[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24825-24826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
application listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: (301) 496-7057; fax: (301) 402-0220. A 
signed Confidential Disclosure Agreement will be required to receive a 
copy of the patent application.

Preparation and Use of Androgenic Compounds: Nandrolone 17beta-
carbonates

Richard P. Blye and Hyun K. Kim (NICHD)
U.S. Provisional Application No. 60/650,376 filed 04 Feb 2005 (DHHS 
Reference No. E-181-2004/0-US-01)
Licensing Contact: Marlene Shinn-Astor; 301/435-4426; 
[email protected].

    Hypogonadism is defined as deficient or absent male gonadal 
function that results in insufficient testosterone secretion. 
Hypogonadism can be caused by surgery; radiation; genetic and 
developmental disorders; liver and kidney disease; infection; and 
certain auto-immune disorders. The most common genetic disorders are 
Klinefelter syndrome found in men and Turner syndrome in women.
    Hypogonadism affects an estimated 4 to 5 million men in the United 
States, and although it may occur in men at any

[[Page 24826]]

age, low testosterone levels are especially common in older males. More 
than 60% of men over age 65 have free testosterone levels below the 
normal values of men aged 30 to 35. Studies suggest that hypogonadism 
in adult men is often underdiagnosed and under treated. This may be 
because the symptoms are easily attributed to aging or other medical 
causes, or ignored by patients and physicians. In fact, only about 5% 
of hypogonadal men receive testosterone replacement. Some experts also 
believe that we need to reevaluate normal testosterone levels and lower 
the diagnostic cutoff for hypogonadism. By doing so, many patients who 
we now consider to be ``low-normal'' would probably be considered 
candidates for androgen replacement.
    The inventors have discovered androgenic compounds, the lead 
compound being 17beta-carbonates of nandrolone derivatives. These 
compounds can be used to treat hypogonadism, as hormonal therapy and as 
a male contraceptive. The disclosed carbonates have potent activity 
when administered as an oral composition. In addition, long-lasting 
activity has also been observed with subcutaneous administration in 
laboratory animals. It is foreseen that these androgens can be utilized 
in hormonal replacement therapy for both men and women, which 
constitute a huge market both in the United States and abroad.

    Dated: May 4, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-9395 Filed 5-10-05; 8:45 am]
BILLING CODE 4140-01-P