E9-11681. Prospective Grant of Exclusive License: The Manufacture, Use, Distribution of and Sale of Fused Azepinone Cyclin Dependent Kinase Inhibitors as Therapeutics

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 6,610,684 entitled, “Fused Azepinone Cyclin Dependent Kinase Inhibitors” and all foreign counterparts [HHS Ref. No. E-025-1998/0] to ShanaRx Pharmaceuticals. The patent rights in this invention have been assigned to the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Cyclin Dependent Kinase Inhibitors and their methods of use in the Licensed Patent Rights for the treatment of: (i) Disorders caused by damage, injury, infection in or abnormal function of the peripheral or central nervous system including pain, neuropathy, retinal degeneration, glaucoma, Alzheimer's disease, Parkinson's disease, ALS, depression, schizophrenia, and anxiety; (ii) disorders caused by damage, injury, infection in or abnormal function of cerebral vasculature and cardiac vasculature including cardiac failure and myocardial infections; (iii) cancer and neoplastic disorders; (iv) inflammatory and autoimmune diseases including Multiple Sclerosis; and (v) endocrine and neuroendocrine disorders including Diabetes Mellitus.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before August 18, 2009 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated co-exclusive license should be directed to: Whitney A. Hastings, M.S., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804. Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The invention describes a class of cyclin dependent kinase (CDK) inhibitors that have anti-proliferative activity in human tumor cell lines. CDKs are important in the control of the cell cycle and alterations in CDK expression, function, or regulation are associated with diseases characterized by cellular proliferation. Increasing CDK activity has been reported in many cancers and observed in a wide variety of primary human tumors and human tumor-derived cell lines, including lung, breast, brain, bone, skin, bladder, kidney, ovary, liver, colon, pancreas as well as in leukemia. The compounds of this invention have also been found to potently inhibit GSK3beta activity. Some of compounds of this invention have been shown to be more potent towards the GSK3beta target than towards CDKs. The GSK3beta enzyme, a proline-directed serine-threonine kinase, has been linked to a variety of cellular processes and several disparate areas of biology. Thus, this technology could provide therapeutic opportunities for a variety of indications, including Alzheimer's, neurological disorders, and cardiac failure.

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless within ninety (90) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: May 12, 2009.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.