Royalty Report: Drugs, Pharmaceuticals, Disease – Collection: 28715

License Grant

Pursuant to an acquisition agreement, the Party entered into a License Agreement, in which Can-Fite granted the Licensee a sole and exclusive worldwide License for the use of CF101.

License Property

CF101 (known generically as IB-MECA), is being developed to treat three ophthalmic indications dry eye syndrome; glaucoma and uveitis. We are currently (i) conducting a Phase III trial with respect to the development of CF101 for dry eye syndrome, under an Investigational New Drug, or IND, application with the United States Food and Drug Administration, or FDA; (ii) conducting a Phase II trial with respect to the development of CF101 for the treatment of glaucoma; and (iii) preparing for Phase II study of the development of CF101 for uveitis.
CF101 is a highly-selective, orally bioavailable small molecule synthetic drug, which targets the A3 adenosine receptor (A3AR). We believe that CF101 has a favorable safety profile and a potent anti-inflammatory activity, mediated via its capability to inhibit the production of inflammatory cytokines, such as TNF-a, MMPs, IL-1, and IL-6. This is mediated by activation of the A3AR, which is highly expressed in inflammatory tissues in contrast to normal tissues where expression levels of the receptor are very low. We believe that the anti-inflammatory and neuroprotective effects of CF101 make it an attractive candidate for use in the treatment of a variety of ophthalmic diseases.

Field of Use

The field of ophthalmic diseases.

License Grant

The Israeli Licensor has agreed to grant the Licensee an exclusive worldwide License for its therapeutic drug in the field of ophthalmic diseases in return for which we have agreed to grant shares and warrants representing approximately 90% of the issued share capitalization of our company.  

The Licensee will be granted to an Israeli subsidiary of the Licensor which will be transferred in whole to us at closing.

License Property

The drug, CF101 (known generically as IB-MECA), is being developed to treat three ophthalmic indications dry eye syndrome; glaucoma and uveitis.

Field of Use

Concurrently with the closing the Licensee is required to enter into a service Agreement with the Licensor or its affiliate for the management of all activities relating to the pre-clinical and clinical studies to be performed for the development of the drug.

License Grant

Licensee was granted an exclusive license for the use of a family of U.S. and European patents and patent applications relating to CF101, CF102 and other small molecules and for the use, sale, production and distribution of products derived from such patents around the world. Licensor is a national research organization.

License Property

CF101 and CF102 are being developed to treat several autoimmune-inflammatory, oncological and ophthalmic indications. They are synthetic A3AR agonists. A3ARs have significant expression in tumor and inflammatory cells, whereas normal cells have low or no expression of this receptor. The A3AR agonists and allosteric modulators bind with high selectivity and affinity to the A3ARs and upon binding to the receptor initiate down-stream signal transduction pathways resulting in apoptosis, or programmed cell death, of tumors and inflammatory cells and to the inhibition of inflammatory cytokines. Cytokines are proteins produced by cells that interact with cells of the immune system in order to regulate the body’s response to disease and infection. Overproduction or inappropriate production of certain cytokines by the body can result in disease.

License Grant

The Israeli Licensor hereby grants to the Israeli Licensee a non-transferable sole and exclusive license, with the right to sublicense under the EYEFITE Patent Rights and CANFITE Know-How, to make, have made, use, sell, offer to sell, import, research, develop, commercialize and otherwise exploit the Licensed Compound and Licensed Product in the Field in the Territory.

License Property

'Licensed Compound' means CF101.

'CF101' means the adenosine A3 receptor agonist designated by the Licensor as CF101, and known generically as IB-MECA (Methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]- β-D-Ibofuronamid).

US3 11/604,905 28-Nov-06 Issued Patent, Serial No. 7,825,102

US* 12/450,094 13-Mar-08 Pending

Field of Use

'Field' means the treatment of any ophthalmic disease, disorder and conditions in humans.

License Grant

The Israel Licensor signed an Agreement regarding the provision of a License for its CF101 drug with a South Korean pharmaceutical Licensee. The Licensor granted a License to use, develop and market its CF101 drug for treating only rheumatoid arthritis only in the Republic of Korea.

License Property

CF101 drug for treating only rheumatoid arthritis only.

Field of Use

The Licensee researches and develops over the counter and prescription drugs in South Korea.

License Grant

Licensor will grant French Licensee an exclusive option to purchase its license of Piclidenoson in the veterinary osteoarthritis market for two years from the signature date, during which time Licensee will conduct proof-of-concept studies and cover all associated costs.

License Property

Piclidenoson, generically known as IB-MECA (methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-b-D-ribofuronamide), is an oral small molecule drug formulated in a tablet. Piclidenosons mechanism of action is A3AR mediated and includes modulation of key signaling proteins, such as PI3K, PKA, PKB/Akt, IKK and NF-kB, resulting in deregulation of the Wnt/ß-catenin pathway and inhibition of inflammatory cytokine production.

Field of Use

Field of use for the treatment of osteoarthritis in companion animals including dogs and cats.

License Grant

Licensor hereby grants to Licensee during the term of this Agreement a sole and exclusive license, even as against Licensor, under the Licensed Technology (i) to develop, import and use the Ingredient in the Field in the Territory, and (ii) to develop, have developed, register, market, have marketed, produce, have produced, distribute, have distributed, sell, have sold, offer for sale and import the Product in the Field in the Territory, and (iii) to have produced the Product outside the Territory for sale of such Product in the Field in the Territory. Such right granted to Licensee shall include Licensee's right under the Licensed Technology to conduct research on doses, formulations and dosage forms of the Product.

License Property

Licensed product is CF101 for autoimmune inflammatory indications

Field of Use

“Field” shall mean systemic use (oral and injectable) of the Product for the therapeutic treatment of inflammatory diseases in humans; provided, however, that notwithstanding the foregoing, Licensee shall not sell Product that is labeled for ophthalmic use.