Future of Sanofi's Inhalable Insulin in Doubt

Disappointing sales were blamed on prior authorization, the FDA label restrictions, and the need for spirometry before doctors could write prescriptions.

Shockingly poor sales have led Sanofi to opt out of its deal to sell the inhalable insulin Afrezza for the company that developed it, a move that led shares of California-based Mannkind to fall 48% yesterday despite management’s promise to find a more effective marketing partner.

The 2 companies have pledged to try and keep the drug available while they work together to ensure a smooth transition over the next 90 to 180 days. Indeed, a Sanofi spokeswoman wrote in an email that the French drugmaker will keep supporting Afrezza on a number of fronts.

“Sanofi will, until the date of termination, continue to work with key national plans reviewing Afrezza in the hopes that they will continue including the product when making formulary decisions,” spokeswoman Susan Brooks wrote.

New deals to put Afrezza on payer formularies could provide a significant boost for Mannkind’s efforts to find a new partner and make its drug a success. Some analysts believe that the single biggest reason for Afrezza’s disappointing sales to date has been the nearly universal need for would-be users to get prior authorization before filling a prescription for the drug.

Still, despite such hurdles, Mannkind’s leadership says that Afrezza can still be the big seller that many people once expected it to be.

“Although this news is obviously not what we anticipated when Mannkind commenced the partnership agreement with Sanofi in August, 2014, it became clear as 2015 progressed and sales forecasts were not met that change would be required if Afrezza were to achieve the market success that we believed and still believe should be possible,” said Matthew Pfeffer, the company’s chief financial officer, speaking with investors on a conference call Tuesday. “This is not the end of the line for Afrezza or MannKind by any means.”

Investors and at least some who follow Mannkind were not so confident about the future of either the company or the 1 drug it has shepherded through the regulatory approval process. Mannkind’s stock price fell 70 cents to close at 74.8 cents a share on Tuesday. The stock has lost more than 90% of its value since share prices briefly rose over $10 when the FDA approved Afrezza in mid-2014.

Analysts from JP Morgan believe that Sanofi’s decision to terminate the sales partnership will most likely end any real chance of major success for Mannkind and Afrezza.

“We can't imagine that another legitimate diabetes company would show serious interest in this asset," they wrote yesterday in a note to investors. "With little hope for resuscitating Afrezza and a dismal balance sheet (net debt), we see Mannkind in an increasingly precarious position.”

Even before Afrezza became available to consumers early last year, predictions about its potential impact varied widely. Skeptics argued that the recent failure of Pfizer’s Exubera demonstrated how little demand there was for inhalable insulin. Worse, they said, the FDA’s insistence on labels urging against Afrezza for patients with any breathing impairment would scare many other patients away. Optimists countered that it was ridiculous to discount the compelling appeal of replacing more than 1000 shots a year with painless sniffs.

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