BURLINGTON, Mass., Oct. 14, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Dainippon Sumitomo Pharma/Sunovion/Takeda Pharmaceutical's atypical antipsychotic Latuda will experience significant uptake in the bipolar disorder (BPD) market following the agent's June 2013 U.S. label extension to treat bipolar depression. In addition to established efficacy in treating this underserved BPD population, Latuda offers a mild metabolic profile relative to other atypical antipsychotics used in BPD such as olanzapine (Eli Lilly's Zyprexa, generics). These clinical and regulatory benefits differentiate the drug within the crowded and increasingly genericized atypical antipsychotic class and will drive peak sales of Latuda in BPD to nearly $900 million in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.
The Pharmacor advisory service entitled Bipolar Disorder finds that major-market sales in the BPD market will decline by 4.9 percent annually from 2012-2022, resulting primarily from generic competition for Abilify (Bristol-Myers Squibb/Otsuka Pharmaceutical's aripiprazole), Seroquel/Seroquel extended-release (XR) (AstraZeneca/Astellas quetiapine, AstraZeneca's quetiapine XR) and other branded agents in the atypical antipsychotic class, such as Geodon/Zeldox (Pfizer's ziprasidone) and in the antidepressant class, such as Cymbalta (Eli Lilly/Boehringer Ingelheim/Shionogi's duloxetine). The uptake of Latuda, the launch of Forest Laboratories/Gedeon Richter/ Mitsubishi Tanabe Pharma's cariprazine for bipolar mania and the off-label use of newly launched or emerging atypical antipsychotics, such as Otsuka Pharmaceutical/Lundbeck's brexpiprazole, will only partially offset the decline in sales lost to generic competition within the BPD market.
BPD patients are commonly prescribed a combination treatment regimen which typically includes lithium (GlaxoSmithKline's Eskalith/Eskalith CR, Solvay's Lithobid/Liskonum/Quilonum, Taisho's Limas, generics), antiepileptics, antidepressants or atypical antipsychotics—particularly when experiencing acute mood episodes. The prevalence of polypharmacy allows room in the treatment algorithm for adjunctive use of newly marketed and emerging agents. However, in order to achieve uptake, new agents entering the BPD market must positively differentiate themselves from the growing number of generic treatment options available on factors other than cost.
"Unmet need remains for additional drugs with efficacy in treating bipolar depression. Few current therapies have regulatory approval for this indication, and, although antidepressants are frequently prescribed off-label in BPD, interviewed experts express concern over the risk of inducing mania or rapid cycling with antidepressant treatment," said Decision Resources Business Insights Analyst John J. Crowley, Ph.D. "Although demonstrating meaningful efficacy and safety in clinical trials for bipolar depression poses a difficult challenge for the developers of an emerging drug, the commercial opportunity is significant for a drug that establishes a clear clinical benefit."
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