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United States : RTU, Takeda and certain affiliates of Takeda enters into settlement and license agreeement.

Sucampo Pharmaceuticals, Inc., a global biopharmaceutical firm, declared that Sucampo, R-Tech Ueno, Ltd. (RTU), Takeda Pharmaceutical Company Limited (Takeda) and certain affiliates of Takeda have finalised a settlement and license deal with Anchen Pharmaceuticals, Inc., Par Pharmaceutical, Inc., and Par Pharmaceutical Companies, Inc., (collectively, Par) that resolves patent litigation in the United States (U.S.) related to Sucampo's AMITIZAA (lubiprostone) 8 mcg and 24 mcg soft gelatin capsules.

Under the conditions of the settlement, Sucampo and RTU will give Par a non-exclusive license to market Par's generic version of lubiprostone 8 mcg soft gelatin capsule and 24 mcg soft gelatin capsule (licensed products) in the U.S. for the indications sanctioned for AMITIZA beginning January 1, 2021, or earlier under certain circumstances. Beginning on January 1, 2021, Par will split with Sucampo the gross proceeds of the licensed products sold during the term of the contract, which continues until each of the Sucampo patents has expired. In the event Par elects to introduce an authorized generic, Sucampo will supply Par under the conditions of a manufacturing and supply contract at a negotiated price. Additional details of the agreement remain confidential.

"This settlement agreement is an important step for Sucampo toward securing our foundation and continuing to grow sales of AMITIZA," said Peter Greenleaf, Chief Executive Officer of Sucampo. "We are on track with the strategic imperatives I communicated in August that include a sharp focus on our flagship product. This is not only beneficial to our company and shareholders, it is important to prescribing physicians and their patients who depend on AMITIZA for treatment."

Additionally, Sucampo said it has got a Paragraph IV certification notice letter (Notice Letter) regarding an Abbreviated New Drug Application (ANDA) presented to the U.S. Food and Drug Administration (FDA) by Dr. Reddy's Laboratories, Inc. (Dr. Reddy's), requesting sanction to market, sell and use a generic version of the 8 mcg and 24 mcg AMITIZAA (lubiprostone) soft gelatin capsule products.

"We will continue to vigorously enforce AMITIZA's intellectual property rights," said Greenleaf. "Generic companies have made Paragraph IV certifications a routine part of business. Sucampo is well prepared to pursue all legal pathways in defense of AMITIZA."

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Publication:Mena Report
Date:Oct 11, 2014
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