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Post by noonen on Feb 20, 2015 0:27:02 GMT -5
noonen, I believe what he meant by "less sensitive to insulin injection" is less of a response or delayed response to insulin injection... not sensitivity as in pain or other adverse reaction. ahh yes got it that makes more sense then.
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Post by gwb on Feb 20, 2015 4:34:13 GMT -5
Best New Diabetes Med: AfrezzaAfrezzaInhaler
After years in the making, the Mannkind Corp inhaled insulin Afrezza finally got FDA approval in mid-2014 after Sanofi signed on as the distribution partner for this new med. It's just recently hit the market in pharmacies across the U.S. This has sure been a long time coming, and while not everyone agrees it will succeed or even come close to "blockbuster" status, many are excited about having this as an option for meal-time insulin. It doesn't take the place of all insulin and many will still need to inject or pump basal or long-lasting insulin, but Afrezza brings a new tool that could be a great D-management choice for many in our community. As Dr. Steven Edelman told us: Afrezza leads to less hypoglycemia and "really does work extremely well."
www.healthline.com/diabetesmine/diabetes-community-oscar-awards#4
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Post by brentie on Feb 20, 2015 6:39:48 GMT -5
Sanofi's new CEO set to focus on US business, product launches Sanofi chairman Serge Weinberg said that one of incoming CEO Olivier Brandicourt's priorities will be stabilising the company's US business, coupled with overseeing a number of product launches. "A lot will be about launches, not only in 2015," Weinberg remarked, noting that Brandicourt is "a very good fit" for Sanofi as he "has the experience of the portfolio businesses we have." Commenting on the appointment, Bernstein analyst Tim Anderson said the move was "likely to be viewed as a moderately positive catalyst for Sanofi as it resolves the uncertainty around not having a permanent CEO." He added "investors will now closely follow Brandicourt's next steps to stabilise Sanofi's diabetes franchise and oversee the launch of new products." www.firstwordpharma.com/node/1264617#axzz3SHgbDOMR
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Post by savzak on Feb 20, 2015 9:25:03 GMT -5
A Feuerstein/Kliff tag team effort...
adamfeuerstein.tumblr.com/post/111559256642/sales-have-been-slower-than-expected-it-takes
Sales have been slower than expected. It takes time to educate the physician.
— Olivier Brandicourt
Brandicourt, the newly appointed CEO of French pharmaceutical giant Sanofi, was speaking in April 2007 about problems with the inhaled insulin product Exubera. At that time, Bandicourt was an executive at Pfizer in charge of the Exubera commercial launch.
Six months later in October 2007, Pfizer pulled Exubera from the market. The failure of the inhaled insulin cost Pfizer almost $3 billion, making it one of the largest commercial flops in the history of the drug industry.
One of the first challenges facing Brandicourt at Sanofi is fixing the company’s ailing diabetes business, which now includes the marketing of a new inhaled insulin — MannKind’s Afrezza. Will Brandicourt’s previous and painful experience with Exubera lead him to divorce Sanofi from Afrezza? Or, will he soldier own in the hope that a second shot at marketing inhaled insulin will be more successful than the last?
Diabetic Investor’s David Kliff, a diabetes business analyst and longtime Afrezza skeptic, believes Brandicourt would be smart to end Sanofi’s marketing of Afrezza. In a recent research note to his newsletter’s subscribers, Kliff writes:
Should Mr. Brandicourt take a realistic long term view of the Sanofi diabetes franchise he could easily reason that Afrezza isn’t the answer. That better to cut ties with MannKind now rather than wait around so that Afrezza can actually prove it’s not the product many think it is. His experience with Exubera may have taught him that for all the sexiness surrounding inhaled insulin, at the end of the day it’s just a short-acting insulin which is inhaled rather than injected and not a better short-acting insulin. That the current injectable short-acting insulins are not only as good as Afrezza but also much cheaper than Afrezza. Given that cost containment is the order of the day combined with payers reluctance to provide Afrezza with premium reimbursement or positive formulary position, Mr. Brandicourt has plenty of ammunition to justify killing this partnership.
