NABI BIOPHARMACEUTICALS
ARRA funding, released in September, will help pay for the first phase III trial ever of a smoking cessation vaccine, NicVAX, designed to help people quit and remain abstinent. Given Fast Track Designation by the U.S. Food and Drug Administration, NicVAX has already successfully completed a proof-of-concept trial; successful completion of the phase III study will bring the vaccine closer to final approval.
Like other vaccines, NicVAX works by stimulating the immune system to produce antibodies, in this case, to the drug nicotine. Normally, nicotine (a small molecule) travels quickly through the lungs into the bloodstream and then the brain. However, when nicotine molecules are bound to antibodies, they become too large to enter the brain, thus subverting the rewarding effects of the drug. Results to date show that smokers who achieved high antibody levels had higher rates of quitting and longer durations of abstinence than those given placebo. The vaccine was also well tolerated, with few side effects.
Remaining abstinent is unquestionably the most challenging part of quitting smoking given that withdrawal symptoms, environmental cues, and stress can all trigger relapse. A vaccine that limits nicotine's ability to enter the brain and continues to be effective for 6-12 months following vaccination will give smokers a fighting chance to end the addiction/relapse cycle that plagues the great majority of those trying to quit.
| AWARD OVERVIEW |
| Award Number |
1RC2DA028837-01 |
Funding Agency |
Department of Health and Human Services |
| Total Award Amount |
$10,007,124 |
Project Location - City |
Rockville |
| Award Date |
09/30/2009 |
Project Location - State |
MD |
| Project Status |
Completed |
Project Location - Zip |
20852-1834
|
| Jobs Reported |
0.00 |
Congressional District |
08 |
| Project Location - Country |
US |
|
|
Recipient Information
(Grants)
| Recipient Information (Grants) |
|
Recipient Name
|
NABI BIOPHARMACEUTICALS |
| Recipient DUNS Number |
048862726
|
| Recipient Address |
12276 WILKINS AVE |
| Recipient City |
ROCKVILLE |
| Recipient State |
Maryland |
| Recipient Zip |
20852-1834 |
| Recipient Congressional District |
08 |
| Recipient Country |
USA |
Required to Report Top 5
Highly Compensated Officials |
No |
Projects and Jobs Information
| Projects and Jobs Information |
| Project Title |
PHASE III STUDY OF A NICOTINE VACCINE FOR SMOKING CESSATION |
| Project Status |
Completed |
| Final Project Report Submitted |
Yes |
| Project Activities Description |
Smoking Cessation |
| Quarterly Activities/Project Description |
Conduct of a phase III clinical trial of a smoking cessation vaccine. |
| Jobs Created |
0.00 |
| Description of Jobs Created |
A total of zero (0) FTE jobs were created or retained during the third quarter of 2011. |
Purchaser Information
(Grants)
| Purchaser Information |
| Contracting Office ID |
Not Reported |
| Contracting Office Name |
Not Available |
| Contracting Office Region |
Not Available |
| TAS Major Program |
75-0908 |
| Award Information |
| Award Date |
09/30/2009 |
| Award Number |
1RC2DA028837-01 |
| Order Number |
|
| Award Type |
Grants |
| Funding Agency ID |
75 |
| Funding Agency Name |
Department of Health and Human Services |
| Funding Office Name |
Not Available |
| Awarding Agency ID |
75 |
| Awarding Agency Name |
Department of Health and Human Services |
| Amount of Award |
$10,007,124 |
| Funds Invoiced/Received |
$10,007,124 |
| Expenditure Amount |
$10,007,124 |
| Infrastructure Expenditure Amount |
$0 |
| Infrastructure Purpose and Rationale |
Not Reported |
| Infrastructure Point of Contact Name |
Not Reported |
| Infrastructure Point of Contact Email |
Not Reported |
| Infrastructure Point of Contact Phone |
Not Reported |
| Infrastructure Point of Contact Address |
Not Reported |
