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Post by benh on May 9, 2015 5:21:24 GMT -5
It's easy to see how people think the FDA are inept and corrupt. Sorry sir, the caffiene trial is null and void. Some drank from blue mugs, not the red ones. Do you know when the 2 short studies were submitted.? Do you have any links, I interpeted that comment to mean that plans for post approval studies, including REMS, were submitted to FDA for approval. I am under the impression that a company seeking to use clinical data in support of an approved drug is wise, if not required, to first seek FDA guidance on its design. Chris C Makes perfect sense. I'm just trying to get a handle on time span. |
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Post by Deleted on May 9, 2015 8:49:16 GMT -5
On the call yesterday, MNKD leadership commented on the challenges of prior authorization. Any Rx manufacturer will tell you about the hassles of this especially if it is a new product, or a product that for whatever reason is not on formulary. Here is a link to a company that has a software solution they call ePA. Perhaps this technology will not make the PA process a breeze for every Afrezza prescription but it can help. www.covermymeds.com/main/I am troubled by managements comments that prior authorization and spirometry have been significant impediments to Rx growth. While challenges, they seem no greater than the multitude of other issues that all Rx manufacturers face when launching a new product. In the case of Afrezza, I would think time to create physician awareness and educate them how Afrezza works and why it is different would be the greatest challenge at this point. |
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Post by rch51 on May 9, 2015 9:39:26 GMT -5
>>>I am troubled by managements comments that prior authorization and spirometry have been significant impediments to Rx growth. While challenges, they seem no greater than the multitude of other issues that all Rx manufacturers face when launching a new product. In the case of Afrezza, I would think time to create physician awareness and educate them how Afrezza works and why it is different would be the greatest challenge at this point.<<<
I am also disturbed by this. Especially troubling because the Spirometry hurdle has been a known entity since day one. It should have been trouble shot months ago. Why didn't Sanofi plan for this before launch?
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Post by hawkfan9 on May 9, 2015 10:10:08 GMT -5
This was just posted by "The Hawk" on SA. Does anyone agree with his/her timeline for prescriptions? Does it really take this long to get into an endo?
It was posted on his article about Afrezza hitting 1 million in sales in case you wanted to read it in context with the other comments.
"I do not think it is a significant obstacle in the long run, but we could see how it could hamper sales in the first 90 days. Lets look at this scenario:
A patient who has heard of Afrezza and would like to try it now, rather than waiting until their next general appointment with their provider, calls and schedules an appointment with their doctor. Depending on if it is an endocrinologist, or a primary provider, the next available appointment could be anywhere from the next day to three weeks from then. Lets say they got an appointment 2 weeks from when they called.
They go into the appointment and talk about getting Afrezza. They agree they would like to try it and schedule a pulmonary test. They are able to get into a place with the test three days later and concurrently schedule another appointment with their provider for (again, highly depends on doctor) two weeks from that date. You are cleared to use Afrezza and are given a 10 day trial. Luckily, you are able to get an appointment with your doctor exactly 10 days from now (possibly unlikely). The trial goes great and you are finally given a prescription for Afrezza.
This whole scenario could have a patient waiting just over 5 weeks and this is from the time that they attempted to schedule an appointment, not including the time they haven't even heard about it, or the time they take doing research deciding if it is something they want to try.
I realize that for many people the wait could be much less then the above scenario. But, I imagine the above scenario happens to quite a few people. Also, your endo must be on board with Afrezza. If not, it could take time to persuade them or take time to find and schedule an appointment with a new doctor.
Hopefully the measures Mannkind and Sanofi are looking to take will make things much easier for everyone involved."
