[Federal Register Volume 71, Number 107 (Monday, June 5, 2006)]
[Notices]
[Page 32364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: GLP-1 Exendin-4 Peptide 
Analogs and Uses Thereof

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

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 license worldwide to practice the invention embodied in 
U.S. Patent Application Number 10/485,140 filed January 27, 2004, 
entitled ``GLP-1 Exendrin-4 Peptide Analogs and Uses Thereof,'' to 
Amylin Pharmaceuticals, Inc., having a place of business in San Diego, 
CA 92121. The contemplated exclusive license may be limited to use to 
human therapeutics for diabetes, obesity and cardiovascular disease, as 
well as neurological and neurodegenerative diseases, disorders and 
injuries. The United States of America is the assignee of the patent 
rights in this invention.

DATES: Only written comments and/or application for a license which is 
received by the NIH Office of Technology Transfer on or before August 
4, 2006 will be considered.

ADDRESSES: Request for a copy of the patent, inquires, comments, and 
other materials relating to the contemplated license should be directed 
to: Marlene Astor, Technology Licensing Specialist, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Type-2 diabetes and neurodegeneration (e.g., 
Alzheimer's disease, Parkinson's disease, peripheral neuropathy, 
stroke) are leading causes of death in the United States and worldwide. 
The present invention pertains to the disclosure of novel peptide 
analogues of Glucagons-like peptide-1 (GLP-1) and Exendin-4 and their 
uses in the treatment of (i) diabetes and (ii) neurodegenerative 
disorders.
    Type-2 diabetes is caused by dysfunction of the pancreatic beta 
cells that may result in concomitant decrease in insulin production. 
Insulin replacement has been an effective therapy for the treatment of 
Type-2 diabetes. However, insulin therapy, although life saving, does 
not restore normal levels of glucose and postprandial levels of glucose 
continues to be excessively high in individuals on insulin therapy. 
Further, the therapy may result in adverse effects including 
hyperglycemia, hypoglycemia, metabolic acidosis and ketosis. Therefore, 
a better therapeutic formula may be needed that may increase the 
efficacy of the treatment and minimize the side effects. The present 
invention discloses a method of treating a subject with diabetes with 
novel GLP-1/Exendin-4 peptides. These are GLP-1 agonists and elicit 
insulinotropic actions.
    The GLP-1 receptor is additionally found in the brain as well as 
associated to pancreatic islets cells. Its stimulation in brain has 
been found to be neurotrophic and neuroprotective in both tissue 
culture and in vivo against a variety of toxic insults. Peptides of the 
said invention possess activity in a variety of predictive models of 
neurodegeneration, and may have potential in a variety of diseases both 
associated (peripheral neuropathy) and unassociated (Alzheimer's 
disease, Parkinson's disease, stroke and peripheral neuropathy) with 
diabetes J. Alz. Dis. 4: 487-96, 2002; J. Pharmacol. Exp. Ther. 
300:958-66, 2002 & 302:881-888, 2002.
    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 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.
    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: May 26, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
 [FR Doc. E6-8678 Filed 6-2-06; 8:45 am]
BILLING CODE 4140-01-P