that's been missing since day of launch. So that will give the air coverage to the sales force. We'll continue to bring thought leaders onboard, and David will share the direction we're going in that environment."

" The STAT study results are accepted for ADA, we announced that during Q1. That will be an oral presentation as well as a poster presentation. And just to remind you, that study was looking at using Dexcom's CGM looking at timing range and post-perennial controls of one to four hours. We believe this is really important as we've not had data to share in a head-to-head study against a meal-time injectable insulin. For the first time we'll have that data out there, and can reinforce what we've seen on social media and people showing their charts."

"And then the last thing I'll mention is we had an ADA late-breaking poster accepted around hypoglycemia and really demonstrating the differences of Afrezza versus other meal time insulin options. We believe the complete dataset when you look at the hypoglycemia plus STAT plus the history of the safety and efficacy of this product across the 65 trials, we start to educate the physicians on all the data we have, and they're very responsive."

Dr Kendall:
"You see here our planning for the American Diabetes Association's scientific sessions that will be held in Orlando, at the end of June of this coming year. As was noted by Pat, he and his team will have a commercial presence. We will have a medical presence, and have a number of executive encounters with professional organizations including the American Diabetes Association and organizations around the world.

We had previously announced the acceptance of both an oral presentation and a poster presentation from the so-called STAT study, a study that was first developed in collaboration with Satish Garg and colleagues at the Barbara Davis Diabetes Center looking at continuous glucose monitoring. And these results will be available in the poster sessions beginning on Saturday of the scientific sessions with an oral presentation being presented on Monday of the scientific sessions. I'm also very pleased to announce that a team here within our medical group took the opportunity to look at data performed from a trial in Type 1 diabetes and assess not just the rates of hypoglycemia, but adjusted total and severe hypoglycemia rates comparing Technosphere Insulin with Insulin Aspart. And these data will be presented as one of approximately 100 late-breaking poster presentations at the American Diabetes Association.

We also are supporting, through an independent educational grant, MannKind is supporting a discussion on the approach to post-prandial blood glucose control to inhale or inject to hope to try to share scientific information with colleagues at the meeting to understand the clinical use of inhaled insulin, comparing it to the 95-year history of injected insulin.

The next slide, please. While I've emphasized our presence at the American Diabetes Association, this is by no means the only scientific presence that our medical team is investing in, in 2018. In just two weeks time we will have both a scientific and commercial presence at the American Association of Clinical Endocrinology to be held in Boston in the middle of May. The American Diabetes Association's scientific sessions we've already discussed. MannKind has been actively involved in the keystone diabetes meetings sponsored by the Barbara Davis Diabetes Center in July of this year. And will be active both with a commercial and medical presence at the American Association of Diabetes Educator Meeting in Baltimore, in August, and the European Association for the Study of Diabetes to be held in Berlin, in October of this year.

We have scientific information being presented at the ADA. We hope to have additional scientific information presented at each of these meetings, and many of the abstracts that have been developed by our medical team are currently under review, and we hope will be accepted for presentation at these upcoming meetings. So the scientific chatter is growing, and we believe
making this scientific information available to clinicians to understand dosing, the effectiveness, safety and appropriate use can do nothing but support the commercial efforts that Pat and his team have put forth to better serve the diabetes population will require more effective meal time insulin therapy."

Operator
I apologize for the interruption.

Michael Castagna
Can you still hear me? I hope you're still here. So, sorry about that, you can't make this up.

seekingalpha.com/article/4171963-mannkinds-mnkd-ceo-michael-castagna-q1-2018-results-earnings-call-transcript?part=single

[

‘Scientific and commercial presence’

AACE Boston May
AADE Baltimore Aug
EASD Berlin October

One would assume any new marketing campaign would be part of this ‘commercial presence’ in the form of a booth at these events. Interesting the first one is this month, starting May 16th, the day of the ASM. Also interesting is the fact there will be a ‘commercial presence’ at EASD in Berlin.

