[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)]
[Notices]
[Pages 53791-53792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25731]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Opportunity for a Cooperative Research
and Development Agreement (CRADA) for the Scientific and Commercial
Development of Homoharringtonine as an Anticancer Agent
AGENCY: National Institutes of Health, PHS, DHHS.
[[Page 53792]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (DHHS) seeks a
pharmaceutical company that can effectively pursue the clinical
development of Homoharringtonine for the treatment of cancer. The
National Cancer Institute has established that this agent may be
effective in treating several types of cancers. The selected sponsor
will be awarded a CRADA for the development of this agent.
The term of the CRADA is anticipated to be three (3) to five (5)
years.
ADDRESSES: Questions about this opportunity may be addressed to Mike
Christini, J.D. or Michelle Rhyu, Ph.D., Office of Technology
Development, NCI, Building 31, Bethesda, Maryland 20892 (301) 496-0477,
from whom further information including a summary copy of the
preclinical and clinical data may be obtained.
DATES: In view of the important priority of developing new drugs for
the treatment of cancer, proposals must be received at the above
address by 5 pm December 18, 1995.
SUPPLEMENTARY INFORMATION: Cooperative Research and Development
Agreement or ``CRADA'' means the anticipated joint agreement to be
entered into by NCI pursuant to the Federal Technology Transfer Act of
1986 and Executive Order 12591 of October 10, 1987 to collaborate on
the specific research project described below. Under the present
proposal, the Government is seeking a pharmaceutical company, which in
accordance with the requirements of the regulations governing the
transfer of technology that the Government has taken an active role in
developing (37 CFR 404.8), can further develop Homoharringtonine to a
marketable status to best meet the needs of the public. The government
does not hold any active patents for this compound.
Homoharringtonine is a cephalotaxine ester isolated from the
cephalotaxus evergreen indigenous to China. It has shown promising
activity in patients with chronic myelogenous leukemia (CML). Clinical
development directed toward licensing includes confirmatory phase 2
trials of HHT in combination with other agents with demonstrated
activity in CML and a phase 3 trial of HHT against standard therapy in
refractory CML.
The Division of Cancer Treatment, NCI, is interested in
establishing a CRADA with a pharmaceutical company to assist in the
continuing development of the agent. The Government will provide all
available expertise and information to date and will jointly pursue new
clinical studies as required, giving the pharmaceutical company full
access to existing data and data developed pursuant to the CRADA.
The successful pharmaceutical company will provide the necessary
financial and organizational support to complete further development of
this agent to establish clinical efficacy and possible commercial
status.
The role of the Division of Cancer Treatment, NCI, includes the
following:
1. The Government will provide information concerning
pharmaceutical manufacturing and controls including dosage development
data.
2. The Government will allow the pharmaceutical company to review
and cross-file the Division's IND for the agent; it is likely that the
pharmaceutical company would wish to undertake clinical studies
independently, as well as jointly under the CRADA.
3. The Government will make the Division's IND for the agent
proprietary under the terms of the CRADA and the IND data will be
offered exclusively to the selected pharmaceutical company.
4. The DCT, NCI will make the collaborator its sole and exclusive
commercialization partner for the development of this compound.
5. The Government will continue the preclinical and clinical
development of this agent under its extramural clinical trials network.
The role of the successful pharmaceutical company for the agent
under a CRADA will include the following:
1. Provide and implement plans to independently secure future
supplies of the agent to assure continued preclinical and clinical
development. The pharmaceutical company will provide for the costs of
production of Homoharringtonine produced from the date of this Notice
until such time as the company shall assume responsibility for
satisfying the supplies required by the Division of Cancer Treatment,
NCI.
2. Generate a plan and provide financial and regulatory support for
the clinical development leading to FDA approval for marketing.
3. In the development of compounds derived from natural products,
the NCI is concerned that the utilization of the plant material comport
with all applicable laws and policies in the source country related to
biodiversity. It is the responsibility of the CRADA partner to
negotiate and enter into agreements with source country agencies as
appropriate to address these concerns.
Criteria for choosing the pharmaceutical company include the
following:
1. Experience in the preclinical and clinical development of
anticancer agents.
2. Experience and ability to produce, package, market and
distribute pharmaceutical agents in the United States.
3. Experience in the monitoring, evaluation and interpretation of
the data from investigational agent clinical studies under an IND.
4. A willingness to cooperate with the Public Health Service in the
collection, evaluation, publication and maintenance of data from
clinical trials of investigational agents.
5. A willingness to cost share in the development of the agent.
This includes the acquisition of bulk material and formulation of
clinical products in adequate amounts as needed for future clinical
trials and marketing, as well as the partial funding of regulatory
costs and personnel dedicated to completion of the CRADA research
project.
6. An agreement to be bound by the DHHS rules involving human and
animal subjects.
7. Formulation of an aggressive clinical development plan,
including appropriate milestones and deadlines.
8. Provisions for equitable distribution of patent rights to any
inventions. Generally the rights of ownership are retained by the
organization which is the employer of the inventor, with (1) an
irrevocable, nonexclusive, royalty-free license to the Government (when
a company employee is the sole inventor) or (2) an option to an
exclusive or nonexclusive license to the company on terms that are
appropriate (when the Government employee is the sole inventor).
9. Willingness and ability to acquire any necessary background
patent rights.
10. Submission of an initial response to the NIH Model Clinical
Trial CRADA boilerplate provisions.
Dated: October 6, 1995.
Thomas D. Mays,
Director, Office of Technology Development, National Cancer Institute,
National Institutes of Health.
[FR Doc. 95-25731 Filed 10-16-95; 8:45 am]
BILLING CODE 4140-01-P