[Federal Register Volume 62, Number 5 (Wednesday, January 8, 1997)]
[Notices]
[Pages 1122-1123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-333]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes Of Health


National Eye Institute; National Institute of Arthritis and 
Musculoskeletal and Skin Diseases: Licensing Opportunity and/or 
Opportunity for a Cooperative Research and Development Agreement 
(CRADA) for the Use of Antiflammins

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health is seeking licensees and/or 
CRADA partners for the further development and commercialization of its 
patent portfolio for antiflammins. The inventions claimed in U.S. 
Patent No. 5,266,562 issued 30 Nov 1993, ``Anti-Inflammatory Agents,'' 
are 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 one or more CRADAs in several clinically important 
applications as described below in the Supplementary Information.
    To speed 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 
antiflammins in the treatment of inflammatory disease processes will be 
considered.

ADDRESSES: CRADA proposals and questions about this opportunity should 
be addressed to: Ms. Sue Patow, Office of Technology Transfer, National 
Heart, Lung, and Blood Institute, Building 31, Room 1B30, Bethesda, MD 
20892 (301/402-5579). CRADA proposals must be received by the date 
specified below.
    Licensing proposals and questions about this opportunity should be 
addressed to: Ms. Carol Lavrich, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 
20852 (301/496-7735 ext. 287). Respondees interested in licensing the 
invention will be required to submit an Application for License to 
Public Health Service Inventions. Respondees interested in submitting a 
CRADA proposal should be aware that it may be necessary to secure a 
license to the above patent rights in order to commercialize products 
arising from a CRADA agreement.

DATES: There is no deadline by which license applications must be 
received. CRADA proposals must be received on or before April 8, 1997.

SUPPLEMENTARY INFORMATION: Antiflammins are biologically active 
synthetic oligopeptides, derived from the sequence similarity between 
lipo-cortin-1 and uteroglobin, an anti-flammatory protein. These 
peptides have antiphospholipase A<INF>2 and immunomodulatory 
properties. Because of the great therapeutic potential of specific and 
potent antiflammin drugs that may be developed, scientists in several 
Institutes at the National Institutes of Health are examining the use 
of antiflammins in the treatment of Health are examining the use of 
antiflammins in the treatment of a variety of inflammatory processes, 
including acute anterior ocular inflammation (uveitis) and psoriasis.
    Dr. Chi-Cho Chan, a clinical investigator at the National Eye 
Institute (NEI), has an IND for the use of antiflammin 2 in acute 
anterior uveitis, and seven patients have previously been enrolled in a 
clinical trial. To date, no toxicity has been observed in patients 
treated with this drug. Dr. Chan and Dr. Whitcup at the NEI are 
interested in developing new topical formulations of antiflammins and 
the initiation of multi-center randomized clinical trials of 
antiflammins for the treatment of anterior uveitis, post-operative 
ocular inflammation, and allergic conjunctivitis.
    Dr. John DiGiovanna, an investigator in the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases (NIAMS), is studying 
the use of antiflammins to treat psoriasis, a hyperproliferative 
inflammatory skin disease. Dr. DiGiovanna would like to continue these 
studies with a collaborator capable of expanding these studies to 
include other inflammatory skin diseases such as atopic and contact 
dermatitis, as well as develop animal and in vitro models to study the 
effects of antiflammins on skin.
    In addition, Dr. Dimitrios T. Boumpas, also of NIAMS, is studying 
the use of anti-inflammatory/immunosuppressive compounds to treat 
psoriatic arthritis, rheumatoid arthritis, and systemic lupus 
erythematosus. Dr. Boumpas would like to initiate studies with a 
collaborator to investigate the effects of antiflammins in animal 
models of these diseases including toxicity studies and its use and 
toxicity in patients with autoimmune rheumatic diseases.
    CRADA aims include the rapid publication of research results and 
the timely exploitation of commercial opportunities. The CRADA 
partner(s) will enjoy rights of first negotiation for licensing 
Government rights to any inventions arising under the agreement and 
will be expected to 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 NEI and NIAMS in these CRADAs will be as follows:
    1. Provide the Collaborator(s) with samples of the subject 
compounds for pharmaceutical evaluation.
    2. Continue the detailed physicochemical characterization of the 
test compounds as well as research on their mechanism of biological 
action, and publish these results and provide

[[Page 1123]]

all data to the Collaborator as soon as they become available.
    3. Conduct controlled clinical trials of antiflammin formulations 
that have been determined to have therapeutic potential in ocular and 
skin inflammatory diseases.
    The role of the Collaborator(s) will be to:
    1. Perform an exhaustive evaluation of these compounds with respect 
to their biological activities and to develop appropriate vehicles for 
drug delivery for disease processes covered under the CRADA. The 
Collaborator(s) will supply data to the NEI and/or NIAMS in a timely 
fashion.
    2. Synthesize and formulate structural variants of these subject 
compounds to optimize desired effects.
    3. Expand the basic toxicological data as needed in preparation for 
additional clinical studies.
    4. Conduct basic studies designed to better understand the 
potential for antiflammins in the treatment of inflammatory diseases, 
bioavailability and how to best administer these agents.
    5. Support the execution of clinical trials designed to evaluate 
efficacy and toxicity. This may include providing pharmaceutical grade 
compound, equipment and supplies, and support personnel.
    6. Provide new and improved formulations in appropriate vehicles.
    Selection criteria for choosing the CRADA partner(s) will include 
but not be limited to:
    1. Ability to complete the quality pharmacological evaluations 
required according to an appropriate timetable to be outlined in the 
Collaborator's proposal. The target commercial application as well as 
the strategy for evaluating the test agents' potential in that capacity 
must be clearly delineated therein.
    2. The level of financial support the Collaborator will supply for 
CRADA-related Government activities.
    3. A willingness to cooperate with the NEI and NIAMS in publication 
of research results.
    4. An agreement to be bound by the DHHS rules involving human 
subjects, patent rights, ethical treatment of animals, and randomized 
clinical trials.
    5. 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 (1) an irrevocable, non-exclusive, 
royalty-free license to the Government (when a company employee is the 
sole inventor) or (2) an option to negotiate an exclusive or non-
exclusive license to the company on terms that are appropriate (when 
the Government employee is the sole inventor).

    Dated: December 23, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-333 Filed 1-7-97; 8:45 am]
BILLING CODE 4140-01-M