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Post by kball on May 9, 2015 10:14:06 GMT -5
On the call yesterday, MNKD leadership commented on the challenges of prior authorization. Any Rx manufacturer will tell you about the hassles of this especially if it is a new product, or a product that for whatever reason is not on formulary. Here is a link to a company that has a software solution they call ePA. Perhaps this technology will not make the PA process a breeze for every Afrezza prescription but it can help. www.covermymeds.com/main/
I am troubled by managements comments that prior authorization and spirometry have been significant impediments to Rx growth. While challenges, they seem no greater than the multitude of other issues that all Rx manufacturers face when launching a new product. In the case of Afrezza, I would think time to create physician awareness and educate them how Afrezza works and why it is different would be the greatest challenge at this point. The more i think about this, the more i see those CC comments as 1. Stopping just short of throwing Sanofi under the bus 2. While at the same time they wouldnt want to get too far ahead of manufacturing capacity early on. That would be a much worse PR problem imo...though better for sales obviously. Solution: Ramp up on production as additional lines fire up alongside a ramp up in sales and educational efforts. |
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Post by pktrump on May 9, 2015 10:43:19 GMT -5
I find the obstacle of a 400$ spirometry machine a small one. Every Pulmonologists, Allergist, most Internists have one and charge 40$ a pop for the procedure which takes 3 minutes. It doesnt take much time to recoup ones spirometry expense. My entire family has a spirometry test once a year at our Allergist. Ridiculously easy and nonivasive.
AFZ is a 2 billion dollar drug and has been through extensive tests for years. That Endocrinologists as a whole are not in a position to prescribe or are not in the know about the pharmokinetics of AFZ says a
lot about Endocrinologists Societies and leadership. (I certainly aware that there are some very good proactive Endos out there, but this is the first real ultra-acting insulin----come on where are the publications, discussions or objective articles?.)
My opinion is SNY should focus on the Endo key leaders but should really focus on the PCPs, PAs, and Internists give the exponentially larger numbers of these providers, appointment availability, and the huge numbers of diabetics. Quit with the secretive nature of marketing and strategies that has suppressed understanding and allowed for relentless attacks: get out there.
Trying to siphon interested Diabetics through Endo apts is like siphoning a lake through a garden hose.
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Post by hawkfan9 on May 9, 2015 11:20:19 GMT -5
Yes, pktrump, I agree. The mass amount of prescriptions are going to come from PAs, PCPs, NPs, etc. I wonder if Sanofi targeted the endo's first because they are the ones most likely to publish articles and do further research on AFZ. NPs, PAs, etc do not usually conduct research and usually are not people that the diabetic treating community looks to for guidance.
You also have to realize that just because we have hours and hours to do due diligence on this one company and one drug, PCPS do not have this luxury. A lot of the people who will be prescribing this drug rely heavily on there peers and leaders on what is truly superior, and even as an investor in Mannkind, if I were a doctor, I am not so sure I would be pushing for patients to get on AFZ. If the patient inquired, I would oblige. But, I would probably wait until a formal article in a journal is published, or until the medical community as whole adopts AFZ as superior.
There are so many situations and speculations about why the slow roll out is occurring it is beginning to make my head spin. But, I am very confident that AFZ will be found superior, the money question is: When?
