E9-12858. Prospective Grant of Exclusive License: Use of N-Acetyl-Mannosamine and Derivatives Thereof to Treat Muscle Wasting Diseases and Kidney Diseases Related to Hyposialylation

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/932,451, filed May 31, 2007, now abandoned, [HHS Ref. No. E-217-2007/0-US-01]; PCT Patent Application No. PCT/US2008/006895, filed May 30, 2008, [HHS Ref. No. E-217-2007/0-PCT-02], both of which are entitled, “N-Acetyl-Mannosamine as a Therapeutic Agent” (Inventors: Drs. Marjan Huizing, William A. Gahl, Irini Manoli, and Enriko Klootwijk, NHGRI) to New Zealand Pharmaceuticals, Ltd., having an office in at Palmerston North, New Zealand. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of N-Acetyl-Mannosamine or derivatives thereof for the treatment of muscle wasting diseases and kidney diseases related to hyposialylation.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before August 3, 2009 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Steven Standley, PhD, Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

N-Acetyl Mannosamine is a precursor for the synthesis of sugar molecules known as sialic acids which play an important role in specific biological processes such as cellular adhesion, cellular communication and signal transduction. Lack of sialic acids also play an important role in disease processes such as cancer, inflammation and immunity.

This invention relates to methods of administering N-Acetyl Mannosamine or its derivative (to produce sialic acid in patients who are deficient in the sugar molecule) to treat muscular atrophy including hereditary inclusion body myopathy (HIBM) and distal myopathy with rimmed vacuoles (DMRV, or Nonaka myopathy). Certain kidney conditions such as those arising from hyposialytion of kidney membranes may be treated by this method as well.

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 sixty (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.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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 27, 2009.

Richard U. Rodriguez,

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