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Post by Deleted on Feb 9, 2016 17:26:52 GMT -5
The Nasdaq link worked for me. Not a bad article, they even have a quote from mikep! Very fair article. Plain english - change the label and Dr's wont be afraid of being sued. This is where smart money got it right while retail has posters of Sam Finta on their walls. The trial design was before my time as a share holder and also is out of my understanding. Whose fault are the trial results? |
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Post by kball on Feb 9, 2016 17:34:24 GMT -5
Excerpts follow. -snip- Forty-year-old Mike Parise said his blood sugar starts falling within five to 10 minutes after he takes Afrezza, much quicker than with injected insulin. "For someone who's had Type 1 for 20 years, that's a beautiful thing," he said.
Jackie Klass, 52, said using Afrezza had helped her gain control over her blood-sugar levels for the first time since she was diagnosed 17 years ago and had "changed my life." She owns shares in MannKind.
But many others didn't stick with it: A Sanofi spokeswoman said that of the 6,000 patients prescribed Afrezza since its launch, only 35% stayed on the treatment.Read more: www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284#ixzz3zi8y5U3OIs this incorrect information? I was under the impression that the 35% figure was lifted from sample packs + prescriptions. If they were averaging way less than 400 new rx a month i dont see how they got to 6000 patients? |
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Post by lakers on Feb 9, 2016 17:36:57 GMT -5
The Nasdaq link worked for me. Not a bad article, they even have a quote from mikep! Very fair article. Plain english - change the label and Dr's wont be afraid of being sued. This is where smart money got it right while retail has posters of Sam Finta on their walls. The trial design was before my time as a share holder and also is out of my understanding. Whose fault are the trial results? I posted this many times here and on YMB. How Mnkd'd Change How They Conduct Clinical Trials in Future October 27, 2014 12:00 p.m Read more: mnkd.proboards.com/thread/4532/change-conduct-clinical-trials-future#ixzz3ziFCvymXSCVBJ: What lessons were learned along the way about how to bring a new drug to market? Hakan: In hindsight it’s always a learning process as to how to benefit going forward. Going forward, we would conduct some of the clinical studies in a different manner if we did it again. We would probably do comparative clinical studies with other therapies for patients and show the superiority or benefit of Afrezza over competitive products. We probably did not give ourselves the optimum ‘label’ (product description) that the product deserves where you can show and differentiate your product from other therapies – showing the incidence of hyperglycemia, high blood sugar, or the recipe of how you can use the product and what you can expect from it, like a prescription advisory to doctors and patients. The benefit would been an even stronger differentiation of benefits for Afrezza as compared to parallel therapies for Type I and type II therapies. It makes it easier to sell the product and presents stronger arguments to present to doctors and patients; why they should use our product as opposed to alternative. It eventually gives you a stronger franchise and better opportunity for higher sales. When you do clinical studies for the FDA you’re trying to prove you have a worthy product and show overall safety and efficacy. We were more focused on the clinical side of our studies given history with Pfizer’s (diabetes) medication and other studies than comparing our treatment to others on the market; we wanted a really clean study. The studies are very expensive and we were being careful about how we managed shareholder investments. Now with an approved product we can do all of the studies and we’ll certainly turn our focus to showing the superiority of the product in therapy.
