Royalty Report: Drugs, Antibody, Therapeutic – Collection: 289928

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 9

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 9

Primary Industries

  • Drugs
  • Antibody
  • Therapeutic
  • Drug Discovery
  • Pharmaceuticals
  • Arthritis
  • Cancer
  • Biotechnology
  • Disease Autoimmune
  • Delivery
  • Pain
  • Osteoarthritis

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 289928

License Grant
The Company entered a joint venture with Chinese Licensor to further develop and commercialize ONS-3010 with Licensor in the agreed countries.
License Property
The Phase I ONS-3010 trial demonstrated pharmacokinetic (PK) bioequivalence on the primary and secondary endpoints for the biosimilar candidate and the US and EU originator product (Humira).

ONS-3010 is a subcutaneous injectable mAb that binds to tumor necrosis factor alpha, or TNFa. TNFa belongs to a family of pro-inflammatory cytokines, or soluble protein mediators, that are key initiators of immune-mediated inflammation in many different diseases, such as rheumatoid arthritis, psoriatic arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Several biologic agents, including Humira, have been developed to inhibit the inflammatory activity of TNFs in the context of these diseases and are collectively referred to as the anti-TNF class of therapeutics.

Humira, the reference product for ONS-3010, is a subcutaneous injectable mAb that binds to tumor necrosis factor alpha, or TNFa. TNFa belongs to a family of pro-inflammatory cytokines, or soluble protein mediators, that are key initiators of immune-mediated inflammation in many different diseases, such as rheumatoid arthritis, psoriatic arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Several biologic agents, including Humira, have been developed to inhibit the inflammatory activity of TNFs in the context of these diseases and are collectively referred to as the anti-TNF class of therapeutics.

Field of Use
Humira is used to treat many inflammatory conditions in adults, such as ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a skin condition called hidradenitis suppurativa.

IPSCIO Record ID: 372447

License Grant
Licensor grants a nonexclusive license under the Licensed Patents during the Term to make, and have made, use, sell, offer for sale, and import Licensed Product in the Territory in the Field of Use.
License Property
Licensor owns and controls certain patent rights relating to methods and compositions in the field of antibodies.

Antigen shall mean Tumor Necrosis Factor alpha.

Licensed Product shall mean any product containing an Antibody related to this agreement.

U.S. patents are commonly known as the “Cabilly” patents. The Cabilly patents cover key steps of therapeutic antibody manufacturing methods. One of the Cabilly patent covers a process for producing an immunoglobulin molecule (Ig) in a single host cell; the second Cabilly patent covers a method for making an antibody heavy chain and antibody light chain in a recombinant host cell.

Field of Use
Cabilly patents are  to manufacture, use and commercialize products containing antibodies that bind to TNF-a.

Tumor necrosis factor, or TNF, belongs to a family of soluble protein mediators, or cytokines, that play an important role in disease progression across a number of inflammatory and chronic conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, psoriasis and ulcerative colitis. Cytokines, such as TNF, are substances produced by cells in the body that can cause a biological effect on other cells in the body. TNF is generally understood as the “master regulator” of the body’s immune response and is the key initiator of immune-mediated inflammation in multiple organ systems. Several biologic agents have been developed that inhibit the inflammatory activity of TNF in the context of these diseases, which are collectively referred to as the anti-TNF class of therapeutics.

IPSCIO Record ID: 385928

License Grant
Licensee of Luxembourg shall purchase and take delivery of its total requirements of the applicable Product exclusively from Licensor of Iceland for Licensee’s marketing, promotion, sale and use in the Licensee Territories. The Parties agree that each Product shall be sold in the Licensee Territories under the Licensee Marks.

Licensee hereby grants to Licensor a limited, revocable, non-exclusive, royalty free, non-transferable license (without the right to sublicense) to use the Licensee Marks and the Product Marks during the Product Terms solely for the purposes of packaging, labeling and branding the Products to be supplied to Licensee in accordance with the Packaging Specifications. Licensor acknowledges and agrees that Licensee is the sole and exclusive owner of all right, title and interest in and to the Licensee Marks and the Product Marks. All goodwill associated with the Licensee Marks and the Product Marks shall inure to the benefit of Licensee.

