[Federal Register Volume 59, Number 151 (Monday, August 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19222]


[[Page Unknown]]

[Federal Register: August 8, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Opportunity for Exclusive or Non-Exclusive Licensing: Prostratin, 
a Novel Anti-viral Compound Useful in the Treatment of Acquired 
Immunodeficiency Syndrome (AIDS)

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

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH), Department of Health 
and Human Services (DHHS), seeks exclusive or non-exclusive licensee(s) 
who can effectively pursue the preclinical, clinical and commercial 
development of prostratin for the treatment of human immunodeficiency 
virus (HIV) infection. Scientists at the National Cancer Institute have 
identified a new composition comprising the 12-deoxyphorbol ester 
derivative, prostratin, and a pharmaceutically acceptable carrier that 
has been found to have strong antiviral activity against HIV-1. These 
compounds may have advantageous pharmacologic, toxicologic, and/or 
antiviral properties, especially in the treatment of AIDS. NIH intends 
to grant the selected firm(s) world-wide royalty-bearing license(s) to 
practice the inventions embodied in U.S. Patent Application SN 07/
530,562 entitled ``Antiviral Composition'' and related foreign patent 
applications for this field of use. The patent rights in these 
inventions have been assigned to the United States of America.

SUPPLEMENTARY INFORMATION: The NIH seeks exclusive or non-exclusive 
licensee(s), who in accordance with requirements and regulations 
governing the licensing of government-owned inventions (37 CFR part 
404), have the most meritorious plan for the development of prostratin 
to a marketable status to meet the needs of the public and with the 
best terms for the NIH. Specifically, firm(s) are sought who directly 
or indirectly, will be able to:
    (1) Isolate or synthesize and provide sufficient amounts (e.g. 
multi-kilogram amounts) of compounds for preclinical drug development;
    (2) Carry out preclinical toxicology and pharmacology studies and 
testing, without guaranteed assistance from the government, to 
complement preclinical toxicology and pharmacology currently being 
performed to the Investigational New Drug (IND) stage by NCI.
    (3) Perform formulation for oral and intravenous use, vialing, 
quality control testing, bioavailability testing and distribution of 
the drug for Phase I and Phase II and, if appropriate, Phase III 
clinical trials both in the NIH intramural program and in the 
extramural AIDS Clinical Trials Groups (ACTGs) established by the 
National Institute of Allergy and Infectious Diseases (NIAID). The 
clinical trials may be performed under the sponsorship of an IND to be 
held by NCI or NIAID. Prior to being released for commercial 
distribution, the drug will have to be granted a product license by the 
Food and Drug Administration (FDA);
    (4) Synthesize bulk pharmaceutical product necessary for the 
treatment of 500-1,500 patients with HIV infection in Phase I, II and 
III developmental studies;
    (5) Perform clinical studies. NCI and NIAID may conduct studies of 
prostratin in the ACTGs and the NIH Clinical Center, and the company 
will be expected to provide the drug free of charge to NIH for studies 
conducted in the ACTGs and in the NIH intramural program; the company 
will be expected to cooperate with NCI and NIAID in providing the drug 
and supporting distribution of the drug under a treatment IND when 
appropriate;
    (6) Provide data management support for both the intramural NIH and 
extramural studies of prostratin necessary for the timely submission of 
a NDA to the FDA;
    (7) Share the cost with NIH of intramural and extramural clinical 
monitoring studies (pharmacokinetics, patient immune profiles and viral 
outgrowth studies) necessary for the demonstration of clinical efficacy 
of prostratin for the treatment of AIDS;
    (8) Since prostratin and its anti-HIV properties were discovered 
through Samoan healers' knowledge of flora indigenous to the primary 
forests of Samoa, the NIH is concerned that the collection and 
utilization of the natural plant material comport with all applicable 
Federal and Samoan policies related to biodiversity. In order to 
comport with such policies, the successful applicant will be required 
to negotiate and enter into agreements with the appropriate Samoan 
government agencies. The original collector of the source plant which 
was tested for anti-HIV activity on the basis of interviews with Samoan 
healers, may be willing to facilitate such negotiations. In the event 
that these negotiations with the Samoan authorities are unsuccessful, 
the licensee must agree to consent to binding arbitration.
    The criteria that NIH will use to evaluate exclusive or non-
exclusive license applications will include, but not be limited to 
those set forth by 37 CFR 404.7(a)(1)(ii)-(iv), as well as:
    (1) Manufacturing capabilities for antiviral compounds and a plan 
for production of prostratin;
    (2) Experience in preclinical and clinical drug development with 
special emphasis on the development of antiviral compounds;
    (3) Experience in the evaluation, monitoring and interpretation of 
data for investigational biologic and virologic assays under an IND;
    (4) Experience in the evaluation, monitoring and interpretation of 
data from Phase I and Phase II clinical studies for an IND;
    (5) Demonstrated expertise in monitoring drug levels using state-
of-the-art methods for measuring drugs in blood, urine and CSF;
    (6) A willingness to cooperate with NCI in the collection, 
evaluation, publication and maintenance of data from animal studies and 
from clinical trials and tests of investigational biologic assays;
    (7) Demonstrated competence in developing oral formulation and 
sustained-release oral formulations;
    (8) Ability to produce, package, market and distribute 
pharmaceutical products in the United States and to provide the product 
at a reasonable price;
    (9) Willingness to sustain the cost of prostratin drug development 
as outlined above (i.e., bulk drug synthesis, data management, animal 
studies, clinical studies, etc.);
    (10) Agreement to be bound by DHHS regulations and guidelines 
involving human and animal subjects;
    (11) An aggressive developmental plan that includes appropriate 
milestones and deadlines for preclinical and clinical development and 
for marketing approval.
    (12) Agreement to negotiate and enter into agreements with the 
appropriate Samoan authorities on terms acceptable to all parties.

EFFECTIVE DATE: In view of the high priority for developing new drugs 
for the treatment of HIV infection, all proposals must be received on 
or before October 7, 1994.

ADDRESSES: Requests for a summary of the anti-HIV activity of 
prostratin or other questions and comments concerning the clinical 
aspects of this technology should be directed to: Kate Duffy Mazan, 
J.D., Office of Technology Development, National Cancer Institute, 
Building 31, Room 4A34, 9000 Rockville Pike, Bethesda, MD 20892. 
Telephone: (301) 496-0477; Fax: (301) 402-2117.
    Requests for a copy of the patent application, license application 
form, or other questions and comments concerning the licensing of this 
technology should be directed to: Steven M. Ferguson, Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852. Telephone: (301) 496-7735 extension 266; E-mail: Steve--
Ferguson@NIHOD601; Fax: (301) 402-0220. A signed confidentiality 
agreement will be required to receive a copy of the patent application.

    Dated: July 30, 1994.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 94-19222 Filed 8-5-94; 8:45 am]
BILLING CODE 4140-01-P