[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19942]
[[Page Unknown]]
[Federal Register: August 16, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Eye Institute; National Institute of Arthritis and
Musculoskeletal and Skin Diseases; National Institute of Child Health
and Human Development; 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, DHHS.
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 the
following patent applications 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:
Anti-Inflammatory Agents, Mukherjee, A. B. (NICHD), Filed 19 Nov
1987 Serial No. 07/122,379, U.S. Patent No. 5,266,562 issued 30 Nov
1993
Method of Treating Ocular Inflammatory Diseases Using Antiflammins,
Chan, C. C. (NEI), Filed 7 Jun 1993, Serial No. 08/073,380
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. Karen Wright, Office of Technology Development,
National Eye Institute, Building 10, Room 10N202, Bethesda, MD 20892
(301/496-9463). 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). Information on the patent and patent
applications and pertinent information not yet publicly described can
be obtained under a Confidential Disclosure Agreement. Respondees
interested in licensing the invention(s) 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 November 14,
1994.
SUPPLEMENTARY INFORMATION: Antiflammins are biologically active
synthetic oligopeptides, derived from the sequence similarity between
lipo-cortin-1 and uteroglobin, an anti-inflammatory 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 a variety of inflammatory
processes, including acute anterior ocular inflammation (uveitis),
psoriasis, neonatal respiratory distress syndrome (RDS) and
bronchopulmonary dysplasia (BPD).
Dr. Chi-Cho Chan and Dr. Scott Whitcup, clinical investigators at
the National Eye Institute (NEI), have an IND for the use of
antiflammin 2 in acute anterior uveitis, and seven patients have
already been enrolled in a clinical trial. To date, no toxicity has
been observed in patients treated with this drug. The NEI is 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 and
expand 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.
Dr. Anil Mukherjee, an investigator in the National Institute of
Child Health and Human Development (NICHD), is interested in
determining whether endotracheal administration of aerosolized
recombinant human uteroglobin (UG) or antiflammins derived from the
sequence of this protein in combination with surfactant prevents the
development of the inflammatory lung disease bronchopulmonary dysplasia
(BPD) in (a) non-human primate models of neonatal respiratory distress
syndrome (RDS) and (b) human neonatal RDS in a multi-center study,
provided the non-human primate study results show no toxicity and
considerable improvement as a result of combination therapy with
surfactant plus human uteroglobin.
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, NIAMS, and NICHD 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 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, skin
and respiratory 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, NIAMS, and/or NICHD 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, NIAMS, and NICHD 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: August 8, 1994.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 94-19942 Filed 8-15-94; 8:45 am]
BILLING CODE 4140-01-P
