[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