MannKind (NASDAQ:MNKD) Gets FDA Approval For Afrezza- Will It Become Profitable?

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By Hanson So on January 3, 2015 Company

The year 2014 was no doubt a roller coaster for the stock holder of MannKind (NASDAQ:MNKD). Sometimes, the stocks of the company were as high as 200 percent whereas at other times, the stocks were as low as 60 percent.

But then again, market experts were expecting this fluctuation in the prices of MannKind since the start of the year, for the company’s pipeline includes Afrezza, a revolutionary drug of the company for diabetes. The drug was given PDUFA by the members of Food and Drug Administration panel. The company does not have any other clinical trials scheduled for the year 2015, and so, it was a relief when the drug received the approval.

Management of the company says that Afrezza has a lot of potential. Moreover, according to a report by Centers for Disease Control and Prevention, around 29.1 million individuals are suffering from diabetes in the region of United States alone. Most of them suffer from type 1 disease whereas the rest suffer from type 2. It is important to mention here that type 1 disease results due to a genetic disorder. The other type develops over the course of one’s lifetime. The report of CDCP further showed that around 86 million people, who are either r20 or above, differ from prediabetes. MannKind (NASDAQ:MNKD) expects the sales figures of its Afrezza to shoot the skies.

What is interesting to note here is the fact that Afrezza would not be required to be injected. Yes, that is right. The patients will not have to use a needle to inject the drug, which means that this can become a top choice of the patients. Moreover, it can be used for both type 1 and type 2 diabetes.

The drug will not cure diabetes; rather it will act as a mediator for the glycemic balance of the patient. Most of the pharmaceutical companies treat the symptoms of the diabetes instead of curing the cause that gives rise to those symptoms in the first place. Until the situation is changed, chances are that the developers of diabetes drugs will continue to benefit.

It is worth mentioning here that Afrezza did not get the approval of FDA back in 2011 when the company filed for the first time. The FDA required the company to change its delivery design completely in order to get an approval. Moreover, the new clinical studies were required to be engineered. MannKind (NASDAQ:MNKD) has gotten the approval, but it still needs to overcome three hurdles if it wants to be successful.

The first issue that the company is facing is as to whether the physicians will prescribe this drug to their patients. The warning on the box of Afrezza says that the drug should not be given to those patients who are suffering from chronic lung diseases. Moreover, the smokers are also warned from using this drug.

Moreover, the deal that MannKind (NASDAQ:MNKD) sealed with Sanofi (NYSE:SNY) no doubt erased all the concerns regarding cash flow of the MannKind; however, it also eliminated all the possibilities of the company becoming profitable from the sales of Afrezza, for Sanofi will receive 65 percent of the profits from the sales of Afrezza.