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9605 Medical Center Drive, Suite 300
Rockville, MD 20850 USA
phone:(240) 599-4500
fax:(301) 294-1900
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| Symbol |
VNDA |
| Exchange |
Nasdaq |
| Founded |
2003 |
| Employees |
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| www.vandapharma.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| Therapeutics for Schizophrenia, Insomnia and Other Central Nervous System Disorders |
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| Management |
| Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer (Bio); Chip Clark, Chief Business Officer (Bio); John Feeney, M.D., Acting Chief Medical Officer (Bio); Stephanie Irish, C.P.A., Acting Chief Financial Officer (Bio); Gunther Birznieks, Vice President, Program Director (Bio) |
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| Keywords |
| atypical anti-psychotics, serotonin, dopamine, transient insomnia, circadian |
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| Description |
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Vanda Pharmaceuticals is a biopharmaceutical company using its expertise in pharmacogenetics and pharmacogenomics (PG) to develop clinical-stage product candidates addressing central nervous system disorders. The company's technology informs its drug discovery, clinical trials and current commercialization efforts. |
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| Products / Services |
Iloperidone is a mixed serotonin receptor/dopamine receptor (5HT2/D2) antagonist (classified as an atypical antipsychotic) under development for the treatment of schizophrenia, bipolar disorders and other psychiatric conditions. The company licensed this compound from Novartis Pharma AG in 2004. VEC-162, which Vanda licensed from Bristol-Myers Squibb in 2004, is a melatonin agonist undergoing clinical trials for the treatment of sleep disorders (e.g., insomnia) and mood disorders (e.g., depression). Additionally, VSF-173 (also licensed from Novartis Pharma AG) is a compound of unknown mechanism with potential applications in sleep apnea, narcolepsy and shift worker sleep disorder. Along with these compounds, Vanda has also acquired and/or is evaluating other candidates for clinical development.
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| Technology / Differentiation |
| Antipsychotics work at the molecular level to regulate specific genes governing the production and transport of lipids. Recent findings suggest that antipsychotic drugs such as iloperidone may alter the fluidity of cell membranes of neurons, which could result in changes in neuronal connectivity. Vanda's clinical trials suggest that iloperidone offers patients improved efficacy with fewer side effects as compared to currently available antipsychotics. The company is developing an extended-release injectable formulation of iloperidone, which can be safely administered once every four weeks based on the results of its two-month Phase I/IIa safety trial in schizophrenia patients. Moreover, Vanda has developed and investigated a genetic test to identify those schizophrenic individuals who may experience greater benefits from iloperidone; approximately 70% of schizophrenia patients possess a common gene mutation linked to nervous system function. VEC-162 treats insomnia by resetting the body's natural sleep-wake cycles, known as circadian rhythms. Unlike some of the most popular sleep disorder medications, which are designated as controlled substances by the FDA, VEC-162 has demonstrated efficacy with diminished potential for withdrawal effects and drug abuse. |
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| Market / Customers |
The insomnia market was valued at $4.1 billion in 2007, down 12% from the previous year due to the loss of Sanofi-Aventis' U.S. patent for Ambien (zolpidem). Nevertheless, due to the launch of new treatments worldwide, it is expected to resume growth in 2009 and reach $6.9 billion in 2017. Of the 73 million U.S. adults who suffer from some form of insomnia, only 11 million currently receive treatment. The total antipsychotics market is worth over $18 billion. According to the National Alliance for Research on Schizophrenia and Depression, approximately 64 million Americans suffer from a diagnosable mental illness in any given year. Of these individuals, over 2 million suffer from schizophrenia and approximately 3 million suffer from bipolar disorder.
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| Status |
| Vanda has completed Phase III trials for iloperidone and received approval of its FDA New Drug Application (NDA) in November 2008. The company reported the publication of its research findings in the March 2009 issue of Schizophrenia Research, the official journal of the Schizophrenia International Research Society, in a manuscript entitled "Common effect of antipsychotics on the biosynthesis and regulation of fatty acids and cholesterol supports a key role of lipid homeostasis in schizophrenia."
Vanda has completed phase II trials for VEC-162 in insomnia-along with phase III trials in transient insomnia-and will initiate a phase III trial in chronic insomnia. |
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