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Post by savzak on May 23, 2014 9:00:19 GMT -5
www.valuewalk.com/2014/05/mannkind-corporation-mnkds-afrezza-sales/
MannKind Corporation (MNKD)’s Afrezza Sales To Reach $3.65B By 2025
by Vikas ShuklaMay 23, 2014, 9:52 am
Initial demand for Afrezza is expected to be strong considering statements from the regulatory panel about its safety, efficacy and attractive size
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MannKind Corporation (NASDAQ:MNKD) and the Wall Street both are eagerly anticipating the approval of the biopharmaceutical company’s diabetes treatment Afrezza. FDA’s advisory committee had recommended the drug for Type-1 and Type-2 diabetes. But the regulator delayed the Prescription Drug User Fee Act (PDUFA) review from April 15 to July 15. Brinson Patrick analyst Christopher James said in a research note that the FDA is highly likely to approve Afrezza.
MannKind and FDA are in advanced talks about labeling, REMS
Brinson Patrick has an Outperform rating on the stock with $12 price target. Based on comments by MannKind Corporation (NASDAQ:MNKD) management, James believes that the approval could come even before July 15. The Valencia, California-based company is in final discussions with the USFDA around REMS, labeling and the pediatric phase IV study. Moreover, the company is sharing its ongoing FDA dialog with its potential partners.
MannKind-1
At this point, the research firm sees negligible risk to approval. For Type-1 diabetes, endocrinologists as well as patients badly need Afrezza’s convenience and reduced hypoglycemia. For Type 2 diabetes, 14-0 votes in favor of the drug and the follow-up discussion at the advisory committee suggests increased confidence and a high adoption rate. Afrezza is a combination of drug and device, which consists of a recombinant human insulin powder formulation. Patients can self-administer the insulin power by oral inhalation, which is absorbed by lungs. Each cartridge contains either 10 units or 20 units of insulin.
MannKind Afrezza
MannKind expected to start selling Afrezza in Q1, 2015
With little approval risk in sight, Christopher James says the investor focus is increasingly shifting to REMS, labeling, commercial partnerships and a successful launch. Brinson Patrick expects MannKind Corporation (NASDAQ:MNKD) to start selling Afrezza in the first quarter of 2015. And annual sales are expected to reach $3.65 billion by FY2025, largely driven by its use in early stage Type-2 diabetes. James expects initial demand for Afrezza to be strong considering statements from the regulatory panel about its safety, efficacy and attractive size.
MannKind Corporation (NASDAQ:MNKD) shares were down 2.96% to $7.53 at 9:37 AM EDT on Friday.
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Post by babaoriley on May 23, 2014 9:18:02 GMT -5
Interesting stuff. But $3.65 billion by 2025? That's certainly a long-term speculation. If nothing untoward happens, I think we may get to that level several years before that, especially considering the world-wide need. This is, after all, already a humongous market, expanding rapidly.
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Post by savzak on May 23, 2014 10:38:07 GMT -5
I agree. Very conservative with the time frame. If Afrezza is to be successfully accepted by the market, there is no reason to think it will take 10 years to ramp to that level of sales.
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Post by nemzter on May 23, 2014 10:50:53 GMT -5
They were off by a decimal point. |
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Post by jpg on May 23, 2014 10:57:48 GMT -5
Anyone who can predict drug sales 10 years out is pretty good... Then again it is an easy and safe thing to say as no one will ever remember a prediction made 10 years ago!
JPG
PS: if I am correct about the way MDs prescribe medication and especially insulin the acceleration in sales will be much faster then many think.
Most MDs (including myself) dislike prescribing insulin for the first time for many reasons and Afrezza does away with many if not most of the barriers to prescribing insulin.
On top of it all many MDs (including myself) don't know what to give past Metformin because we feel the rest of the oral agents suck and might not help anything else then control glucose numbers at unclear secondary morbidity and mortality. Insulin should therefor be the next line but many delayed and delayed. Afrezza will probably change all this.
If early use of Afrezza is shown to be of any value in delaying the progression of diabetes this will be, as A. Mann said, possibly the best selling drug ever. Think Lipitor without any competition for 15 years. Had a small biotech company come up with Lipitor how much would it have been worth 5 years after hitting the market?
JPG
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Post by seanismorris on May 23, 2014 23:47:22 GMT -5
I've also concluded (from my research) that insulin by pill is terrible and doctors hate prescribing them. Thanks for confirming that. Replacing the existing pills on the market (the low hanging fruit) should get Afrezza to 3B+ within a few years. By 2025 Mannkind better have Afrezza 2.0 out, because diabetes treatments are advancing rapidly. I'm confident 2.0 is already in the works.
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Post by jpg on May 24, 2014 0:05:47 GMT -5
I've also concluded (from my research) that insulin by pill is terrible and doctors hate prescribing them. Thanks for confirming that. Replacing the existing pills on the market (the low hanging fruit) should get Afrezza to 3B+ within a few years. By 2025 Mannkind better have Afrezza 2.0 out, because diabetes treatments are advancing rapidly. I'm confident 2.0 is already in the works. Insulin does not exist in a pill form. I guess you are referring to oral agents at large for type II? And if so I agree with your statement. JPG |
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Post by seanismorris on May 24, 2014 0:49:36 GMT -5
Sorry, when I said insulin pills I meant diabetes pills.
While I do think Afrezza will replace many of them, I do wonder is some of them would be useful as a combination therapy added to Technosphere powder. I.e. Afrezza + a sulfonyurea (or metformin)
All of them have potential side effects much more nasty than a cough though. We will probably have to wait and see what pills doctors continue to prescribe after Afrezza has been on the market a while, to see if a combination therapy makes sense.
The FDA complained Afrezza didn't lower HBA1c enough, we will see if doctors in the field feel the same...
Afrezza + a sulfonyurea (in a lesser amount than normally prescribed) may be more effective but without the side effects
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Sulfonylureas. These diabetes pills lower blood sugar by causing the pancreas to release more insulin. The first drugs of this type that were developed -- Dymelor (acetohexamide), Diabinese (chlorpropamide), Orinase (tolbutamide), and Tolinase (tolazamide) -- are not as widely used since they tend to be less potent and shorter-acting drugs than the newer sulfonylureas. They include Glucotrol (glipizide), Glucotrol XL (extended release), DiaBeta (glyburide), Micronase (glyburide), Glynase PresTab (glyburide), and Amaryl (glimepiride). These drugs can cause a decrease in the hemoglobin A1c (HbA1c) of up to 1%-2%.
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Post by seanismorris on May 24, 2014 1:21:49 GMT -5
My new favorite quote:
The oral diabetes market could be worth more than $18 billion by 2020, a Novo spokesperson tells Reuters, which was following up on a report in the Danish business publication Børsen. And Novo Nordisk plans to remain one of the leading drug developers in the disease.
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Novo Nordisk, if you like the oral diabetes market potential you have to love Afrezza. Mr. Mann is waiting with a pen for you to sign that partnership agreement.
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