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Post by Chris-C on May 9, 2015 11:23:20 GMT -5
I find the obstacle of a 400$ spirometry machine a small one. Every Pulmonologists, Allergist, most Internists have one and charge 40$ a pop for the procedure which takes 3 minutes. It doesnt take much time to recoup ones spirometry expense. My entire family has a spirometry test once a year at our Allergist. Ridiculously easy and nonivasive. AFZ is a 2 billion dollar drug and has been through extensive tests for years. That Endocrinologists as a whole are not in a position to prescribe or are not in the know about the pharmokinetics of AFZ says a lot about Endocrinologists Societies and leadership. (I certainly aware that there are some very good proactive Endos out there, but this is the first real ultra-acting insulin----come on where are the publications, discussions or objective articles?.) My opinion is SNY should focus on the Endo key leaders but should really focus on the PCPs, PAs, and Internists give the exponentially larger numbers of these providers, appointment availability, and the huge numbers of diabetics. Quit with the secretive nature of marketing and strategies that has suppressed understanding and allowed for relentless attacks: get out there. Trying to siphon interested Diabetics through Endo apts is like siphoning a lake through a garden hose. Therefore, given all that has been revealed by the companies, and by anecdotal reports, it is clear that sales require a long term, persistent, multifaceted approach that involves many moving parts- spirometry, targeting Key opinion leaders, endo education, education for other PCPs and providers, including nurses and diabetes educators, plus navigating the maze of insurance providers for approvals. In some ways, this makes the ramping up of new production lines less problematic, as capacity will expand as demand expands. The marathon is just beginning...a paradigm shift will occur, and eventually, the turtle will catch up with the rabbit. This will happen- but until it does, don't expect great changes in the share price. |
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Post by EveningOfTheDay on May 9, 2015 16:32:55 GMT -5
This will happen- but until it does, don't expect great changes in the share price. Right now I would be happy if the sp would stop eroding, although I do not even expect that. It was always somewhat obvious that penetration would take time, the issues we are seeing were the same issues Pfizer saw with Exubera. It is somewhat of a pity that neither Sanofy nor Mannkind seem to have paid much attention to the recent history of that attempt to learn some lessons. Afrezza is clearly superior, but it is not enough that the companies know it, they have to find a way to present that effectively. Perhaps they are working on it and we will be surprised in a few quarters, but the longer they go without an apparent operating plan, the more I am convinced they went into it with a rather naive approach. IMHO the range of alternatives could be much worst and might include accepting that Sanofi might not really be interested, for whatever reason, in pushing Afrezza. That has never made any sense to me, so I choose to believe that they have a reason for all this, but as a MNKD shareholder I don't look to Sanofi for answers, but to MNKD's management, and this last conference call was completely dysfunctional. It is twice or three times now that Hakan has mentioned positive feedback in Tweeter as prove of the superiority of the drug and its potential. The first time it really bother me, but I brushed it off as a somewhat naive comment. This last time, taken together with his cute assertion that he is a candidate for Afrezza but he is having a hard time getting an appointment with his endo, made me really concerned. I can easily put up with the company not revealing anything on the grounds of their agreement with Sanofi, but this last conference call was a total disaster. It almost felt like they were completely winging it as they went. Again, is not what it was not said that bothered me, but what was said and how they presented it. When I first started investing in MNKD i decided I would wait a couple of years to see where it was going before deciding how to proceed. I am in a bit over a year not and that is still my plan, but, unfortunately, I am much less confident today than I was a year ago. The only advantage I see is that this has allowed me to actively work in getting a lower weighted average for my shares, but even that is quickly turning into a rather meager consolation. |
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Post by jimo on May 9, 2015 17:44:41 GMT -5
>>>I am troubled by managements comments that prior authorization and spirometry have been significant impediments to Rx growth. While challenges, they seem no greater than the multitude of other issues that all Rx manufacturers face when launching a new product. In the case of Afrezza, I would think time to create physician awareness and educate them how Afrezza works and why it is different would be the greatest challenge at this point.<<< I am also disturbed by this. Especially troubling because the Spirometry hurdle has been a known entity since day one. It should have been trouble shot months ago. Why didn't Sanofi plan for this before launch? I'm with you on this. Management had to blame something and they chose the known issues as they couldn't state the real issue which is Sanofi's scaled back efforts. It's true but they can't call it out. No way 1200 reps produce that few scripts. There is no language in the agreement that MannKind gets a dedicated sales force. Sanofi can do what it wants with its people and right now its pushing Toujeo as they have Billions at stake. They are in not rush for Afrezza as it can't produce the revenue they need NOW and don't want reps slowed down by focusing on it. |
