MannKind's ($MNKD) third-time's-the-charm win on its inhaled insulin Afrezza isn't the finish line for the long-suffering company. Its quest to gain FDA approval may be over, but the marketing job is just beginning.
It promises to be a tough one. The diabetes market is full of experienced contenders, all with established products and entrenched sales teams. And Afrezza is an inhaled insulin, a formulation that may seem like a natural for needle-shy patients, but winning doctors over won't be easy. They've all seen one inhaled-insulin predecessor--Pfizer's ($PFE) Exubera--crash and burn.
So, what next? MannKind says it's not going to go solo on this drug launch. It's in talks with potential marketing partners, and the Afrezza roll-out will wait till that partner can do the job, MannKind CFO Matthew J. Pfeiffer told CNBC.
Afrezza will go up against Novo Nordisk's ($NVO) NovoLog and Eli Lilly's ($LLY) Humalog in the mealtime insulin market. Both are blockbusters, with $3 billion and $1.5 billion in 2013 sales, respectively. Then there's Sanofi's ($SNY) Apridra jockeying for position, with $394 million in revenue for last year, among others. All three companies have experienced groups of diabetes reps, and Novo Nordisk has a newly expanded sales force, too.
No word on which Big Pharma companies are considering the job, but it's conceivable that one of these three diabetes players might add Afrezza to their product mixes. There's AstraZeneca, which bought out partner Bristol-Myers Squibb last year to double down on the diabetes market. Merck might be another possibility; it has a very successful diabetes drug, the incretin mimetic Januvia--and several prospects in its pipeline--but no fast-acting mealtime product. Plus, Merck has said it's interested in developing alternate-delivery insulin products, including inhaled forms. Then there's Pfizer, which is developing a PCSK9 drug, and might have learned some lessons from the Exubera fiasco.
Whoever rolls out the new drug, Afrezza will still be haunted by the ghost of that first inhaled insulin, a spectacular failure that Pfizer pulled off the market in 2007. Afrezza will not only need to overcome those memories, but persuade doctors that the new delivery system works as advertised. Plus, Afrezza comes with a boxed warning, pointing to a risk of acute bronchospasm in patients with asthma and chronic lung disease.
One key difference between Afrezza and Exubera: The Afrezza inhaler is about the size and shape of a coach's whistle. Exubera's was about the size and shape of a Pringle's can. Plus, it's been almost 7 years since Pfizer pulled Exubera off the market.
And at least one analyst figures that the boxed warning won't have much effect on MannKind's sales efforts. "I consider the boxed warning to be a non-event," Keith Markey, a New York-based analyst at Griffin Securities, told Bloomberg. "MannKind never wanted to market it to people with COPD."
- read the Bloomberg story
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Editor's note: This story was updated with comments about MannKind's search for a marketing partner.