As Valencia drugmaker MannKind scrambles to replace the strategic partner it was relying on to market and distribute its Afrezza inhalable insulin treatment, diabetics who have come to rely on the drug are wondering whether they’ll be able to continue using it — despite assurances that it will remain available.
On Twitter, on online diabetes discussion boards and even in a YouTube video parody, Afrezza users also took shots at Sanofi, the French pharmaceutical giant that earlier this week pulled out of the marketing agreement.
“We may have to figure out a way to buy up all the remaining supply and stockpile it,” an Afrezza user wrote on a TuDiabetes.org discussion board.
“A world-changing drug deserves better marketing. I’ve done more to market Afrezza myself than Sanofi ever did,” another TuDiabetes user wrote.
“There is no doubt that Sanofi has been a poor partner. One wonders if there was ever any commitment to the product at all,” wrote a third.
Sanofi has defended its decision to no longer sell the drug, saying that patient and doctor demand was disappointing despite strong marketing support. Since the drug hit the market in February, the company had reported U.S. sales of only about $5.5 million through Sept. 30. It was not yet available overseas.
Some experts say the drug may have run into unexpected competition from a new class of diabetes treatments. And it might not have been able to overcome the high-profile failure of Exubera, a previous inhalable insulin from Pfizer that was torpedoed by concerns that it impaired lung function, among other issues.
Meanwhile, MannKind executives said patients shouldn’t lose access to the drug, which the company manufactures at a plant in Connecticut.
Still, even before Sanofi pulled out, Afrezza was difficult to get.
Many insurers require special authorization for doctors to prescribe it, with some limiting it to patients who cannot give themselves injections because of a physical impairment or “documented needle-phobia.”
Afrezza is what’s known as a fast-acting or mealtime insulin. It’s meant to be taken just before or after meals to help prevent blood-sugar spikes. It is approved for both Type 1 diabetes, in which the body does not product any insulin, and Type 2, the disease’s most common form, in which the body’s own insulin loses effectiveness.
It’s not a replacement for all insulin treatments. But for Larissa Zimberoff, a New York freelance writer who has Type 1 diabetes, using Afrezza means taking fewer shots.
Now 44, she’s been taking insulin since she was 12, which has left her with scar tissue at injection sites. She still takes a daily shot, but, with Afrezza, doesn’t have to do so before meals — something she’s particularly grateful for when dining out.
“I got really good at taking a shot under the table so people don't see,” she said. “People are much more interested in seeing me inhale something than seeing me taking a shot. I love it and I would be extremely sad to see it go.”
Cynthia Goldstein, a West Los Angeles woman who’s been using Afrezza since May, said she only uses the drug a few times a week when her blood sugar is especially high — for instance, after particularly carb-heavy meals.
She also uses an insulin pump, which supplies a steady insulin flow throughout the day and a boost at mealtime. But she likes Afrezza because it acts more quickly than her pump.
“It takes effect immediately. It’s amazing,” she said.
Now, with Sanofi out of the picture, Goldstein said she’s concerned a new sales and marketing partner — assuming MannKind can find one — will mean more disruption. It took her months for her doctor to get approval to prescribe Afrezza, and she now worries that she and others might have to repeat the process.
“Even if they replace Sanofi, it’s still change,” Goldstein said. “There will be mistakes and learning curves and all that. Any kind of change like that is going to be troublesome.”
During a brief conference call Tuesday, MannKind Chief Financial Officer Matthew Pfeffer said his company and Sanofi aimed to ensure there was “no interruption of coverage or therapy for patients,” and that MannKind would be looking for new partners to market the drug.
Pfeffer did not respond to requests for further comment.
Joel Hay, a professor of pharmaceutical economics at USC, said patients should not be concerned that Afrezza will suddenly become unavailable. He said that even without Sanofi, MannKind will probably be able to get Afrezza to customers, though he said a new distribution deal could come with unattractive terms for MannKind.
“There is always some specialty distributor that will stock it at the right price,” he said.
The wholesale price of the drug is between $7 and $9 a day, already pricier than the roughly $5 a day for an injectable insulin from Sanofi. Still, sales of the drug weren’t covering manufacturing costs.
Through the first nine months of last year, MannKind reported manufacturing costs of $15.7 million on Sanofi’s $5.5 million in Afrezza sales.
Hay said a retail prike hike could be the next move.
“That happens all the time. If this is a small, vocal group that supports it, it would not surprise me if that were the strategy,” Hay said.
Hay and Dr. Alan Marcus, an endocrinologist in Laguna Hills, noted that Afrezza may simply have come too late to be a big hit. In 2014, the same year the FDA approved Afrezza, a new class of diabetes drugs hit the market. Doctors say those drugs — taken orally, not injected — could be taking some of the market share Afrezza hoped to capture.
The new drugs, with brand names including Farxiga and Invokana, allow the kidneys to expel some excess sugar through urine. That allows patients to take less insulin than they otherwise might, Marcus said.
Hay said the rise of those drugs could explain why Sanofi pulled out of its worldwide marketing agreement less than a year and a half after it was signed in August 2014.
“That seems to be the most obvious innovation in that time frame,” Hay said. “I don’t think most people, including Sanofi, see inhaled insulin as fitting a really important need at this point, particularly with these new diabetes drugs.”