Back in August 2014, when MannKind ($MNKD) inked a $925 million marketing partnership for inhaled insulin Afrezza with diabetes heavyweight Sanofi, then-CEO Alfred Mann called the French drugmaker the "ideal partner" to take the therapy forward. Now, though, Sanofi ($SNY) is out of the picture--but MannKind insists it's down but not out.
On Tuesday, MannKind announced that Sanofi had terminated the pair's commercialization deal, which will officially cease no later than July 4. As Sanofi told Bloomberg in a statement, "the product never met even modest expectations, and we do not project Afrezza reaching even the lowest patient levels anticipated." And that performance came even with Sanofi's "substantial efforts" behind hawking the product, spokeswoman Mary Kathryn Steel told FiercePharmaMarketing via email.
So what's next for the California company? According to TheStreet, "MannKind is as close to financial insolvency as it can possibly be without actually declaring bankruptcy," and its shares plunged on the Sanofi news. But the company isn't giving up. As CFO Matthew Pfeffer said on a call with investors, "this is not the end of the line for Afrezza or MannKind by any means."
MannKind doesn't have the bandwidth to get the job done on its own, though--and that means it'll have to convince another partner to sign on to market, sell and distribute Afrezza if it wants to move forward with the drug. And with the luck inhaled insulins have had so far, it'll likely be hard sell. Before Afrezza's struggles, Pfizer ($PFE) pulled the first one, Exubera, off the market in 2007 amid spectacular failure.
And if MannKind can ink another pact, its partner will have to take Afrezza up against blockbusters from Novo Nordisk ($NVO) and Eli Lilly ($LLY) in the mealtime insulin market in NovoLog and Humalog, respectively. Sanofi will also be on the other side of the fence this time, with its Apidra jockeying for position.
But as Pfeffer sees it, the company knows what it needs to do. Future Afrezza plans have to involve educating patients and doctors, as well as improving patient access, he said on the call. The one thing that doesn't need to change, according to Pfeffer? "The real world experience of Afrezza users, which is everything we hoped it would be."
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