Government-Owned Inventions; Availability for Licensing, 56649-56650 [E9-26313]
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Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
56649
a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable
or is not feasible, or
(iii) the clinician judges IV therapy is appropriate due to other circumstances.
b. Pediatric patients for whom an IV agent is clinically appropriate because:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable
or is not feasible).
C.5. Health Care Providers will ensure that patients with known or suspected renal insufficiency have creatinine clearance determined prior to peramivir dose calculation and first administration. (See Fact Sheet For Health Care Providers; Dosage and Administration for Impaired Renal Function Dosing).
C.6. Health Care Providers prescribing and/or administering authorized peramivir will ensure that patients with history of severe
allergic reaction to any other neuraminidase inhibitor (zanamivir or oseltamivir) or any ingredient of peramivir will not receive authorized peramivir. (See Fact Sheet for Health Care Providers; Product Description.)
C.7. Health Care Providers will only make available additional written information relating to the emergency use of authorized
peramivir to the extent that it is consistent with and does not exceed the terms of this letter of authorization (including the facts
sheets referenced in Section II of this letter).
C.8. Heath Care Providers will make available to FDA and/or CDC upon request any records maintained in connection with this
letter. Upon request, Health Care Providers will report to FDA and/or CDC information with respect to the emergency use of authorized peramivir.
D. BioCryst
D.1. BioCryst will post on its website the following statement: ‘‘For information about the FDA-authorized emergency use of
peramivir, please see www.cdc.gov/h1n1flu/eua.’’
D.2. BioCryst will distribute authorized peramivir only to CDC and/or its designees subject to the terms and conditions of this letter.
D.3 BioCryst will contact FDA concerning the need for any FDA review and approval before any changes are made to the manufacturing, packaging, and labeling processes authorized as of the date of this letter.
D.4. BioCryst (or anyone acting on behalf of BioCryst) will not represent authorized peramivir in a promotional context or otherwise promote authorized peramivir.
D.5. BioCryst will make available to FDA and (as reasonably appropriate) CDC upon request any records maintained in connection with this letter. Upon request, BioCryst will report to FDA and/or (as reasonably appropriate) CDC information with respect
to the emergency use of authorized peramivir.
The emergency use of authorized peramivir as described in this letter of authorization must comply with the conditions above and
all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
srobinson on DSKHWCL6B1PROD with NOTICES
1 FDA is authorizing the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and
pediatric patients as described in the scope section of this letter (Section II of this letter). For ease of reference, this letter of authorization will also use the term ‘‘authorized peramivir.’’
2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
3 The activities with respect to authorized peramivir refer to requesting, preparing, prescribing, and/or administering authorized
peramivir, unless otherwise specified.
Dated: October 26, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26291 Filed 10–30–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
VerDate Nov<24>2008
17:03 Oct 30, 2009
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PO 00000
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SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
E:\FR\FM\02NON1.SGM
02NON1
56650
Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Novel Inhibitors of Interleukin-6 for
Kaposi Sarcoma Therapy
Description of Invention: The cancer
therapy market is forecast to reach $40.9
billion by 2012. With
immunosuppressant drugs set for
phenomenal growth over the next six
years, revenues could reach $26.2
billion by 2014. One market for which
there is a significant need for new
therapies is cancers induced by Kaposi
Sarcoma-associated Herpesvirus
(KSHV).
Researchers at the National Cancer
Institute have identified novel nucleic
acid sequences that act through a
unique mechanism to inhibit the
expression of interleukin-6 that occurs
in cancerous cells transformed by KSHV
infection and which promotes cancer
cell proliferation. The researchers have
also identified a key protein involved in
the mechanism which could be
inhibited using antibodies.
These inhibitors are likely to be
accepted in the marketplace because
their unique specificity in mechanism of
action gives them a distinct advantage
over the mechanisms of other existing
therapies.
Applications:
• Therapies for KSHV-induced
cancers (Kaposi sarcoma (KS), primary
effusion lymphoma (PEL)) and
multicentric Castleman disease (MCD).
• Therapies for KSHV infection.
• Therapies for interleukin-6
associated inflammatory diseases.
• Immunosuppression of
interleukin-6.
Advantages:
• Utilizes available small-molecule
and antibody technologies.
• Targets a key pathway in
interleukin-6 production.
• Specificity of mechanism of action
may reduce/limit potential side-effects.
Development Status: Pre-clinical.
Inventors: Zhi-Ming Zheng and JeongGu Kang (NCI).
Relevant Publication: JG Kang et al.
KSHV infection induces IL6 expression
by interrupting microRNA-mediated
translational repression. Submitted.
VerDate Nov<24>2008
17:03 Oct 30, 2009
Jkt 220001
Patent Status: U.S. Provisional
Application No. 61/241,678 filed 11 Sep
2009 (HHS Reference No. E–296–2009/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Patrick P. McCue,
Ph.D.; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Center for Cancer Research,
HIV and AIDS Malignancy Branch, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
technology. Please contact John D.
Hewes, Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Prediction of Immune Response
Outcomes to Keyhole Limpet
Hemocyanin (KLH) Treatment
Description of Invention: Keyhole
limpet hemocyanin (KLH) is a large,
heterogeneous glycosylated protein that
is being tested as an immunotherapeutic
agent to treat bladder cancer. KLH is
approved for use in parts of Europe and
Asia and is in late stage clinical trials in
the U.S. KLH immunotherapy however
only produces a clinical response in
approximately 40–50% of patients, and
currently there is no good method to
select the subset of patients that will
respond best to this treatment. This
invention revealed that levels of certain
serum antibodies can be used as
biomarkers to predict the magnitude of
the antibody response to the
glycoprotein KLH. The best correlations
are obtained by using a combination of
markers. Since the size of the antibody
response correlates with the clinical
response, the invention provides a
method to select the subset of patients
that may benefit most from this form of
treatment.
