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Aripiprazole Launched in Europe

Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today the European launch of ABILIFY(R) (aripiprazole), the first in a new generation of antipsychotic medications, at the 24th Annual Meeting of the Collegium Internationale Neuro-Psychopharmacologicum (CINP), a key psychiatry conference held in Paris, France.

Two in every three patients rated ABILIFY as 'much better, I prefer this medication' eight weeks after switching from a previous antipsychotic treatment, according to results of BETA (Broad Effectiveness Trial with Aripiprazole), a naturalistic study involving 1,500 patients, presented at the congress today.

"ABILIFY offers an effective new option for millions of people affected by schizophrenia in Europe," said Professor Rajiv Tandon, Professor of Psychiatry at the University of Michigan Medical Centre, Ann Arbor, Michigan, USA. "Preference of medication is a key factor in helping patients to stay on therapy and avoid relapse," he continued.

BETA was conducted in a 'real world' setting, where physicians prescribed ABILIFY or another antipsychotic (in a four to one ratio) to patients who needed to switch treatment because of lack of effect or intolerable side effects. The results of BETA showed that two out of three patients and more than half of their caregivers rated ABILIFY as 'much better, I prefer this medication' eight weeks after switching from a previous antipsychotic treatment. ABILIFY showed a beneficial effect after one week of treatment, and by the end of the 8-week study, 69 percent of patients taking ABILIFY were rated by physicians as 'much improved' or 'very much improved'.[1]

ABILIFY delivers short and long-term efficacy, controls the symptoms of schizophrenia, and is enhanced by a comprehensive safety and tolerability profile. ABILIFY is the first dopamine system stabiliser used to treat schizophrenia and it is suggested that it works in a different way to all other antipsychotics. Due to its unique mechanism of action, ABILIFY works by decreasing dopamine activity where D2 receptors are over stimulated and increasing dopamine activity where they are under stimulated, thus creating dopamine stabilisation in certain areas of the brain.[2]

"The unique pharmacology of ABILIFY means it provides proven efficacy with a favourable tolerability and safety profile. This is an important factor in ensuring patients adhere to their treatment, which will help prevent relapse and hospitalisation," said Professor Michel Bourin, Head of Psychiatry Research, Faculty of Medicine, University of Nantes, France.

At the congress, results of an epidemiological study of more than 1,900 patients with schizophrenia and their psychiatrists in Spain were presented. The results showed that 65 percent of patients reported adverse events related to their antipsychotic treatment. The most commonly cited were weight gain (33.5%; 56.8% of which were increases more than or equal to 5 kg), fatigue and drowsiness (20.6%), movement disorders (14.3%), and mouth dryness (13.4%).[3]

"Adverse events are one of the leading reasons (together with lack of efficacy) reported by psychiatrists for switching antipsychotic treatment. ABILIFY provides an excellent new option for patients in Europe as it has been shown to be weight neutral, and causes less sedation and few movement disorders," said Professor Michel Bourin.

ABIILFY has also been shown to be less likely to cause metabolic syndrome, which may put patients with schizophrenia at risk for heart attack and diabetes. Metabolic syndrome occurred half as often in patients taking ABILIFY compared with patients taking olanzapine,[4] according to a new study presented at CINP. Metabolic syndrome, defined as >5 percent increase in weight, worsening of lipid levels, hypertension and increased glucose, occurred in 10 percent of patients taking ABIILFY, compared with 20 percent of patients taking olanzapine during the one-year study (relative risk=2.1; 95% CI: 1.3-3.1; p=0.0016).

ABILIFY is now available to patients in the EU and many other European countries. In Europe, ABILIFY is manufactured in 5 mg, 10 mg, 15 mg and 30 mg tablets. The recommended starting dose is 15 mg. It is taken once-daily with or without food, with no need for titration.

Schizophrenia is a chronic and persistent brain disorder and one of the most severe common mental illnesses. It occurs in all cultures and affects approximately one in one hundred people worldwide. Schizophrenia interferes with a person's ability to think clearly, manage emotions, make decisions and relate to others. This illness tends to manifest itself in early adulthood and is characterised by positive symptoms, such as hallucinations, delusions, and paranoia, as well as negative symptoms, such as social withdrawal and emotional flatness. While there is no cure for schizophrenia, it is a treatable illness.

About ABILIFY(R) (aripiprazole)
As part of the EU filing, the authorities were provided with data on more than 3476 patients with schizophrenia who received aripiprazole, with approximately 2024 patient years of exposure.

ABILIFY is manufactured in 5 mg, 10 mg, 15 mg and 30 mg tablets. It is taken in a once-daily dose. Clinical trials of ABILIFY have shown that it is effective in controlling symptoms in people with schizophrenia who present with acute psychotic symptomatology. ABILIFY is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

In three short-term (4-6 weeks) placebo-controlled trials involving 1,228 patients with schizophrenia, presenting with positive or negative symptoms, ABILIFY was associated with statistically significant greater improvements in psychotic symptoms.

In several long term studies (6-12 months), on average no weight gain was seen with patients on ABILIFY.

In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medication at 52 weeks was similar in both groups (ABILIFY 77% and haloperidol 73%). The overall completion rate was significantly higher for patients on ABILIFY (43%) than for haloperidol (30%). Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Åsberg Depression Rating Scale showed a significant improvement over haloperidol.

In a 26-week, placebo-controlled trial in stabilised patients with chronic schizophrenia, ABILIFY had significantly greater reduction in relapse rate, 34% in the ABILIFY treatment group and 57% in the placebo group.

In a 26-week olanzapine-controlled study, the incidence of extrapyramidal symptoms ('EPS') was 16.8% for aripiprazole and 15.7% for olanzapine-treated patients. In a long-term, 52-week haloperidol controlled study, aripiprazole-treated patients had an overall lower incidence of EPS (27.1%), compared with those treated with haloperidol (59.2%). EPS refers to involuntary shaking, abnormal movements and tremors, which are common side effects of antipsychotics.

Uncommon cases of seizures were reported during treatment with aripiprazole. Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.

Source: Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd

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