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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by an agency of the U.S. Government and are 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 applications 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 copies of the patent applications.

Method of Detecting and Quantifying Contaminants in Heparin Preparations

Description of Technology: Heparin is a naturally occurring acidic carbohydrate produced commercially from extracts of animal tissues (such as bovine lung or porcine intestine) and is used in the treatment of a wide range of diseases in addition to their classic anticoagulant activity. Heparin is also used to coat many medical devices, such as catheters, syringes, stents and filters. Recently, certain lots of heparin were associated with serious side effects and adverse events. Recalls were issued in multiple countries and it became evident that there was an extensive problem with heparin manufacture.

Traditional tests may not be able to determine the presence of contaminant(s) without lyophilizing and concentrating each sample and may not be suitable for testing finished medical devices. Therefore, there is a demonstrated need to develop other assay methods for detecting contaminating oversulfated compounds of any source in heparin and heparin-derived products.

This technology relates to methods for detecting and/or quantifying oversulfated glycosaminoglycans based on inhibition of nucleic acid polymerases and resistance to enzymatic degradation. It also relates to the use of these methods to screen and quantify pharmaceutical preparations such as heparin preparations for oversulfated contaminants.

Potential Applications: Robust, simple and effective method for detecting and optionally quantifying oversulfated contaminants in heparin preparations.

Development Status: The method has been developed and qualified for sensitivity and identity, but full validation and commercialization have not been undertaken.

Inventor: Daniela Verthelyi et al. (FDA).

Publication: C Tami, M Puig, JC Reepmeyer, H Ye, DA D'Avignon, L Buhse, D Verthelyi. Inhibition of Taq polymerase as a method for screening heparin for oversulfated contaminants. Biomaterials 2008 Dec;29(36):4808-4814.

Patent Status: U.S. Provisional Application No. 61/095,562 filed 09 Sep 2008 (HHS Reference No. E-227-2008/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; Fatima.Sayyid@hhs.nih.gov.

Collaborative Research Opportunity: The FDA, Division of Therapeutic Proteins, Laboratory of Immunology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this high throughput screening test for oversulfated glycosamineglycan contaminants in heparin. Please contact Daniela Verthelyi at daniela.verthelyi@fda.hhs.gov or Alice Welch at alice.welch@fda.hhs.gov for more information.

Immunogenic West Nile Virus-Like Particles

Description of Technology: Currently, no specific vaccine or therapy for West Nile Virus (WNV) is available for human use; a killed-virus vaccine and booster is in use for horses (efficacy not yet reported). Virus-like particles (VLPs) are an exciting new strategy, as it combines the safety of killed-virus and DNA-based vaccines with the potential for immunogenicity of live-attenuated virus. VLPs have been used in approved vaccine for humans, including human papilloma virus (HPV). Generating VLPs for West Nile Virus, however, has proven difficult.

The inventors have successfully generated West Nile VLPs in insect cells by using recombinant baculoviruses expressing the WNV structural proteins prME or CprME. Mice immunized with purified West Nile VLPs developed antibodies specific to WNV with potent neutralizing activities; moreover, the mice showed no morbidity or mortality after a subsequent challenge with live WNV and showed no evidence of viremia or viral RNA in the spleen or brain.

The patent application covers applications ranging from pharmaceutical/vaccine preparations for WNV-LPs to methods for making and using them.

Applications: Antiviral therapies, vaccines, and diagnostic kits based on West Nile VLPs.

Advantages:

  • Demonstrated efficacy in mice.
  • Noninfectious.
  • Manufacture using insect cells is simple and inexpensive.
  • Vaccines or therapeutics are a preferable means to control infection versus the current method (reduce mosquito populations using toxic pesticides).
  • First successful generation of West Nile VLPs.

Development Status: Successful completion of proof-of-principle tests in mice.

Market: For the last few years, the CDC has reported between 2,000-3,000 human cases of WNV in the United States each year, typically with a mortality rate of about 5-6% (cumulatively since 1999, 27,000 cases and approaching 2,000 deaths). People over age 50 are at greatest risk for severe illness. Birds and horses are also vulnerable, with up to about 15,000 horse cases reported per year.

Inventors: T. Jake Liang (NIDDK) et al.

Relevant Publication: M Qiao et al. Induction of sterilizing immunity against West Nile Virus (WNV), by immunization with WNV-like particles produced in insect cells. J Infect Dis. 2004 Dec 15;190(12):2104-2108.

Patent Status: HHS Reference No. E-352-2003/0—U.S. Patent Application No. 11/579,459 (2008/0118528) and European Patent Application 05746277.2, both filed 03 Nov 2006 (from PCT publication WO 2005/018560) and claiming priority to 4 May 2004.

Licensing Status: Available for licensing.

Licensing Contact: Bruce Goldstein, J.D., M.S.; 301-435-5470; goldsteb@mail.nih.gov.

Collaborative Research Opportunity: The National Institute of Diabetes and Digestive and Kidney Diseases, Liver Diseases Branch, is seeking parties Start Printed Page 20960interested in collaborative research directed toward molecular strategies for vaccine and antiviral development, and animal models of viral hepatitis C. For more information, please contact Dr. T. Jake Liang at 301-496-1721, jliang@nih.gov, or Ms. Patricia Lake at 301-594-6762, lakep@mail.nih.gov.

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Dated: April 29, 2009.

Richard U. Rodriguez,

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

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[FR Doc. E9-10410 Filed 5-5-09; 8:45 am]

BILLING CODE 4140-01-P