[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