[Federal Register Volume 64, Number 127 (Friday, July 2, 1999)]
[Notices]
[Page 36029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Prodrug Forms of the 
Anti-Cancer Agent 9--D-Arabinofuranosyl-2-Fluoroadenine as 
Therapeutics for the Treatment of Cancers and Leukemia

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a worldwide co-exclusive license to practice the invention embodied in 
U.S. Patent 4,357,324, issued November 2, 1982 and entitled ``Prodrug 
Derivatives 9--D-arabinofuranosyl-2-fluoroadenine'', to Ash 
Stevens, Inc., having a place of business in Detroit, Michigan. The 
patent rights in these inventions have been assigned to the United 
States of America.
    A co-exlusive license had been granted to Schering AG and its U.S. 
affiliate, Berlex Laboratories, Inc. in January 1984. PHS intends to 
grant one additional co-exclusive license to these patent rights.
    The field of use may be limited to the development of therapeutics 
for the treatment of cancers and leukemia.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before August 
31, 1999 will be considered.

ADDRESSES: Requests for a copy of the patent, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Girish C. Barua, PhD., Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 496-7057, ext. 263; Facsimile: (301) 
402-0220; E-mail` [email protected].

SUPPLEMENTARY INFORMATION: This invention involves the preparation of 
the 5'-formate and the 5'-phosphate derivatives of 9--D-
arabinofuranosyl-2-fluoroadenine as prodrug forms of the anti-cancer 
agent 9--D-arabinofuranosyl-2-fluoroadenine, known as F-ara-A. 
These derivatives are quite water soluble whereas F-ara-A itself is 
sparingly soluble in water or in any organic solvents. Delivery of 
these prodrug forms to mice with L1210 leukemia results in the 
formation of higher levels of the triphosphate of F-ara-A, the active 
form of the drug, in the target L1210 leukemia cells. These prodrug 
forms are much more active chemotherapeutically than 9--D-
arabinofuranosyl, known as ara-A, and equivalent in activity to the 
combination of ara-A and 2-deoxycoformycin, known as 2'-dCF, an 
effective in vivo inhibitor of adenosine deaminase, a ubiquitous enzyme 
that destroys ara-A in vivo.
    The prospective co-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 co-exclusive license may be granted unless, 
within 60 days from the date of this published Notice, 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.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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 25, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 99-16895 Filed 7-1-99; 8:45 am]
BILLING CODE 4140-01-M