Knobias Clip Report (10-1-2007)

Sumbmited From Knobias ClipReport


VNDA: Submits NDA After Successful Ph III Trial of Iloperidone in Schizophrenia

Vanda Pharmaceuticals Inc. (VNDA) submitted a New Drug Application (NDA) to the FDA for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. A Phase III clinical trial demonstrated that the drug is a potentially safe and effective treatment for schizophrenia in both the acute and the chronic setting. In addition, iloperidone demonstrated a potentially favorable side effect profile, with low potential for weight gain and induction of diabetes, low extrapyramidal symptoms including akathisia, and low incidence of sleepiness and effects on cognition. Akathisia is a debilitating sensation of restlessness that manifests as an inability to sit still. The NDA submission also contains pharmacogenetic data aimed to further improve the benefit/risk profile of iloperidone.

Iloperidone has demonstrated efficacy in treating the symptoms of schizophrenia both in the acute and the chronic setting. Iloperidone's binding to a number of dopamine and serotonin receptors provides a favorable safety profile on adverse symptoms, such as weight gain, extrapyramidal symptoms, akathisia and prolactin elevation. The NDA submission also contains pharmacogenetic data aimed to further improve the benefit/risk profile of iloperidone in the treatment of patients with schizophrenia.

Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals Inc., said, "For a serious brain disorder like schizophrenia, which affects about three million Americans in the prime of life, it is vital that new pharmacotherapeutic agents be developed in light of the fact that existing antipsychotic treatments work partially in some patients and not others, leaving many patients continuously disabled."

Iloperidone in the treatment of schizophrenia will compete with other atypical antipsychotics such as Janssen’s Risperdal(R) (risperidone); Invega(R) (paliperidone) by Johnson & Johnson (JNJ); Zyprexa(R) (olanzapine) by Eli Lilly and Company (LLY), Seroquel(R) (quetiapine) by AstraZeneca PLC (AZN); Abilify(R) (aripiprazole) by Bristol-Myers Squibb Company (BMY)/Otsuka Pharmaceutical Co., Ltd.; Geodon(R) (ziprasidone) by Pfizer Inc.(PFE) and generic clozapine, as well as the typical antipsychotics haloperidol, chlorpromazine, thioridazine, and sulpiride (all of which are generic). In addition to the approved products, compounds in Phase III trials (or for which an NDA has been recently filed) for the treatment of schizophrenia include bifeprunox (Wyeth/Solvay S.A./Lundbeck A/S), and asenapine (Schering-Plough Corporation). The antipsychotic market is worth an estimated $10.7 billion. After 2007, the market is expected to plateau due to the genericization of Risperdal(R) and Geodon(R).

Upon commercialization of iloperidone, Titan Pharmaceuticals, Inc. (TTP) will receive a royalty of between 8-10% on worldwide sales.

In addition to iloperidone, Vanda is developing VEC-162, a compound for the treatment of sleep and mood disorders which is currently in Phase III for sleep disorders. Vanda's third product candidate in clinical development, VSF-173, is currently in a Phase II trial for the treatment of excessive sleepiness.

At June 30, 2007, the Company had cash and cash equivalents and marketable securities of approximately $119.7 million and an accumulated deficit of $131.2 million.

Bank of America recently intitiated a Buy rating for VNDA and set a price target of $23. Friedman, Billings and Ramsey reiterated and Outperform rating and said VNDA's stock does not reflect the potential of iloperidone.


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