Royalty Report: Drugs, Drug Discovery, Autoimmune – Collection: 329550

License Grant

The Canadian Licensor grants the Japanese Licensee an exclusive, transferable license, with the right to grant sublicenses, under the Licensor Technology, the Product Marks and Licensor’s interest in Joint Technology to
(i)    use, Develop, have Developed, Commercialize and conduct Medical Affairs for the Products in the Field in the Licensee Territory, and
(ii)    Package and have Packaged the Products for use in the Field in the Otsuka Territory.

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

License Property

Licensor is a biopharmaceutical company, is developing its proprietary investigational drug known as Voclosporin, a proprietary calcineurin inhibitor.

Voclosporin is a novel, investigational, orally administered treatment developed to treat patients with LN, a chronic, progressive inflammation of the kidneys that is one of the most serious complications of the autoimmune disease systemic lupus erythematosus (SLE).

Field of Use

The Field means use of the Product for the treatment and prevention of any and all diseases, conditions and indications in humans.  Voclosporin is known for the treatment of Lupus Nephritis (LN).

Lupus nephritis is inflammation of the kidney that is caused by systemic lupus erythematous (SLE). Also called lupus, SLE is an autoimmune disease. With lupus, the body's immune system targets its own body tissues. Lupus nephritis happens when lupus involves the kidneys.

License Grant

The Licensor entered into an agreement for the sale of Voclosporin with a undisclosed Licensee.

License Property

Voclosporin is an investigational drug for the treatment of LN, FSGS, and DES.

Dry Eye Syndrome (DES)
Focal segmental glomerulosclerosis (FSGS)
Lupus nephritis (LN)

Dry eye syndrome is caused by a chronic lack of sufficient lubrication and moisture on the surface of the eye

Focal segmental glomerulosclerosis (FSGS) is a cause of nephrotic syndrome in children and adolescents, as well as a leading cause of kidney failure in adults.

Lupus nephritis is inflammation of the kidney that is caused by systemic lupus erythematous (SLE).

Field of Use

This agreement pertains to the drug industry.

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

Licensor grants an exclusive license, with the right to sublicense, under the AMG 623 Licensed Patents, solely to research, develop, make, have made, use, sell, offer for sale, and import Licensed Products in the Field in the Territory; provided, however, that no license is granted under the AMG 623 Licensed Patents to any clinically active ingredient other than Licensed Molecule.

Licensor grants a non-exclusive license, with the right to sublicense, under the Other Licensed Patents, solely to research, develop, make, have made, use, sell, offer for sale, and import Licensed Products in the Field in the Territory; provided, however, that no license is granted under the Other Licensed Patents to any clinically active ingredient other than Licensed Molecule.

Licensor grants an exclusive license, with the right to sublicense, under the Licensed Know-How, solely to research, develop, make, have made, use, sell, offer for sale, and import Licensed Products in the Field in the Territory; provided, however, that no license is granted under the Licensed Know-How to any clinically active ingredient other than Licensed Molecule.

License Property

Licensor owns or controls certain intellectual property and information related to a molecule known as AMG 623.

BAFF Peptibody shall mean a fusion protein comprising a peptide generated by methods described in the AMG 623 Licensed Products that bind to BAFF as the primary intended therapeutic mechanism of action and a constant domain of an antibody or any other moiety intended to extend the half-life of such peptide. For purposes of this definition, AMG 523 shall be deemed a BAFF Peptibody.

BAFF shall mean B-Cell Activating Factor. BAFF is also referred to as TALL-1 and AGP-3 in the patents and patent applications within the Licensed Patents.

AMG 623 is a peptide fusion protein, for the treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases

Field of Use

Licensee plans to initiate a Phase 2 study in systemic lupus erythematosus.

Systemic lupus erythematosus (SLE), is the most common type of lupus. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels.

