Neurocrine gives up on Parkinson's drug Ongentys, citing 'unsustainable' launch

Even though Nuerocrine Biosciences has had great success with one neurological disorder drug, Ingrezza, it has struggled with Parkinson’s disease med Ongentys. Now, the company has decided to call it quits on the latter medicine.

Neurocrine will return Ongentys to its original licenser, Portuguese company Bial, in December, the California biotech said Wednesday.

The reason behind the decision is simple: The launch is “unsustainable,” the company said in the release.

In a statement to Fierce Pharma, a Neurocine spokesperon said it isn’t planning any layoffs. It’s not clear whether Bial will continue to market Ongentys in the U.S. after the transition. The company didn’t reply to a Fierce Pharma’s request for comment by publication time.

For Neurocrine, the decision will wrap up nearly three years of commercial struggles around the medicine. For 2022, Ongentys only brought in $13 million in sales. In the first quarter of this year, the drug pulled in $5.3 million.

In 2017, Neurocrine paid Bial $30 million upfront to in-license Ongentys rights in the U.S. and Canada. At that time, the drug was already available in Europe. Three years later, the FDA approved Ongentys as an add-on treatment to treat Parkinson’s disease during “off” episodes, when patients experience motor symptoms between their usual levodopa/carbidopa treatment doses.

The Ongentys approval came in April 2020 at the height of the COVID-19 pandemic. As the world reeled from the crisis, Neurocrine delayed the launch into the fall of 2020.

“Unfortunately, from the time we licensed this medicine to the launch in 2020, the Parkinson’s adjunctive therapeutic category went through fundamental changes, which posed significant commercial challenges,” Neurocrine CEO Kevin Gorman told investors during a call Wednesday.

Gorman didn’t provide further details about the “fundamental changes” afflicting the treatment field, but he did say Neurocrine wasn’t alone in struggling in this category.

Competing with older COMT inhibitors and their generics, Ongentys was not included on formularies of most Medicare plans, Neurocrine noted at the beginning of 2022. The problem was seen across all branded Parkinson’s medicines, Neurocrine’s chief commercial officer Eric Benevich noted at the time. Although Ongentys is dosed less frequently, experts aren’t excited about its well-known COMT inhibition mechanism, SVB Securities analysts wrote in a note back in 2021.

In 2019, the FDA also approved Kyowa Kirin’s Nourianz as an add-on treatment to levodopa/carbidopa. That drug delivered 6.5 billion Japanese yen ($48 million) in sales outside of Japan in 2022.

Just a month after Ongentys’ nod, Sumitomo Pharma’s Sunovion won an FDA go-ahead for Kynmobi sublingual film to treat Parkinson’s “off” episodes. Sumitomo earlier this year booked an impairment loss of 56 billion yen ($410 million) after reviewing the sales forecast for Kynmobi.

Neurocrine is ditching Ongentys as the company gears up for a potential label expansion for Ingrezza to treat involuntary body movements in patients with Huntington's disease. The FDA is expected to reach a decision by August 20. If approved, Ingrezza would go up against Teva’s Austedo and Lundbeck’s Xenazine. All three drugs are VMAT2 inhibitors.

Only about 20% of Huntington patients with chorea are treated with existing VMAT2 drugs, Neurocrine’s Benevich noted during Wednesday’s call.

“We believe that some of the reasons that Ingrezza is the most prescribed agent in [tardive dyskinesia] would apply equally here in HD chorea,” Benevich said.

Unlike Ongentyx, Ingrezza has had a successful launch. Ingrezza’s sales reached $410 million in the first quarter, handily beating Wall Street’s expectation of $397 million. Based on the strong growth during the first three months of the year, Neurocrine believes Ingrezza will reach $1.67 billion to $1.77 billion in sales this year. That figure excludes any potential contribution from a label expansion into Huntington's disease.

In a Wednesday note to clients, William Blair analysts said the new nod could add $14 million to Ingrezza sales this year

Without any meaningful contribution from Ongentys, Ingrezza remains Neurocrine’s bread and butter. But that may start to change later. The company expects pivotal trial data for crinecerfont in both adult and pediatric congenital adrenal hyperplasia in the fourth quarter.

In their note, the William Blair analysts called crinecerfont “the next major addition to [Neurocrine’s] pipeline with blockbuster potential if successful.” In a separate note on Wednesday, Evercore ISI analysts also said they believe crinecerfont could become a blockbuster by the end of the decade.

Editor's note: The story has been updated to show that Neurocrine isn't planning any layoffs at this point.