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Jun 18, 2014 7:36:22 GMT -5
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Post by BD on Jun 18, 2014 7:36:22 GMT -5
www.retailinvestor360.com/biotech/199-mannkind-corporation-catalyzing-the-next-revolutionn-in-diabetes-treatment.html
Mannkind Corporation: Catalyzing The Next Revolutionn In Diabetes Treatment
Published: Monday, 16 June 2014 18:00
Written by Doctor Hung V. Tran, MD, MS
Sharesholders of the small cap Valencia, California, biopharma firm are witnessing shareprice appreciation. Mannkind Corporation (Nasdaq:MNKD) is nearing an FDA approval for its lead drug, Afrezza, indicated as treatments for both Diabetes Mellitus Type 1 and Type 2. Revolutionary for its ability to mimic the work of the human pancreas, Afrezza is easily inhaled throught a small whistle-like device.
In April 2014, the company received the near unanimous votes from the Advisory Committee (ADCOM), 13 to 1 and 14 to 0– overwhelmingly favored Afrezza as treatments for Type I and Type II Diabetes, respectively. The committee includes experts such as physicians, scientiests, industry leaders, and consumer advocates. The FDA usually follow these experts recommendations. The Mannkind expected to receive a final decision from the Agency by less than two weeks, specifically July 15.
With positive phase III data for the Affinity I and Affinity II demonstrated that Afrezza met the study's primary endpoints without any serious side effects, as well as stellar properties of the drug, the odds strongly favors an FDA approval.
The Agency has reasons to approve Afrezza for the drug is quite revolutionary in many aspect such as in enhancing patient compliance, improving diabetes care, as well as, saving billion dollars … that we spend annually on diabetic complications
One of the culprits underlying compliance is that patients with diabetes have to administer multiple insulin shots daily. The typical treatment include both long acting and short-acting insulin. Doctors commonly prescribe either Lantus or Levemir for long acting insulin, and likelwise Novolog or Humolog for short-acting insulin. However, conventional treatments are far from perfect.
There is a lag time when patient inject insulin before it start to work so patients sometime takes too much insulin and dangerously lower their blood sugar, below 60 resulting in a deadly condition called hypoglycemia.
Fortunately, Afrezza works faster and exits the body quicker comparing to existing drugs. Data from the Affinity Trials suggested that the revolutionary pharmacokinetics of the drug enabled it to significantly dampen the swing in blood sugar after meal. As follows, this minimizes the chances of "hypos," as well as improving diabetes and quality of life in general. For instance, patients with Type 1 diabetes tend to be younger and would benefit more by not having to deal with the stigma associated with injections.
The path leading toward the success for inhale insulin has been marred with the failures, notably a previously FDA-approved inhale insulin Exubera. Pfizer lost around $2billion invested in Exubera. The market have yet forgot this previous dissapoitment; thereby, it has not shown the red carpet for Mannkind until recently. Exubera looks similar to a bong and it also has issues with dosing. Contrarily, Afrezza is completely revolutionary from both pharmocological and practical views. Afrezza is much smaller and it can fit conspicuously in one's pocket. Moreover, it pharmacology enable patients to manage their diabetes as if they do not have diabetes at all.
Afrezza is quite easy to use so more patients would likely use it, thus, saving patients from losing their limbs, vision, or heart complications. As a physician, I believe that this is one of the keys favoring physicians adopting Afrezza as the first line theraphy for diabetes in the future. This is plausible because an independent consulting firm also found high physician adoption rate in their study published last year.
The market for diabetes is gigantic. We spend billions of dollars in insulin per annum. While the spending on long-acting insulin is a bit more than those for short-acting analogues, that figure is still substantial. Assuming that Afrezza would only be able to penetrate 25% of the market, Mannkind should earn billion of dollars. This would not a far stretch of the imagination given that Afrezza has superior performance over competiting drugs. On the final note, I strongly believe in Mannkind's prospect despite investing research is an imperfection science making not guarantee promises. Decades after Doctor Best/Banting discover insulin, Doctor Mann and the management would indeed mark the beginning of the third revolution in diabetes treatment in less than two weeks.
