MannKind Corporation (NASDAQ:MNKD) – One of its kind in insulin development
On 31 May MannKind Corporation (NASDAQ:MNKD) announced the completion of all the follow-up visits for patients who had been enrolled Study 171 in the Phase III clinical study of AFREZZA® inhalation powder. This is an investigational, rapid-acting, mealtime insulin therapy. It will be administered using the company’s next-generation inhaler. The inhalation powder is based on a class of certain potential of hydrogen- sensitive organic molecules. AFREZZA uses its Technosphere formulation technology. MNKD expects the data from this study to be released toward the end of this summer.
The right Mann
If AFREZZA is finally able to win the FDA nod either this year or at the start of 2014, there is a strong possibility that Alfred Mann will be considered a powerful runner-up to Banting and Best as the “Man of the Century” for diabetes. The company is creating extremely effective, ultra-fast, inhalable insulin. In addition to this, it is developing MiniMed, the very first mass-market insulin pump, broad framework for an artificial pancreas, the very first continuous glucose-monitor. This is definitely a potent combination for success. It will definitely be quite a task to find anyone else who has made a more hefty contribution to the treatment of diabetes over the last century, other than the actual discoverers of insulin.
Will AFREZZA make the cut?
This will be AFFREZA’s third shot at moving through unscathed through the FDA fire-test but this time around there are several positive signs. However, Mann will just say that’s something that’s happened before, but approval has been as elusive as an illusion. Two more sets of these clinical trials now approach a close and the only thing that Mann and his company can now do is to hope for the best.
The AFREZZA story
The AFREZZA story is very much like a reel-life one. An extraordinarily innovative CEO discovered a considerably small company that has technology. He thought that he will be able to transform the development, use as well as absorption speed of any man-made insulin. He sold the diabetes business that he already had, to an industry biggie for billions of dollars and set about commercializing his new product. He invested nearly a billion dollars from his own pockets. He faced retaliation from a pharmaceutical giant who was unsuccessful at marketing what was it considered sort of a similar treatment. The FDA denied Mann’s product approval, two times around. Now is the time or reckoning.