| Infrastructure Point of Contact City |
Not Reported |
| Infrastructure Point of Contact State |
Not Reported |
| Infrastructure Point of Contact Zip |
Not Reported |
Product or Service Information
(Grants)
| Product or Service Information |
| Primary Activity Code |
F08.08 |
| Activity Description |
Smoking Cessation |
| Sub-Awards Information |
| Sub-awards to Organizations |
0 |
| Sub-award Amounts to Organizations |
$0 |
| Sub-Awards to Individuals |
0 |
| Sub-Award Amounts to Individuals |
$0 |
| Number of Sub-awards less than $25,000/award |
0 |
| Amount of Sub-awards less than $25,000/award |
$0 |
| Number of payments to vendors greater than $25,000 |
102 |
| Total Amount of payments to vendors greater than $25,000/award |
$4,550,398 |
| Number of payments to vendors less than $25,000/award |
265 |
| Total Amount of payments to vendors less than $25,000/award |
$1,648,510 |
Affiliated Research Institute - Award Number 1RC2DA028837-01 - Affiliated Research Institute
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
Not reported |
| Vendor HQ Zip Code + 4 |
92108-1605 |
| Vendor Name |
Affiliated Research Institute |
| Product and Service Description |
Patient study visit Payments |
| Payment Amount |
$25,956 |
Affiliated Research Institute - Award Number 1RC2DA028837-01 - Affiliated Research Institute
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
Not reported |
| Vendor HQ Zip Code + 4 |
92108-1605 |
| Vendor Name |
Affiliated Research Institute |
| Product and Service Description |
Patient study visit Payments |
| Payment Amount |
$26,208 |
Affiliated Research Institute - Award Number 1RC2DA028837-01 - Affiliated Research Institute
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
Not reported |
| Vendor HQ Zip Code + 4 |
92108-1605 |
| Vendor Name |
Affiliated Research Institute |
| Product and Service Description |
Patient study visit Payments |
| Payment Amount |
$27,905 |
Central Kentucky Research Associates, Inc. - Award Number 1RC2DA028837-01 - Central Kentucky Research Associates, Inc.
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
611210572 |
| Vendor HQ Zip Code + 4 |
|
| Vendor Name |
Central Kentucky Research Associates, Inc. |
| Product and Service Description |
Patient Payments |
| Payment Amount |
$26,292 |
Central Kentucky Research Associates, Inc. - Award Number 1RC2DA028837-01 - Central Kentucky Research Associates, Inc.
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
611210572 |
| Vendor HQ Zip Code + 4 |
|
| Vendor Name |
Central Kentucky Research Associates, Inc. |
| Product and Service Description |
Patient Payments |
| Payment Amount |
$29,080 |
Central Kentucky Research Associates, Inc. - Award Number 1RC2DA028837-01 - Central Kentucky Research Associates, Inc.
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
611210572 |
| Vendor HQ Zip Code + 4 |
|
| Vendor Name |
Central Kentucky Research Associates, Inc. |
| Product and Service Description |
Patient Payments |
| Payment Amount |
$29,352 |
Central Kentucky Research Associates, Inc. - Award Number 1RC2DA028837-01 - Central Kentucky Research Associates, Inc.
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
611210572 |
| Vendor HQ Zip Code + 4 |
|
| Vendor Name |
Central Kentucky Research Associates, Inc. |
| Product and Service Description |
Patient Payments |
| Payment Amount |
$37,877 |
Central Kentucky Research Associates, Inc. - Award Number 1RC2DA028837-01 - Central Kentucky Research Associates, Inc.
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
611210572 |
| Vendor HQ Zip Code + 4 |
40509-2500 |
| Vendor Name |
Central Kentucky Research Associates, Inc. |
| Product and Service Description |
Patient study visit Payments |
| Payment Amount |
$41,427 |
Central Kentucky Research Associates, Inc. - Award Number 1RC2DA028837-01 - Central Kentucky Research Associates, Inc.
