[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Page 4284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1378]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Inhaled Nitrite 
Therapy for the Treatment of Pulmonary Conditions

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 (HHS), is contemplating the 
grant of an exclusive license to practice the invention embodied in: 
PCT patent applications PCT/US2004/21985 and PCT/US2004/22232, filed 
July 9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of 
Cardiovascular Conditions'' [HHS Reference Number: E-254-2003/2-3-PCT-
01], to Aires Pharmaceuticals, Inc., a portfolio company of ProQuest 
Investments LLC, Princeton, N.J. The field of use of inhaled 
administration of nitrite salts for this exclusive license may be 
limited to the use of inhaled formulations of nitrite salts for the 
treatment of Pulmonary Hypertension and pulmonary and/or 
cardiopulmonary conditions. The United States of America is an assignee 
of the patent rights in these inventions.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
April 2, 2007 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Susan Carson, D.Phil., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; E-mail: [email protected]; 
Telephone: (301) 435-5020; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The core invention is the unexpected finding 
that low, physiological and non-toxic concentrations of sodium nitrite 
are able to increase blood flow and produce vasodilation by infused and 
nebulized routes of administration. Pulmonary Hypertension (PH) occurs 
as a primary or idiopathic disease as well as secondary to a number of 
pulmonary and systemic diseases, such as neonatal PH and sickle cell 
disease. There is no cure for pulmonary hypertension, a nitric-oxide 
deficient state characterized by pulmonary vasoconstriction and 
systemic hypoxemia and therapies vary in efficacy and cost. Recent 
studies by NIH researchers and their collaborators provided evidence 
that the blood anion nitrite contributes to hypoxic vasodilation 
through a heme-based, nitric oxide (NO)-generating reaction with 
deoxyhemoglobin and potentially other heme proteins [Nature Medicine 
2003 9: 1498-1505]. These initial results indicate that sodium nitrite 
can be used as a potential cost-effective platform therapy for a wide 
variety of disease indications characterized broadly by constricted 
blood flow or hypoxia.
    These results have been further corroborated by work in the 
neonatal lamb model for PH. Inhaled sodium nitrite delivered by aerosol 
to newborn lambs with hypoxic pulmonary hypertension elicited a rapid 
and sustained reduction (65%) in hypoxia-induced pulmonary 
hypertension. Pulmonary vasodilation elicited by aerosolized nitrite 
was deoxyhemoglobin- and pH-dependent and was associated with increased 
blood levels of iron-nitrosyl-hemoglobin. Notably, short term delivery 
of nitrite dissolved in saline through nebulization produced selective, 
sustained pulmonary vasodilation with no clinically significant 
increase in blood methemoglobin levels. [Nature Medicine 2004 10: 1122-
1127]. Method of use claims for nitrite salt formulations are directed 
to conditions associated with high blood pressure, decreased blood flow 
and for the treatment of specific conditions such as pulmonary 
hypertension and other indications.
    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, 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: January 22, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-1378 Filed 1-29-07; 8:45 am]
BILLING CODE 4140-04-P