[ This article and JAC meeting minutes would shine in deposition. Mnkd urged Sanofi to start the Phase 4 Superiority Trial ASAP to no avail. Mnkd's fault was giving Sanofi full Sales and Marketing control. Matt said next time Mnkd would control that. The new partners would be co-marketers. Sanofi started the 2 clamp studies and Pediatric very late, let alone the 5yr/8K lung study. NRx hardly budged since June 2015. This showed Olivier planned to drop Afrezza soon after he became CEO while masquerading it as a Controlled, Slow Launch. Investors ate that up like hungry fools.] Read more: mnkd.proboards.com/thread/4532/change-conduct-clinical-trials-future#ixzz3ziFOc7QG |
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Post by agedhippie on Feb 9, 2016 18:05:28 GMT -5
This article and JAC meeting minutes would shine in deposition. Mnkd urged Sanofi to start the Phase 4 Superiority Trial ASAP to no avail. Mnkd's fault was giving Sanofi full Sales and Marketing control. Matt said next time Mnkd would control that. The new partners would be co-marketers. Sanofi started the 2 clamp studies and Pediatric very late, let alone the 5yr/8K lung study. NRx hardly budged since June 2015. This showed Olivier planned to drop Afrezza soon after he became CEO while masquerading it as a Controlled, Slow Launch. Investors ate that up like hungry fools. The timelines for the trials was drawn up and given to the FDA by Mannkind before Sanofi were even involved. Sanofi have completed or are on target for all of these trials. You can blame Sanofi for a lot of things but the trials are on target. |
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Post by dreamboatcruise on Feb 9, 2016 18:19:25 GMT -5
@mindovermattter... if you're expecting a large parting gift then it probably won't take much searching to find a way to disappoint. That would be an expectation set up for disappointment.
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Post by dreamboatcruise on Feb 9, 2016 18:21:15 GMT -5
Excerpts follow. -snip- Forty-year-old Mike Parise said his blood sugar starts falling within five to 10 minutes after he takes Afrezza, much quicker than with injected insulin. "For someone who's had Type 1 for 20 years, that's a beautiful thing," he said.
Jackie Klass, 52, said using Afrezza had helped her gain control over her blood-sugar levels for the first time since she was diagnosed 17 years ago and had "changed my life." She owns shares in MannKind.
But many others didn't stick with it: A Sanofi spokeswoman said that of the 6,000 patients prescribed Afrezza since its launch, only 35% stayed on the treatment.Read more: www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284#ixzz3zi8y5U3OIs this incorrect information? I was under the impression that the 35% figure was lifted from sample packs + prescriptions. If they were averaging way less than 400 new rx a month i dont see how they got to 6000 patients? Maybe a sizable number got the prescription and it was rejected by their insurance. In that case unless they were willing to pay out of pocket, the prescription would never show up as filled. |
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Post by agedhippie on Feb 9, 2016 18:22:52 GMT -5
@mindovermattter... if you're expecting a large parting gift then it probably won't take much searching to find a way to disappoint. That would be an expectation set up for disappointment. My favorite would be that the agreement specifically says they will not sue each other but will settle all disputes by arbitration. Good luck getting a large parting gift out of that clause (good luck getting anything out of that clause)! |
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Post by sluggobear on Feb 9, 2016 18:25:26 GMT -5
I saw a post on tudiabetes about a month ago maybe, ostensibly from the WSJ author (Denise Roland) asking if "any diabetics on Afrezza would like to discuss their experiences". I was heartened by that, thinking that she might interview 10 Afrezza users who respond to her request and get a patient's perspective that isn't getting through. Denise Roland actually reached out to understand the user experiences...and how very underwhelming. 2 sentences from 2 actual users...and one of them is implicitly discredited by the fact that she owns shares. Sure it's the WSJ and the "real" story is about the stock and the financial ruination of the company.
I have to ask myself if it's possible that I am completely wrong about this idea that the "perspective isn't getting through". What if it is getting through and insulin-using diabetics just can't be bothered enough to switch or even try it? Given the results we hear about from the small Afrezza Army, why not?? If the problem really is the price and lack of insurance coverage, then on April 5th, Mannkind should price it for less than any other RAA. Then even though it's "only as good as any other RAA", insurance companies will cover it because it's the cheapest prandial RAA insulin?
Just get it into the hands of thousands of people who use insulin! If half of them figure out how to use it right and get the results that the Afrezza Army seems to get - then sales will take off. No one will care what the revenues are at first - sales volume growth and market share/penetration will be paramount. Then, assuming the product is as good as the Afrezza Army tells us it is, it could work. It's Hail Mary time...
Mannkind To Price Afrezza Below All Other Rapid-Acting Insulin's To Drive Adoption.
That headline should be published BEFORE April 5th.
