SUCAMPO VOLUNTARILY HALTS TACROLIMUS EYE DROPS DEVELOPMENT, FILES COMPLAINT AGAINST BUSINESS PARTNER
 
Release Date: Jun 24, 2005

Bethesda, MD (June 24, 2005) – Despite completion of Phase II safety and efficacy research, Sucampo Pharmaceuticals, Inc. (www.sucampo.com), announced today that it is voluntarily suspending its tacrolimus eye drops development program, owing to U.S. Food And Drug Administration (FDA) safety concerns about Protopic®, a prescription cream for treating atopic dermatitis marketed by Astellas Pharma, Inc.

Tacrolimus, the active ingredient in Protopic®, is Fujisawa’s (now Astellas Pharma, Inc.) flagship compound. Tacrolimus is marketed by Astellas in many countries, including the United States, as Protopic® and the immunosuppressive agent Prograf® for prevention of organ graft rejection.

Sucampo was developing tacrolimus eye drops for the treatment of dry eye syndrome under a license from Fujisawa Pharmaceutical Co., Ltd. (Japan). Although the company’s agent is not a topical ointment, Sucampo officials stressed that patient safety must come first, in explaining why it halted the development program. Sucampo will continue to consult with FDA to determine if and when the dry eye program should resume.

Sucampo also announced today that it filed a complaint against Fujisawa (Astellas Pharma, Inc.) on March 11, 2005 in the U.S. District Court for the District of Maryland, alleging a breach of the safety information exchange agreement.

Information about Forward-Looking Statements

This press release contains certain forward-looking statements with respect to Sucampo Pharmaceutical’s financial condition, results of operations, plans, objectives, future performance and business. Expressions of future goals and similar expressions including, without limitation, "may," "will," "should," "could," "expects," "does not currently expect," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "targets," or "continue," reflecting something other than historical fact are intended to identify forward-looking statements. Management believes that these forward-looking statements are reasonable. You should not, however, place undue reliance on these statements as they are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that are difficult to predict that could cause actual results to differ materially from those expressed, implied or forecasted in any of these forward-looking statements. The following risks, among others, may materially adversely affect Sucampo Pharmaceuticals Inc.'s operations: irrespective of the outcome of this trial, the United States Food and Drug administration may not approve FK-506 for marketing or it may approve FK-506 under only limited conditions and even if FK-506 is approved for marketing, it may not become a successful product due to other factors.


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