[Federal Register Volume 73, Number 118 (Wednesday, June 18, 2008)]
[Notices]
[Page 34770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13671]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: (301) 435-5560; Facsimile: (301) 402-0220; E-mail: 
[email protected].

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.
[FR Doc. E8-13671 Filed 6-17-08; 8:45 am]
BILLING CODE 4140-01-P