Royalty Report: Drugs, Cancer, Pharmaceuticals – Collection: 1345

License Grant

The Licensee and the Japanese Licensor have an oncology collaboration for Sprycel and Ixempra (ixabepilone) in the U.S., Japan and the EU. The Licensor has the right to co-promote Sprycel in the U.S., Japan, and the top five markets in the EU.

License Property

Sprycel (dasatinib) is a cancer medication that slows the growth and spread of cancer cells in the body.

Field of Use

Sprycel is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) when other cancer treatments have not been effective.

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.

License Grant

Under the terms of the License Agreement, Licensee will be granted an exclusive license to develop and commercialize Iclusig in the Territory (the License).

License Property

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Field of Use

This agreement pertains to the drug industry relating to oncology indications.

License Grant

Licensor granted the rights to Licensee to any and all therapeutic and/or diagnostic uses in humans for IXEMPRA® in the European Union (Great Britain but excluding Switzerland and Lichtenstein)(the Territory). As a condition to the exercise of the Option, Licensee are required to offer Licensor a right to re-acquire the licensed rights from Licensee on terms to be mutually agreed upon.

License Property

IXEMPRA® (ixabepilone), a selective microtubule inhibitor, which has been shown to interfere with cancer cell division, leading to cell death. Ixabepilone (IXEMPRA®) is a semisynthetic derivative of epothilone B, with improved in vitro metabolic stability. It is a novel antineoplastic agent that stabilizes microtubule dynamics, resulting in blockade of cancer cells in mitosis during cell division, leading to cell death. Ixabepilone induces a distinct pathway of cellular apoptosis via activation of caspase-2, whereas other tubulin agents, such as the taxanes, act via caspase-9. Ixabepilone is a poor substrate for efflux transporters such as the multidrug resistance-related protein (MRP1) and P-glycoprotein (P-gp) that are involved in drug-resistance mechanisms. Epothilones have a tubulin-binding mode distinct from that of other microtubule- stabilizing agents. Ixabepilone’s tubulin-binding mode affects the microtubule dynamics of multiple ß-tubulin isoforms, including the class III isoform of ß-tubulin (ß-III tubulin), the expression of which has been implicated in clinical taxane resistance. Ixabepilone has anti-tumor activity in vivo against a broad spectrum of tumor types, including tumors that overexpress P-gp and are resistant to multiple agents including taxanes, anthracyclines, and vinca alkaloids. Ixabepilone demonstrated synergistic in vivo activity in combination with capecitabine. In addition to direct anti-tumor activity, ixabepilone demonstrated antiangiogenic activity in vivo.

Field of Use

Field of use is for therapeutic and/or diagnostic uses in humans and the treatment of metastatic breast cancer treated with two or more prior chemotherapies.

License Grant

Licensor and Hong Kong Licensee agreed to collaborate for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China and to advance the preclinical and clinical development of GMI-1687.

License Property

GMI-1687 is a potential life-cycle extension to uproleselan that has been designed as an innovative antagonist of E-selectin that could be suitable for subcutaneous administration.

Uproleselan is a glycomimetic drug candidate and a specific E-selectin inhibitor that is being developed to be used in combination with chemotherapy to treat patients with acute myeloid leukemia, or AML, a life-threatening hematologic cancer, and potentially other hematologic cancers.

E-selectin plays a critical role in binding cancer cells within vascular niches in the bone marrow, which prevents the cells from entering the circulation where they can be more readily killed by chemotherapy.  Glycomimetics are molecules that mimic the structure of carbohydrates involved in biological processes.

Field of Use

The field of use is for the treatment in combination with chemotherapy to treat patients with acute myeloid leukemia (AML) and potentially other hematologic cancers.

License Grant

Licensor grants an exclusive, world-wide license under the Licensed Patents to import, make, have made, use, sell, offer for sale and have sold Licensed Products for the Field of Use.

License Property

Licensor has certain intellectual property rights related to nucleoside analog pharmaceuticals including Nicotinamide Adenine Dinucleotide and prodrugs of Cordycepin.

The patents relate to Nucleoslde Prodrugs Resistant to Metabolic Deactivatlon.

Field of Use

Cordycepin has been studied in a National Cancer Institute-sponsored Phase I clinical trial for treating TdT-positive ALL leukemia patients. The therapy depends upon the presence of TdT for its activity. TdT is a polymerase expressed in immature, pre-B, pre-T lymphoid cells, and acute lymphoblastic leukemia/lymphoma cells. TdT, and similar enzymes found in fungi and parasites, recognize Cordycepin and its analogues and add them onto growing nucleic acid chains thereby terminating synthesis of the nucleic acid and replication of the cell. Importantly, TdT expression in normal human tissue is limited to primitive lymphoid cells in the bone marrow and thymus, so most normal cells in the body are unaffected by the drug. In addition to effectively treating TdT-positive ALL and CML, Cordycepin can also be used to treat diffuse high-grade lymphoblastic lymphoma, which also expresses TdT.