Sepracor Signs Agreement With Eisai To Market Lunesta In Japan
Eisai will develop and market Sepracor's insomnia treatment Lunesta (eszopiclone) in Japan under an in-licensing agreement announced by the companies July 26.
The deal "is reflective of our overall global corporate strategy to fully leverage our product franchises across the globe," Sepracor CEO Adrian Adams said in a second quarter earnings call the next day.
"Eisai is a large and well-recognized pharmaceutical company based in Japan with a strong focus in the [central nervous system] therapeutic area. We are very excited about this partnership and feel that the expertise in CNS, as well as their established sales force in Japan, makes a perfect fit for Lunesta."
The 15-year agreement includes an initial milestone payment in addition to development, regulatory and pricing milestone payments and royalties.
Once approved, Lunesta will address a Japanese insomnia market estimated by Sepracor to be approximately $500 million in 2006.
The firm expects to submit a Japanese application for Lunesta in 2010 or 2011, Adams said. The products is being studied in a Phase I clinical trial in Japan.
Lunesta will compete with Sanofi-Aventis' sleep aid Ambien (zolpidem), marketed as Myslee in Japan, but the firm is confident it will be able to differentiate eszopiclone by virtue of its lower dose.
"One of the interesting things about Ambien is that it is available in Japan at the 10 mg level, which is extraordinarily high," Exec VP-Research and Development Mark Corrigan said. "So ... it's usage is principally in very ill patients. I think the full potential for the Japanese physician to prescribe lower doses as well as the data sets that we have will strongly differentiate our product."
Sepracor also is seeking approval in Europe, where the drug will be called Lunivia. Corrigan reported during the call that the company has submitted its EU marketing application, and anticipates approval in the second half of 2008. The firm is currently looking for a marketing partner in the region.
Lunesta, Sepracor's most successful product, was approved in the U.S. in late 2004 and hit the market in April 2005 ("The Pink Sheet" DAILY, April 1, 2005).
The firm faced a difficult quarter with the launch of generics of Ambien immediate-release tablets in April ("The Pink Sheet" DAILY, April 23, 2007).
With wholesalers moving to stock generic zolpidem, Lunesta inventory levels declined 50 percent in volume by the end of the second quarter, according to Sepracor. However, the medication still saw some growth, with sales rising 2.7 percent to $143 million. Total revenues were up 5.2 percent to $278.1 million.
-Brooke McManus
This article is reprinted from "The Pink Sheet" DAILY – July 30, 2007
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