Bristol-Myers Squibb will return to the antidepressant market under an agreement to commercialize Somerset's Emsam .

Bristol will be responsible for all marketing and detailing of Emsam (selegiline transdermal) under the deal announced Dec. 22.

Emsam, a monoamine oxidase inhibitor patch, has been "approvable" at FDA since February (¹ Also see "Mylan/Watson Emsam "Approvable"" - Pink Sheet, 2 February, 2004.).

Somerset is a joint venture between Mylan and Watson; the entity is seeking approval of Emsam for acute and maintenance treatment of major depressive disorder.

Watson has said that Somerset would seek a partner with significant experience in the psychiatric market before proceeding with Emsam labeling discussions with FDA (² Also see "Mylan/Watson Emsam Label Discussions Await Marketing Partner" - Pink Sheet, 4 August, 2004.).

Bristol will now participate in those labeling discussions, as well as in talks with the agency about Phase IV and toxicology studies.

The companies do not have an estimated date for commercial launch.

Emsam will bring Bristol back into the antidepressant category, which the company left in June when it stopped shipping Serzone .

Bristol announced in May that it would discontinue sales of Serzone (nefazodone) because of a rapid decline in brand sales due to generic competition (³ Also see "Bristol Pulls Serzone; Cites Generic Erosion, Not Safety Issues" - Pink Sheet, 20 May, 2004.).

Serzone was the subject of longstanding safety concerns, and Bristol's decision to stop supplying the product to the U.S. market followed withdrawal of the antidepressant in Europe and Canada.

A "black box" warning on hepatic failure was added to Serzone labeling in December 2001, and labeling was further revised in June 2004 to suggest use as a second-line therapy in certain cases due to an increased risk of hepatic failure (⁴ Also see "Bristol Serzone Hepatic Risk Suggests Need For Second-Line Use, Revised Labeling Says" - Pink Sheet, 23 June, 2004.).

In October, FDA denied Public Citizen's request that nefazodone be withdrawn from the market due to adverse events associated with the drug (⁵ Also see "Nefazodone Generics Stay On Market Following FDA Analysis Of Serzone Withdrawal" - Pink Sheet, 25 October, 2004.).

Under the agreement with Somerset, Bristol will hold exclusive rights to commercialize Emsam, if approved, in the U.S. and Canada, with the option to negotiate rights for other countries.

"Somerset will receive an upfront payment and a further payment following regulatory approval in the U.S.," the companies said. "In addition to the upfront payment, Somerset will receive milestone payments based on achievement of certain sales levels, as well as reimbursement of certain development costs incurred over the term of the agreement."

Somerset will supply product to Bristol and receive royalties on Bristol's sales of the antidepressant.

Bristol said it has not yet been determined whether sales reps for its antipsychotic Abilify (aripiprazole) will also handle detailing for Emsam.

- Sue Sutter

Emsam Deal Marks Bristol's Return To The Antidepressant Market

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