Mannkind Corporation: Catalyzing The Next Revolutionn In Diabetes Treatment
Published: Monday, 16 June 2014 18:00
Written by Doctor Hung V. Tran, MD, MS
Sharesholders of the small cap Valencia, California, biopharma firm are witnessing shareprice appreciation. Mannkind Corporation (Nasdaq:MNKD) is nearing an FDA approval for its lead drug, Afrezza, indicated as treatments for both Diabetes Mellitus Type 1 and Type 2. Revolutionary for its ability to mimic the work of the human pancreas, Afrezza is easily inhaled throught a small whistle-like device.
In April 2014, the company received the near unanimous votes from the Advisory Committee (ADCOM), 13 to 1 and 14 to 0– overwhelmingly favored Afrezza as treatments for Type I and Type II Diabetes, respectively. The committee includes experts such as physicians, scientiests, industry leaders, and consumer advocates. The FDA usually follow these experts recommendations. The Mannkind expected to receive a final decision from the Agency by less than two weeks, specifically July 15.
With positive phase III data for the Affinity I and Affinity II demonstrated that Afrezza met the study's primary endpoints without any serious side effects, as well as stellar properties of the drug, the odds strongly favors an FDA approval.
The Agency has reasons to approve Afrezza for the drug is quite revolutionary in many aspect such as in enhancing patient compliance, improving diabetes care, as well as, saving billion dollars … that we spend annually on diabetic complications
One of the culprits underlying compliance is that patients with diabetes have to administer multiple insulin shots daily. The typical treatment include both long acting and short-acting insulin. Doctors commonly prescribe either Lantus or Levemir for long acting insulin, and likelwise Novolog or Humolog for short-acting insulin. However, conventional treatments are far from perfect.
There is a lag time when patient inject insulin before it start to work so patients sometime takes too much insulin and dangerously lower their blood sugar, below 60 resulting in a deadly condition called hypoglycemia.
Fortunately, Afrezza works faster and exits the body quicker comparing to existing drugs. Data from the Affinity Trials suggested that the revolutionary pharmacokinetics of the drug enabled it to significantly dampen the swing in blood sugar after meal. As follows, this minimizes the chances of "hypos," as well as improving diabetes and quality of life in general. For instance, patients with Type 1 diabetes tend to be younger and would benefit more by not having to deal with the stigma associated with injections.
The path leading toward the success for inhale insulin has been marred with the failures, notably a previously FDA-approved inhale insulin Exubera. Pfizer lost around $2billion invested in Exubera. The market have yet forgot this previous dissapoitment; thereby, it has not shown the red carpet for Mannkind until recently. Exubera looks similar to a bong and it also has issues with dosing. Contrarily, Afrezza is completely revolutionary from both pharmocological and practical views. Afrezza is much smaller and it can fit conspicuously in one's pocket. Moreover, it pharmacology enable patients to manage their diabetes as if they do not have diabetes at all.
Afrezza is quite easy to use so more patients would likely use it, thus, saving patients from losing their limbs, vision, or heart complications. As a physician, I believe that this is one of the keys favoring physicians adopting Afrezza as the first line theraphy for diabetes in the future. This is plausible because an independent consulting firm also found high physician adoption rate in their study published last year.
The market for diabetes is gigantic. We spend billions of dollars in insulin per annum. While the spending on long-acting insulin is a bit more than those for short-acting analogues, that figure is still substantial. Assuming that Afrezza would only be able to penetrate 25% of the market, Mannkind should earn billion of dollars. This would not a far stretch of the imagination given that Afrezza has superior performance over competiting drugs. On the final note, I strongly believe in Mannkind's prospect despite investing research is an imperfection science making not guarantee promises. Decades after Doctor Best/Banting discover insulin, Doctor Mann and the management would indeed mark the beginning of the third revolution in diabetes treatment in less than two weeks.
