Market Opportunity

Schizophrenia is a devastating disease that occurs in early adulthood. It affects 0.8 - 1 percent of the population—some 80 million people worldwide—and is characterized by symptoms of hallucinations, delusional beliefs, disorganized thinking or speech, social withdrawal and apathy. The social and financial effects of schizophrenia are significant, with the estimated cost of lost productivity and medical care to be about US$32.5 billion per year in the U.S. alone.

Drugs for psychiatric disorders (antipsychotics) have an global annual market of USD18.2 billion growing at 11%(IMS Health, 2006).

Current Treatments and Issues

Despite the introduction of new antipsychotic treatments for schizophrenia, the outcome for many patients has remained poor. The new antipsychotic medications exhibit a high degree of variation in their therapeutic efficacy and side effect profiles.

In 2005, the National Institute of Mental Health (NIMH) released the results of a large study it funded comparing the effectiveness and side effects of five schizophrenia medications. The researchers found that overall the newer medications have no substantial advantage over the older medications, developed in the 1950s.

The primary issues with current treatments are firstly the treatment-resistant nature of schizophrenia in some patients and inadequate long-term maintenance medications, with up to 30 percent of patients resistant to all available drugs. Secondly existing drugs cause side effects that are often distressing to patients and sometimes dangerous. Some of these are:
• sedation;
• extrapyramidal side effects, such as tremors, acute muscle contractions, akathisia (inner restlessness),
stiffness and shuffling gait;
• repetitive, involuntary, purposeless movements, such as grimacing, tongue protrusion, lip smacking,
puckering and pursing and rapid eye blinking;
• dry mouth, blurred vision, urinary hesitancy, constipation;
• cardiovascular effects, such as abnormally rapid beating of the heart and postural hypotension;
• weight gain;
• skin and eye effects, such as cutaneous rash, photo toxic skin reactions, pigmentary changes in skin,
granular deposits in the cornea and lens.

Mostly these side effects are mild or only occur for the first few weeks of treatment. However some create serious, long-term problems for schizophrenics. World Health Organisation research reports that akathisia and other extrapyramidal symptoms affect up to 70 percent of patients, causing distress that includes restlessness, anxiety, irritability and inability to feel comfortable.

Current drug treatments for schizophrenia are called “atypical antipsychotics”. The first of the new antipsychotic drugs was clozapine, introduced in 1990. It treats psychotic symptoms effectively but can produce a serious problem called agranulocytosis, a loss of the white blood cells that fight infection. Many people find treatment with clozapine difficult because of the inconvenience and cost of both the blood tests and the medication itself. But for many it remains the drug of choice for those whose symptoms do not respond to the other antipsychotic medications, old or new.

“The improvement in medication has not changed the proportion of schizophrenics who even maintain a steady job, about 10% - about the same proportion who eventually suicide.” Neuroinvestment. Number 117, March 2005. NI Research Publications