[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]
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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.
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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 A2 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