By Patrick Rajan, Research Analyst, Pharmaceutical and Biotechnology Practice
The outstanding performance of Abilify is increasing the presence of Bristol-Myers Squibb and Otsuka America Pharmaceutical in the U.S. antipsychotics market. Despite the fact that 2003 was just the first full year on the market for the drug, Abilify has already surpassed established antipsychotics such as Geodon from Pfizer in terms of prescriptions and sales and become a first-line therapy among many physicians and psychiatrists. Expectations are high for Abilify, but early returns indicate that BMS and Otsuka have a winner that could soon reach blockbuster status.
Abilify functions by inhibiting a brain receptor for dopamine, a key neurotransmitter that is overactive in the brains of people suffering from schizophrenia. The product has a unique pharmacology; unlike other atypical antipsychotics, Abilify does not fully block or stimulate the receptors, but does a little of both, resulting in supreme efficacy. In addition to its proven efficacy, Abilify has a comprehensive safety and tolerability profile that gives it a significant competitive advantage over its major competitors such as Zyprexa, Geodon, Risperdal, and Seroquel.
Abilify was jointly developed by Bristol-Myers Squibb and Otsuka Pharmaceuticals and approved for treating schizophrenia by the FDA in November 2002. Research is currently being done on additional indications for Abilify to reach supplementary patient populations suffering from mental illnesses. Potential uses include treating psychosis resulting from Alzheimer’s disease and treating bipolar disorder. Bristol-Myers Squibb and Otsuka have already submitted a supplemental new drug application for Abilify for the treatment of acute mania in patients with bipolar disorder to the FDA based on efficacy and safety data from three three-week studies and a 12-week study in the treatment of acute mania.
There have already been more than 2.4 million prescriptions written for Abilify and Otsuka projects that U.S. sales will exceed $750 million this year. Since its launch Abilify has rapidly expanded in terms of revenue and market share while its major competitors have steadily declined comparatively because Abilify is superior in many aspects in regards to side effects. In clinical studies, Abilify was associated with minimal weight change, a major selling point that BMS and Otsuka have aggressively and effectively established. Weight gain is a common reason many people stop taking antipsychotics. Also, there is a concern that long-term use of antipsychotics such as Zyprexa can increase the risk of diabetes. Researchers have reported in long-term trials that taking Abilify does not elevate the risk of schizophrenic patients subsequently developing Type 2 diabetes. Studies have not shown Abilify to differ from placebo in terms of altering heart rhythms, a problem noted in a warning on Geodon’s label. Patients have experienced loss of interest in sex when taking Risperdal due to elevated prolactin levels, something Abilify has not demonstrated. Many antipsychotic medicines can cause fatigue, but during clinical studies for Abilify nine out of ten people did not feel tired while taking the drug.
Since differences in efficacy are negligible among the top antipsychotics, patient compliance is the key issue on which companies compete. Because side effect profiles are the main factor taken into consideration when doctors choose an antipsychotic to prescribe, Abilify should receive an increasing large fraction of newly diagnosed schizophrenia patients and patients who need to switch between antipsychotics due to excessive side effects. While Abilify emerges as a first-line therapy for schizophrenia, it should continue to displace the established antipsychotics in the U.S. market and further erode their revenues and market shares.
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Last updated on: 27/08/2010