Royalty Report: Drugs, Cancer, Disease – Collection: 60836

License Grant

The Company entered into an exclusive U.S. licensing agreement to market, sell and distribute Docetaxel Injection Concentrate, Non-Alcohol Formula.

The Licensor granted to us a royalty-bearing, exclusive right and license under and to patent rights and know how to make, use,  market, commercialize, and offer for sale Non-Alcohol Docetaxel Injection described in NDA 205934.

License Property

“Competing Product” means any alcohol-free formulation of a product containing docetaxel as an active pharmaceutical ingredient, in any dosage form, strength or size.

Docetaxel is a taxane product indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Docetaxel Injection, Non-Alcohol formulation-Chemotherapeutic agent for Breast, non-small cell lung, prostate, head and neck cancers/ gastric adenocarcinoma

Field of Use

“Field” means the field of oncology.

The agreement pertains to an investigational product in the drug industry intended for the treatment of various cancers.

License Grant

Licensor hereby grants to Licensee a royalty-bearing, exclusive right and license, with the right to grant sublicenses under [ * ] (i) to make, have made, use, have used, market, have marketed, commercialize, have commercialized, offer for sale, sell, have sold, import and have imported Current Products in the Field in the Territory, and (ii) to make, have made, use and have used Current Products anywhere in the world for the purpose of marketing, commercialization or sale of Current Products in the Field in the Territory.

License Property

Non-Alcohol Docetaxel Injection, an investigational product intended for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Field of Use

“Field” means the field of oncology.

License Grant

One Licensor grants to the Licensee of Korea an exclusive, non-transferable license, under the other Licensors Patents, including the right to sublicense, to research, develop, make, have made, use, offer for sale, sell and import Products, in each case solely within the Field and within the Territory.

For the Non-exclusive License, both Licensors grant to Licensee a non-exclusive, non-transferable license, under the other Licensors Know-How, including the right to sublicense, to research, develop, make, have made, use, offer for sale, sell and import Products, in each case solely within the Field and within the Territory.

License Property

The one Licensor owns certain patent rights related to a pharmaceutical product candidate known as ANX514.

Product means any one or more of the pharmaceutical product candidate known as ANX-514 (docetaxel emulsion) or any improvement or derivative thereof, or any product for which the manufacture, use, sale or importation is covered by a Valid Claim of the other Licensors Patents.

Patents include; Vitamin E succinate stabilized pharmaceutical compositions, methods for the preparation and the use thereof, and, Low oil emulsion compositions for delivering taxoids and other insoluble drugs.

ANX-514 is a reformulation of the blockbuster chemotherapeutic agent, Taxotere®, an anti-cancer agent that is approved to treat breast, non-small cell lung, prostate, head and neck and gastric cancers.

ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a formulation of which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and/or incidence of hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular network that is essential for cell division. Immunosuppressant premedication is recommended for docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.

Field of Use

The Licensee has the right to sublicense, to research, develop, make, have made, use, offer for sale, sell and import licensed products, in each case solely for the treatment of cancer by intravenous administration of formulations of docetaxel as emulsified products and solely in South Korea.

The Field means the treatment of cancer by intravenous administration of formulations of
docetaxel as emulsified products.

License Grant

The German Licensor grants the Swiss Licensee a worldwide, exclusive, right and license, or sublicense, with the right to grant sublicenses, under the Licensed Technology to make, have made, use, offer for sale, sell, and import the Product in the Field in the Territory.

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

License Property

Licensor is developing a pharmaceutical product comprising a human antibody of IgG-1 subtype binding to EpCAM.

The patents include Novel Method for the Production of anti-human Antigen Receptors and Uses thereof, and, Anti-EpCAM Immunoglobulins.

Decatumumab (MT201) is a recombinant human monoclonal antibody with a binding specificity to epithelial cell adhesion molecule (Ep-CAM). Adecatumumab (MT201) is being evaluated in two European Phase 2 clinical trials, one in patients with prostate cancer, and one in patients with metastatic breast cancer.

Field of Use

The Field means the treatment of human diseases, disorders and conditions.

License Grant

The Taiwanese Licensor hereby grants sole licensing rights to Licensee, a shareholder, in the Field and in the Territory under the Intellectual Property, Confidential Information, Data and Trademark, to develop Product.

