E8-13671. Prospective Grant of Exclusive License: Geldanamycin Derivative and Method of Treating Viral Infections

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 invention embodied in U.S. Patent No. 6,890,917, issued May 10, 2005, entitled “Geldanamycin Derivative and Method of Treating Cancer Using Same” [E-050-2000/0-US-15] and foreign equivalents, to Avira Therapeutics, LLC, having a place of business in Menlo Park, California. The patent rights in these inventions 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 manufacture, use, distribution and sale of 17-DMAG, an analog of geldanamycin, as a therapeutic to inhibit the influenza virus, respiratory syncytial virus (RSV) and dengue virus.

This replaces a notice published in 73 FR 31702 on Tuesday, June 3, 2008, which omitted the name of the potential licensee.

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, 2008 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Adaku Madu, J.D., Technology Licensing Specialist, 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:

This technology relates to novel cytotoxic compounds derived from 17-aminoalkylamino-substituted geldanamycin and pharmaceutical compositions thereof. In particular, this invention refers to 17-(dimehtylamino) propylamino-geldanamycin, 17-(dimethylamino) ethylamino-geldanamycin, and the hydrochloride salt of 17-(dimethylamino) ethylamino-geldanamycin (DMAG and analogs). These compounds are Hsp90 inhibitors. Hsp90 inhibition downregulates B-Raf, decreases cell proliferation and reduces activation of the MEK/ERK pathways in some cells. Hsp90 plays an essential role in maintaining stability and activity in its client proteins. Hsp90 inhibitors interfere with diverse signaling pathways by destabilizing and attenuating activity of such proteins, and thus exhibit antitumor activity. Specifically, 17-DMAG shows cytotoxicity against a number of human colon and lung cell lines, specific melanoma, renal and breast lines, and potentially against various viral infections. In addition, these compounds appear to have favorable pharmaceutical properties including oral activity and improved water-solubility.

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 Part 404.7. The prospective exclusive license may be granted unless within sixty (60) 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: June 9, 2008.

Richard U. Rodriguez,

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