Biopharmaceutical player MannKind (MNKD) has faced a roller coaster ride this year. Although MannKind is preparing for the commercialization of its marquee drug, Afrezza, which is a fast-acting and inhalable insulin, the drug is supposed to be presented in front of an FDA panel on April 1. However, MannKind is moving forward in a way that shows its confidence in Afrezza. Let’s take a look at what plans Afrezza has in store and what it could do for MannKind in the long run.
Why Afrezza Is Important
MannKind is focusing on accelerating its operations by commercializing Afrezza. The company expects this insulin drug to perform well if it gets accepted due to the ease of use. As such, MannKind is looking forward to the AdCom committee meeting in April as it is hopeful of getting the drug approved fast. The company is getting ready to commercially manufacture Afrezza and is also busy entering into partnerships to market the drug.
MannKind expects the FDA to approve Afrezza since it is the first ultra-fast acting insulin. Once approved, Afrezza will be able to tap a huge market since it would enable substantial lowering of prandial glucose elevations, and also safely lower fasting glucose levels without the risk of hypoglycemia and weight gain, which are key points that can attract more customers.
A study by MannKind showed that Afrezza achieved superior prandial control without any hypoglycemia when it was used for bolus dosing and closed-loop control. The study also resulted in good prandial control without any depressions at all, and this is an encouraging factor for MannKind going forward. Moreover, the company is focusing on the American Diabetes Association meeting to discuss the clinical potential of Afrezza, as this will enable it to disclose certain facts from the pivotal trials publicly.
Pipeline and Patents
MannKind is also focusing on its drug development pipeline. It is trying to diversify its patent portfolio for Afrezza as the drug’s patents would expire by 2020. Recognizing the significance of its intellectual property in the form of the drug, MannKind’s scientists and engineers are working hard to expand and diversify its patent portfolio in order to gain better patent protection.
The company’s patents in Technosphere particles and inhaler system and components are expected to provide robust patent protection. As such, Afrezza is protected globally with over 550 issued patents and another 470 patent applications pending, giving MannKind the opportunity to enjoy revenue from the drug exclusively for many years.
Also, some of the company’s products such as Cricket, which is a tiny single-use disposable inhaler used occasionally to treat chronic pain, is expected to gain traction in the future due to its ease of use. Moreover, getting pain relief in a couple of minutes from a drug provides valuable medical and business opportunity to MannKind. The company is focusing on providing patients with only a single cartridge per meal, providing higher efficacy.
Further, the increasing usage of Afrezza by PCPs (primary care physicians) as a second line of therapy in type 2 diabetes with very high blood glucose such as with an HgbA1c of over 9% is also giving MannKind encouragement regarding the drug’s approval. Going forward, PCPs are expected to continue using Afrezza instead of a third oral drug in type 2 patients.
Quite clearly, MannKind’s future depends on the fate of Afrezza. But there are some good indications that the drug could pass the FDA process due to its popularity among physicians and ease of use that it provides to diabetes patients. Moreover, MannKind has erected a fort around Afrezza by recording several patents and is in the process of getting more. Hence, investors with a high appetite for risk should definitely consider Afrezza for their portfolio because if the drug gets approved, it would be a big success considering that the number of diabetic patients across the globe is a staggering 347 million, out of which 3.4 million have died as a result of high fasting blood sugar that Afrezza looks to address.