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Post by kball on Apr 6, 2016 17:56:31 GMT -5
Excerpts:
“We think we know what went wrong in Sanofi's hands, and we think we can fix that,” said Matthew Pfeffer, MannKind's CEO.
In recent months MannKind hired Michael Castagna, a former VP and global commercial lead at Amgen, as chief commercial officer, tasking him with building a sales force targeting primary care physicians. It is in the midst of finalizing a contract with a new advertising agency. The company also changed its strategy, identifying new patient populations to target, evaluating new pricing tactics, and reopening discussions with payers.
The “Surprise, it's Insulin!” campaign, which was developed by Havas Health, primarily targeted patients in the early stages of a diagnosis with type 2 diabetes.
Still, Pfeffer viewed Sanofi's strategy as flawed and said it failed to include potential patient populations. “They ignored segments, like type 1,” he said. “We think that was a mistake.”
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It appears, now that the License & Collaboration Agreement is terminated, CEO Pfeffer can be a lot more vocal about Sanofi's mishandling of Afrezza
Wait, what? Wasnt the entire december san diego head fake group gathering all type 1's? Thought those on the drug leaned 75% or more Type 1. btw--my own thought was that very meeting was to keep silent the loudest voices through legal means by signing NDA's, so i found it not ironic that Laura Kronen (sp?), who did not attend that conference/muzzle, had been mentioned as joining the mannkind team as a new voice to help spread the company message
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Post by sportsrancho on Apr 6, 2016 18:05:14 GMT -5
Seems to me that SNY went after some Endo's, and the type 2's in their ads. When the Type 1's are a better target. (And so many of their Endo's said no to writing a script and they had to get one from a GP.)
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Post by prosper on Apr 7, 2016 7:08:54 GMT -5
I have just returned home after two+ weeks in hospital after surgery. It was nothing to do with diabetes, but daily blood draws, finger sticks, and Heparin injections. To my surprise, the daily H injections, sub-cutaneous in the stomach were painless and the syringe and needle looked like, and were confirmed by the nurse, the same as the diabetes injection needles and were almost completely painless. Fear or dislike of needles was finally made apparent to me that inhaling instead of injecting is not going to be enough of a primary reason for diabetics to switch. On the other hand, I really disliked the finger stick for testing. Having followed Sam and others for years now, I am convinced the reality of how A works, the kinetics, are the selling point. Education and guidance in the use of A has to be the key. MY concern is that none of the great anecdotal success stories can be used in advertising or even education of doctors because of the FDA. I would greatly appreciate any comments concerning the limitations of what MNKD can actually say. I am afraid that our hands are not only tied, but handcuffed by the FDA
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Post by peppy on Apr 7, 2016 7:26:13 GMT -5
I have just returned home after two+ weeks in hospital after surgery. It was nothing to do with diabetes, but daily blood draws, finger sticks, and Heparin injections. To my surprise, the daily H injections, sub-cutaneous in the stomach were painless and the syringe and needle looked like, and were confirmed by the nurse, the same as the diabetes injection needles and were almost completely painless. Fear or dislike of needles was finally made apparent to me that inhaling instead of injecting is not going to be enough of a primary reason for diabetics to switch. On the other hand, I really disliked the finger stick for testing. Having followed Sam and others for years now, I am convinced the reality of how A works, the kinetics, are the selling point. Education and guidance in the use of A has to be the key. MY concern is that none of the great anecdotal success stories can be used in advertising or even education of doctors because of the FDA. I would greatly appreciate any comments concerning the limitations of what MNKD can actually say. I am afraid that our hands are not only tied, but handcuffed by the FDA What is being said: Afrezza (uh-FREZZ-uh), approved in 2014 by the U.S. Food and Drug Administration, is a rapid-acting inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes. Taken at the start of a meal using a specially designed inhaler, Afrezza dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of use and help to control post-meal blood sugar spikes that affect HbA1C levels. Afrezza should not be used by patients who have problems with their lungs (such as asthma or COPD) and is not recommended in patients who smoke or who have recently stopped smoking. - See more at: investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=963557#sthash.zUUBdApn.dpuf What may help, we will see: The company also plans to present four abstracts at the American Diabetes Association (ADA) scientific meeting in June, including the results of two completed post-marketing studies. Two additional late-breaking abstracts have also been submitted to the ADA and, if accepted, will be presented. -
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Post by agedhippie on Apr 7, 2016 7:30:33 GMT -5
Seems to me that SNY went after some Endo's, and the type 2's in their ads. When the Type 1's are a better target. (And so many of their Endo's said no to writing a script and they had to get one from a GP.) In fairness this was also Mannkind's strategy if you look at the statements in their patents. There was the idea that the market for Afrezza was Type 2 diabetics where Metformin no longer controlled things. I suspect this was mostly done because it was a far bigger market so the business case was clearer. Targeting Type 1 diabetics has the advantage that they know how to titrate doses, and that insulin doesn't scare them. The down side is that they tend to be incredibly conservative about treatment which is understandable since an error can put you in hospital or kill you. Type 1s are also very cynical about pharmas so marketing to them is not trivial.
