MannKind Corporation (NASDAQ:MNKD) and the Wall Street both are eagerly anticipating the approval of the biopharmaceutical company’s diabetes treatment Afrezza. FDA’s advisory committee had recommended the drug for Type-1 and Type-2 diabetes. But the regulator delayed the Prescription Drug User Fee Act (PDUFA) review from April 15 to July 15. Brinson Patrick analyst Christopher James said in a research note that the FDA is highly likely to approve Afrezza.
MannKind and FDA are in advanced talks about labeling, REMS
Brinson Patrick has an Outperform rating on the stock with $12 price target. Based on comments by MannKind Corporation (NASDAQ:MNKD) management, James believes that the approval could come even before July 15. The Valencia, California-based company is in final discussions with the USFDA around REMS, labeling and the pediatric phase IV study. Moreover, the company is sharing its ongoing FDA dialog with its potential partners.
At this point, the research firm sees negligible risk to approval. For Type-1 diabetes, endocrinologists as well as patients badly need Afrezza’s convenience and reduced hypoglycemia. For Type 2 diabetes, 14-0 votes in favor of the drug and the follow-up discussion at the advisory committee suggests increased confidence and a high adoption rate. Afrezza is a combination of drug and device, which consists of a recombinant human insulin powder formulation. Patients can self-administer the insulin power by oral inhalation, which is absorbed by lungs. Each cartridge contains either 10 units or 20 units of insulin.
MannKind expected to start selling Afrezza in Q1, 2015
With little approval risk in sight, Christopher James says the investor focus is increasingly shifting to REMS, labeling, commercial partnerships and a successful launch. Brinson Patrick expects MannKind Corporation (NASDAQ:MNKD) to start selling Afrezza in the first quarter of 2015. And annual sales are expected to reach $3.65 billion by FY2025, largely driven by its use in early stage Type-2 diabetes. James expects initial demand for Afrezza to be strong considering statements from the regulatory panel about its safety, efficacy and attractive size.
MannKind Corporation (NASDAQ:MNKD) shares were down 2.96% to $7.53 at 9:37 AM EDT on Friday.