License Grant

The Israeli Licensee entered into a licensing Agreement with the Israeli Licensor, the technology transfer company of the University, to research, develop, and commercialize hCDR1.
“Licence” shall mean an exclusive, worldwide, sublicenseable licence to use the Licensed Information and under the Patents, for the research, development, production, marketing and sale of Products, subject to the provisions of clause 4 below and the other terms and conditions of this Agreement.

License Property

hCDR1, is a Phase II-ready asset for the treatment of Systemic Lupus Erythematosus, or SLE, the most prominent type of Lupus, among other indications. hCDR1, is a peptide that is administered subcutaneously and acts as a disease-specific treatment to modify the SLE-related autoimmune process.

U.S.A* 08/913,994 – 6,613,536

1.
A method to dissolve the peptide (hCDR1) in PBS for the tolerogenic administration.

2.
Mode of injection of hCDR1 for the prevention of an autoimmune response.

3.
Characterization of the isotypes of the antibodies produced following a chronic treatment with hCDR1.

4.
Binding of hCDR1 to MHC class II on APC in comparison with control peptides.

5.
Determination of complement C3 levels in sera of mouse models and effects of treatment with hCDR1.

6.
Assays for the evaluation of the effects of treatment with hCDR1 in the presence of immunosuppressive drugs (such as Methotrexate, Mofetil Mycophenolate, Immuran) used for the treatment of lupus (especially lupus nephritis).

7.
Methods to assess the effects of treatment with hCDR1 on CNS lupus (pathology and behavior dysfunction) in spontaneous and induced experimental SLE.

8.
Determination of anti-NMDA specific antibodies in sera of mice with induced lupus and the effects of hCDR1 on the latter.

9.
Induction of neurogenesis and expression of BDNF in brains of SLE afflicted mice following treatment with hCDR1.

10.
Methods to determine B cell dysfunction and the effect of hCDR1 on the latter especially in the target organs of lupus, namely, brain and kidney.

11.
Evaluation of hCDR1 activity using a short term in vitro assay. This method was used in one of our publications and is written in the Methods section. However, because this technology can be used in the future to determine whether a patient might be a responder to the treatment of hCDR1 (which is not mentioned in the publication) we think that it might be the most important know how of the whole list.

Field of Use

Lupus is a debilitating disease affecting approximately five million people worldwide. hCDR1, is a peptide and acts as a disease-specific treatment to modify the SLE-related autoimmune process. It does so by specific upstream immunomodulation through the generation of regulatory T cells, reducing inflammation and resuming immune balance.

License Grant

University Licensor grants a license in the Licensed Field of Use to make, use, and sell Licensed Product(s) in the Licensed Territory.  This license is Exclusive.

License Property

The licensed product is any product using the licensed technology.  Licensor has an assignment of 'Use of ehydroepiandrosterone (DHEA) in the Medical Treatment of Systemic Lupus Erythematosus (SLE)' and has additional technology.

Systemic lupus erythematosus also known simply as lupus, is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body.

'Licensed Patent(s)' means any Letters Patent issued upon STANFORD's U.S. Patent Application, Serial Number 07/958,911 filed October 9, 1992, and/or any divisions, continuations, continuations-in-part or reissues thereof, and/or any foreign patents corresponding thereto.

Field of Use

The Licensed Field of Use means therapeutic use for treatment of Systemic Lupus Erythematosus.

License Grant

The parties agree to commercialize fostamatinib in all potential indications, including chronic ITP and AIHA, in Canada and Israel.

License Property

Fostamatinib has the brand name of Tavlesse (Tavalisse). It is a tablet, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment.

ITP means immune thrombocytopenia where the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts.

Field of Use

Field of use is for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to other treatments and to reduce the destruction of red blood cells in the AIHA disease.

AIHA means autoimmune hemolytic anemia.  It is is a rare, serious blood disorder where the immune system produces antibodies that result in the destruction of the bodys own red blood cells. Symptoms can include fatigue, shortness of breath, rapid heartbeat, jaundice or enlarged spleen.