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Post by mnholdem on Apr 7, 2016 7:38:35 GMT -5
Last week I forwarded a recommendation to MannKind management that they serious consider marketing Afrezza as the world's first prescription monomer insulin, with the benefit of being inhalable as a secondary benefit. With its current non-inferior label, Afrezza really needs something to make it stand out in marketing the drug. Inhaled medicines are not unique. An insulin that is delivered as a ready-to-use monomer (vs injected hexamers) is an industry first. It's never been done before in the history of diabetes treatment, as Alfred Mann himself has stated. IMHO, Sanofi missed the boat by not explaining/demonstrating the market the true reason WHY Afrezza works so well. Instead, Sam, Eric and others, thankfully, picked up that ball and ran with it. Many physicians may simply give a shrug when they hear "inhaled". Perhaps when they hear that Afrezza is a NEW type of insulin they will pay better attention, although I wonder if the FDA restricted what Sanofi could advertise. For example, is MannKind allowed to advertise that Afrezza imitates the pancreas in how it delivers a 1st Phase insulin response to the body? prosper , I agree with you that the FDA may be handcuffing MannKind. They may not even be permitting the use of the word "monomer" for all we know.
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Post by peppy on Apr 7, 2016 8:05:01 GMT -5
Seems to me that SNY went after some Endo's, and the type 2's in their ads. When the Type 1's are a better target. (And so many of their Endo's said no to writing a script and they had to get one from a GP.) In fairness this was also Mannkind's strategy if you look at the statements in their patents. There was the idea that the market for Afrezza was Type 2 diabetics where Metformin no longer controlled things. I suspect this was mostly done because it was a far bigger market so the business case was clearer. Targeting Type 1 diabetics has the advantage that they know how to titrate doses, and that insulin doesn't scare them. The down side is that they tend to be incredibly conservative about treatment which is understandable since an error can put you in hospital or kill you. Type 1s are also very cynical about pharmas so marketing to them is not trivial.
There did not seem to be an underlying plan for this as the guidelines are to add a second and perhaps a third oral/injection before insulin therapy. see dual and triple therapy. www.ndei.org/AACE-guidelines-diabetes-treatment-algorithm.aspx
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Post by lakon on Apr 7, 2016 10:12:54 GMT -5
FTA: “We're not going to hand over the product to another pharma company,” Pfeffer said. Lesson learned. Why does this remind me of the story about how Mr. Mann (RIP) got in the cochlear implant business? I think another meaning of FTA applies. Please share that story. I haven't heard it. Here is the story straight from Al Mann about how he got in the cochlear implant business. www.youtube.com/watch?v=muBuxTqxmQo#t=57m25sWatching the whole hour is definitely worth it. He revealed a lot of history worth knowing. Most naysayers, including SNY, do NOT really understand who Al was. He did A LOT for his COUNTRY before he did A LOT for ALL HUMANITY, and he was NOT a one trick pony. He was a polymath with an IQ of 172. He was 90 years old, and he worked until the end to try to make a difference. He also encouraged and motivated genius in many others. He will be missed. Given his history of planning, I think that we will see more of him soon and in the actions of his protégés. We should all strive to live like A. Mann. Also, here is a good read. davidovit.com/articles/Al-Mann-Article.pdfEnjoy!
