94-19941. Prospective Grant of Exclusive License: Acetylcholinesterase Inhibitors for the Treatment of Alzheimer's Disease and Cognitive Disorders  

  • [Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-19941]
    
    
    [[Page Unknown]]
    
    [Federal Register: August 16, 1994]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
     
    
    Prospective Grant of Exclusive License: Acetylcholinesterase 
    Inhibitors for the Treatment of Alzheimer's Disease and Cognitive 
    Disorders
    
    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 
    an exclusive world-wide licenses to practice the inventions embodied in 
    U.S. Patent 5,171,750, entitled ``Substituted Phenserines as Specific 
    Inhibitors of Acetylcholinesterase'' and U.S. Patent Applications SN 
    07/861,329 and 08/096,207, both entitled ``Phenylcarbamates of (-)-
    Eseroline, (-)-N1-Noreseroline and (-)-N1-Benzylnoreseroline: Selective 
    Inhibitors of Acetyl and/or Butyrylcholinesterase,'' 07/765,766, 
    entitled ``Thiapysovenine and Carbamate Analogs, Pharmaceutical 
    Compositions and Method for Inhibiting Cholinesterases,'' 07/845,081 
    and 08/182,301, both entitled ``Carbamate Analogs of Thiaphysovenine, 
    Pharmaceutical Compositions, and Method for Inhibiting 
    Cholinesterases,'' and 07/980,399, entitled ``Method for Treating 
    Cognitive Disorders With Phenserine'' to CURE, Inc. of Baltimore, 
    Maryland. The patent rights in these inventions have been assigned to 
    the United States of America.
        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 licenses 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.
        The patent and patent applications disclose several novel, potent 
    and long-acting anti-cholinesterase agents that enhance cognition and 
    are highly promising drug candidates for the treatment of Alzheimer's 
    disease and other neurological disorders as well as methods for 
    treating these conditions. The two series of drugs are based loosely on 
    the first-generation cholinesterase inhibitor, physostigmine. 
    Physostigmine has produced demonstrable but small clinical improvements 
    in patient's with Alzheimer's disease, but these are severely limited 
    by (i) its short half-life (approximately 30 minutes) and (ii) its high 
    incidence of toxic side-effects at doses that produce only modest 
    enzyme inhibition. It is widely accepted that the narrow therapeutic 
    index of physostigmine and some other first generation 
    acetylcholinesterase inhibitors limits the administration of these at 
    adequate doses to affect cognition. The present drug candidates are 
    long-acting and highly selective for acetyl- (AChE) as opposed to 
    butyrylcholinesterase (BChE). Whereas AChE is involved in the 
    metabolism of ACh, and inhibiting AChE augments the action of ACh and 
    thereby cholinergic function and memory in Alzheimer's disease, BChE 
    has been proposed to be involved in lipid and phospholipid metabolism, 
    in permeability control and transport of ions across membranes, and in 
    slow nerve conduction. Co-inhibition of BChE in Alzheimer's patients, 
    as a consequence of anticholinesterase therapy, probably is not of 
    clinical value, and may be deleterious.
    
    ADDRESSES: Requests for copies of the patent and the patent 
    applications, inquiries, comments and other materials relating to the 
    contemplated licenses should be directed to: Mr. Arthur J. Cohn, Esq., 
    Technology Licensing Specialist, Office of Technology Transfer, 
    National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
    Rockville, Maryland 20892. Telephone: (301) 496-7735; Facsimile: (301) 
    402-0220. A signed Confidentiality Agreement will be required to 
    receive copies of the patent applications. Applications for a license 
    in the any field of use filed in response to this notice will be 
    treated as objections to the grant of the contemplated licenses. Only 
    written comments and/or applications for a license which are received 
    by NIH within sixty (60) days of this notice will be considered.
    
        Dated: August 9, 1994.
    Barbara M. McGarey,
    Deputy Director, Office of Technology Transfer.
    [FR Doc. 94-19941 Filed 8-15-94; 8:45 am]
    BILLING CODE 4140-01-P
    
    
    

Document Information

Published:
08/16/1994
Department:
Health and Human Services Department
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-19941
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: August 16, 1994