Afreeza had a positive ADCOM meeting months ago and formal FDA approval in June.
As days turn into weeks and weeks turn into months without a deal, the lack of interest becomes more and more apparent.
Most diabetics are cared for by primary care physicians who will not want the extra bother of ordering regular spirometries for their patients. And the concern about lung cancer will scare away patients.
Exubera was a commercial flop. Afrezza may not even get a a chance to get onto the market and flop.
"WARNINGS AND PRECAUTIONS
Acute Bronchospasm: Acute bronchospasm has been observed in patients with asthma and COPD. Before initiating, perform spirometry (FEV1) in all patients. Do not use in patients with chronic lung disease.
Change in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring.
Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to; insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness.
**Decline in Pulmonary Function: Assess pulmonary function (e.g., spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms.**
Lung Cancer: AFREZZA should not be used in patients with active lung cancer. In patients with a history of lung cancer or at risk for lung cancer, the benefit of AFREZZA use should outweigh this potential risk.
Diabetic Ketoacidosis: More patients using AFREZZA experienced diabetic ketoacidosis in clinical trials. In patients at risk for DKA, monitor and change to alternate route of insulin delivery, if indicated.
Hypersensitivity Reactions: May be life-threatening. Discontinue AFREZZA, monitor and treat if indicated.
Hypokalemia: May be life-threatening. Monitor Potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. "
Hence, Afreezza's doom.
The FDA warnings about damage to the lungs and requirement for spirometry and the FDA's order to do studies to evaluate for the risk of lung cancer appear to be dooming Afreeza's commercial viability.
MNKD is the most overpriced bioturd stock currently listed. MNKD is the poster child for Yellen's assessment of the biotechnology sector being overvalued.
Well, if billionaire al mann wants to spend tons of money marketing Afrezza, that is his prerogative. But don't count on any large pharma being willing to pay much for Afrezza.
The FDA label warnings and requirements for multiple large extensive post-approval studies seems to have scared away suitors.
In the event that MNKD does find a partner, the deal would be so unfavorable, and MNKD investors will be forced to confront the fact that MNKD is overvalued by a factor of 40 or more.
The only thing of any value at BTX is Hextend, and the market for Hextend's is rapidly diminishing.
Everything else at BTX is vaporware.
I have no position in MNKD.
Warning people about MNKD's doomed future is a good deed.
Pumping a drug that is doomed to fail is diabolical.
I am a physician too.
How many of your Type II diabetics have no history of smoking or asthma or any lung disease?
And, if they were expecting to charge more than ordinary injectable insulins, you know that the insurance coverage will be poor. And, if you are a physician, you surely know the hassle of getting prior auths for medications that are not preferred and that the trend is for it to become harder and harder for the prior auths to succeed.
Yes, the delay was bad news for Afrezza. It was a sign that the FDA was working on major black box warnings and onerous post-marketing requirements.
"Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.
Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk."
"The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza.
The FDA is requiring the following post-marketing studies for Afrezza:
a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;
a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function);
two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability."
The boxed warning, need to get spirometry, the mention of a risk of lung cancer, the exclusion of COPD and asthma are all going to severely limit any appeal for Afrezza. And, if they were thinking of charging any more for Afrezza than injectable insulin or insulin analogues, then the difficulty of getting insurance coverage for it will bury Afrezza.
I have no position in MNKD, I'm just an observer here.