Notice2023-14761
Government-Owned Inventions; Availability for Licensing and Collaboration for Phase 3 Study
Primary source
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Published
July 12, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The invention described below will be a first-in-class, reversible, hormonal contraceptive method for males and is co-owned by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, and The Population Council, Inc., a New York not-for-profit corporation based in New York City ("Population Council"). The co-owners will complete the Phase 2b clinical stage of development in 2024 and are seeking a licensee and investor/collaborator for the Phase 3 clinical stage, anticipated to begin as early as 2024.
Full Text
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<title>Federal Register, Volume 88 Issue 132 (Wednesday, July 12, 2023)</title>
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[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44377-44378]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14761]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing and
Collaboration for Phase 3 Study
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The invention described below will be a first-in-class,
reversible, hormonal contraceptive method for males and is co-owned by
the Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), National Institutes of Health, and The Population
Council, Inc., a New York not-for-profit corporation based in New York
City (``Population Council''). The co-owners will complete the Phase 2b
clinical stage of development in 2024 and are seeking a licensee and
investor/collaborator for the Phase 3 clinical stage, anticipated to
begin as early as 2024.
ADDRESSES: Inquiries relating to this licensing and collaboration
opportunity should be directed to: Heather Gunas, JD, MPH, Senior
Technology Transfer Manager, National Cancer Institute (NCI) Technology
Transfer Center, 9609 Medical Center Drive, Room 1E446, Rockville, MD
20850 (for overnight mail) or Bethesda, MD 20892 (for regular mail),
Telephone: (240) 276-5530; Facsimile: (240) 276-5504; Email:
<a href="/cdn-cgi/l/email-protection#8deaf8e3ecfee5cde0ece4e1a3e3e4e5a3eae2fb"><span class="__cf_email__" data-cfemail="3e594b505f4d567e535f57521050575610595148">[email protected]</span></a>. A Confidential Disclosure Agreement will be
required to receive copies of unpublished information regarding this
invention.
SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and
foreign patents/patent applications thereof are available for
licensing: PCT Application No. PCT/US23/21154, filed May 5, 2023, and
entitled ``Progestin/Testosterone Transdermal Gel''. Government rights
to this invention are consolidated to Population Council under an
active Interinstitutional-Agreement Institution Lead. The invention
pertains to a combination of progestin and testosterone in a
transdermal composition for use as male contraception. The transdermal
gel is applied daily to the shoulders and upper arms, has had a low
incidence of adverse events in early clinical trials, and its sperm
suppression is reversible. There is currently no available highly
effective reversible method of male contraception; the methods of
condom and withdrawal are not highly effective, and vasectomy is not
always reversible.
[[Page 44378]]
NICHD's Contraceptive Clinical Trials Network is currently
conducting the Phase 2b clinical study, which will complete in 2024.
The Phase 2b study had favorable interim results and high acceptability
with subjects; some subjects requested to re-enroll or participate in a
later phase trial. The co-owners are planning the Phase 3 stage and
will finalize the protocol design in conjunction with a licensee and
after Food and Drug Administration (FDA) feedback. A licensee and
commercial collaborator for Phase 3 is desired--the license will be
established with Population Council as the technology lead, and if the
NICHD Contraceptive Clinical Trials Network conducts the Phase 3
clinical program or a portion of it, the licensee would collaborate
with NICHD under a Cooperative Research and Development Agreement
(CRADA) to facilitate funding and conduct of the study.
The licensee needs the capacity to file and maintain an NDA (New
Drug Application) with the US FDA and take responsibility for sales,
marketing, and distribution of the approved product in the U.S. and
other territories to be determined.
Achieving expeditious commercialization of federally funded
research and development is consistent with the goals of the Bayh-Dole
Act, codified as 35 U.S.C. 200-212.
Potential Commercial Application: male contraceptive.
Development Stage: Phase 2b study completes in 2024; Phase 3 study
starts in 2024+.
Dated: July 7, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2023-14761 Filed 7-11-23; 8:45 am]
BILLING CODE 4140-01-P
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