Lundbeck, Otsuka's new Abilify Maintena to face entrenched rivals

Lundbeck has another chance to crow this week, now that its once-monthly version of Abilify has FDA approval. The agency nod comes fast on the heels of another, for the Danish drugmaker's alcohol addiction drug Selincro. This double victory opens the way for Lundbeck to transform turnaround promises into actual sales. And it badly needs those revenues to backfill its fast-eroding Lexapro sales, and to make up for fast-approaching generic competition for that drug's European counterpart, Cipralex.

The injectable Abilify Maintena won't necessarily be an easy sell, however. Consider the history of its oral predecessor. Abilify was a latecomer to the atypical antipsychotic market, approved in 2002, years after Johnson & Johnson's ($JNJ) Risperdal (1994), Eli Lilly's ($LLY) Zyprexa (1996), and AstraZeneca's ($AZN) Seroquel (1997). The entire class is associated with weight gain and diabetes risks, but before those safety concerns emerged publicly, the early drugs grabbed market share and became megablockbusters. They also became centerpieces of whistleblower lawsuits and government marketing investigations, but that's another story.

Abilify pills have ginned billions for Bristol-Myers Squibb ($BMY) and partner Otsuka Pharmaceutical; in 2011, it generated $5.2 billion worldwide, according to Evaluate Pharma. But the drug still falls short of the sales levels of a Seroquel, say, which topped $6 billion in 2011. And because of its late market entry, its lifetime sales are commensurately lower. And it now has to compete with generic versions of those earlier brands. Bristol renegotiated that Abilify marketing partnership last year as the pill came up against that generic competition. (It does still manufacture the drug and share in the proceeds.)

Meanwhile, Otsuka and Lundbeck were together developing Abililfy Maintena, a depot version injected once a month. But J&J already has a long-acting injectable version of Risperdal--Risperdal Consta, approved since 2003. It launched Invega Sustenna, a once-monthly formulation of its Risperdal follow-up, Invega, in 2009. Lilly has a lesser-known long-lasting Zyprexa injectable. So, Abilify Maintena was already destined to be late to the party, but development roadblocks made it even more tardy. It will face already entrenched products--just as the oral version did.

Then there's the market size. The rationale for long-acting antipsychotics is compliance. Schizophrenia patients are notoriously poor at taking their pills as directed, and some research shows that they're more likely to comply with less-frequent dosing (though other studies contradict that notion). In any case, there's a natural marketing hook. But it wasn't schizophrenia that made the oral atypicals into sales juggernauts. Their makers expanded into bipolar disorder (both I and II) and depression--and, as government settlements show, touted the drugs for a variety of uses not approved by FDA.

Abilify Maintena might be able to expand into other indications. Risperdal Consta has an approval in Bipolar I, for instance. And though the injectables can't hold a candle to the pills, sales-wise, J&J nabbed $796 million from Invega Sustenna and $1.4 billion from Risperdal Consta last year. Abilfy Maintena is expected to peak at $800 million, provided Otsuka and Lundbeck succeed on the marketing side.

To put that in perspective, Lundbeck's Lexapro sales plummeted by $2 billion last year. It will need to execute on Abilify Maintena, and follow up with a basketful of other drugs, to jumpstart its growth.

- get the Lundbeck release (PDF)
- see the Reuters story
- here's FierceBiotech's take

Special Reports: Abilify - The 15 best-selling drugs of 2012 | Bristol-Myers Squibb, Abilify - Pharma's Top 11 Marketing Settlements

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