Sucampo Pharmaceuticals, a global biopharmaceutical company, announced that Sucampo and R-Tech Ueno, Ltd. (RTU), have entered into a stipulation and licence agreement with Par Pharmaceutical, Inc. (Par). The agreement states that in limited circumstances, Sucampo or RTU would grant Par a licence for a generic version of the RESCULA (unoprostone isopropyl ophthalmic solution) 0.15 per cent product approved for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension prior to the latest expiration date of the patents, which is July 2021. Par had previously submitted an Abbreviated New Drug Application to the US Food and Drug Administration requesting approval to market, sell, and use a generic version of RESCULA.

Under such licence, Par will split with Sucampo the gross profits of the generic or authorised generic version sold during the term of the agreement, which continues until the last of Sucampo patents relating to RESCULA have expired. In the event Par elects to launch an authorized generic, Sucampo will supply Par under the terms of a manufacturing and supply agreement at a negotiated price.

"We previously announced our exit from commercialisation activities for RESCULA as we focus on the growth of AMITIZA sales with our partners and the expansion and advancement of our pipeline," says Peter Greenleaf, chief executive officer of Sucampo. "However, we still remain committed to enforcing our intellectual property for RESCULA and believe the terms of this agreement are favourable to Sucampo."

Sucampo Pharmaceuticals, Inc. is focussed on the development and commercialisation of medicines that meet major unmet medical needs of patients worldwide. Sucampo has one marketed product AMITIZA and a pipeline of drug candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the United Kingdom.