Source: Pharmalive
Date: 22 December 2004

Bristol-Myers Squibb and Somerset Pharmaceuticals Enter Into Agreement to Distribute and Commercialize EMSAM, Investigational Transdermal Treatment for Major Depressive Disorder

NEW YORK and TAMPA, Fla., December 22, 2004 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company

BMY and Somerset Pharmaceuticals, Inc., a joint venture between Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc., today announced they have entered into an agreement for the commercialization and distribution of Somerset's EMSAM(R) (selegiline transdermal system), an investigational monoamine oxidase inhibitor administered as a transdermal patch for the acute and maintenance treatment of patients with major depressive disorder. Somerset received an "Approvable" letter from the U.S. Food and Drug Administration (FDA) for EMSAM(R) in February, 2004, and if approved by the FDA, EMSAM(R) would be the first transdermal treatment for major depressive disorder.

Under the terms of the agreement, Bristol-Myers Squibb receives exclusive distribution rights to commercialize EMSAM(R), if approved, in the U.S. 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, however, Somerset will receive an upfront payment and a further payment following regulatory approval in the U.S. 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(R).

"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, U.S. Pharmaceuticals, Bristol-Myers Squibb. "This collaboration exemplifies our new corporate strategy which focuses our efforts on 10 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."

"We are excited to announce that we have partnered on EMSAM(R) with Bristol-Myers Squibb, which has a strong record in neuroscience," said Mel Sharoky, M.D., Somerset's president and chief executive officer. "Together with our partner, we look forward to working with FDA on EMSAM(R) because there is a need for additional treatment options for major depressive disorder. The EMSAM clinical program, to date, has involved more than 2,000 patients with major depressive disorder."

Approximately 19 million adults in the U.S., or close to 10 percent of the American population, suffer from major depressive disorder. Depression costs U.S. employers about $31 billion a year in productivity, not including disability-leave payments.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb on the World Wide Web at

About Somerset Pharmaceuticals, Inc.

Somerset Pharmaceuticals, Inc. is a joint venture between Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc. .

For more information about Somerset, visit

About Mylan Laboratories Inc.

Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Mylan Bertek Pharmaceuticals Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.

For more information about Mylan, visit

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

For press releases and other company information, visit Watson Pharmaceuticals' Web site at

Forward-looking statement

The parties caution that this press release may contain forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual future results may differ materially from those expressed or implied by such forward-looking statements due to such factors including, but not limited to, changing market conditions, the availability and cost of raw materials, the impact of competitive products and pricing, the timely development, FDA approval, and market acceptance of Somerset's and its competitors' products, the outcome of litigation and other risks detailed from time to time in the Securities and Exchange Commission filings of Mylan Laboratories Inc., Watson Pharmaceuticals, Inc. and Bristol-Myers Squibb Company. Except as required by law, the parties undertake no obligation to update these statements for revisions or changes after the date of this release.

Mylan Laboratories Inc.; Watson Pharmaceuticals, Inc.

CONTACT: Media - Robert Hutchison, +1-609-252-3901,, or Investors - John Elicker, +1-212-546-3775, , both of Bristol-Myers Squibb; Media & Investors -Melissa Goodhead, +1-813-288-0040, ext. 276, , of Somerset; Media & Investors - Patty Eisenhaur, +1-951-493-5611,, of Watson; Media - Heather Bresch,+1-724-514-1800, , or Investors - Kris King,+1-724-514-1800, , both of Mylan

Web site:


EMSAM (pdf file)
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February 2006: EMSAM (transdermal selegiline) licensed by FDA