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www.fdanews.com/articles/90381-shionogi-eli-lilly-develop-and-market-cymbalta-in-japan

SHIONOGI, ELI LILLY DEVELOP AND MARKET CYMBALTA IN JAPAN

February 6, 2007

Shionogi and Eli Lilly Japan have signed an agreement to co-develop and co-market duloxetine HCl in Japan. Duloxetine, marketed in many countries as Cymbalta, is a serotonin-norepinephrine reuptake inhibitor approved in more than 70 countries in Europe and Latin America and in the United States for the treatment of major depressive disorder and for the management of diabetic peripheral neuropathic pain.

The drug is also approved for the treatment of stress urinary incontinence in more than 30 countries. Its 2006 worldwide sales were $1.3 billion, according to the companies.

"We are very excited that this partnership with Shionogi will be adding duloxetine to our CNS portfolio in Japan," Masanobu Kambara, director of the CNS Business Unit of Eli Lilly Japan. "With both duloxetine and Zyprexa, an existing treatment of schizophrenia, Eli Lilly Japan will be able to provide patients and doctors with a broader range of innovative medicines for the treatment of serious mental illnesses and related diseases."

In Japan, duloxetine is currently undergoing Phase III and Phase II clinical trials sponsored by Shionogi for the indications of depression and pain related to diabetic peripheral neuropathy. As a result of this agreement, the two companies will collaborate on the development in Japan of duloxetine for pain related to diabetic peripheral neuropathy, while Shionogi will continue sole development of the drug for the indication of depression. The companies will co-market the drug under the same product name.