Royalty Report: Drugs, Disease, Therapeutic – Collection: 6958

License Grant

Licensor of Switzerland grants to Licensee a royalty-bearing and exclusive license, with right of sublicense as provided in Section 2.3, under the Licensed Patents to develop, import, use, make, have made, export, offer for sale and sell Licensed Products throughout the SPI Territory.

License Property

Original Compound means any of (i) SPI-0211, (ii) SPI-8811 or (iii) SPI-017, or any isomer, ester, salt, hydrate, solvate, homolog, conjugate or polymorph thereof.

Lubiprostone Product means a pharmaceutical preparation for human use that contains the compound SPI-0211 as an active ingredient.

Selection Pool Compound means any prostone compound (or analog, prodrug, precursor or metabolite thereof) (i) derived.

IP relates to develop and commercialize AMITIZA, cobiprostone and SPI-017 and any other prostone compounds, other than Rescula, subject to the Company’s patents.

The patents that are owned and maintained by Licensor are based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body.  The Licensee  provides certain development funding to the Licensor.

If the Licensee has not committed specified development efforts to any prostone compound other than AMITIZA, cobiprostone and SPI-017 by the end of a specified period, which ends on the later of June 30, 2011, then the commercial rights to that compound will revert to the Company, subject to a 15-month extension in the case of any compound designated by the Licensee in good faith as planned for development within that extension period. Upon expiration of the 15th anniversary of the first commercial sale of the Licensed products, the Licenses shall be royalty free.

Licensed Patents
A-11 PROSTAGLANDINS OF THE D SERIES, AND TRANQUILIZERS AND SOPORIFICS CONTAINING THE SAME U.S.A. CIP 403774 1989/9/6 5073569 1991/12/17
A-11 PROSTAGLANDINS OF THE D SERIES, AND TRANQUILIZERS AND SOPORIFICS CONTAINING THE SAME U.S.A. DIV 715151 1991/6/13 5137915 1992/8/11
A-11 PROSTAGLANDINS OF THE D SERIES, AND TRANQUILIZERS AND SOPORIFICS CONTAINING THE SAME U.S.A. CA3 8/310109 1994/9/23 5534547 1996/7/9
A-12 PROSTAGLANDINS E AND ANTI ULCERS CONTAINING SAME U.S.A. DIV2 08/401675 1995/3/10 5886034 1999/3/23
A-12 PROSTAGLANDINS E AND ANTI ULCERS CONTAINING SAME U.S.A. DIV3 09/073253 1998/5/6 6265440 2001/7/24
A-15 FERVESCENCE COMPOSITION U.S.A. CIP 440449 1989/11/22 5001154 1991/3/19
A-17 CATHARTICS U.S.A. CA2 996495 1992/12/30 5317032 1994/5/31
A-22 TRACHEOBRONCHODILATOR U.S.A. CA2 8/77495 1993/6/17 5362751 1994/11/8

Field of Use

AMITIZA (24 mcg) twice daily is approved to treat Chronic Idiopathic Constipation in adults.
Cobiprostone is an investigational drug, for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).

We are conducting preclinical development of SPI-017 for the treatment of peripheral arterial and vascular disease, central nervous system disorders. Initially, we are working on the development of an intravenous formulation of SPI-017 for the treatment of peripheral arterial disease and stroke. We also are developing an oral formulation of SPI-017 for the treatment of Alzheimer’s disease.

License Grant

The Licensee holds an exclusive worldwide royalty-bearing License from the Swiss Licensor to develop and commercialize Amitiza and all other prostone compounds covered by patents and patent applications held by the Licensor. The Licensee are obligated to assign to the Licensor all patentable improvements made in the field of prostones, which the Licensor will in turn License back to the Licensee on an exclusive basis.

License Property

Amitiza®, is for the treatment of Chronic Idiopathic Constipation in adults.  Amitiza increases the secretion of fluid in your intestines to help make it easier to pass stools (bowel movements).

