[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]



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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.

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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