A Sept. 27 NDA submission for Vanda Pharmaceuticals' iloperidone includes data from 35 clinical trials indicating a safety profile that may differentiate the investigational antipsychotic from competitors, the firm announced.

The company anticipates a standard review for the schizophrenia treatment, setting its user fee date in late July 2008.

"What we've seen in over 3000 patients is that the compound has efficacy that is comparable to peers, but it appears to have safety advantages," Vanda Chief Business Officer Chip Clark told "The Pink Sheet" DAILY.

"It appears to be very mild on things that matter most to doctors, like weight gain, blood glucose, cholesterol, triglycerides and prolactin elevation, and appears to have a very mild profile on other CNS side effects like extrapyramidal, or Parkinsonian-type, symptoms, and akathisia, [the] severe inability to sit still," he explained.

"What we understand is that the compounds differentiate themselves through their safety profile, so since it appears to be very well tolerated means that it should have a commercially attractive profile," Clark said.

The drug has demonstrated efficacy in treating schizophrenia both in the acute and chronic settings, the firm stated in a release.

Phase III data also showed that patients with a certain gene hypothesized to be associated with the pathogenesis of schizophrenia experienced a greater response to iloperidone than the total study population, signaling the potential for use in genetic profiling in the treatment of schizophrenia (¹ Also see "Vanda Atypical Antipsychotic Shows Apparent Genetic Response In Phase III" - Pink Sheet, 8 December, 2006.).

In light of those data, approval of iloperidone could "help usher the field of psychiatry into an era of personalized medicine," Vanda President and CEO Mihael Polymeropoulos said in a statement.

Iloperidone would face competition from six branded antipsychotics, including Johnson & Johnson's Risperdal (risperidone) and Invega (paliperidone), AstraZeneca's Seroquel (quetiapine furmarate), Bristol-Myers' Ablify (aripiprazole), Pfizer's Geodon (ziprasidone), and Lilly's Zyprexa (olanzapine).

The Rockville, Md.-based biopharmaceutical company took over the development of iloperidone from Titan Pharmaceuticals and Novartis in June. Titan out-licensed iloperidone to Vanda after a six-week trial showed QT interval prolongation - an atypical antipsychotic class side-effect - with the product.

A sales force has not yet been fielded, and the firm is currently evaluating both solo launch and partnership opportunities. The company has indicated that it is close to hiring a head of sales and marketing, with an announcement expected as early as the fourth quarter of 2007.

Wall Street may be more partial to a collaboration with another company, as opposed to a solo launch by Vanda.

"We continue to believe that iloperidone is attractive to multiple potential partners," FBR Research analyst David Amsellem stated in a research note.

Vanda has two other candidates in clinical development, including VEC- 162, a Phase III compound for the treatment of sleep and mood disorders, and VSF-173 for excessive sleepiness, currently in a Phase II trial.

- Jamie Hammon (j.hammon@elsevier.com)

Vanda Submits NDA For Antipsychotic Iloperidone

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