Recently, Bristol-Myers Squibb Co. (BMY) received approval from the U.S. Food and Drug Administration (FDA) to market Abilify (aripiprazole) for the treatment of irritability in pediatric patients having autistic disorder. Abilify can be used to treat children aged 6 to 17 years for symptoms of aggression toward others, deliberate self injury, temper tantrums and quick mood swings.
Bristol-Myers and Otsuka Pharmaceutical Co. jointly develop and distribute the drug in the U.S. and Europe. The FDA approval of Abilify for treating irritation in pediatric patients with autistic disorder is based on data from two eight-week late-stage studies in which Abilify significantly improved scores on the irritability subscale of the caregiver-rated Aberrant Behavior Checklist (ABC-I), compared to placebo.
The most common adverse affects were sedation, fatigue, vomiting, somnolence, tremor and pyrexia. However, the efficacy of Abilify for the maintenance treatment of irritability associated with autistic disorder was not evaluated. Abilify, which is approved to treat depression, bipolar disorder, and schizophrenia, generated sales of $2,153 million in 2008, up 30% from 2007. Furthermore, sales in the third quarter of 2009 grew 16% to $653 million.
Abilify has been growing at about five times the overall antipsychotic market. The company’s beefed-up sales force and new Direct to Consumer (DTC) campaigns are aiding sales growth. Abilify faces competition from other drugs in the market such as Merck’s (MRK) Saphris, Pfizer Inc.’s (PFE) Geodon, Johnson & Johnson’s (JNJ) Risperdal, AstraZeneca PLC’s (AZN) Seroquel and Eli Lilly & Co.’s (LLY) Zyprexa.
Plavix, the antiplatelet blood thinner indicated to reduce the risk of heart attack in patients with atherosclerosis, is the top growth driver for Bristol. However, patent expirations loom large on the company starting 2011 when the Plavix patent expires. The company has lost patent protection on products worth about $4 billion in sales over the past four years.
Drugs such as Cefzil, Paraplatin, Glucophage, Monopril and Taxol are also experiencing declining sales due to generic competition. However, the $1 billion addition in cost cuts in 2012-2013, the extension of the Abilify agreement with Otsuka, and the acquisition of Medarex indicate that management is taking meaningful steps to prepare for the loss of exclusivity of Plavix. Currently, we are Neutral on Bristol-Myers.
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