E8-2750. Cooperative Research and Development Agreement (CRADA) Opportunity With the National Heart Lung and Blood Institute and Licensing Opportunity for Development of Multi-Domain Amphipathic Helical Peptides for the Treatment of Cardiovascular ...

AGENCY:

National Institutes of Health, PHS, HHS.

ACTION:

Notice.

SUMMARY:

Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended, and in accordance with 35 U.S.C. 207 and 37 CFR Part 404, the National Institutes of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services (HHS) seeks a Cooperative Research and Development Agreement (CRADA) and/or license(s) with a pharmaceutical or biotechnology company to develop and commercialize amphipathic helical peptides potentially useful for the treatment and prevention of cardiovascular disease. The CRADA would have an expected duration of one (1) to five (5) years. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, methods of treatment or prevention that may result from the research. The CRADA Collaborator will have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA defined by the CRADA Research Plan, subject to any pre-existing licenses already issued for other fields of use, and can apply for background licenses to the existing patent applications encompassed within HHS Reference Nos. E-114-2004/0-US-01 (United States Patent Application Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and Methods of Their Use.

DATES:

Inquiries regarding CRADA proposals and scientific matters may be forwarded at any time. Confidential preliminary CRADA proposals, preferably two pages or less, must be submitted to the NHLBI on or before April 14, 2008. Guidelines for preparing final CRADA proposals will be communicated shortly thereafter to all respondents with whom initial confidential discussions will have established sufficient mutual interest.

There is no deadline by which license applications must be received by the Office Technology Transfer however applicants are encouraged to respond on or before April 14, 2008. This notice replaces that published in the Federal Register on May 11, 2005 (70 FR 24832).

ADDRESSES:

Proposals and questions about this CRADA opportunity may be addressed to Dr. Denise Crooks, Office of Technology Transfer and Development, NHLBI 6705 Rockledge Drive, MSC 7992, Bethesda, MD 20892 (phone: [phone], Fax: [phone], E-mail: [e-mail]).

Scientific Inquiries should be directed to Dr. Alan T. Remaley, NHLBI, 10 Center Drive, Building 10, Room 2C-433, MSC 1508, Bethesda, MD 20892 (phone: [phone]; fax: [phone]; E-mail: [e-mail]).

Licensing inquiries and requests for license application should be directed to Ms. Fatima Sayyid, Technology Licensing Specialist, Office of Technology Transfer, NIH, 6011 Executive Blvd., Suite 325, Rockville, MD, 20852 (phone: [phone], Fax: [phone], E-mail: [e-mail]).

SUPPLEMENTARY INFORMATION:

Technology Available

HHS scientists within the Lipoprotein Metabolism Section (LMS), NHLBI, have discovered a novel class of non-hemolytic amphipathic synthetic peptides that are specific for effluxing excess cellular cholesterol by the ABCA1 transporter. These agents have been shown to significantly inhibit the progression of atherosclerosis in a mouse model of cardiovascular disease. Details are noted in HHS Reference #s E-114-2004/0-US-01 (United States Patent Application Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and Methods of Their Use. They are available for review under an appropriate Confidential Disclosure Agreement.

Technology Sought

Accordingly, HHS now seeks collaborative arrangements to provide more extensive biological and pharmacological evaluation of both current and any new amphipathic peptides that are being developed within the Lipoprotein Metabolism Section of NHLBI. The ultimate purpose of the collaboration would be to advance the most promising agents into clinical trials for the prevention and regression of cardiovascular disease. For collaboration with the private sector, a Cooperative Research and Development Agreement (CRADA) will be established to provide for equitable distribution of intellectual property rights developed under the collaboration. CRADA aims will include rapid publication of research results as well as full and timely exploitation of commercial opportunities.

NHLBI and Collaborator Responsibilities

The role of LMS, NHLBI in this CRADA may include, but not be limited to:

1. Providing intellectual, scientific, and technical expertise and experience to the research project.

2. Perform in conjunction with Collaborator in vitro studies to identify novel peptides.

3. Perform in conjunction with Collaborator animal studies on peptides with anti-atherosclerotic properties.

4. Provide the Collaborator with sequences of any novel peptides for future pharmaceutical development.

5. Planning and conducting research and clinical studies and interpreting research results.

6. Publishing research results.

The role of the CRADA Collaborator may include, but not be limited to:

1. Providing significant intellectual, scientific, and technical expertise or experience to the research project.

2. Planning scientific and clinical research studies and interpreting research results.

3. Providing some financial support for CRADA-related research as outlined in the CRADA Research Plan.

4. Publishing research results.

Selection criteria for choosing the CRADA Collaborator may include, but not be limited to:

1. The ability to collaborate with NHLBI on further research and development of this technology. This ability can be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to on-going research and development.

2. Expertise and experience in the following areas: Peptide design and synthesis, performance of preclinical studies including animal model studies of atherosclerosis, animal toxicology studies, knowledge of GMP grade production and scale up and lipid reconstitution of synthetic peptides, and design, U.S. Food and Drug Administration regulatory filings, and performance of clinical trials. The demonstration of adequate resources to perform the research, development and commercialization of this technology (e.g. facilities, personnel, expertise and funds) and accomplish objectives according to an appropriate timetable to be outlined in the CRADA Collaborators proposal.

3. The willingness to commit best efforts and demonstrated resources to the research, development and commercialization of this technology.

4. The demonstration of expertise in the commercial development, production, marketing and sales of products related to this area of technology.

5. The willingness to cooperate with the National Heart Lung and Blood Institute in the timely publication of research results.

6. The willingness to accept the legal provisions and language of the CRADA with only minor modifications, if any. These provisions govern the equitable distribution of patent rights to CRADA inventions. Generally, the rights of ownership are retained by the organization that is the employer of the inventor, with (1) the grant of a license for research and other Government purposes to the Government when the CRADA Collaborator's employee is the sole inventor, or (2) the grant of an option to elect an exclusive or non-exclusive license to the CRADA Collaborator when the Government employee is the sole or joint inventor.

Dated: February 7, 2008.

Steven M. Ferguson,

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