Royalty Report: Drugs, Kidneys, Disease – Collection: 263343

License Grant

Through this Amendment, the Parties desire to clarify and further establish their respective rights and obligations under the 2002 Agreement, as well as to license certain additional intellectual property rights to Licensee.

This Amendment is to ratify existing Sub-Licenses and Supply Agreements.

The Parties further agree to complete a subsequent Amendment according to the binding terms and consistent with the Commercialization and Technology License Agreement – IV Triferic (IV License) executed on even date to the extent that it would not conflict with this Amendment.

License Property

The Technology is relating to Triferic® soluble ferric pyrophosphate.

Triferic® is a proprietary iron therapy that replaces iron and maintains hemoglobin in dialysis patients without increasing iron stores.  The Company has developed two presentations of Triferic that are added to the dialysate, or Dialysate Triferic.  Triferic is the first and only FDA-approved iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). It is believed Triferic addresses an important unmet need in the treatment of ongoing iron losses and anemia in ESRD patients. Triferics unique mode-of-action distinguishes it from conventional I.V. iron products because Triferic donates iron to transferrin, immediately, and completely, as soon as it enters the blood. The iron bound to transferrin is transported to the bone marrow to make hemoglobin.  Triferic delivers approximately 5 & 7 mg of iron with every hemodialysis.  Triferic is the first and only FDA-approved iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). We believe Triferic addresses an important unmet need in the treatment of ongoing iron losses and anemia in ESRD patients. Triferic s unique mode-of-action distinguishes it from conventional I.V. iron products because Triferic donates iron to transferrin, immediately, and completely, as soon as it enters the blood. The iron bound to transferrin is transported to the bone marrow to make hemoglobin. Triferic delivers approximately 5 & 7 mg of iron with every hemodialysis.

Field of Use

This agreement pertains to the drug industry relating to iron therapy.

License Grant

Licensor, an individual, hereby grants and Licensee hereby accepts an exclusive, sublicenseable, royalty-bearing license for use of Licensor Technology to make, have made, use, offer for sale, export, import, and sell Licensed Products, in the licensed field of use in the licensed territory during the term.

License Property

Licensor owns inter alia certain patent rights, trade secrets, know how, and other proprietary information and technology related to the use of soluble ferric pyrophosphate (“SFP”) including for use in management of iron disorders including preventing and treating medical conditions such as absolute or functional iron deficiency and iron deficiency anemia.

TPN TRIFERIC® is a total parenteral nutrituional (TPN) product incorporating SFP (soluble ferric pyrophosphate)  including those for replacement/maintenance of iron, management of iron disorders,  preventing and treating medical conditions such as absolute or functional iron deficiency and iron deficiency anemia in any and all indications where SFP, delivered by TPN, may be useful.

Licensor owns certain patent rights, trade secrets, know how, and other proprietary information and technology related to the  use of soluble ferric pyrophosphate (“SFP”) including for use in management of iron disorders including preventing and treating medical conditions such as absolute or functional iron deficiency and iron deficiency anemia.
Iron deficiency anemia is a common type of anemia — a condition in which blood lacks adequate healthy red blood cells. Red blood cells carry oxygen to the body's tissues.

Patent
9,161,951 – United States – Issue Date 10/20/2015 – Parenteral nutrition composition containing iron

Licensed Products means all compositions of matter, formulations, articles of manufacture, materials, and products using, including, comprising or incorporating SFP or any specific species thereof, including generics, in the licensed field of use that incorporate the Licensor Technology.

Licensor Technology means subject matter disclosed, described or claimed in Licensor Patent Rights and Licensor Know How that has been documented prior to the effective date.

Field of Use

Licensed Field of Use is limited to only TPN formulations of SFP and TPN formulations of specific species of SFP, and indications treated by such TPN formulations of SFP and its specific species. For clarity, the licensed field of use expressly excludes non-IV formulations for instance delivery of SFP via a dialysate solution which is the subject of the 2002 Agreement as amended. SFP formulations for other modes of delivery, e.g., transdermal, shall require additional licenses, which the parties shall negotiate in good faith should the occasion arise; and Licensee shall have no implied or actual license or other right to exploit or commercialize any non-TPN formulations for delivery of SFP through any such other modes of delivery which are based in any manner upon Licensor Technology.

Triferic is a revolutionary iron therapy that replaces iron and maintains hemoglobin without increasing iron stores, and Triferic is the only FDA approved product indicated to replace iron and maintain hemoglobin concentration in adult HDD-CKD hemodialysis patients.

License Grant

Licensor hereby grants and Licensee hereby accepts an exclusive, sublicenseable, royalty-bearing license for use of Licensor Technology to make, have made, use, offer for sale, export, import, and sell licensed products, in the licensed field of use in the licensed territory during the term.

License Property

IV TRIFERIC® is certain intravenous (“IV”) delivered products incorporating SFP (soluble ferric pyrophosphate) including those for replacement/maintenance of iron, management of iron disorders,  preventing and treating medical conditions such as absolute or functional iron deficiency and iron deficiency anemia in any and all indications where SFP delivered by IV, may be useful.

Licensor owns certain patent rights, trade secrets, know how, and other proprietary information and technology related to the use of soluble ferric pyrophosphate (“SFP”) including for use in management of iron disorders including preventing and treating medical conditions such as absolute or functional iron deficiency and iron deficiency anemia.

