[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44377-44378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14761]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected]. 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required to receive copies of unpublished information regarding this 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