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Post by dreamboatcruise on Feb 9, 2016 18:35:59 GMT -5
I saw a post on tudiabetes about a month ago maybe, ostensibly from the WSJ author (Denise Roland) asking if "any diabetics on Afrezza would like to discuss their experiences". I was heartened by that, thinking that she might interview 10 Afrezza users who respond to her request and get a patient's perspective that isn't getting through. Denise Roland actually reached out to understand the user experiences...and how very underwhelming. 2 sentences from 2 actual users...and one of them is implicitly discredited by the fact that she owns shares. Sure it's the WSJ and the "real" story is about the stock and the financial ruination of the company. I have to ask myself if it's possible that I am completely wrong about this idea that the " perspective isn't getting through". What if it is getting through and insulin-using diabetics just can't be bothered enough to switch or even try it? Given the results we hear about from the small Afrezza Army, why not?? If the problem really is the price and lack of insurance coverage, then on April 5th, Mannkind should price it for less than any other RAA. Then even though it's "only as good as any other RAA", insurance companies will cover it because it's the cheapest prandial RAA insulin? Just get it into the hands of thousands of people who use insulin! If half of them figure out how to use it right and get the results that the Afrezza Army seems to get - then sales will take off. No one will care what the revenues are at first - sales volume growth and market share/penetration will be paramount. Then, assuming the product is as good as the Afrezza Army tells us it is, it could work. It's Hail Mary time... Mannkind To Price Afrezza Below All Other Rapid-Acting Insulin's To Drive Adoption. That headline should be published BEFORE April 5th. I wish I had confidence in your assumption about pricing and formulary... I don't. I think getting good formulary placement is more complicated than that. The big guys use their portfolios of drugs to negotiate exclusive deals with PBM. They have more bargaining power than MNKD... plus some exclusive deals might not be immediately cancellable even if the PBM wanted to. Further, it would be hard for MNKD to try to bargain to be an exclusive prandial, because they do have the restrictions for people with COPD, asthma and smokers. I'll be jumping for joy if my fears turn out to be unfounded and we see immediate improvement in coverage with a price reduction. |
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Post by tw12 on Feb 9, 2016 18:48:14 GMT -5
Here's what I wrote just now to the WSJ's reporters:
Dear Denise and Noemie,
I was glad to see your article this evening in the Wall Street Journal. I have family members with diabetes and have followed the Afrezza story closely over the past year. Since “any publicity is good publicity”, I’m happy more diabetics now will know about Afrezza.
But there were significant omissions in your coverage (perhaps caused by lack of space) which may in fact end up discouraging diabetics from trying Afrezza. They include:
* There was absolutely nothing “substantial” about their efforts. By any measure, Sanofi made only minimal efforts to promote Afrezza. There is evidence of only one or two poorly designed print ads and not one TV ad. There is no evidence whatsoever that they educated or encouraged their reps with any real commitment.
* Thus it was much less a question of safety concerns with users of Afrezza (you’ve read the chat and seen the Youtube videos, I’m sure, about the across-the-board positive and in many instances life-changing experiences from diabetics about Afrezza), it was simply an issue that the vast majority of diabetics and many endoctrinologists have not yet even heard of Afrezza.
* Through careful reading of one of the better discussion boards (e.g. ProBoards), you may likely suspect that Sanofi in fact clearly decided - likely from the moment the leadership passed to Mr. Brandicourt — to sandbag Afrezza, so it would not cut into sales of their Toujeo insulin.
* One of the ways in which Sanofi sandbagged MannKind was to set and keep a premium price, as you noted. This is easily the reason many of the original adopters did not renew their prescriptions. (And of course, as you know, Mannkind will not venture any public statements on any of these issues as they are still negotiating with Sanofi the exact terms and timing of the termination agreement.)
* Afrezza replicates exactly what the pancreas produces: it is the only insulin on the market that is a monomer, not a polymer, like injectable ones. This provides not only rapid uptake but also fast dispersal from the blood, which makes it much less likely to cause long-term health issues to other organs.