Applications and Market:
• It is estimated that 70,980 men and
women will be diagnosed with and
14,330 men and women will die of
cancer of the urinary bladder in 2009;
• Biomarkers for immune response
outcomes to keyhole limpet hemocyanin
(KLH);
• Patient selection based on
prediction of response.
Development Status: Pre-clinical stage
of development.
Inventors: Jeffrey C. Gildersleeve and
Oyindasola Oyelaran (NCI).
Publications: Manuscript accepted,
Proteomics—Clinical Applications.
Patent Status: U.S. Provisional
Application No. 61/243,849 filed 18 Sep
2009, (HHS Reference No. E–295–2009/
0–US–01).
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Licensing Status: Available for
licensing.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Center for Cancer Research,
Laboratory of Medicinal Chemistry, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize a
set of serum antibody-based biomarkers
for personalized cancer immunotherapy
using keyhole limpet hemocyanin
(KLH). Please contact John D. Hewes,
Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: October 26, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–26313 Filed 10–30–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastroenterology
and Urology Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 11, 2009, from 8 a.m.
to 5 p.m.
Location: Holiday Inn, Ballroom, Two
Montgomery Village Ave., Gaithersburg,
MD.
Contact Person: Megan M. Mickal,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD, 20993, 301–796–5590, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512523. Please call the Information
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Notices]
[Pages 56649-56650]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
[[Page 56650]]
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Novel Inhibitors of Interleukin-6 for Kaposi Sarcoma Therapy
Description of Invention: The cancer therapy market is forecast to
reach $40.9 billion by 2012. With immunosuppressant drugs set for
phenomenal growth over the next six years, revenues could reach $26.2
billion by 2014. One market for which there is a significant need for
new therapies is cancers induced by Kaposi Sarcoma-associated
Herpesvirus (KSHV).
Researchers at the National Cancer Institute have identified novel
nucleic acid sequences that act through a unique mechanism to inhibit
the expression of interleukin-6 that occurs in cancerous cells
transformed by KSHV infection and which promotes cancer cell
proliferation. The researchers have also identified a key protein
involved in the mechanism which could be inhibited using antibodies.
These inhibitors are likely to be accepted in the marketplace
because their unique specificity in mechanism of action gives them a
distinct advantage over the mechanisms of other existing therapies.
Applications:
Therapies for KSHV-induced cancers (Kaposi sarcoma (KS),
primary effusion lymphoma (PEL)) and multicentric Castleman disease
(MCD).
Therapies for KSHV infection.
Therapies for interleukin-6 associated inflammatory
diseases.
Immunosuppression of interleukin-6.
Advantages:
Utilizes available small-molecule and antibody
technologies.
Targets a key pathway in interleukin-6 production.
Specificity of mechanism of action may reduce/limit
potential side-effects.
Development Status: Pre-clinical.
Inventors: Zhi-Ming Zheng and Jeong-Gu Kang (NCI).
Relevant Publication: JG Kang et al. KSHV infection induces IL6
expression by interrupting microRNA-mediated translational repression.
Submitted.
Patent Status: U.S. Provisional Application No. 61/241,678 filed 11
Sep 2009 (HHS Reference No. E-296-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The NCI Center for Cancer
Research, HIV and AIDS Malignancy Branch, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact John D. Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Prediction of Immune Response Outcomes to Keyhole Limpet Hemocyanin
(KLH) Treatment
Description of Invention: Keyhole limpet hemocyanin (KLH) is a
large, heterogeneous glycosylated protein that is being tested as an
immunotherapeutic agent to treat bladder cancer. KLH is approved for
use in parts of Europe and Asia and is in late stage clinical trials in
the U.S. KLH immunotherapy however only produces a clinical response in
approximately 40-50% of patients, and currently there is no good method
to select the subset of patients that will respond best to this
treatment. This invention revealed that levels of certain serum
antibodies can be used as biomarkers to predict the magnitude of the
antibody response to the glycoprotein KLH. The best correlations are
obtained by using a combination of markers. Since the size of the
antibody response correlates with the clinical response, the invention
provides a method to select the subset of patients that may benefit
most from this form of treatment.
Applications and Market:
It is estimated that 70,980 men and women will be
diagnosed with and 14,330 men and women will die of cancer of the
urinary bladder in 2009;
Biomarkers for immune response outcomes to keyhole limpet
hemocyanin (KLH);
Patient selection based on prediction of response.
Development Status: Pre-clinical stage of development.
Inventors: Jeffrey C. Gildersleeve and Oyindasola Oyelaran (NCI).
Publications: Manuscript accepted, Proteomics--Clinical
Applications.
Patent Status: U.S. Provisional Application No. 61/243,849 filed 18
Sep 2009, (HHS Reference No. E-295-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity: The NCI Center for Cancer
Research, Laboratory of Medicinal Chemistry, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize a set of serum
antibody-based biomarkers for personalized cancer immunotherapy using
keyhole limpet hemocyanin (KLH). Please contact John D. Hewes, Ph.D. at
301-435-3121 or hewesj@mail.nih.gov for more information.
Dated: October 26, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-26313 Filed 10-30-09; 8:45 am]
BILLING CODE 4140-01-P