License Property

Drug and therapeutic use of five products BLI-1005 CNS-Major Depressive Disorder; BLI-1008 CNS-Attention Deficit Hyperactivity Disorder; BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1; BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer; and BLI-1501 Hematology-Chronic Lymphocytic Leukemia
The new drug products that originate from Maitake Combination Therapy. The three drugs licensed from BriVision to Rgene are ABV-1507 HER2/neu Positive Breast Cancer Combination Therapy, ABV-1511 Pancreatic Cancer Combination Therapy and ABV-1527 Ovary Cancer Combination Therapy.

Field of Use

Maitake Combination Therapy for indications including but not limited to the following breast cancer, brain tumor, hepatocellular carcinoma, pancreatic cancer, renal cell carcinoma, nasopharyngeal carcinoma, prostate cancer, cervix cancer, oral/ pharynx/larynx cancer, lung cancer, leukemia, myeloma, lymphoma, gastric cancer, thyroid cancer, esophageal cancer, gastric cancer, small intestine cancer, large intestine/colon/rectal cancer, ovary cancer, skin cancer, head and neck, soft tissue sarcoma, bone tumor, bladder cancer, and cholangiocarcinomab.”

License Grant

Through a partnership with a third party, Licensee develops and/or commercialize sugemalimab for worldwide sales which results in royalty payments to Licensor.

License Property

Sugemalimab (CS1001), an OmniAb-derived anti-PD-L1 monoclonal antibody used in combination with chemotherapy for lung cancer.

Field of Use

Field of use is for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer (“NSCLC”).

Lung cancer is a type of cancer that starts in the lungs. Cancer starts when cells in the body begin to grow out of control. The main subtypes of NSCLC Lung Cancer are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.

License Grant

The Parties entered into an exclusive commercial sub-license agreement, relating to the development and marketing of KRX-0403. The KRX-0403 license agreement provides for worldwide sublicense rights, with the exception of the Far East. Under the agreement, Licensee has assumed responsibility for the development and marketing of KRX-0403.

The Canadian Licensor grants to Licensee an exclusive sublicense, even as against the Licensor, under the Patent Rights to develop and have developed, market and have marketed, sell and have sold, distribute and have distributed, and manufacture and have manufactured, the Licensed Products in the Territory, said license to include the right to further sub-license.

License Property

Licensor is engaged in research and development related to the drug known as AVLB, including all of its forms.

Licensed Product shall mean anhydrovinblastine sulfate (AVLB), with the chemical name 3 ,4 – dehydrovinblastine sulphate and molecular formula C4Jls~40s-H2SO4•.

KRX-0403 is a novel spindle poison in the vinca alkaloid class of drugs. Derived from the periwinkle plant, the family of vinca alkaloids and the mechanistically similar family of taxanes include some of the most successful cancer drugs ever developed, including Navelbine®, Taxol® and Taxotere®. Although these agents have been widely prescribed, they can be very toxic and may cause varying degrees of neurotoxicity and/or bone marrow suppression. We believe that an equally or more effective but less toxic therapy would satisfy a substantial need for these patients. In a number of pre-clinical animal studies of human cancers, including non-small cell lung cancer, KRX-0403 demonstrated greater anti-cancer activity and lower toxicity than currently marketed vinca alkaloids. In a Phase I clinical trial designed to evaluate the safety, toxicity profile and pharmacokinetics of KRX-0403 in patients with different tumor types, including lung cancer, breast cancer, sarcoma and colon cancer, KRX-0403 was demonstrated to be safe in humans with reversible and manageable toxicities. We believe KRX-0403 may have utility in the treatment of breast, lung and other forms of cancer. We plan to conduct additional dosing clinical trials for KRX-0403.

Field of Use

The Licensee is a biopharmaceutical focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer.

License Grant

Ixabepilone was developed by the Company, but is subject to a License Agreement with a German Licensor, relating to epothilone technologies.

License Property

Ixabepilone (INN; also known as azaepothilone B, codenamed BMS-247550) is an epothilone B analog[1] developed as a cancer drug.  Ixempra(ixabepilone) is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones and their analogs.

The Company manufactures its bulk requirements for ixabepilone in its own facilities including the manufacturing of the active ingredient. The drug product which comprises a pharmaceutical kit is finished by Baxter Oncology GmbH.

Field of Use

In October 2007, the FDA approved ixabepilone in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated, and in monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.