MannKind and Sanofi launch inhaled insulin in U.S.

The Afrezza inhaled insulin drug/device combination product--Courtesy of MannKind

It's finally here. After suffering from unflattering comparisons to Pfizer's ($PFE) infamous inhaled insulin flop Exubera at a cost of $2.8 billion, two FDA rejections, and mockery over its long-running promise to find a marketing partner, MannKind ($MNKD) today announced that Afrezza, its fast-acting inhaled insulin, is available at U.S. pharmacies.

"In terms of the early market initiation ... we are looking at the insulin intensification of those patients that have been on a long-acting (insulin) initially to just avoid frequent injections and certainly those that are failing on orals and need to start an insulin therapy," said the company's new CEO, Hakan Edstrom, at last month's JP Morgan Healthcare Conference in San Francisco.

Afrezza is supposed to be administered at the beginning of each meal.

The dry powder insulin is delivered via a small inhaler that easily fits in your hand (unlike Exubera's, which was the size of a Pringles can). But FDA safety concerns about the inhaled product resulted in a black-box warning contraindicating the medication in patients with a lung disease, such as asthma or COPD. The label also calls for a physical exam and spirometry to be performed prior to initiation of the combination product.

French Big Pharma Sanofi ($SNY) agreed to co-market Afrezza following last year's FDA approval. It seeks help in the fast-acting segment of the insulin market because its Aprida lags behind the competitors.

"Afrezza is an important addition to Sanofi's growing diabetes portfolio of integrated, personalized offerings, and it is one that highlights our dedication to bringing innovative therapies to people with this disease," said Pierre Chancel, senior vice president of Sanofi's diabetes division, in a statement. "There is a recognized need for an insulin that doesn't require an injection, and our organization is committed to making this new treatment option available to patients."

During an investor presentation late last year, Sanofi said it aims to market Afrezza at the two-thirds of diabetics who are not on injected insulin and those on long-lasting insulin, such as the company's popular Lantus, who need another dose of insulin at mealtimes. Those patient populations, combined, could reach 3 million, RBC analyst Adnan Butt said in a recent investor note.

According to Sanofi's market research, 39% of patients using oral meds didn't want to start insulin therapy specifically because they wanted to avoid injections. To about 60% of surveyed patients, Afrezza was a preferable alternative to a pen injector. Almost as many said they'd prefer to use Afrezza daily than add injections at mealtime.

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