The FDA late Friday approved a new treatment meant to help Parkinson’s disease patients cope with “off” episodes, when their medications stop working.
The drug, Inbrija, from Acorda Therapeutics (NASDAQ: ACOR), is one of two similar treatments—along with APL-130277, from Sunovion Pharmaceuticals—expected to come to market in 2019. And its commercial success is critical for the future of Ardsley, NY-based Acorda, whose flagship multiple sclerosis drug dalfampridine (Ampyra) now faces generic competition.
An Acorda spokesperson said the company isn’t yet disclosing the price of Inbrija. The company will hold a conference call on Monday morning to discuss the approval and the drug’s launch.
Parkinson’s affects close to 1 million people in the U.S., according to the nonprofit American Parkinson’s Disease Association. Levodopa has helped millions of patients since the 1970s manage the neurodegenerative disease. But it doesn’t slow or reverse the loss of brain cells, and its effects wane over time. This leads to more and more “off” episodes, when the drug isn’t working and patients can have trouble thinking, grow anxious, “freeze” up while walking, and more.
There are a few currently available options for “off” episodes: apomorphine (Apokyn), an injectable rescue drug; taking more levodopa pills or extended release versions; deep brain stimulation; and Duopa, a surgically implanted infusion pump from AbbVie (NYSE: ABBV) that delivers levodopa directly into the small intestine for 16 straight hours.
But all of these methods have flaws: apomorphine, for instance, causes nausea, light-headedness, and low blood pressure; and there’s no guarantee that patients will respond to more levodopa pills. Acorda’s medication, as well as Sunovion’s drug, which could be approved by Jan. 29, are meant to provide fast-acting alternatives. Inbrija is a puff of levodopa delivered through an inhaler. APL-130277 is a film placed under the tongue that dissolves and delivers apomorphine. Both therapies have shown in clinical trials an ability to improve patients’ motor function, compared to placebo, 30 minutes after they are taken. And they haven’t been linked to any serious side effects—though they also haven’t been tested in multi-year studies.
The most common side effects seen in patients on Inbrija in a 12-month study were cough, dyskinesia (involuntary movement), throat irritation, and discolored sputum, but Acorda said most cases were mild. Stifel analyst Paul Matteis noted there had been some concern the FDA would want patients have their lungs examined before treatment, as it does with the inhalable insulin medicine Afrezza. That which would’ve been a “big hassle for neurologists,” Matteis wrote, but the agency didn’t go that far. In its prescribing information, or label, the FDA only said that Inbrija “isn’t recommended” for people with lung diseases like asthma or COPD. The label “looks as good as one would’ve hoped for,” Matteis wrote.
That’s important for Acorda, which is banking on Inbrija to turn its fortunes around. The company has suffered several clinical setbacks over the past few years, faced a few delays getting Inbrija to market, and fended off efforts by an activist investor last year to push the company to sell itself. The last patent protecting its flagship drug, dalfampridine (Ampyra), has already expired; Mylan (NASDAQ: MYL) began selling a generic version in September. Inbrija, acquired via Acorda’s 2014 buyout of Civitas Therapeutics, is its best chance to keep its footing. Acorda shares closed Friday at $12.94 apiece, their lowest levels in more than a decade.
Acorda has said that it believes that the U.S. market for Inbrija could be worth more than $800 million and is gearing up to sell the drug on its own, not flip the company. But Inbrija will likely soon fight for market share with Sunovion’s drug. It’s unclear how clinicians and payers will handle each of them. As Parkinson’s experts told Xconomy earlier this year, while these two treatments fill a need, it’s unclear how much additional benefit they will provide over levodopa, whether their benefits will hold up as the disease progresses, and whether patients with problems controlling their motor function will actually be able to use them when needed. Plus, Matteis wrote, will payers view Inbrija as a novel drug or one “with some characteristics of a branded generic”? Will they make patients try other drugs first?
“We think are a few variables here suggesting the market for this product will take time to develop,” Matteis wrote. He’s predicting $32 million in Inbrija sales in 2019, below consensus estimates of $55 million.