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
611210572 |
| Vendor HQ Zip Code + 4 |
40509-2500 |
| Vendor Name |
Central Kentucky Research Associates, Inc. |
| Product and Service Description |
Patient study visit Payments |
| Payment Amount |
$57,787 |
Clinical Research Associates of Tidewater - Award Number 1RC2DA028837-01 - Clinical Research Associates of Tidewater
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
541282982 |
| Vendor HQ Zip Code + 4 |
23507-1901 |
| Vendor Name |
Clinical Research Associates of Tidewater |
| Product and Service Description |
Subject visits per Clinical Investigation Agreement |
| Payment Amount |
$56,260 |
Clinical Research Associates of Tidewater - Award Number 1RC2DA028837-01 - Clinical Research Associates of Tidewater
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
541282982 |
| Vendor HQ Zip Code + 4 |
23507-1901 |
| Vendor Name |
Clinical Research Associates of Tidewater |
| Product and Service Description |
Subject visits per Clinical Investigation Agreement |
| Payment Amount |
$43,705 |
Clinical Research Associates of Tidewater - Award Number 1RC2DA028837-01 - Clinical Research Associates of Tidewater
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
790934285 |
| Vendor HQ Zip Code + 4 |
23507-1901 |
| Vendor Name |
Clinical Research Associates of Tidewater |
| Product and Service Description |
Clinical study investigator site subject visits per Clinical Investigation Agreement |
| Payment Amount |
$70,321 |
Clinical Research Associates of Tidewater - Award Number 1RC2DA028837-01 - Clinical Research Associates of Tidewater
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
541282982 |
| Vendor HQ Zip Code + 4 |
23507-1901 |
| Vendor Name |
Clinical Research Associates of Tidewater |
| Product and Service Description |
Subject visits per Clinical Investigation Agreement and advertising reimbursement. |
| Payment Amount |
$103,516 |
Clinical Research Associates of Tidewater - Award Number 1RC2DA028837-01 - Clinical Research Associates of Tidewater
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
541282982 |
| Vendor HQ Zip Code + 4 |
23507-1901 |
| Vendor Name |
Clinical Research Associates of Tidewater |
| Product and Service Description |
Subject visits per Clinical Investigation Agreement |
| Payment Amount |
$29,272 |
Clinical Research Associates of Tidewater - Award Number 1RC2DA028837-01 - Clinical Research Associates of Tidewater
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
541282982 |
| Vendor HQ Zip Code + 4 |
23507-1901 |
| Vendor Name |
Clinical Research Associates of Tidewater |
| Product and Service Description |
Subject visits per Clinical Investigation Agreement |
| Payment Amount |
$28,115 |
Hopkins Johns University - Award Number 1RC2DA028837-01 - Hopkins Johns University
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
001910777 |
| Vendor HQ Zip Code + 4 |
21218 |
| Vendor Name |
Hopkins Johns University |
| Product and Service Description |
Interim Payment |
| Payment Amount |
$28,605 |
Hopkins Johns University - Award Number 1RC2DA028837-01 - Hopkins Johns University
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
001910777 |
| Vendor HQ Zip Code + 4 |
21218 |
| Vendor Name |
Hopkins Johns University |
| Product and Service Description |
Interim Payment |
| Payment Amount |
$30,952 |
Hopkins Johns University - Award Number 1RC2DA028837-01 - Hopkins Johns University
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
001910777 |
| Vendor HQ Zip Code + 4 |
21218 |
| Vendor Name |
Hopkins Johns University |
| Product and Service Description |
Clinical study investigator site quarterly payment for protocol implementation/activities |
| Payment Amount |
$27,101 |
Hopkins Johns University - Award Number 1RC2DA028837-01 - Hopkins Johns University
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
001910777 |
| Vendor HQ Zip Code + 4 |
21218 |
| Vendor Name |
Hopkins Johns University |
| Product and Service Description |
Data management, programming, statistical analysis and medical writing, database maintenance services. |
| Payment Amount |
$28,375 |
Hopkins Johns University - Award Number 1RC2DA028837-01 - Hopkins Johns University
| Award Number |
1RC2DA028837-01 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
001910777 |
| Vendor HQ Zip Code + 4 |
21218 |
| Vendor Name |
Hopkins Johns University |
| Product and Service Description |
Data management, programming, statistical analysis and medical writing, database maintenance services. |
| Payment Amount |
$28,375 |
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| Location Information |
| Latitude, Longitude |
39º 3' 29",
-77º 6' 46" |
| Congressional District |
08 |
| Address 1 |
12276 Wilkins Avenue |
| Address 2 |
|
| City |
Rockville |
| County |
Montgomery |
| State |
MD |
| Zip |
20852-1834 |
|
 |