Licensed Products means all compositions of matter, formulations, articles of manufacture, materials, and products using, including, comprising or incorporating SFP or any specific species thereof, including generics, in the licensed field of use that incorporate the Licensor Technology.

Licensor Patent Rights means
6,779,468 – United States – Issued 08/24/2004 – Method and pharmaceutical composition for iron delivery in hemodialysis and peritoneal dialysis patients
61/759531 – United States – Application
14/765111 – United States – Application
14/765111 – United States – Application

Field of Use

Licensed Field of Use is limited to only IV formulations of SFP and IV formulations of specific species of SFP, and indications treated by such IV formulations of SFP and its specific species. For clarity, the Licensed Field of Use expressly excludes non-IV formulations for instance delivery of SFP via a dialysate solution which is the subject of the 2002 Agreement as amended. SFP formulations for other modes of delivery, e.g., transdermal, shall require additional licenses, which the PARTIES shall negotiate in good faith should the occasion arise; and Licensee shall have no implied or actual license or other right to exploit or commercialize any non-IV formulations for delivery of SFP through any such other modes of delivery which are based in any manner upon Licensor Technology.

License Grant

Licensor hereby grants to Licensee an exclusive sublicense under the Licensed Patents in the Field of Use to make and have made, manufacture and have manufactured Agreement Compounds and Licensed Products from Agreement Compounds for sale in the Territory and to use and have used and lease, sell and have sold Licensed  Products, and to practice the Licensed Processes, and Improvements, with the right to grant sublicenses (with the prior written consent of Licensor, which consent shall not be unreasonably withheld), in the Territory and Licensor further grants to Licensee an exclusive sublicense  to use the Know-How to make and have made, manufacture  and have manufactured Agreement Compounds and Licensed Products from Agreement Compounds for sale in the Territory and to use the Know-How to use and hav  used and lease, sell and have sold Licensed Products, and to practice the Licensed Processes, and Improvements, with the right to grant sublicenses (with the prior written consent of Licensor, which consent shall not be unreasonably withheld), in the Territory.

License Property

Licensed Patents means all of the intellectual property, granted to Licensor identified herein as Agreement  Compounds for the described Field of Use.

Patent Application # U.S.S.N. 60/073,603 entitled 'N,N-Bis(2-Hydroxybenzyl) Ethylenediamine-N,N-Diacetic Acid in Iron Chelating Theraphy'.

Agreement  Compounds means the monosodium salt of N,N-bis (2-hydroxybenzyl) ethylenediamine-N,N diacetic acid (hereinafter 'NaHBED' or 'HBED'), or any other mono-cation salt of HBED.

Intellectual property relates to develop and market a proprietary iron chelator.  Iron chelation therapy is the removal of excess iron from the body with special drugs.

Field of Use

Field of Use means iron overload conditions, including, but not limited to, Thalassemia, sickle-cell anemia, and myelodysplasia (but excluding neuro- degenerative disorders), but shall exclude uses of Agreement Compounds by a route of delivery other than subcutaneous or IM injection or IV infusion or transdermal.

Thalassemia is a blood disorder passed down through families (inherited) in which the body makes an abnormal form or inadequate amount of hemoglobin. Hemoglobin is the protein in red blood cells that carries oxygen. The disorder results in large numbers of red blood cells being destroyed, which leads to anemia.

Sickle cell anemia is an inherited form of anemia — a condition in which there aren't enough healthy red blood cells to carry adequate oxygen throughout your body.

Myelodysplastic syndromes (MDS) are a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells.

License Grant

The Contribution Agreement is relating to the development of License Product.

This Amendment is for changes with respect to the development of Licensed Product, as well as, changes to allow the Licensee, in certain circumstances, to return either Licensors 101 or 102, as applicable, to Licensor without terminating the Agreement.

If the Licensee determines, in its sole and reasonable discretion, that it is commercially reasonable for the Licensee to discontinue development of a Licensed Product incorporating either Licensors 101 or 102, then, upon prior written notice by the Licensee to Licensor of such facts, the parties agree that the Licensee shall be free to cease and shall cease all development activities relating to such Licensed Product incorporating either Licensors 101 or 102.

License Property

The licensed property relates to Deferiprone, a bidentate oral iron chelator.

Deferiprone is an oral iron chelator used to treat patients with iron overload due to the frequent blood transfusions required in certain disorders such as thalassemia.

Field of Use

The field of use is for the treatment of iron overload in patients with thalassemia major for whom deferoxamine therapy is contraindicated or inadequate.

Thalassemia is an inherited blood disorder that causes your body to have less hemoglobin than normal. Hemoglobin enables red blood cells to carry oxygen. Thalassemia can cause anemia, leaving you fatigued. If you have mild thalassemia, you might not need treatment.
Deferoxamine is an iron-chelating agent that binds free iron in a stable complex, preventing it from engaging in chemical reactions. Deferoxamine chelates iron from intra-lysosomal ferritin and siderin forming ferrioxamine, a water-soluble chelate excreted by the kidneys and in the feces via the bile.

License Grant

With this amendment Licensor now grants a worldwide, exclusive license under jointly held patents to develop, manufacture and commercialize OMONTYS.

The amendment effectuated a transfer of regulatory responsibilities.

License Property

OMONTYS, or peginesatide, injection is for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. OMONTYS is a synthetic, peptide-based erythropoiesis stimulating agent designed to stimulate production of red blood cells.

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.