Dainippon Sumitomo Rolls Out Latuda; Will Sepracor's $2.6 Billion Sales Force Pay Off?
This article was originally published in PharmAsia News
Executive Summary
TOKYO - Dainippon Sumitomo launched its atypical antipsychotic Latuda (lurasidone) in the U.S. Feb. 4, and now the pressure is on to capitalize on the sales force it acquired in the acquisition of Sepracor. Analysts' eyes will be on Latuda's initial sales to gauge the company's acquired ability to market its in-house drugs in the U.S
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TOKYO - Dainippon Sumitomo launched its atypical antipsychotic Latuda (lurasidone) in the U.S. Feb. 4, and now the pressure is on to capitalize on the sales force it acquired in the acquisition of Sepracor. Analysts' eyes will be on Latuda's initial sales to gauge the company's acquired ability to market its in-house drugs in the U.S. Sunovion - the new name for the acquired Sepracor - committed 336 employees to Latuda's sales force, more than a quarter of the sales force Dainippon Sumitomo gained when it acquired Sepracor for $2.6 billion (Also see "Japanese Dainippon Sumitomo Pharma To Acquire Sepracor For $2.6 Billion" - Scrip, 3 Sep, 2009.). The atypical antipsychotic space is crowded and about to become even more difficult as generics of Eli Lilly's Zyprexa (olanzapine) hit the market in 2011. Regardless, Sunovian President Mark Iwicki was upbeat about Latuda's chances for market penetration. Speaking at an event in Tokyo, Iwicki noted the lack of a single, preferred agent for schizophrenia treatment in the U.S. According to market research by the company, six products have at least 8% of the U.S. schizophrenia market: risperidone holds 21.2% of the market, only slightly ahead of AstraZeneca's Seroquel (quetiapine fumarate). In addition, discontinuation rates - caused by adverse events, lack of efficacy and breakthrough symptoms - remain high for antipsychotics. Supported by four positive efficacy claims in Latuda's label, Iwicki said the company plans to differentiate the product from current treatments that offer partial response. No Cardiac Safety Signal Seen The product's lack of a cardiac safety signal may be enough to differentiate it from some of its competitors. There was no signal of risk for QTc prolongation in its clinical trials (Also see "Cardiac Safety Could Be Distinguishing Point For Sunovion's New Antipsychotic Latuda" - Pink Sheet, 8 Nov, 2010.). The company touted a smaller list of common adverse events compared to Seroquel XR and risperidone. However, Latuda trials showed higher rates of three very unpleasant adverse events compared to Seroquel: akathisia, nausea and Parkinsonism. Among Latuda patients, nearly 8 percent experienced akathisia, compared to 1.7 percent among Seroquel patients. In addition, the company released top-line results Jan. 25 for a long-term safety study, which showed a higher discontinuation rate for Latuda than risperidone. Only 34% of Latuda patients completed 12 months of treatment, compared to 44% for risperidone patients. Full data from the safety study will be released later this year. Bank of America Merrill Lynch analyst Ritsuo Watanabe forecast the drug will produce 2011 sales of $50 million, due to the highly competitive market, and added in a Feb. 4 note that the drug's initial sales will be a key focus of full year results in May. The company still sees good potential for the drug and is conducting additional trials to expand the drug's indications and market access. Dainippon Sumitomo expects to complete the first of its trials for a bipolar depression indication by the end of fiscal year 2011. An sNDA for the indication is planned for the first half of 2012. The company is also considering indications for bipolar maintenance and major depressive disorder. Elsewhere, Dainippon Sumitomo is currently analyzing Phase III data in Japan and expects to file in Canada and China in 2011. The company says it is in active partnering discussions for Europe. The company has been vocal in increasing sales in China. In December 2010, Dainippon Sumitomo completed a merger between its Chinese subsidiary and Kyowa Hakko Kirin's China operations. The companies reached an agreement in November 2008. Dainippon Sumitomo expects to begin packaging operations at Kyowa Hakko facilities in the first quarter of 2011. Sales in China increased 38.1% year-on-year to reach ¥4.1 billion for the third quarter, due almost entirely to the antibiotic Meropen (meronpenem). - Daniel Poppy ([email protected]) |