Indivior's new antipsychotic wins FDA nod, but Suboxone patent fight could delay its launch

lawsuit and book
Besides its Suboxone patent fight and Sublocade launch, Indivior is also facing a DOJ investigation over its marketing of Suboxone. (Getty/eccolo74)

Just as Indivior stalled Dr. Reddy’s rollout of a generic to its top-selling drug, Suboxone Film, the launch of a new drug of Indivior’s own might become collateral damage of the patent fight and the slow ramp-up of fellow newcomer Sublocade.

Indivior won FDA approval Friday for Perseris, an extended-release injectable formula of the antipsychotic risperidone, to treat schizophrenia. Most companies would soon move to cash in on a drug approval, but probably not in this case, thanks to a tangle of other problems at the British drugmaker.

As Jefferies’ analyst James Vane-Tempest sees it, the Perseris approval is a key positive step for Indivior toward a more diversified portfolio. The drug sustains risperidone levels over one month, making it a contender in the long-acting antipsychotic market.  

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

Indivior had been eyeing a fourth-quarter launch, Vane-Tempest said, but in a Monday release (PDF), the U.K. drugmaker said it “will now review the appropriate launch timing for Perseris,” and will provide a date no later than Nov. 1, when it’s scheduled to report third-quarter results. The reason? A U.S. Court of Appeals expedited Dr. Reddy’s Laboratories appeal against a temporary injunction that keeps its generic Suboxone Film off the market.

Indivior in July obtained that restraining order after Dr. Reddy’s won FDA approval for its copycat challenger to Indivior’s key opioid addiction treatment. The Indian drugmaker fought back, and with the expedited appeal, oral arguments will happen in early October.

The Suboxone patent lawsuit isn’t the only problem on Indivior’s plate, either. The company is having a hard time selling Sublocade, the first extended-release buprenorphine, which was approved last November.

RELATED: Dr. Reddy's forced to stop Suboxone generic rollout amid Indivior patent dispute

The opioid disorder treatment suffered a slow start ever since it was put on the stand in March. For the four months it’s been on the market, Sublocade delivered sales of just $2 million, below analysts’ expectations, wrote Vane-Tempest in a note to investors Friday. The problem isn’t about physician’s desire to use it, but about what the Jefferies analyst calls “teething troubles.”

On the company’s second-quarter earnings call, Indivior CEO Shaun Thaxter said payer coverage of the drug has reached 67% of lives. But of more than 6,400 unique patient prescriptions, only 1,000 of those patients actually received the injection by the end of June. The time from prescription to injection is still slow—even though it improved from 43 to 62 days in March to around a month now—mainly due to a slow prescription verification process currently handled manually instead of through a computer system, according to Thaxter.

While the company maintained its blockbuster peak revenue forecast for Sublocade, Vane-Tempest has lowered its 2018 outlook for the drug to $26 million.

“Indivior has reconfirmed that it may have to reconsider the timing of the Perseris launch dependent on the outcome of the appeal as it continues to prioritize the Sublocade launch,” wrote Vane-Tempest in a Monday note.

RELATED: Mylan scores FDA approval of generic Suboxone for opioid addiction, but a strong launch is no sure bet

Besides the Suboxone patent dispute and slow Sublocade launch, Indivior is also facing a Department of Justice investigation over its marketing of Suboxone, but the company recently said it is in “advanced” discussions with the feds on a possible settlement.

As for Perseris, it will face many long-acting antipsycotic injectables currently on the market, including Otsuka and Lundbeck’s recently approved Abilify Maintena, and Johnson & Johnson’s Invega Sustenna and Invega Trinza. Indivior currently expects $200 million to $300 million in Perseris peak sales.