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Post by mnholdem on Apr 7, 2016 10:13:30 GMT -5
Insulin initiation and/or intensification for early Type 2's is still a good target, IMHO. Unfortunately, Sanofi priced Afrezza so high that the PBM's simply refused coverage at a preferred/unrestricted level for early diabetic patients for who orals simply weren't doing the job as the disease progressed.
Early diabetics may prefer an inhalable to an injection, but not if they have to pay a fortune out of pocket.
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Post by lakon on Apr 7, 2016 10:22:14 GMT -5
... Wasnt the entire december san diego head fake group gathering all type 1's? Thought those on the drug leaned 75% or more Type 1. btw--my own thought was that very meeting was to keep silent the loudest voices through legal means by signing NDA's, so i found it not ironic that Laura Kronen (sp?), who did not attend that conference/muzzle, had been mentioned as joining the mannkind team as a new voice to help spread the company message kball you have been rather negative lately, but I found this comment to be rather constructive. I had the same thoughts. Dirty, but they [SNY] still have plausible deniability, depending on what was said at the private meeting...
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Post by lakon on Apr 7, 2016 10:48:11 GMT -5
I have just returned home after two+ weeks in hospital after surgery. It was nothing to do with diabetes, but daily blood draws, finger sticks, and Heparin injections. To my surprise, the daily H injections, sub-cutaneous in the stomach were painless and the syringe and needle looked like, and were confirmed by the nurse, the same as the diabetes injection needles and were almost completely painless. Fear or dislike of needles was finally made apparent to me that inhaling instead of injecting is not going to be enough of a primary reason for diabetics to switch. On the other hand, I really disliked the finger stick for testing. Having followed Sam and others for years now, I am convinced the reality of how A works, the kinetics, are the selling point. Education and guidance in the use of A has to be the key. MY concern is that none of the great anecdotal success stories can be used in advertising or even education of doctors because of the FDA. I would greatly appreciate any comments concerning the limitations of what MNKD can actually say. I am afraid that our hands are not only tied, but handcuffed by the FDA My hands are not tied by the FDA. Are yours? Are your doctors? This issue is a big problem in cases like MNKD. The FDA and Congress were discussing ways to include anecdotal evidence in a fair and unbiased way under a regulatory framework. Also, the First Amendment argument still stands unanswered for a pharma; however, it will be too late to wait for a resolution on these matters. Doctors could independently give training based on their beliefs and experiences. I think this area is where VDEX clinics and their protocols can do a lot to help. The FDA should not be a problem for them because they are independent of MNKD. Also, I thought that non-profits could deploy similar strategies, and it would be politically and legally difficult to challenge as long as accurate information is presented. IANAL so any lawyers out their with regulatory expertise could help us out... I had an idea to setup a more formal web site to do what Afrezzauser, and friends, started to keep track of anecdotal patient results. If they volunteer their information, I think that it is alright. The site would just be a tool for patients. As the sample size increases with spectacular HbA1C's, it would be hard to deny. Right now, the information is all over the place. An easier way would help. I think that it would be very difficult for MNKD to do something like this, but independent patient driven groups would work. Integrating a site like this into social networking would scale out the reach of such information. Again, MNKD cannot do it, but others could. Ultimately, a lot of free publicity could come from it.