[goyocafe]

Ever since Dr. Kendall came on board, the use of the term "Standard of care" has become a prominent point that has not been used before. We've talked about it on PB, but I don't recall MNKD using that term aggressively in the past. I don't know if that's due to confidence being built from the STAT study, or something Dr. Kendall has established as MNKD's rallying cry, but it seems to be used frequently now compared to before.

[od]

May 11, 2018 9:49:33 GMT -5 golfeveryday said:

May 11, 2018 9:26:37 GMT -5 peppy said:

Mike C: On CC

"Coming into this quarterly call, I've conducted 10 listening sessions with several key members of our team around the country, in California, Texas, New York, as well as met with about 70% of the -- payers who make up about 70% of their lives, really sharing with them where the company is going, getting insights into the data coming out of ADA, and building our level of confidence as we continue to go forward to hit this year's guidance.

We continue to make progress on our prescriptions, our new writers, our new member patients coming into the brand, as well as the pipeline and international expansion. The buildup of the scientific story is something that we believe has been missing on Afrezza since day one. And I'm really proud with David Kendall here, over the last 12 weeks we've gotten several key data abstracts submitted, accepted, as well as publications that David will walk you through. And when people say when will you launch Afrezza, where you're going to make a difference, I think you're really going to start to see the scientific agenda come out for the brand starting at ADA.

What that means is we can have evening symposiums, we can have CME events that we can sponsor, we can have booths at all the key conferences, and really [indiscernible] on that scientific chatter around the brand that's been missing since day of launch. So that will give the air coverage to the sales force. We'll continue to bring thought leaders onboard, and David will share the direction we're going in that environment."

" The STAT study results are accepted for ADA, we announced that during Q1. That will be an oral presentation as well as a poster presentation. And just to remind you, that study was looking at using Dexcom's CGM looking at timing range and post-perennial controls of one to four hours. We believe this is really important as we've not had data to share in a head-to-head study against a meal-time injectable insulin. For the first time we'll have that data out there, and can reinforce what we've seen on social media and people showing their charts."

"And then the last thing I'll mention is we had an ADA late-breaking poster accepted around hypoglycemia and really demonstrating the differences of Afrezza versus other meal time insulin options. We believe the complete dataset when you look at the hypoglycemia plus STAT plus the history of the safety and efficacy of this product across the 65 trials, we start to educate the physicians on all the data we have, and they're very responsive."

Dr Kendall:
"You see here our planning for the American Diabetes Association's scientific sessions that will be held in Orlando, at the end of June of this coming year. As was noted by Pat, he and his team will have a commercial presence. We will have a medical presence, and have a number of executive encounters with professional organizations including the American Diabetes Association and organizations around the world.

We had previously announced the acceptance of both an oral presentation and a poster presentation from the so-called STAT study, a study that was first developed in collaboration with Satish Garg and colleagues at the Barbara Davis Diabetes Center looking at continuous glucose monitoring. And these results will be available in the poster sessions beginning on Saturday of the scientific sessions with an oral presentation being presented on Monday of the scientific sessions. I'm also very pleased to announce that a team here within our medical group took the opportunity to look at data performed from a trial in Type 1 diabetes and assess not just the rates of hypoglycemia, but adjusted total and severe hypoglycemia rates comparing Technosphere Insulin with Insulin Aspart. And these data will be presented as one of approximately 100 late-breaking poster presentations at the American Diabetes Association.

We also are supporting, through an independent educational grant, MannKind is supporting a discussion on the approach to post-prandial blood glucose control to inhale or inject to hope to try to share scientific information with colleagues at the meeting to understand the clinical use of inhaled insulin, comparing it to the 95-year history of injected insulin.

The next slide, please. While I've emphasized our presence at the American Diabetes Association, this is by no means the only scientific presence that our medical team is investing in, in 2018. In just two weeks time we will have both a scientific and commercial presence at the American Association of Clinical Endocrinology to be held in Boston in the middle of May. The American Diabetes Association's scientific sessions we've already discussed. MannKind has been actively involved in the keystone diabetes meetings sponsored by the Barbara Davis Diabetes Center in July of this year. And will be active both with a commercial and medical presence at the American Association of Diabetes Educator Meeting in Baltimore, in August, and the European Association for the Study of Diabetes to be held in Berlin, in October of this year.

