Otsuka, Lundbeck bag blockbuster FDA approval for antipsychotic Rexulti

Tatsuo Higuchi

Otsuka is facing plenty of bleeding, now that its blockbuster antipsychotic Abilify has generic competition. But the company is working hard to soften the blow, and a brand-new FDA approval for an antipsychotic could help.

Otsuka and partner Lundbeck got the agency's blessing for Rexulti (brexpiprazole) on its own and as an add-on therapy for depression and schizophrenia. Otsuka and Lundbeck plan to roll out the product in August.

"Psychiatric diseases remain a challenging therapeutic area where many people are unsatisfied with their treatments," Tatsuo Higuchi, Otsuka's President, said in a statement. "Today's approval of Rexulti is another example of Otsuka and Lundbeck's commitment to bringing new therapeutic alternatives to the mental health community."

The FDA approval marks a critical win for Otsuka, which had fought to the bitter end to keep generic versions of the original Abilify off the market. In April, a federal judge issued a final ruling against the Japanese drugmaker and its marketing partner Bristol-Myers Squibb ($BMY), allowing companies such as Alembic Pharmaceuticals, Teva Pharmaceuticals ($TEVA), Hetero Labs and Torrent Pharmaceuticals to move ahead with generic copycats. In its heyday, Abilify brought in billions for Otsuka and BMS. In 2013, for example, the drug made up about 40% of Otsuka's sales.

But Otsuka is working hard to fill Abilify's big shoes, striking deals and concentrating on new products to expand its offerings. Last year, the drugmaker snatched up Avanir Pharmaceuticals for $3.5 billion to beef up its portfolio of neurological drugs. And analysts are expecting big things from Rexulti, forecasting annual sales of $1.4 billion by 2020, according to numbers cited by Reuters.

Meanwhile, Otsuka and Lundbeck are marketing a once-monthly injection of the med, dubbed Abilify Maintena, which could also provide some extra cushioning.

Still, Otsuka faces competition from other drugmakers that are charging full speed ahead with their own antipsychotic drugs. Eli Lilly's ($LLY) long-acting version of its antipsychotic blockbuster Zyprexa, dubbed Zyprexa Relprevv, is still bringing in sales for the company after the original pill went generic. Johnson & Johnson ($JNJ) recently scored FDA approval for Invega Trinza, a quarterly formula of its once-a-month antipsychotic med Invega Sustenna, helping keep the brand alive after J&J lost its original Invega patent last year.

- read the statement (PDF)
- here's the Reuters story

Special Reports: The 10 best-selling drugs of 2013 - Abilify | The top 10 patent losses of 2015 - Abilify | Top 10 drug brands by payments to doctors - Abilify Maintena