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Sumitomo Dainippon Pharma Co., Ltd.

Drug Names(s): Lunivia (EU), Estorra, eszopiclone, SEP-190

Description: Lunesta (Eszoplicone) is a non-benzodiazepine (cyclopyrrolone) sedative-hypnotic that targets a specific GABA-A (gamma-aminobutyric acid A) receptor site, just as the other currently marketed non-benzodiazepine sedative-hypnotics. Lunesta is most similar to Sanofi-Synthélabo's Ambien (zolpidem) and King Pharmaceutical's Sonata (zaleplon), both of which have been successful as prescription sleep medications.

Lunesta is a refined version of racemic zoplicone (Imovane, Aventis), a drug that has been used for nearly a decade in Europe. Lunesta has a longer half-life than either of the other non-benzodiazepine drugs - Sonata and Ambien: it stays in the bloodstream about six or seven hours, so it's good for people who have trouble staying asleep. The non-benzodiazepine drugs also have a better tolerability profile than the benzodiazepines.

Like benzodiazepine sedatives (Alprazolam, Clonazepam, Diazepam, Temazepam etc.), Lunesta works by enhancing the actions of the neurotransmitter GABA. GABA inhibits the transmission of nerve signals, thereby reducing nervous excitation in the brain. However, unlike benzodiazepines, Lunesta appears to be more selective in its action and targets only one type of GABA receptor. This is important because, with daily use, benzodiazepine medications are somewhat infamous for causing tolerance (where escalating doses are needed to achieve the same beneficial effects) and may cause serious withdrawal symptoms if discontinued too abruptly. Due to its selectivity, Lunesta appears to be less likely to cause tolerance problems, and withdrawal symptoms.

Lunesta is expected to be available as a 1-, 2-, or 3-mg tablet. Sepracor expects the recommended dosing for achieving sleep maintenance to be 2 mg or 3 mg for adults and 2 mg for older persons, contingent upon approval. The recommended dosing for older persons whose primary complaint is difficulty falling asleep is expected to be 1 mg.

The purpose of a new film-coated formulation of Lunesta is to reduce bitterness of the pill for the proportion of patients who experience bitterness almost immediately (which the company estimates is about 30% of those who experience bitterness).

Deal Structure: In October 1999, Sepracor announced that it had entered into an agreement with Rhone-Poulenc Rorer SA (RPR), a unit of Rhone-Poulenc SA, whereby Sepracor has exclusively licensed RPR's preclinical, clinical and post-marketing surveillance data package relating to zopiclone, its isomers and metabolites, to develop, make, use and sell (+)-zopiclone (Eszoplicone) in the United States. Zopiclone, marketed by RPR (now Aventis S.A.) under the brand names of Imovane and Amoban, is available in approximately 80 countries worldwide and has never been registered for the U.S market.

In July 2007, Sepracor announced an agreement with Eisai Co. Ltd. for the development and commercialization of Lunesta for the Japanese market. Under the agreement, Eisai will be responsible for completing the remaining clinical trials necessary for attaining marketing approval from the Japanese regulatory authorities, and contingent on regulatory approval, commercialization of the product in Japan. In exchange,...See full deal structure in Biomedtracker

Partners: Sanofi Eisai Co., Ltd.

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