- The Food and Drug Administration approved a sublingual form of apomorphine, to be sold as Kynmobi, for the "off" episodes Parkinson's disease patients suffer when their medications stop working.
- The approval for Kynmobi's developer, Sunovion Pharmaceuticals, comes more than a year after the FDA rejected its initial application. It sets up a commercial battle between Sunovion and three other companies who have recently been cleared to sell rescue medications for Parkinson's patients.
- But Sunovion may find tough sledding. There are several generic options for patients with "off" episodes, too. And Acorda Therapeutics, which was first of the new branded group to market, recently withdrew sales guidance for its medicine, citing challenges related to the coronavirus pandemic.
Parkinson's affects nearly 1 million people in the U.S., according to the nonprofit American Parkinson's Disease Association. And while levodopda helps many of them manage their disease, it doesn't reverse the course of Parkinson's and its effects diminish over time. That leads to increases in "off" episodes, when the drug stops working and patients can have cognitive problems, anxiety, freeze up while walking and more.
Since December 2018, the FDA has approved multiple drugs intended to provide patients with relief during "off" episodes. Those include Acorda's Inbrija; Kyowa Kirin's Nourianz; Ongentys, from Neurocrine Biosciences; and now Kynmobi, from Sunovion.
Their arrival has crowded a space that already had plenty of options, albeit flawed ones. Among them: deep brain stimulation; Duopa, a surgically implanted infusion pump; apomorphine (Apokyn), an injectable rescue drug; or just taking more levodopa pills or extended release versions.
The new crop of treatments are intended to be more convenient and act fast. Inbrija is a puff of levodopa from an inhaler. Nourianz is a tablet that boosts levels of the brain chemical GABA. Ongentys is a once-daily form of a pill meant to make levodopa last longer. And Kynmobi is a film placed under the tongue that dissolves and delivers apomorphine.
Selling them, however, has proved challenging. Acorda was first of the group to win FDA approval, and, before Inbrija's launch, estimated the U.S. market could be worth more than $800 million. But the drug has yet to gain traction. Inbrija has generated about $20 million since its launch, including $4.4 million in its last quarter. Acorda's share price has gone from roughly $13 a share upon Inbrija's approval to 74 cents apiece as of midday Friday.
"Our bottom-line takeaway is that symptomatic Parkinson's Disease launches are tough," wrote Stifel analyst Paul Matteis, earlier this month. "There are a lot of options (many generic) in the off-time space, and while Inbrija is somewhat unique, this is a launch that we thought could initially lag consensus and unfortunately even our initial estimates were too optimistic."
Separately, Matteis projects a "conservative" $150 million in peak sales for Ongentys, given the tough sales environment.
Sunovion is optimistic, however, because most treatments for "off" episodes focus on "keeping people 'on,'" rather than treating them when they happen, as Kynmobi does, a spokesperson said in an email to BioPharma Dive. "Patients will now have a new treatment option, with a novel route of administration, that can quickly improve mobility when disruptive off episodes occur," the spokesperson said. Sunovion also has experience selling drugs for other neurological conditions like bipolar disorder and seizures.
Nonetheless, Sunovion has some other challenges to overcome. The FDA rejected its initial application in January 2019, and a Phase 3 study published in Lancet showed that roughly a third of patients who got Kynmobi stopped treatment, primarily due to side effects. Sunovion is now behind three rivals and has to deal with a new problem, too — launching a drug during a global pandemic.
The coronavirus outbreak has already taken a toll on Sunovion's rivals. Acorda withdrew its financial forecasts for Inbrija as a result, with CEO Ron Cohen noting in a statement that the company doesn't yet know "how changes in patient behavior may impact new prescription starts." Neurocrine delayed the launch of Ongentys until the second half of the year. CEO Kevin Gorman told BioPharma Dive in April that the company didn't think it was an appropriate time to pitch a new product to neurologists.
Sunovion isn't launching its drug immediately either, though the spokesperson said the timing isn't related to the pandemic. The drug will be available in U.S. pharmacies in September, at which point Sunovion doesn't think COVID-19 will impact its launch. Sunovion will disclose the drug's price then, the spokesperson said.