Field of Use

The Licensee is an emerging pharmaceutical company focused on the discovery, development and commercialization of proprietary drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body.  We believe that most prostones function as activators of cellular ion channels and, as a result, may be effective at promoting fluid secretion and enhancing cell protection, which may give them wide-ranging therapeutic potential, particularly for age-related diseases. We are focused on developing prostones with novel mechanisms of action for the treatment of gastrointestinal, respiratory, vascular and central nervous system diseases and disorders for which there are unmet or underserved medical needs and significant commercial potential.

License Grant

Licensor grants a worldwide, exclusive license, with the right to sublicense, under the Licensors Rights, to Develop, make, have made, use, sell, offer for sale, have sold and import the Compound and Products in the Field, and otherwise to perform its obligations expressly set forth in this Agreement and the Co-Promotion Agreement.

License Property

The Compound means either (a) the Initial Compound or (b) any compound that is claimed in U.S. Patent No. 6,288,122 Bl and any hydrates, anhydrides, solvates, salts, esters or polymorphs thereof.

The initial compound means the compound ICA-17043 having the molecular structure set forth and any hydrates, anhydrides, solvates, salts, esters, isomers, prodrugs, metabolites or polymorphs thereof.

The Product means a pharmaceutical product that contains, incorporates or is comprised of the Compound, whether in development or approved by any Regulatory Authority, including all formulations, line extensions and modes of administration thereof.

The Licensor Patents means all Patents, other than CMCC Patents, Controlled by Licensor as of the Effective Date or during the Term, that, absent rights thereunder, would be infringed by the Development, Manufacture, formulation, use, distribution, importation, sale, or offer for sale of Compound or Product, including without limitation any such Patents claiming the composition of matter or the use of Compound or Product or any Improvements thereto.

Licensors know-how means all Information, except for CMCC Know-How, that Licensor Controls as of the Effective Date or during the Term.

Field of Use

The field means prevention and treatment of all human and animal diseases and disorders.  The licensed technology is for use of these compounds include treating sickle cell disease, preventing erythrocyte dehydration and inhibiting potassium flux.

License Grant

The Licensor of Spain grants to an exclusive, even as to Licensor, license under the Patent Assets and the Licensor Know-How, including the right to grant sublicenses, to develop, make, have made, use, import, offer for sale, promote, market, commercialize, distribute and sell Product in the Territory, and insofar as necessary for the purposes of exercising such rights, to develop, make, have made, use, import, offer for sale, commercialize, distribute and sell Compound.

License Property

The compound is UR-12746 Sodium Salt, meaning UR-12746 (including UR-12715) and UR-12746(S), and any derivative, homolog or analog of any of the foregoing or any isomer, salt, hydrate, solvate, amide, ester, metabolite, or prodrug of any of the foregoing, and any pharmaceutical composition containing any of the foregoing in any pharmaceutically acceptable form.

Licensor possesses significant expertise in the field of antiinflammatory therapeutics, and dersalazine represents the culmination of years of internal research.

Dersalazine is a new chemical entity that combines a well-known anti-inflammatory agent, 5-ASA, with a novel potent agent that acts as a PAF antagonist and an inhibitor of key interleukin cytokines to achieve a synergistic therapeutic effect when compared to the activities of each component separately. Chemical cleavage of dersalazine by colonic bacteria releases the two active compounds for the topical treatment of inflammation in the colon. The 5-ASA molecule contained in dersalazine has known antioxidant properties which may ameliorate the deleterious inflammatory effects ascribed to the overproduction of free radicals.

Field of Use

Dersalazine is a compound in early clinical development to treat Inflammatory Bowel Disease (IBD), which includes ulcerative colitis and Crohn's disease.

License Grant

Licensors, a non-profit organization including a University, grant to Licensee the exclusive right and license to use the Licensed Technology to make, have made, use, lease and sell Licensed Products and to practice the Licensed Processes in the Licensed Territory during the term of this Agreement.

License Property

The technology relates to compositions of and methods for using spin-trapping compounds.

The patents include Methods and Compositions for Inhibition of Aging, and, Spin-Trapping Pharmaceuticals Compositions and Methods for Use Thereof.

Field of Use

The field of use for the patents is treatment and prevention of gastrointestinal ulceration.