No Partner for Afresa; the PDUFA date may get delayed (NASDAQ:MNKD)

Afresa (also known as Afrezza) is a type of insulin developed by Mannkind Corporation (NASDAQ: MNKD). The company has already submitted the application for the approval of Food & Drug Administration to market Afresa. Upon receiving the application, the FDA has given it a Prescription Drug User Fee Act date (also called Action date or just PDUFA date). This is the date on which the Food & Drug Administration must respond to Mannkind’s application for marketing approval of Afresa. The PDUFA date for Afresa was January 16, 2010.

@@CalendarRight@@ However, on last year’s October, the company disclosed that it had not yet signed any partner for its drug Afresa. In addition, it seemed the company was not also planning to (or hoping to) sign any partner before the PDUFA date. This statement from the corporation itself became the cause of much turmoil in the stock market, as a result of which the shares of Mannkind Corp. dropped significantly. In fact, in October 6, 2009, the shares dropped by 23 per cent to $7.01 which was much lower than the stocks’ usual price.

So, why is not Mannkind signing a partner for its much talked-about Afresa? According to a phone interview with Jason Butler, who is an analyst at JMP Securities, the reason is not that Mannkind is not willing to sign a partner. Instead, it is that Mannkind is not finding a partner. The executives of Mannkind Corp. recently attended a conference held by JMP Securities in New York. According to Jason Butler, It was in this conference where the corporation disclosed that “a partner is not willing to sign on before the FDA’s PDUFA date”.

In the 8-K filing at Securities & Exchange Commission, the corporation talked about how it had gone very far on its way to form a partnership with another corporation (whose name Mannkind did not disclose). However, the company later “came to believe” that forming a partnership after getting response from the Food and Drug Administration would be “more productive”. According to Mannkind, this was the reason why the corporation itself – not the partner- moved with the partnership.

However, the lack of partner for Afresa was not the worst of what could happen to Mannkind Corp. The statement at the SEC filing made the outsiders and the stockholders fear that the United States of America’s strictest regulator, the Food and Drug Administration, may not approve the marketing application for Afresa. This was why the stocks of Mannkind fell by such a large proportion.

At the conference held by JMP Securities in New York, stakeholders wanted to know about whether there was any sign of getting FDA’s full approval on January 16 or whether it would take a longer time period for getting the approval. However, the executives of Mannkind who were present at the conference were reluctant to answer the question. They also did not say whether they would have to bring Afresa before the advisory panel of FDA for getting the approval.

Afresa is new type of insulin which is taken by people with type 1 and type 2 diabetes mellitus during mealtime. It acts rapidly and is used to treat hyperglycemia. This drug consists of Afresa Inhalation Powder, which must be taken with Afresa inhaler. As a result, Mannkind Corp. calls it a “drug-device combination product”.