Bristol Abilify To Launch In Late November; Antipsychotic Approved Nov. 15
Executive Summary
Bristol-Myers Squibb/Otsuka's Abilify (aripiprazole) will be launched by the end of November following FDA's Nov. 15 approval of the atypical antipsychotic
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Bristol-Myers Squibb/Otsuka's Abilify (aripiprazole) will be launched by the end of November following FDA's Nov. 15 approval of the atypical antipsychotic. Lower doses will be priced comparably to existing atypicals, while higher strengths will cost less than the more expensive products, Bristol said. Abilify will be available in 10 mg, 15 mg, 20 mg and 30 mg tablets. Abilify is Bristol's first NME approved since the antibiotic Tequin in 1999. Bristol licensed aripiprazole from Otsuka in September 1999. The drug is Otsuka's third marketed Rx product; Otsuka co-promotes the intermittent claudication agent Pletal (cilostazol) with Pharmacia, and the nitroglycerin angina pectoria spray Nitrolingual Pumpspray with First Horizon. Abilify will compete in a crowded atypical antipsychotic market with Lilly's Zyprexa (olanzapine), Pfizer's Geodon (ziprasidone), AstraZeneca's Seroquel (quetiapine) and Johnson & Johnson's Risperdal (risperidone). Lilly has already warned investors of a potential slow-down in Zyprexa sales following the Abilify launch; the company anticipates olanzapine sales to "flatten temporarily" as psychiatrists experiment with Abilify therapy (1 (Also see "Lilly Expects Zyprexa Sales To Flatten During Bristol Abilify Launch In Q4" - Pink Sheet, 28 Oct, 2002.), p. 24). Bristol sales reps are likely to emphasize Abilify's weight gain profile in detailing the drug. Abilify "demonstrated a favorable weight profile in short-term clinical trials," with patients gaining an average of .7 kg, versus .05 kg for placebo, Bristol said. Zyprexa labeling states that olanzapine patients gained an average 2.8 kg, compared to .4 kg in placebo patients in trials. Abilify's weight gain appears closer to that of Geodon; ziprasidone labeling says that a "median weight gain of .5 kg was observed...compared to no median weight change in placebo patients." Geodon, however, is contraindicated in patients with a known history of QT prolongation and carries a long bolded warning about the adverse event. "The incidence of QTc interval prolongation with Abilify treatment is not different than placebo," Bristol said. The aripiprazole NDA was filed on Oct. 31, 2001 and was deemed "approvable" by FDA Aug. 30. |