Licensor shall manufacture for, and sell and deliver to, Licensee its total requirements for the applicable Product for sale, or resale by its Affiliates and Third Parties (including Distributors) in the Licensee Territories

Licensor shall (i) use commercially reasonable efforts to develop such Product for the uses of such Product set forth in the Product Data Sheet for such Product in accordance with the Research Plan and (ii) use commercially reasonable efforts (taking into account the commercial potential of such Product in each Licensee Territory) to obtain, in its own name (or the name of one of its Affiliates) and at its own cost, Regulatory Approvals for such Product in the Licensee Territories. Licensor shall use commercially reasonable efforts to conduct the Research Program in good scientific manner and using cGxP of the applicable Territory or other applicable jurisdiction where the Research Program is being conducted, to achieve the objectives of the Research Program efficiently and expeditiously, in compliance with all Applicable Laws. Licensor shall complete all Phase 4 and post-marketing surveillance studies required to be completed by any Regulatory Agency with respect to a Product as a condition to Regulatory Approval of such Product.

License Property
Licensee Marks means the corporate name “Alvogen” and trademarks, trade names, service marks, label marks and logos of Licensee and its Affiliates, excluding the Product Marks.

Initial Products means the Adalimumab Product, the Denosumab Product, the Golimumab Product, and the Ustekinumab Product.

Biosimilar means, as compared to the reference product of a Product, a biologic product consisting of a protein or peptide targeting one or more of the same indications as such reference product and that does not differ in any clinically meaningful way from such reference product with respect to its amino acid sequence, analytical comparability, safety or efficacy.

Field of Use
Adalimumab is a disease-modifying antirheumatic drug and monoclonal antibody that works by inactivating tumor necrosis factor-alpha (TNFa).[5]  It is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis.

Denosumab is a human monoclonal antibody for the treatment of osteoporosis and hypercalcemia. It can also treat bone cancer and bone problems in patients who have cancer.

Golimumab is a human monoclonal antibody which is used as an immunosuppressive medication use to treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Ustekinumab is a monoclonal antibody medication for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis,[5] targeting both IL-12 and IL-23.[6]

IPSCIO Record ID: 26092

License Grant
The Compny announced that it had reached a settlement agreement.
License Property
Humira(R) is licensed to Licensee, is the first Licensor-derived antibody to be approved for marketing. It was isolated and optimized in collaboration with Licensee and has been approved for marketing as a treatment for rheumatoid arthritis (RA) in 57 countries, and for Psoriatic arthritis and early RA in some European countries and the US.

Humira (adalimumab) is a fully human anti-TNFa monoclonal antibody, isolated and optimized by Licensor in collaboration with Licensee and now approved for marketing as a treatment for rheumatoid arthritis or RA, early RA and Psoriatic arthritis.  Humira (adalimumab) is Licensor's only marketed product, approved as a rheumatoid arthritis treatment.

IPSCIO Record ID: 289246

License Grant
Licensor grants the Chinese Licensee an exclusive, non-transferable, perpetual license in the field of Therapeutic usage in order to develop and conduct clinical trials to achieve Chinese FDA (SFDA) approval of the rabbit anti-TNFalpha monoclonal antibody compounds. Under these rights, Licensor grants both the manufacturing and distribution rights of anti-TNFalpha monoclonal antibody therapeutics covered under the intellectual properties rights owned by Licensor.
License Property
Licensor utilizes a proprietary and patented technology in the development and production of Rabbit Monoclonal Antibodies (RabMAb technology).

Licensor has developed a panel of 50 novel anti-TNFalpha rabbit monoclonal antibodies that are highly potent compared with Remicade and Humira in in-vitro assays.

Licensor will provide Humanized Rabbit anti-TNFalpha monoclonal antibodies to Licensee.

Field of Use
The field is for commercializing anti-TNFalpha monoclonal antibodies to be used as therapeutic agents.  Anti-TNFalpha therapies are effective in treating Rheumatoid arthritis, Psoriasis, Psoriatic arthritis, Ankylosing spondylis and Crohns diseases.

IPSCIO Record ID: 289253

License Grant
The Licensor of China grants the right to use all intellectual properties generated during the development of the Therapeutic Product under this agreement.
License Property
The developments will be related to Anti-TNFalpha therapies.

Tumor necrosis factor a (TNF) is one of the key chemical messengers that help regulate the inflammatory process and plays an important role in the underlying mechanisms of conditions such as rheumatoid arthritis, psoriasis, and many other inflammatory disorders. When the body produces too much TNF, it overwhelms the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin areas. The TNF inhibitors are molecules that disrupt the TNF function by blocking the binding of TNF to the TNF receptors. Blockage of these receptors can result in a significant reduction in inflammatory activity and reduce symptoms, inhibit the progression of structural damage, and improve physical function in patients with moderate to severe rheumatoid arthritis.

