[Federal Register Volume 62, Number 30 (Thursday, February 13, 1997)]
[Notices]
[Pages 6788-6789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


National Institute of Child Health and Human Development: 
Licensing Opportunity and/or Opportunity for a Cooperative Research and 
Development Agreement (CRADA) for Novel Progesterone Antagonists and 
Pharmaceutical Compositions Thereof

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health is seeking licensees and/or 
CRADA partners for the further development, evaluation, and 
commercialization of novel progesterone antagonists and pharmaceutical 
compositions thereof. The invention claimed in U.S. Patent Application 
60/016,628 entitled ``21-Substituted Progesterone Derivatives As New 
Antiprogestational Agents'' (HK Kim, RP Blye, PN Rao, JW Cessac, and CK 
Acosta), filed May 1, 1996, is available for either exclusive or non-
exclusive licensing (in accordance with 35 U.S.C. 207 and 37 CFR part 
404) and/or further development under a CRADA for clinical and research 
applications described below in SUPPLEMENTARY INFORMATION.
    To expedite the research, development, and commercialization of 
this new class of drugs, the National Institutes of Health is seeking 
one or more license agreements and/or CRADAs with pharmaceutical or 
biotechnology companies in accordance with the regulations governing 
the transfer of Government-developed agents. Any proposal to use or 
develop these drugs will be considered.

DATES: There is no deadline by which license applications must be 
received. CRADA proposals must be received on or before May 14, 1997.

ADDRESSES: CRADA proposals and questions about this opportunity should 
be addressed to Dr. Diana Blithe, Contraceptive Development Branch, 
Center for Population Research, National Institute of Child Health and 
Human Development, 6100 Executive Boulevard, Room 8B13, Bethesda, 
Maryland 20892; Telephone: 301/496-1661.
    Licensing proposals and questions about this opportunity should be 
addressed to Ms. Carol Lavrich, Technology Licensing Specialist, Office 
of Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, Maryland 20852-3804; Telephone: 301/
496-7735, ext. 287.
    Information about the patent application and pertinent information 
not yet publicly described can be obtained under a Confidential 
Disclosure Agreement. Respondees interested in licensing the 
invention(s) will be required to submit an Application for License to 
Public Health Service Inventions. Respondees interested in submitting a 
CRADA proposal should be award that it may be necessary to secure a 
license to the above patent rights in order to commercialize products 
arising from a CRADA.

SUPPLEMENTARY INFORMATION: The discover of antiprogestational steroids 
can be traced back to the work of chemists at Roussel in the early 
1970s who were trying to develop synthetic routes for some new 
glucocorticoids which require substitution at position 11 of the 
steroid nucleus. They found that the size of the substituent largely 
determined whether the compound exhibited agonist or antagonist 
activity. By extending this work to the sex steroids, Georges Teutsch 
and his colleagues prepared RU 38486 or mifepristone in 1980 which was 
subsequently shown to exhibit both antiprogrestational and 
antiglucocorticoid activity. Clinical studies showed that mifepristone 
could terminate pregnancy when it was administered prior to day 49 of 
gestation when the source of progesterone shifts from the corpus luteum 
to the placenta and could also prevent pregnancy when administered 
within 72 hours of unprotected intercourse.
    As part of its steroid synthetic program, a novel antiprogestin, 
code named CDB-2914, was prepared by the Research Triangle Institute 
under contract to the Contraceptive Development Branch and subsequently 
evaluated by the Branch's Biological Testing Facility. Chemically, CDB-
2914 is 17-acetoxy-11-(4-N,N-dimethylaminophenyl)-19-
norpregna-4,9-diene-3,20-dione. It differs from mifepristone in that it 
is a derivative of progesterone rather than 19-nortestosterone. 
However, it shares many pharmacological properties with mifepristone, 
and is being developed as a postcoital contraceptive.
    The compounds available for licensing under this notice are 21-
substituted analogs of CDB-2914. Although they have not been studied as 
extensively as CDB-2914, they exhibit greater antiprogestational and 
reduced antiglucocorticoid activity and thus have substantial clinical 
potential as contraceptive agents and for a broad spectrum of 
therapeutic uses in gynecic medicine. While a licensee/CRADA partner 
may wish to pursue development of these antiprogestins for the most 
extensive clinical applications, contributions by the Government will 
be limited to contraceptive development. Development as abortifacients 
will be prohibited.
    In an effort to expedite research, development, and 
commercialization of the novel antiprogestational steroids, the 
National Institute of Child Health and Human Development seeks a CRADA 
partner(s) for joint exploration and possible commercialization. Any 
CRADA proposed for these purposes will be considered.
    The CRADA aims will include the rapid publication of research 
results consistent with protection of proprietary information and 
patentable inventions as well as the timely exploitation of commercial 
opportunities. The CRADA partner will enjoy the benefits of first 
negotiation for licensing Government