Whether Mr. Brandicourt stays the course with Afrezza or makes a change could well come down not to his previous experience rather how much true power Serge and the board give him. Sanofi is not exactly an organization known for admitting mistakes. Yet based on comments made by Serge [Weinberg, Sanofi’s chairman] that Sanofi management must now be held accountable could push Mr. Brandicourt to cut ties sooner rather than later.
A move which becomes more likely as the partnership with MannKind was pushed through by former CEO. In a way jettisoning MannKind would help the company get past the mess that [former CEO Chris] Viehbacher left behind, a mess which includes an ongoing whistleblower lawsuit. It would provide some justification that Serge and the board actually did the right thing by canning Viehbacher.
The simple fact is every new CEO likes to come in and make a statement. A statement which tells everyone there’s a new sheriff in town. Ending the MannKind partnership is a low risk high reward statement that would a signal to everyone at Sanofi and their stakeholders that the new guy in town gets it, that he understands what the problems are and isn’t afraid to take action. This would be a welcome departure from the past and refreshing change in attitude. Let’s just hope that Serge allows Mr. Brandicourt the latitude to make his statement and doesn’t get in the way by doing what he’s done so well; opening his mouth and inserting his foot.
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Post by esstan2001 on Feb 20, 2015 9:29:41 GMT -5
So pathetic how the twisted title was derived from the content.
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Post by savzak on Feb 20, 2015 9:30:12 GMT -5
www.forbes.com/sites/kenkam/2015/02/20/afrezza-will-succeed-but-initial-sales-likely-to-disappoint/?utm_campaign=yahootix&partner=yahootix
Afrezza Will Succeed But Initial Sales Likely To Disappoint
Comment Now Follow Comments
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.
(Photo credit: istockphoto.com) 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.
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.
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Post by cubonwallstreet on Feb 20, 2015 9:37:17 GMT -5
This might be one of AF's worst hit pieces to-date. I am glad I believe in karma or this man would really get to me.
I do, however, appreciate Ken's articles and insight; seems like a reasonable and knowledgeable man.
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Post by gomnkd on Feb 20, 2015 9:50:48 GMT -5
Speaking of Karma, I like to see David Kliff get his comeuppance. Ah this list goes on and on.
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Post by otherottawaguy on Feb 20, 2015 9:52:15 GMT -5
Adumb Fartstain, is anyone still reading his tripe? Sent that lad and what he has to back to the minors, heard he even got cut from the farm team.
Heard a good comment this week about his educational background.
The only question a Poli Sci major is qualified to answer is: "How did it feel to move back into your parents basement after graduating?"
But one that they are qualified to ask is: "Will that be fires with that, sir?"
Sorry if I offended anybody, so just to self deprecate, remember that I went to Carleton, where the "K" stands for Quality...
Laughed I did, hope you are too,
OOG
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Post by shortslaver on Feb 20, 2015 10:04:09 GMT -5
So pathetic how the twisted title was derived from the content. Yeah, completely misleading and of no integrity.
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Post by notamnkdmillionaire on Feb 20, 2015 10:15:02 GMT -5
Notice how it's not on Street.com but on Adam's own Tumblr account. I wonder if the street looked at it and told Adam that they wouldn't post such nonsense.
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Post by babaoriley on Feb 20, 2015 10:22:23 GMT -5
Crazy man, that Adam! I'm sure the first thing Olli wants is to get hit with a giant breach of contract suit by MannKind! I can't imagine SNY has any sort of "easy out" clause in that contract, so they'd have to pay a bunch to avoid a lawsuit, Adam fails to mention the cost of that. Oh, wait, I'm arguing logic here, where it doesn't deserved to be used - that article is just the worst kind of financial journalism. Come on, Karma!
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Post by liane on Feb 20, 2015 10:23:38 GMT -5
OK, I think we've given more than enough attention to AF; let's move on...
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Post by jpg on Feb 20, 2015 14:12:39 GMT -5
This Forbes writer (had given up on Forbes a few years ago) is turning out to be a really interesting read. Well thought out way of looking at a product and comes back for a follow up.
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Post by dreamboatcruise on Feb 20, 2015 14:56:26 GMT -5
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