Field of Use
The field is for commercializing anti-TNFalpha monoclonal antibodies to be used as therapeutic agents.

IPSCIO Record ID: 341530

License Grant
Under the terms of the new arrangement, Belgium Licensee will assume all development, manufacturing, commercialization and certain other rights for filgotinib in Europe.
License Property
Filgotinib preferential JAK1 inhibitor with a potential best-in-class product profile (Jyseleca). Janus kinases (JAK) are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in RA. Filgotinib is a preferential JAK1 inhibitor. Jyseleca® is the brand name for filgotinib
Field of Use
Field of Use is for the treatment of IBD (Inflammatory Bowel Disease), CD (Crohns Disease), UC (Ulcerative Colitis) and potentially other inflammatory diseases such as RA (Rheumatiod arthritus).

Inflammatory Bowel Disease (IBD) This is a general term for an autoimmune disease affecting the bowel, including CD and UC. CD affects the small and large intestine, while UC affects the large intestine. Both diseases involve inflammation of the intestinal wall, leading to pain, bleeding, and ultimately, in some cases, surgical removal of part of the bowel.

Crohn’s disease (CD) An IBD involving inflammation of the small and large intestines, leading to pain, bleeding, and ultimately in some cases surgical removal of parts of the bowel.

Ulcerative colitis (UC) An IBD causing chronic inflammation of the lining of the colon and rectum (unlike CD with inflammation throughout the gastrointestinal tract).

Rheumatoid arthritis (RA) A chronic, systemic inflammatory disease that causes joint inflammation, and usually leads to cartilage destruction, bone erosion and disability.

Inflammatory diseases is a large, unrelated group of disorders associated with abnormalities in inflammation.

IPSCIO Record ID: 314

License Grant
The Licensee and the German Licensor entered into a Joint Ownership and Exclusive License Agreement, JOELA, pursuant to which the Licensee agreed to jointly own all intellectual property arising from the Project.

The Licensor also granted the Licensee an exclusive worldwide License (including the right to sublicense) to its interest in the Joint Intellectual Property and its know-how related to the Project and the right to commercialize products that, without the Licenses granted under the JOELA, would infringe the Licensed IP.

The Licensor retains the non-exclusive and non-transferable right to use the Licensed IP for its own internal, academic purposes.

License Property
The IP relates to a Research Agreement between the parties relating to, among other things, identify and evaluate secretory proteins from TSO.

TSO, or CNDO-201, is a biologic comprising Trichuris suis ova, the microscopic eggs of the porcine whipworm, which we believe could be used for the treatment of a range of autoimmune diseases, such as Crohn’s disease, or Crohn’s, ulcerative colitis, or UC, multiple sclerosis, or MS, autism, psoriasis, Type 1 diabetes, or T1D, psoriatic arthritis and rheumatoid arthritis.

Field of Use
TSO (Trichuris suis ova or CNDO-201), the Licensee's lead program, is a biologic immunomodulator. The concept for using TSO as a therapeutic is based on the 'hygiene hypothesis' and numerous animal and human studies. Multiple investigator-sponsored clinical trials of TSO for the treatment of Crohn's disease, ulcerative colitis and multiple sclerosis have been completed in which TSO demonstrated benefit with regard to accepted outcome measurements of remission of disease and was shown to be well tolerated.

In February 2012, the licensee announced positive results from a Phase 1 clinical trial of TSO in 36 patients with Crohn’s. The trial was a sequential dose-escalation, double-blind, placebo-controlled study to examine safety and tolerability. TSO was shown to be safe and well tolerated, with no serious treatment-related adverse events reported. To date, a number of investigator-sponsored clinical trials have been conducted using TSO in patients suffering from Crohn’s, UC or MS. These studies also demonstrated that TSO is safe and well tolerated.

IPSCIO Record ID: 66786

License Grant
The company transferred to the Licensee, a Swedish corporation, the Investigational New Drug (IND) and New Drug Applications (NDA) for the product.  The Licensee is responsible for the commercialization of VIMOVO.  The Licensee will have rights to commercialize VIMOVO outside of the United States.
License Property
VIMOVO is the brand name for a proprietary fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID and immediate-release esomeprazole magnesium, a PPI, in a single delayed-release tablet and is a product in our PPI-NSAID (“PN”) platform.  It is for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers
Field of Use
This agreement pertains to the drug industry relating to the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.  Also to decrease the risk of gastric ulcers.
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