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Post by mannmade on May 23, 2015 15:47:24 GMT -5
www.fool.com/investing/general/2015/05/23/could-incoming-threats-sink-mannkind-corporation.aspxCould Incoming Threats Sink MannKind Corporation? Source: MannKind Drugmaker MannKind Corp. (NASDAQ: MNKD ) and its marketing partner Sanofi (NYSE: SNY ) have officially launched Afrezza, an inhaled insulin, to the market. If Afrezza is able to live up to its full potential, it could pose a serious threat to the sales of several currently-available short acting insulins. Drugs like NovoLog and Humalog, which are currently sold by Novo Nordisk (NYSE: NVO ) and Eli Lilly and Co. (NYSE: LLY ) , respectively, currently drive billions of dollars in revenue, so you can bet they are taking the threat that Afrezza poses seriously. Novo and Lilly have certainly known about inhaled insulin for a long time, as both companies had previously devoted resources to developing their own inhaled insulins. However, they both ended up abandoning their inhaled insulins projects while they were still in development. Novo didn't think that the product held enough commercial potential. Lilly stated that the regulatory environment at the time was too uncertain to continue development, and also mentioned uncertainties about its commercial potential. One of the key benefits that Afrezza can claim over currently-available rapid acting insulins is that it goes to work very quickly, reaching peak levels within 12 to 15 minutes. This compares quite favorably to NovoLog and Humalog, which by comparison reach peak insulin levels within 45 to 90 minutes after injection. Faster absorption is important -- blood sugar levels can spike after eating a meal, so having the insulin work quickly can help patients better control their blood sugar levels. However, a few companies have been working on injectable meal time insulins that work faster than NovoLog and Humalog currently do. If these drugs can eventually find their ways to the market, it may reduce one of the key selling advantages that Afrezza has going for it. While companies like Halozyme Therapeutics Inc have announced clinical studies of very rapid acting insulins, MannKind investors probably need to keep the closest watch on Novo's pipeline. Novo Nordisk currently lists NN1218, an insulin analog that is intended to provide faster onset than NovoLog, in Phase 3 development on its website. While the company has yet to file the drug for approval with the FDA, if Novo can eventually get the drug to market it could potentially knock out one of the key selling advantages that Afrezza currently claims. We don't know how much faster NN1218 absorption is when compared to NovoLog, so there is still is a good chance that even if the drug can find its way to the market Afrezza would remain the fasting absorbing meal time insulin. But Novo Nordisk is a diabetes powerhouse with billions of dollars in sales at stake, and they have the scale, resources, and motivation to compete effectively against an inhaled insulin. It will still be some time before MannKind will see a potential faster acting insulin get to market, and the company has plenty of near term challenges ahead with the launch of Afrezza, particularly after disappointing initial sales figures. However, if MannKind and Sanofi can clear the marketing and adoption hurdle, investors need to be aware of what is in other drugmakers' pipelines -- especially ones that could be real threats to Afrezza. Until we get more information about how the market is reacting to Afrezza's availability, and about the clinical progress of these potential incoming threats, I'll personally continue to curiously watch MannKind from the sidelines.
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Post by Deleted on May 23, 2015 16:06:15 GMT -5
It's like a factory of FUD
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Post by mannmade on May 23, 2015 16:26:55 GMT -5
It's like a factory of FUD I agree with you for a number of reasons... But more importantly it looks like the shorts are still going to be active and engaged for a while longer. And with next week a short week script numbers may be lower so the pps roller coaster may continue...
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Post by Deleted on May 23, 2015 16:30:47 GMT -5
Next Friday won't include the holiday, the Friday after will. But I hear ya.
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Post by xoxoxoxo on May 23, 2015 16:31:31 GMT -5
Can you please explain how any drug could possibly have faster absorption delivered subcutaneously compared to via the lungs or directly into a vein?
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Post by liane on May 23, 2015 16:32:17 GMT -5
The short week will be reflected June 5th.
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Post by mannmade on May 23, 2015 17:44:24 GMT -5
My bad... Thx Fugacity and Liane.