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Post by mnholdem on Apr 7, 2016 11:37:22 GMT -5
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Post by lakon on Apr 7, 2016 13:21:21 GMT -5
Thanks. I am aware of this option, and I am impressed with the work of compound26. In fact, I had my idea before him, but I kind of left it languish after he got going. I also wanted to see how the MNKD/SNY team worked out. (That did not go as I'd hoped.) Anyway, the key difference is more formal. Sorry for the vague statement, but I am not really prepared to clarify a lot besides verified databases, geographically tagged and coordinated groups, streamlined insurance/pharmacy, social networked graphs, etc. Basically, everything that Afrezza.com cannot be. I view Just Breathe as a great informative site, but I propose a more active site that can do things besides provide general information -- a members-only group of Afrezza Users that can share protocols, results, and other data. A site for diabetics by diabetics where they are not just blogging or posting comments endlessly lost in free form, but rather a place that outlines how to use Afrezza when eating lasagna with a bottle of wine with timing data. Basically, it would be a combination of Just Breathe, Matt B's Afrezza Down Under, sprinkled with scientific trial-like data trackers, and a complete ecosystem with a portal for diabetics. My group put out some feelers to compound26 a while ago, and he said to go here so we came. We also had been in touch with Matt B, and recently, I tried to reach VDEX via the board's contact. We are still undecided about pursuing this endeavor, but we are evaluating. It depends on the responses that we get as well as the resources that we can expect to bring to make it worthwhile. The last year has been painful.
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Post by esstan2001 on Apr 7, 2016 14:24:27 GMT -5
Thanks. I am aware of this option, and I am impressed with the work of compound26 . In fact, I had my idea before him, but I kind of left it languish after he got going. I also wanted to see how the MNKD/SNY team worked out. (That did not go as I'd hoped.) Anyway, the key difference is more formal. Sorry for the vague statement, but I am not really prepared to clarify a lot besides verified databases, geographically tagged and coordinated groups, streamlined insurance/pharmacy, social networked graphs, etc. Basically, everything that Afrezza.com cannot be. I view Just Breathe as a great informative site, but I propose a more active site that can do things besides provide general information -- a members-only group of Afrezza Users that can share protocols, results, and other data. A site for diabetics by diabetics where they are not just blogging or posting comments endlessly lost in free form, but rather a place that outlines how to use Afrezza when eating lasagna with a bottle of wine with timing data. Basically, it would be a combination of Just Breathe, Matt B's Afrezza Down Under, sprinkled with scientific trial-like data trackers, and a complete ecosystem with a portal for diabetics. My group put out some feelers to compound26 a while ago, and he said to go here so we came. We also had been in touch with Matt B, and recently, I tried to reach VDEX via the board's contact. We are still undecided about pursuing this endeavor, but we are evaluating. It depends on the responses that we get as well as the resources that we can expect to bring to make it worthwhile. The last year has been painful. For what you are proposing, do you anticipate it being of value (being usable) toward changing the FDA label in any way? How can you ensure the validity of voluntarily provided data unless there is some type of accepted clinical research protocol in place? Don't get me wrong, I am a big fan of the idea- just wondering if it can be structured in some way to also help with the FDA (anecdotal outcomes data base that would be accepted by them)... ... iin this ever changing world of First Amendment protections of free speech and Congressional pressure on the FDA to accept things short of another trial.
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Post by lakon on Apr 7, 2016 15:16:34 GMT -5
For what you are proposing, do you anticipate it being of value (being usable) toward changing the FDA label in any way? How can you ensure the validity of voluntarily provided data unless there is some type of accepted clinical research protocol in place? Don't get me wrong, I am a big fan of the idea- just wondering if it can be structured in some way to also help with the FDA (anecdotal outcomes data base that would be accepted by them)... ... iin this ever changing world of First Amendment protections of free speech and Congressional pressure on the FDA to accept things short of another trial. You got the point, and you asked the right question. That would be a goal. I think there is room for serious and positive disruption in the regulatory space through technological innovation in order to produce better, faster, and cheaper outcomes. A lot of the tools and technology exist to transition to a more distributed model than the centrally managed one of today, but would need to be put together in an acceptable form. Even so, it's hard to change. The MNKD saga has taught me a lot. When I see problems, I can't help but look for solutions. Whether they fly is another matter... We will continue our research to see if MNKD Afrezza would be a good case study. If we do it, the solution would have to go beyond just Afrezza.
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