Biotech Values

[DewDiligence]

VNDA TTP – Iloperidone for schizophrenia is back
from the dead. It still has a QT-prolongation problem
but it’s a problem that VNDA evidently thinks is
manageable. (This is the reason NVS dropped
development of the compound a few years ago.)
CC at 9am ET.

http://biz.yahoo.com/prnews/061207/dcth012.html?.v=82

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Vanda Pharmaceuticals Confirms Iloperidone Efficacy With Positive Phase III Clinical Trial Results in Schizophrenia

Thursday December 7, 6:00 am ET

Demonstrates Statistically Significant Efficacy vs. Placebo

Achieves Significant Efficacy on Positive and Negative Symptoms

Validates Pharmacogenetic Markers of Efficacy and Safety

New Drug Application (NDA) Filing Expected in Late 2007

ROCKVILLE, Md., Dec. 7 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA ), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates, today announced positive top-line results from the company's Phase III clinical trial evaluating iloperidone, an atypical antipsychotic, in patients with schizophrenia. Iloperidone demonstrated statistically significant improvement compared to placebo on the Positive and Negative Symptom Scale (PANSS), the trial's primary endpoint. Additionally, iloperidone achieved significant efficacy on the positive and negative symptom subscales of PANSS. The safety profile was consistent with what has been observed in previous iloperidone Phase III trials.

Vanda also evaluated iloperidone's efficacy and safety in patients with specific genetic profiles using its expertise in pharmacogenetics (PG), as part of its commitment to give physicians and patients information to help personalize their antipsychotic therapy. Vanda had previously identified a polymorphism in a gene, occurring in approximately 70% of patients, hypothesized to be associated with the pathogenesis of schizophrenia which appeared to correlate with iloperidone response. Iloperidone achieved statistical significance vs. placebo on the PANSS scale in these patients, with a magnitude of response greater than that seen in the overall iloperidone population.

The Phase III trial was a randomized, double-blind, placebo-controlled, multi-center, 4 week inpatient study that enrolled 604 patients with schizophrenia. The trial examined iloperidone 12 mg dosed twice-daily, or 24 mg per day. The primary endpoint was efficacy vs. placebo in PANSS (total) using the Mixed Method Repeated Measures (MMRM) methodology. The secondary endpoint was efficacy in the genetic subpopulation.

The specific findings of efficacy vs. placebo include:

* Efficacy (intent to treat population):

* PANSS (total): p=0.006

* PANSS (positive symptoms only): p=0.0009

* PANSS (negative symptoms only): p=0.027

* Brief Psychiatric Rating Scale (BPRS): p=0.0128

* Efficacy (genetic subpopulation):

* PANSS (total): p=0.002

Under Last Observation Carried Forward (LOCF) methodology, iloperidone met the primary and secondary endpoints with statistical significance. Iloperidone efficacy was also equal to the active arm. [I’m not sure what this sentence means in this context.]

Vanda also measured the effect of iloperidone on the QT interval, a well understood atypical antipsychotic class side effect. The mean QT prolongation was consistent with previous experience. No patients experienced QT intervals in excess of 500 milliseconds, a threshold of concern to the FDA. Vanda also confirmed with an additional genetic marker that the QT prolongation was shorter in the majority of patients who are good iloperidone metabolizers.

The specific findings include:

* QTc change from baseline:

* All patients: 11.4 milliseconds (msec)

* Good metabolizers: 10.4 msec

* Poor metabolizers: 15.0 msec (p=0.008, good vs. poor)

"We are extremely pleased to have achieved this outcome with iloperidone. The success of this trial moves us one step closer to our NDA filing, expected in late 2007, and one step closer to making iloperidone available to patients and providers dealing with schizophrenia," stated Paolo Baroldi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Vanda.

"We are especially pleased to have achieved our pharmacogenetic results," stated Mihael Polymeropoulos, M.D., President and CEO of Vanda. "For the first time in the treatment of a psychiatric disease, we have applied pharmacogenetic tools to identify patients best suited for a specific drug therapy. Our market research indicates that physicians treating schizophrenia patients would enthusiastically welcome such information in making prescribing decisions. We are committed to further exploration, after iloperidone approval, to identify the genetic basis of many aspects of iloperidone response."

About Schizophrenia

Schizophrenia is a chronic, debilitating mental disorder characterized by hallucinations, delusions, racing thoughts and other psychotic symptoms (collectively referred to as "positive symptoms"), as well as moodiness, anhedonia (inability to feel pleasure), loss of interest, eating and sleep disturbances, and difficulty concentrating (collectively referred to as "negative symptoms"). Schizophrenia develops in late adolescence or early adulthood in approximately 1% of the world's population. Genetic and environmental factors are believed to be responsible for the disease.

CONFERENCE CALL

The company has scheduled a conference call for today, Thursday, December 7, 2006 at 9:00 AM ET. During the call, Mihael Polymeropoulos, M.D., President and CEO will discuss the results of this Phase III trial. Investors can call 1-800-638-5495 (domestic) and 1-617-614-3946 (international) prior to the 9:00 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos. A replay of the call will be available on Thursday, December 7, 2006, beginning at 11:00 AM ET and will be accessible until Thursday, December 14, 2006, at 5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers. The access number is 49811320.

The conference call will be broadcast simultaneously on the company's Web site, http://www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the Web site at least 15 minutes early to register, download, and install any necessary audio software. The call will also be archived on the Vanda Web site for a period of 30 days, through January 6, 2007.

ABOUT VANDA PHARMACEUTICALS INC.:

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates in clinical development. Vanda's lead product candidate, iloperidone, is a compound for the treatment of schizophrenia and bipolar disorder and is in Phase III for schizophrenia. Vanda's second product candidate, VEC-162, is a compound for the treatment of sleep and mood disorders which is currently in Phase III for insomnia. Vanda's third product candidate, VSF-173, is a compound for the treatment of excessive sleepiness and is ready for a Phase II clinical trial. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
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