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Post by EveningOfTheDay on May 9, 2015 20:09:58 GMT -5
>>>I am troubled by managements comments that prior authorization and spirometry have been significant impediments to Rx growth. While challenges, they seem no greater than the multitude of other issues that all Rx manufacturers face when launching a new product. In the case of Afrezza, I would think time to create physician awareness and educate them how Afrezza works and why it is different would be the greatest challenge at this point.<<< I am also disturbed by this. Especially troubling because the Spirometry hurdle has been a known entity since day one. It should have been trouble shot months ago. Why didn't Sanofi plan for this before launch? I'm with you on this. Management had to blame something and they chose the known issues as they couldn't state the real issue which is Sanofi's scaled back efforts. It's true but they can't call it out. No way 1200 reps produce that few scripts. There is no language in the agreement that MannKind gets a dedicated sales force. Sanofi can do what it wants with its people and right now its pushing Toujeo as they have Billions at stake. They are in not rush for Afrezza as it can't produce the revenue they need NOW and don't want reps slowed down by focusing on it. And you know this how? For all I know you could be right, but I am pretty sure neither you or anybody else at this point can have the level of certainty you are expressing in your post. Furthermore, it would make sense for Sanofi to cut back efforts after actually putting some effort into selling Afrezza and being unsuccessful. So far all I have seen is that Afrezza has been thrown out to swim on its own. I have to assume that this was done by design, and that it is part of a larger strategy Sanofi is following because, truly, nothing else makes much sense. Basically, even though I agree with you that 1200 reps working actively at it would probably have produced a better outcome in terms of RXs, I am not ready yet to admit, because there is no real indication of it and because it would make very little sense, that Sanofi has lost interest on Afrezza. You might choose to speculate about it if you wish, but I would certainly refrain from statements like the one above. |
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Post by kball on May 9, 2015 20:25:28 GMT -5
I put a copy of the partnership agreement on the right hand side of the -***-, just above the -***-. You can find it there for a good read. They trained 1200 reps in January for a Feb launch. We're adding new 5 scripts a week per state on average. That to me is bad. I've corresponded with 4 Sanofi reps over the past two months and I've gotten the company line from all of them "slow start due to...but lots of excitement". A few weeks ago I pinged them for an update on priority vs Toujeo and one rep responded "Toujeo is now the future of Sanofi that's all I can say, good luck". I should have sold then. I fully believe they are refocusing the 1200 reps on Toujeo and this was done after the new CEO started. He knows the difficulties of this monumental change for docs & patients and must back-fill the Lantus revenue. Mannkind has no clear picture of the Sanofi strategy and absolutely no influence to change it. Of all the very good posts in this thread, this one, sounding ominous as it is, has me the most unsettled. Though i get why it would be their main focus. Just hoping 2 drugs by 1 pharma in the same space can share and even dominate an ever increasing pie |
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Post by spiro on May 9, 2015 20:58:28 GMT -5
There has never been 1200 Afrezza reps, the number is closer to 800. Still pathetic results so far.
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Post by notamnkdmillionaire on May 9, 2015 21:05:06 GMT -5
If you are a SNY diabetic rep, which drug are you going to earn your paycheck on? Toujeo or Afrezza? I think we all know the answer to that, especially anyone who is paid on commission.
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Post by jpg on May 9, 2015 21:06:11 GMT -5
They trained 1200 reps in January for a Feb launch. We're adding new 5 scripts a week per state on average. That to me is bad. I've corresponded with 4 Sanofi reps over the past two months and I've gotten the company line from all of them "slow start due to...but lots of excitement". A few weeks ago I pinged them for an update on priority vs Toujeo and one rep responded "Toujeo is now the future of Sanofi that's all I can say, good luck". I should have sold then. I fully believe they are refocusing the 1200 reps on Toujeo and this was done after the new CEO started. He knows the difficulties of this monumental change for docs & patients and must back-fill the Lantus revenue. Mannkind has no clear picture of the Sanofi strategy and absolutely no influence to change it. Of all the very good posts in this thread, this one, sounding ominous as it is, has me the most unsettled. Though i get why it would be their main focus. Just hoping 2 drugs by 1 pharma in the same space can share and even dominate an ever increasing pie Obviously Sanofi giving up is the big deal that scares everyone. Then again why would they? It's not as if Afrezza is that expensive to keep around and nothing would hurt their competition more then this while giving them a really interesting tool. I don't recall many pharmas giving up on highly effective drugs. These things take time and Sanofi knows this. In the drug business we are still very very early in the game. |
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