Sincerely,
TB
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Post by Deleted on Feb 9, 2016 19:17:37 GMT -5
Here's what I wrote just now to the WSJ's reporters: Dear Denise and Noemie, I was glad to see your article this evening in the Wall Street Journal. I have family members with diabetes and have followed the Afrezza story closely over the past year. Since “any publicity is good publicity”, I’m happy more diabetics now will know about Afrezza. But there were significant omissions in your coverage (perhaps caused by lack of space) which may in fact end up discouraging diabetics from trying Afrezza. They include: * There was absolutely nothing “substantial” about their efforts. By any measure, Sanofi made only minimal efforts to promote Afrezza. There is evidence of only one or two poorly designed print ads and not one TV ad. There is no evidence whatsoever that they educated or encouraged their reps with any real commitment. * Thus it was much less a question of safety concerns with users of Afrezza (you’ve read the chat and seen the Youtube videos, I’m sure, about the across-the-board positive and in many instances life-changing experiences from diabetics about Afrezza), it was simply an issue that the vast majority of diabetics and many endoctrinologists have not yet even heard of Afrezza. * Through careful reading of one of the better discussion boards (e.g. ProBoards), you may likely suspect that Sanofi in fact clearly decided - likely from the moment the leadership passed to Mr. Brandicourt — to sandbag Afrezza, so it would not cut into sales of their Toujeo insulin. * One of the ways in which Sanofi sandbagged MannKind was to set and keep a premium price, as you noted. This is easily the reason many of the original adopters did not renew their prescriptions. (And of course, as you know, Mannkind will not venture any public statements on any of these issues as they are still negotiating with Sanofi the exact terms and timing of the termination agreement.) * Afrezza replicates exactly what the pancreas produces: it is the only insulin on the market that is a monomer, not a polymer, like injectable ones. This provides not only rapid uptake but also fast dispersal from the blood, which makes it much less likely to cause long-term health issues to other organs. Sincerely, TB Take a pic of what you wrote in a notepad and post it on twitter |
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Post by kball on Feb 9, 2016 19:58:50 GMT -5
Any chance we can alter this pic a little (maybe curling all the fingers but the middle one) once Mannkind gets it back from Sanofi?
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Post by bradleysbest on Feb 9, 2016 21:26:05 GMT -5
At my GP's office for my son & not a single pamphlet on Afrezza! I see an Insulin Therapy brochure that features Toujeo made by SNY. Did they sandbag MNKD? I think so.....
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Post by agedhippie on Feb 9, 2016 21:46:03 GMT -5
At my GP's office for my son & not a single pamphlet on Afrezza! I see an Insulin Therapy brochure that features Toujeo made by SNY. Did they sandbag MNKD? I think so..... Under the current standard of care the market is far larger for basal insulin than it is for prandial insulin and that is a market Sanofi need to protect. They are trapped between a biosimilar Lantus which is undercutting them on one side, and Novo Nordisk aggressively going after their market also with price cuts on the other side. While that stings in the US it really hurts in the rest of the world where the margins are far thinner. The upshot is that Sanofi absolutely has to make Toujeo a success in the US because the US has far fatter margins than anywhere else. With the Lantus franchise being eroded this directly hits their profits and Toujeo is hitting headwinds in Europe. Over there Levemir has displaced Lantus as the preferred basal analog on price and Toujeo is clearly priced out. If I was a Sanofi shareholder (I am not!) I would be seriously concerned if I wasn't seeing Toujeo advertising everywhere because that has to succeed and so is where the bulk of the marketing dollars will go. No sandbagging, just a fact of life. |
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Post by kc on Feb 10, 2016 1:32:41 GMT -5
Well it's evident that Bernie Sanders is going to focus on the drug companies. He targeted three of them tonight. He didn't say who they are so it's hard to determine if Sanofi was one of them. But you can imagine that drug stocks will tank tomorrow.
Bernie's comments below
We should not be paying by far the highest prices in the world for prescription drugs at a time -- listen to this, when the top three drug companies in this country made $45 billion dollars in profit last year. That is an obscenity, and let me tell you something. When we make it to the White House, the pharmaceutical industry will not continue to rip-off the American people.
Feel the Bern.....
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