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Deborah Dunsire kicks off her new gig as Lundbeck CEO with a key PhIII trial failure

You have to feel almost sorry for Deborah Dunsire.

Deborah Dunsire

No sooner does the Millennium vet take the helm of Lundbeck after back-to-back biotechs collapse on her watch than the company’s schizophrenia drug candidate fails a Phase III study, torpedoing the stock as shares plunge 30%.

Lu AF35700 failed to measure up against conventional therapy in its first Phase III study, likely eliminating any potential upside as far as regulators might be concerned. Investigators tested the drug on 964 treatment-resistant patients treated over 10 weeks.

The company’s researchers based the drug design on its preference for the human dopamine D1 receptor as opposed to the dopamine D2 receptor, which they thought would give it an advantage on efficacy as well as tolerability.

We don’t know what the hard data are, but the company says it continues to study the results. Jefferies had assigned a potential blockbuster status for the drug, with peak sales projected at $1.2 billion.

This is the company’s lead late-stage compound, sharing the Phase III column with the Alzheimer’s drug brexpiprazole, discovered at Otsuka.

In May of last year, seven months after Lundbeck and Otsuka reported a Phase III flop for their Alzheimer’s drug idalopirdine, the partners reported a hit-and-miss score on easing Alzheimer’s agitation for Rexulti (brexpiprazole).

Already approved for schizophrenia and major depression, the collaborators were looking for the first approval of an antipsychotic specifically for agitation triggered by Alzheimer’s dementia, a condition that afflicts millions of people in the US and millions more worldwide. Agitation can be expressed in many ways, running from wandering to aggressive behavior.

Now there’s a much bigger setback to deal with.

“This is a setback for patients with schizophrenia, but we will continue to advance our pipeline of innovative therapies to meet the needs of patients suffering from psychiatric and neurological diseases,” says Anders Gersel Pedersen, the head of R&D at the Danish company.


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