We have scientific information being presented at the ADA. We hope to have additional scientific information presented at each of these meetings, and many of the abstracts that have been developed by our medical team are currently under review, and we hope will be accepted for presentation at these upcoming meetings. So the scientific chatter is growing, and we believe
making this scientific information available to clinicians to understand dosing, the effectiveness, safety and appropriate use can do nothing but support the commercial efforts that Pat and his team have put forth to better serve the diabetes population will require more effective meal time insulin therapy."

Operator
I apologize for the interruption.

Michael Castagna
Can you still hear me? I hope you're still here. So, sorry about that, you can't make this up.

seekingalpha.com/article/4171963-mannkinds-mnkd-ceo-michael-castagna-q1-2018-results-earnings-call-transcript?part=single

[

‘Scientific and commercial presence’

AACE Boston May
AADE Baltimore Aug
EASD Berlin October

One would assume any new marketing campaign would be part of this ‘commercial presence’ in the form of a booth at these events. Interesting the first one is this month, starting May 16th, the day of the ASM. Also interesting is the fact there will be a ‘commercial presence’ at EASD in Berlin.

Why the fuss over MNKD acting as a professionally managed pharmaceutical company?  (If the message is 'about time', I get it.) 

[peppy]

May 11, 2018 10:56:06 GMT -5 goyocafe said:

Ever since Dr. Kendall came on board, the use of the term "Standard of care" has become a prominent point that has not been used before. We've talked about it on PB, but I don't recall MNKD using that term aggressively in the past. I don't know if that's due to confidence being built from the STAT study, or something Dr. Kendall has established as MNKD's rallying cry, but it seems to be used frequently now compared to before.

Here is my take, Kendall is an ADA man. Chief Scientific Officer at the ADA.
Kendall knows well, mealtime insulin is already on the ADA standard of care. So all those type two's that are failing in their triple therapy and should be moved to mealtime insulin, the physician resisting, frankly because of the danger of meal time insulin hypoglycemia. With afrezza, there is a mealtime insulin alternative, both the physician and the patient could buy into, especially with a CGM, which is now paid for by insurance in the USA for the most part. 



Turns out Mango happened to put up a chart showing a CGM with an individual on triple therapy.



The maximum recommended daily dose of GLUCOPHAGE is 2550 mg in adults and 2000 mg in pediatric patients (10-16 years of age); the maximum recommended daily dose of GLUCOPHAGE XR in adults is 2000 mg.

Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation.

FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)

Triple therapy.

Our other market. 

investors.mannkindcorp.com/static-files/76875d41-2743-4a29-a76a-bc00f6d1ea33

[digger]

May 11, 2018 10:56:06 GMT -5 goyocafe said:

Ever since Dr. Kendall came on board, the use of the term "Standard of care" has become a prominent point that has not been used before. We've talked about it on PB, but I don't recall MNKD using that term aggressively in the past. I don't know if that's due to confidence being built from the STAT study, or something Dr. Kendall has established as MNKD's rallying cry, but it seems to be used frequently now compared to before.

Every year the ADA adjusts its standards of care and releases updates -- www.diabetes.org/newsroom/press-releases/2017/american-diabetes-association-2018-release-standards-of-medical-care-in-diabetes.html.

Judging from what I read there, getting those adjusted takes some serious work.

[peppy]

May 11, 2018 11:31:39 GMT -5 digger said:

May 11, 2018 10:56:06 GMT -5 goyocafe said:

Ever since Dr. Kendall came on board, the use of the term "Standard of care" has become a prominent point that has not been used before. We've talked about it on PB, but I don't recall MNKD using that term aggressively in the past. I don't know if that's due to confidence being built from the STAT study, or something Dr. Kendall has established as MNKD's rallying cry, but it seems to be used frequently now compared to before.

Every year the ADA adjusts its standards of care and releases updates -- www.diabetes.org/newsroom/press-releases/2017/american-diabetes-association-2018-release-standards-of-medical-care-in-diabetes.html.

