Lack of marketing partner delays Afrezza launch
No marketing; no money. It's been four weeks since the approval of MannKind's novel inhalable insulin, Afrezza, and the company has yet to find a marketing partner. The drug's failure to launch illustrates the difficulties in post-approval market access—even with an innovative product.
After 10 years jumping through regulatory hurdles (which included two outright rejections), Afrezza's approval was greeted by some as the inflection point MannKind needed for its fast-acting insulin. And while the rapid-acting segment has not been as successful as the long-acting insulins (Sanofi's Lantus is the best-selling diabetes drug), MannKind expected Afrezza's unique mechanism of action to grow the pie—especially with diabetes prevalence on the rise.
As the deadline for MannKind's second-quarter earnings call approaches, though, pressure is mounting on the firm to announce a launch partner. Afrezza faces entrenched competition in Novo Nordisk's NovoLog and Eli Lilly's Humalog. NovoLog and Humalog brought in $1.4 billion and $1.2 billion in US sales last year, respectively.
Some members of the analyst community have already doomed Afrezza's commercial chances. Their standard reference case is Pfizer's Exubera—the first inhalable insulin to be approved. While many remember a similar level of excitiment around it, Exubera was pulled from the market in 2008 after less than one year due to poor sales, and scattered cases of cancer in clinical trials.
To lay Pfizer's faults at the feet of MannKind, however, is reductive at best. Jami Rubin, at the time an analyst with Goldman Sachs, characterized the drug's launch simply as “poor marketing.”
"I think Pfizer felt that the drug would sell itself," Rubin stated. "Samples were sparse, the TV ads were late, and they were too benign and not exciting. They did not court the nurses, the certified diabetic educators, who play an even bigger role than physicians in deciding to put patients on insulin. They ignored them."
And not only was the earlier drug saddled by irrelevant messaging, the inhaler's shape and size was oft-described as unwieldy and “bong-like." Afrezza, by contrast, touts a much smaller device (pictured above).
Another commonly cited reservation for Afrezza is the drug's warning label. Its black-box warning, the most severe kind, cautions that difficulty breathing was observed in patients with a history of asthma and COPD. But it's unlikely MannKind would market the drug to people with either condition.
There is one warning, though, which may seem to be more of a pitfall to a potential co-marketer. Before receiving Afrezza, patients must receive a lung test—which in and of itself doesn't seem too difficult. But patients must also get a follow-up lung test, “after the first six months and annually thereafter,” even if they aren't experiencing symptoms.
While these factors may or may not be what's keeping commercial partners at arm's length, what is clear is that without a big pharma company to hitch its drug to, Afrezza may never get properly out of the gate.
Out of the three big names in diabetes—Eli Lilly, Novo Nordisk and Sanofi—the latter, Sanofi, could have the most to gain from a co-promotion deal. While Eli Lilly and Novo Nordisk both already sell blockbuster fast-acting insulins, sales of Sanofi fast-acting mealtime insulin Apidra lag behind its competitors in the category.
Paris-based Sanofi also has the best-selling diabetes drug in the world in Lantus and knowledgeable reps who have helped it attain that lofty perch.