Mannkind Completes Key Afrezza StudyMonday, June 3, 2013
Shares of Mannkind Corp. rose sharply Monday after the Valencia biotech said that it had completed one of two required trials of its experimental inhaled insulin drug Afrezza.
Mannkind announced on Friday that it had completed a Phase III trial of the drug, and planned to submit the information to the Food and Drug Administration later this year. The study compared the safety and effectiveness of the drug for patients with Type I diabetes when administered by either the MedTone inhaler, the first model tested by MannKind, and a newer version, the Dreamboat inhaler. Both also were compared to traditional injected insulin.
A second study, which will compare the three delivery methods in patients with Type II diabetes, is expected to be completed in the coming months.
The trials were done at the request of the Food and Drug Administration, which called for more research in 2011 after MannKind had completed testing with the MedTone but then introduced the newer inhaler. The drug could be used to treat adults with Type I and II diabetes.
It’s the second run the company’s stocks has experienced in as many weeks. Last Wednesday, shares jumped almost 16 percent after an article was published speculating that the company was a prime acquisition target, though company officials denied it.
The company went public in 2004 and has yet to introduce a drug to the market. Most income has come through secondary offerings and the backing of its founder, billionaire entrepreneur Alfred Mann.
In December, Mann converted more than $107 million debt owed to him by MannKind into 40 million shares and warrants to purchase another 30 million.
Shares closed up 97 cents, or more than 14 percent, to $7.63 on the Nasdaq.