Judging from what I read there, getting those adjusted takes some serious work.

so did you see hypoglycemia qualified? there is an adjustment.

"Three new recommendations were added to highlight the importance of individualizing pharmacologic therapy for older adults with diabetes to reduce the risk of hypoglycemia, avoid overtreatment and simplify complex regimens while maintaining personalized blood glucose targets. (Section 11, page S122)"

[mnholdem]

May 11, 2018 11:31:39 GMT -5 digger said:

May 11, 2018 10:56:06 GMT -5 goyocafe said:

Ever since Dr. Kendall came on board, the use of the term "Standard of care" has become a prominent point that has not been used before. We've talked about it on PB, but I don't recall MNKD using that term aggressively in the past. I don't know if that's due to confidence being built from the STAT study, or something Dr. Kendall has established as MNKD's rallying cry, but it seems to be used frequently now compared to before.

Every year the ADA adjusts its standards of care and releases updates -- www.diabetes.org/newsroom/press-releases/2017/american-diabetes-association-2018-release-standards-of-medical-care-in-diabetes.html.

Judging from what I read there, getting those adjusted takes some serious work.

We posted on this a few weeks ago on another thread. The ADA just announced their Living Standards of Care, which can be updated several times each year as new developments occur.

[dreamboatcruise]

May 11, 2018 11:31:39 GMT -5 digger said:

May 11, 2018 10:56:06 GMT -5 goyocafe said:

Ever since Dr. Kendall came on board, the use of the term "Standard of care" has become a prominent point that has not been used before. We've talked about it on PB, but I don't recall MNKD using that term aggressively in the past. I don't know if that's due to confidence being built from the STAT study, or something Dr. Kendall has established as MNKD's rallying cry, but it seems to be used frequently now compared to before.

Every year the ADA adjusts its standards of care and releases updates -- www.diabetes.org/newsroom/press-releases/2017/american-diabetes-association-2018-release-standards-of-medical-care-in-diabetes.html.

Judging from what I read there, getting those adjusted takes some serious work.

Especially with the financial might behind the entrenched players benefiting from current standard of care.  Regardless of how often they review, it is still going to be a long time to see changes that would meaningfully tilt things in Afrezza's favor.

[mnholdem]

Don't be so sure of yourself. MannKind has some heavy hitters working for it now.

[dreamboatcruise]

May 11, 2018 11:24:45 GMT -5 peppy said:

May 11, 2018 10:56:06 GMT -5 goyocafe said:

Here is my take, Kendall is an ADA man. Chief Scientific Officer at the ADA.
Kendall knows well, mealtime insulin is already on the ADA standard of care. So all those type two's that are failing in their triple therapy and should be moved to mealtime insulin, the physician resisting, frankly because of the danger of meal time insulin hypoglycemia. With afrezza, there is a mealtime insulin alternative, both the physician and the patient could buy into, especially with a CGM, which is now paid for by insurance in the USA for the most part. 

Medicare yes, but I don't think that is yet true for other insurance for T2s.

It should be for all patients needing insulin.

[mnholdem]

[mnholdem]

MannKind's Booth #403 is located at the hall entrance near the Product Theatre (image lower left).  Not a bad location, IMO.

[agedhippie]

May 11, 2018 15:04:13 GMT -5 dreamboatcruise said:

May 11, 2018 11:24:45 GMT -5 peppy said:

Here is my take, Kendall is an ADA man. Chief Scientific Officer at the ADA.
Kendall knows well, mealtime insulin is already on the ADA standard of care. So all those type two's that are failing in their triple therapy and should be moved to mealtime insulin, the physician resisting, frankly because of the danger of meal time insulin hypoglycemia. With afrezza, there is a mealtime insulin alternative, both the physician and the patient could buy into, especially with a CGM, which is now paid for by insurance in the USA for the most part. 

Medicare yes, but I don't think that is yet true for other insurance for T2s.

It should be for all patients needing insulin.

The Advantage plans are bit spotty - I *think* Kaiser is the only one that will let you have a CGM at the moment. If you are direct with Medicare then there is a lot less of a problem. Medicare has selection criteria to decide if you get a CGM.