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news.Bristol-Myers Squibb and Somerset Pharmaceuticals, a joint venture between Mylan Laboratories and Watson Pharmaceuticals, have entered into an agreement for the commercialization and distribution of Somerset's Emsam, an investigational transdermal treatment for major depressive disorder.
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Under the terms of the agreement, Bristol-Myers Squibb will receive exclusive distribution rights to commercialize Emsam (selegiline transdermal system), if approved, in the US and Canada, with an opportunity to negotiate, within a specified time frame, rights in any or all of the rest of the world.
Financial terms were not disclosed, although Somerset will receive an upfront payment and a further payment following regulatory approval in the US. In addition to the upfront payment, Somerset will receive milestone payments based on achievement of certain sales levels, as well as the reimbursement of certain development costs incurred over the term of the agreement.
Somerset will supply product to Bristol-Myers Squibb and receive royalties on Bristol-Myers Squibb sales of Emsam.
“This agreement with Somerset Pharmaceuticals marks a continued step forward in our efforts to deliver new and effective treatments to people with psychiatric disorders,” said Anthony Hooper, president of US pharmaceuticals at Bristol-Myers Squibb.
“This collaboration exemplifies our new corporate strategy which focuses our efforts on ten disease areas, including affective disorders such as major depressive disorder. We look forward to partnering with Somerset in a venture that could provide an alternative for physicians treating patients with this disorder.”
Somerset received an approvable letter from the FDA for Emsam in February 2004, and, if approved by the FDA, Emsam would be the first transdermal treatment for major depressive disorder.