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Post by joeypotsandpans on May 23, 2015 19:44:22 GMT -5
This article confirms we are making waves and the (short) troops are getting restless. Just had that McDonald's moment after reading it..."LOVIN IT"...this is how I read it - Sanofi now has a leg up on the competition, if they (Novo or Lilly) don't step up to the plate, they stand to lose billions in market share as they can't reinvent the closest holy grail to a pancreas since the minimed pump ...bring on the ADA symposium!!and keep bringing on those A1c readings...I'm lovin it! Zzzz Zzz Oh yeah almost forgot...and keep bringing those interest payments
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Post by jpg on May 23, 2015 21:39:43 GMT -5
Mannkind has a better product that could be disruptive to the big players in the prandial insulin business so these big players will try coming up with something almost as good (eventually...) therefor Mannkind will get sunk by the competition so Mannkind isn't a good investment.
That kind of sums up their argument. Does that even make sense??? There are so many errors in logic in this kind of argument...
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Post by mannmade on May 23, 2015 23:42:28 GMT -5
This article confirms we are making waves and the (short) troops are getting restless. Just had that McDonald's moment after reading it..."LOVIN IT"...this is how I read it - Sanofi now has a leg up on the competition, if they (Novo or Lilly) don't step up to the plate, they stand to lose billions in market share as they can't reinvent the closest holy grail to a pancreas since the minimed pump ...bring on the ADA symposium!!and keep bringing on those A1c readings...I'm lovin it! Zzzz Zzz Oh yeah almost forgot...and keep bringing those interest payments Let me preface what I am about to post with a bit about my history. I was a very senior executive at one of the Big 3 TV Networks in charge of commercial production for their owned stations and the affiliates. And we produced several pharma campaigns over the years. I also like television and watch it a bit... So to add to Joey's post above, coincidently I was watching television tonight and I just saw my first ever commercial for Novolog. I have never seen a commercial for Novolog or Humalog. In addition it was in a pen form (am guessing to counter the convenience of Afrezza). I have seen many commercials for diabetic products such as Farxiga, etc but never one for a prandial insulin. And it was on CBS in primetime (although Sat is a lower viewing audience than during the week). Joey I think you may be on to something...
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Post by Chris-C on May 24, 2015 13:05:06 GMT -5
This article confirms we are making waves and the (short) troops are getting restless. Just had that McDonald's moment after reading it..."LOVIN IT"...this is how I read it - Sanofi now has a leg up on the competition, if they (Novo or Lilly) don't step up to the plate, they stand to lose billions in market share as they can't reinvent the closest holy grail to a pancreas since the minimed pump ...bring on the ADA symposium!!and keep bringing on those A1c readings...I'm lovin it! Zzzz Zzz Oh yeah almost forgot...and keep bringing those interest payments Let me preface what I am about to post with a bit about my history. I was a very senior executive at one of the Big 3 TV Networks in charge of commercial production for their owned stations and the affiliates. And we produced several pharma campaigns over the years. I also like television and watch it a bit... So to add to Joey's post above, coincidently I was watching television tonight and I just saw my first ever commercial for Novolog. I have never seen a commercial for Novolog or Humalog. In addition it was in a pen form (am guessing to counter the convenience of Afrezza). I have seen many commercials for diabetic products such as Farxiga, etc but never one for a prandial insulin. And it was on CBS in primetime (although Sat is a lower viewing audience than during the week). Joey I think you may be on to something... I tend to agree with you both. I noticed the same commercial and wondered the same thing. No doubt about it, some of the big players are very concerned about their cheese being moved by the introduction of Afrezza. I don't wear a tin hat, but I do know that where there are big dollars involved and there is cash to "put on the case", all manner of strategies will be employed as defensive tactics to maintain the revenue. I would not rule out malfeasance by the FDA in earlier CRLs (although the device issue misfire was just poor judgment, IMO); and I don't rule out competitor influence in the stock's manipulation, either. It's so much cleaner if you can work economic "magic" to have a company fail for financial reasons. Although I was not at the annual shareholders meeting, I do think there is justifiable reason for the confidence being displayed by Mannkind executives. Of course they need to pay heed to stockholders who are concerned about timelines and seeing red numbers in their portfolio accounts; but knowing the market is there, the product is out, and the tipping point will be reached soon enough, they are certain there will be outstanding sales numbers reported within two years or earlier. They also know they have a potential gold mine in their technosphere delivery platform. As soon as a convincing partnership is announced on that front, the short thesis will be mortally wounded and the questions discussed here will be about buyouts and potential SP upsides. GLTA Chris C
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