[[Page 6789]]

rights to any inventions arising under the agreement and will advance 
funds payable upon signing the CRADA to help defray Government expenses 
for patenting such inventions and other CRADA-related costs.
    The role of the National Institute of Child Health and Human 
Development will be as follows:
    1. Provide the collaborator with all biological data on 
compositions of matter covered by the agreement.
    2. Provide samples of compositions of matter covered by the 
agreement.
    3. Provide chemical data on compositions of matter covered by the 
agreement including synthetic routes, analytical methods employed, and 
purity.
    4. Provide conformational analysis of compositions of matter 
covered by the agreement where possible.
    5. Continue studies on the pharmacokinetics and biological activity 
of compositions of matter covered by the agreement.
    6. Conduct studies to optimize formulations for administration of 
the compositions of matter covered by the agreement by various routes 
in rodents and primates.
    7. Conduct Ames Test and other genetic toxicology on compositions 
of matter covered by the agreement scheduled for clinical evaluation.
    8. Participate in meetings with the Food and Drug Administration 
for establishment of the drug safety studies required for Phase I, II, 
and III clinical investigations of any of the compositions of matter 
covered by the agreement and provide liaison with that Agency.
    The role of the collaborator will be as follows:
    1. Undertake studies to identify any unique properties of the 
compositions of matter covered by the agreement including 
pharmacological differences from mifepristone.
    2. Undertake relative binding affinity studies using human receptor 
proteins.
    3. Undertake acute, subacute, chronic, carcinogenicity, and 
reproductive toxicology studies necessary to proceed with the orderly 
evaluation of selected compositions of matter covered by the agreement 
in human subjects.
    4. Undertake an orderly sequence of clinical investigations of 
selected compositions of matter covered by the agreement for their 
safety and efficacy as postcoital contraceptives and for therapeutic 
use in gynecic medicine.
    Selection criteria for choosing the CRADA partner(s) will include 
but are not limited to the following:
    1. The collaborator must present in their proposal a clear 
statement of their capabilities and experience with respect to the 
tasks to be undertaken. This would include experience in drug 
development, regulatory affairs, and marketing.
    2. The proposal must contain a clear and concise outline of the 
work to be undertaken, a schedule of significant events, an outline of 
objectives to be accomplished in a timely manner and such experimental 
details as will provide a basis for evaluation of competing 
submissions.
    3. The proposal must contain the level of financial support the 
collaborator will supply for CRADA-related Government activities.
    4. A willingness to cooperate with the NICHD in publications of 
research results consistent with the protection of proprietary 
information and patentable inventions which may arise during the period 
of the agreement.
    5. Agreement to be bound by DHHS rules and regulations regarding 
the use of human subjects in clinical investigations, patent rights, 
ethical treatment of animals, and randomized clinical trials.
    6. Agreement with provisions for equitable distribution of patent 
rights to any inventions developed under the CRADA(s). Generally, the 
rights of ownership are retained by the organization which is the 
employer of the inventor, with an irrevocable, non-exclusive, royalty-
free license to the Government (when a company employee(s) is the sole 
inventor) or an option to negotiate an exclusive or non-exclusive 
license to the company on terms that are appropriate (when the 
Government employee(s) is the sole inventor).

    Dated: February 4, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-3527 Filed 2-12-97; 8:45 am]
BILLING CODE 4140-01-M