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Government-Owned Inventions; Availability for Licensing

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National Institutes of Health, Public Health Service, DHHS.




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.


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;

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 Start Printed Page 24826age, 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.

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Dated: May 4, 2005.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 05-9395 Filed 5-10-05; 8:45 am]