NEW YORK (
(MNKD) won the support of an FDA advisory panel Tuesday for its rapid-acting inhaled insulin Afrezza.
By a 13-1 margin, experts on the panel voted to recommend the approval of Afrezza as a new insulin therapy for Type 1 diabetics. The same panel supported Afrezza use in Type 2 diabetics by a 14-0 vote.
Congratulations to Mannkind and its supporters, who were clearly right to believe in Afrezza's approval chances. Despite some reservations about Afrezza being less effective than injected meal-time insulin and questions about long-term safety, the panel votes were overwhelmingly positive and should compel the FDA to approve the new inhaled insulin. The agency's decision is expected on April 15, although a standard three-month delay might be put in place given the short time period between Tuesday's meeting and the approval decision date.
Mannkind skeptics who believed FDA criticism of Afrezza would persuade the panel to reject the new insulin were wrong. I was one of those Afrezza non-believers, predicting a negative panel vote for both Type 1 and Type 2 diabetes. I was wrong.
Shares of Mannkind were halted Tuesday but more than doubled in price to $8.46 when the stock opened for trading in the after-hours session. Mannkind's last, best closing high was $8.29 per share on Aug. 2, 2013, before the Afrezza phase III study results were announced. Where the stock settles Wednesday will be interesting to watch given a variety of factors, including a relatively large short interest, a rabid retail investor fan base and Mannkind's unsettled financial position. The company needs cash so a financing will be widely expected. At its after-hours stock price, Mannkind's enterprise value already approaches $5 billion.
Mannkind seized victory at Tuesday's panel with two key arguments favoring Afrezza: First, the convenience of an inhaled insulin is an important and much-needed alternative treatment option for diabetics. Second, the company emphasized Afrezza's ability to reduce the risk of low blood sugar, or hypoglycemia, which is a big safety concern for diabetics.
FDA staff, on the other hand, argued that Afrezza's ability to lower blood glucose was inferior to standard, injected mealtime insulin. The agency's review staff also raised questions about Afrezza's long-term safety, including a possible lung cancer risk. FDA was also skeptical about Afrezza's hypoglycemia benefit, believing the inhaled insulin's modest efficacy compared to injected insulin could explain the reduced incidences of low-blood sugar events recorded in the clinical trials.
At the end of the panel deliberations, however, Mannkind's arguments won the day. Speaking after their votes, many panel experts expressed concerns about Afrezza's inferiority to standard, injected insulin and said the inhaled option might only be suitable for certain subgroups of diabetic patients. However, they also believed diabetics would be better served if an alternative, inhaled insulin therapy were available for those who can't use, or don't want to use, needle injections of insulin. Many of the panel experts also agreed with Mannkind that Afrezza's lower incidence of hypoglycemia was a benefit for patients.
Next, the Mannkind bear-bull battle shifts to Afrezza's commercial outlook. Marketing Afrezza will require a lot of money that Mannkind does not have, which is why the company is seeking a partner. Mannkind executives have told investors that talks with prospective partners were already underway. But any potential partner might wait to see FDA's final label for Afrezza, including the potential for restrictions to certain types of diabetic patients, before deciding whether to invest in the product.
Competing rapid-acting insulins from Novo Nordisk and Eli Lilly bring in approximately $3 billion in annual sales each.
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