Royalty Report: Drugs, Drug Discovery, Autoimmune – Collection: 344577

License Grant

Sub-licensor grants to Sub-licensee of Japan an exclusive sublicense, with the right to further sublicense to its Affiliates, to develop, have developed, make, have made, use, have used, offer to sell, sell, have sold, and import and export the Product or the Compound in the Sublicense Territory and to make, manufacture, have made and have manufactured outside the Sublicense Territory under the Sub-licensor Know-How, and the Patent Rights for all Indications in the Field.

License Property

Sub-licensor acquired an exclusive license under the Patent Rights and Know-How to sublicense, develop, have developed, make, have made, use, have used, offer to sell, sell, have sold, import and export the Product in the Sublicense Territory for all Indications in the Field.

Compound means ferric citrate FeC6Hs01 • xH20.

Patent
Ferric Organic Compounds, uses thereof and methods of making same
Method for treating Renal Failure

Field of Use

Field means the field of nephrology.

Nephrologyis a specialty of adult internal medicine and pediatric medicine that concerns with study of the kidneys, specifically normal kidney function (renal physiology) and kidney disease (renal pathophysiology), the preservation of kidney health, and the treatment of kidney disease, from diet and medication to renal replacement therapy (dialysis and kidney transplantation).

Indication means any therapeutic application for a Product for the treatment of hyperphosphatemia in end-stage renal disease, and for all other indications covered by the Patent Rights.

Hyperphosphatemia is an electrolyte disorder in which there is an elevated level of phosphate in the blood. Most people have no symptoms while others develop calcium deposits in the soft tissue. Often there is also low calcium levels which can result in muscle spasms.

License Grant

The Taiwanese Licensor hereby grants to Licensee an exclusive license, in the Territory, with the right to sublicense, to develop, have developed, make, have made, use, have used, offer to sell, sell, have sold, and import and export the Product in the Territory under the Licensor Know-How, and the Patent Rights for all Indications in the Field.

License Property

Product means the Compound or any pharmaceutical product containing the Compound as an active ingredient, either alone or in combination with other active ingredients.

Compound means ferric citrate (PBF1681).

Patent Rights means the Licensed Patent Property, and the patents and patent applications, patents and patent applications in which Licensor holds rights and which are directed to Licensor’s interest in Improvements, and any and all patents in which Licensor holds rights and that may issue from all such patent applications, including any and all divisions, continuations, continuations-in-part, extensions, substitutions, renewals, registrations, supplementary protection certificates, revalidations, reissues or additions of or to any of the aforesaid patents and patent applications, and any additional patents or patent applications to which Licensor acquires rights during the term of this Agreement which pertain in any way to the use or manufacture of the Compound or the Product.
United States Patent Rights (Attorney Dkt. No.)
859-A-(PCT)-US
859-B-PRO
1092-US
1098-US

Field of Use

Field means the field of nephrology.

Nephrology is a specialty of medicine and pediatric medicine that concerns itself with the kidneys the study of normal kidney function and kidney disease, the preservation of kidney health, and the treatment of kidney disease, from diet and medication to renal replacement therapy.

Zerenex is in phase II development in the U.S. for the management of elevated phosphorus and iron deficiency in anemic patients with stage 3 to stage 5 non–dialysis-dependent CKD.

License Grant

Licensee of Sweden was granted (i) an exclusive license to certain patents and joint intellectual property developed with Licensor and (ii) a non-exclusive license to certain of Licensor know-how as necessary or useful to develop and commercialize Nefecon or other product candidates.

License Property

Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant. Nefecon is currently the only pharmaceutical candidate in development for IgAN that is intended to be disease-modifying. Nefecon targets the ileum, the distal region of the small intestine, which is the presumed origin of IgAN due to the ileum being the location of the highest concentration of the Peyer’s patches, which are responsible for the production of secretory immunoglobulin A, or IgA, antibodies. Nefecon has been granted orphan drug designation for the treatment of IgAN in the United States and the European Union.

Field of Use

The filed of use is for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN for which there is a high unmet medical need and there are no approved treatments. IgAN is a progressive, chronic disease that over time results in deterioration of kidney function in patients, many of whom end up at risk of developing end-stage renal disease, or ESRD, with the need for dialysis or kidney transplant.

IgA nephropathy (IgAN), also known as Berger's disease or synpharyngitic glomerulonephritis, is a disease of the kidney (or nephropathy) and the immune system; specifically it is a form of glomerulonephritis or an inflammation of the glomeruli of the kidney. Aggressive Berger's disease (a rarer form of the disease) can attack other major organs, such as the liver, skin and heart.

Licensee is a clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.  Licensee expects that Nefecon will be the first treatment on the market indicated for IgAN, and, that Nefecon can successfully treat IgAN patients, their kidney function will be preserved.

License Grant

With this Exclusive License to Complete Pre-Clinical Development Plan, The Licensor grants the Licensee of France
–  a worldwide, exclusive, including with regard to Licensor and its Affiliates, right and license under both the Licensed Technology and Licensors rights in the Joint Technology to conduct research regarding Program Compounds solely for the purpose of completing the PreClinical Development Plan, with the right to grant sublicenses solely to Affiliates.

–  an exclusive License to Licensee Following the Exercise of the Option to Continue, a worldwide exclusive, including with regard to Licensor and its Affiliates, right and license under the Licensed Technology and Licensors rights in the Joint Technology to Exploit the Program Compounds solely for the purpose of Developing, Manufacturing and Commercializing Program Products in the Field and in the Territory, with the right to grant sublicenses.

Licensor grants an exclusive option, exercisable at any time during the Option Exercise Period, to Exploit Program Compounds and Program Products under the terms set forth in this Agreement.

This agreement includes a non-exclusive grant-back from Licensee to Licensor.

License Property

Licensor has certain proprietary compounds known as NaP2b inhibitors for use in the treatment of diseases and disorders, and has identified a lead compound, designated as NTX 1942.

The Lead Licensor Compound shall mean the NaP2b inhibitor, designated as NTX1942, and any metabolites, salts, esters, free acid forms, crystal forms, free base forms, pro-drug forms, racemates and all optically active forms thereof.

NaP2b shall mean the sodium phosphate co-transporter 2B encoded by the SCL34A2 gene, also sometimes identified in scientific literature as NaPi2b or NPT2b.

The licensed patents are Licensors NaP2b Patent Portfolio.

Field of Use

NaP2b program includes a portfolio of minimally-absorbed NaP2b inhibitors in discovery and preclinical stage of development, and Licensee will have full responsibility for further discovery efforts and development of any products. NaP2b is an intestinal phosphate transporter whose activity accounts for a significant portion of dietary phosphate absorption in humans. The inhibition of NaP2b should have utility for the treatment of hyperphosphatemia (elevated serum phosphate) in patients with end stage renal disease (ESRD) and other forms of chronic kidney disease (CKD).
Hyperphosphatemia is an electrolyte disorder in which there is an elevated level of phosphate in the blood. Most people have no symptoms while others develop calcium deposits in the soft tissue. Often there is also low calcium levels which can result in muscle spasms.