The forecast for inhaled insulin--at least for Mannkind--just got a little sunnier. And with the firm's ($MKND) stock up more than 20% early this morning, investors appear to be pumped about the drug developer's news that it has a green light from the FDA on two key trials of its experimental inhaled insulin, Afrezza, in patients with type 1 and type 2 diabetes.
After taking hits to its stock price due to delays on the development of the drug, Mannkind announced it has come to an agreement with U.S. regulators on the design of the trials it needs for market approval. One of the trials, involving patients with type 1 diabetes, will compare the company's next-generation inhaler head-to-head with its previously studied MedTone inhaler. That should satisfy regulators' previous request to see data on how the different inhalers impact pulmonary safety.
Afrezza is important to Mannkind, which has no marketed products and has weathered several setbacks to the inhaled insulin market over the years. Once a holy grail of the drug industry, inhaled insulin has fallen from grace in the eyes of some investors after heavyweights such as Pfizer and Eli Lilly pulled the plug on their programs. Yet Alfred Mann, chairman and CEO of Mannkind, has been keeping the faith all of these years that there's a future for inhaled insulin.
On FDA's nod for the type 1 trial (dubbed 171) and the type 2 study (called 174), Mann said: "We are very encouraged and pleased with this outcome. Our attention now turns to the execution of these trials. The protocol for Study 171 has already been sent to Institutional Review Boards and the protocol for Study 174 is being finalized and will be distributed to our sites shortly."
- here's the company's release
- see the AP story