Navigation Links
Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE(R) With the FDA After Successful End of Phase II Meeting
Date:3/3/2009

KVISTGAARD, Denmark, March 3 /PRNewswire-FirstCall/ -- Following the completion of the Phase II clinical development of IMVAMUNE(R), a third-generation smallpox vaccine, Bavarian Nordic has held an end of Phase II meeting with the FDA to discuss the Phase III development. The meeting was a success and there was an open and highly constructive discussion with the FDA.

This meeting represented the first ever formal discussions with the agency to license a vaccine under the new legislation of the animal rule - a new regulatory path which allows the efficacy of products for indications like smallpox to be established in suitable animal efficacy models. This marks a major regulatory milestone in the successful development of IMVAMUNE(R).

The animal efficacy models and phase III protocol have essentially been agreed with the agency - outlining a clear path for licensure of IMVAMUNE(R). Once all protocols have been agreed with the FDA a Vaccines Related Biological Product Advisory Committee (VRBPAC) will be scheduled to ratify the license strategy. This exceptional review path will likely push the initiation of the Phase III studies into late 2010, leading to the submission of a BLA in 2013.

The outcome of the meeting has no impact on the delivery of vaccines to the Strategic National Stockpile (SNS) under the RFP-3 contract with the US government, which is still expected to be initiated in 2009.

In clinical trials to-date, IMVAMUNE(R) has shown to be safe and well tolerated in more than 2,400 people including more than 900 immune compromised people, either infected with HIV or diagnosed with atopic dermatitis. These clinical studies have demonstrated that IMVAMUNE(R) induces a fast and strong immune response, which is comparable to that induced by traditional smallpox vaccines. However, the efficacy of IMVAMUNE(R) cannot be established in the clinic, because smallpox no longer exist
'/>"/>

SOURCE Bavarian Nordic A/S
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Bavarian Nordics Case Against Oxford BioMedica
2. Bavarian Nordic Receives USD 25 Million Milestone Payment After Submission of Important IMVAMUNE(R) Data to The U.S. Health Authorities
3. Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008
4. Bavarian Nordic Update - 2007 Annual Results, IMVAMUNE(R) Delivery Contract, Strategy Process
5. Bavarian Nordic Receives $50 Million Advance Payment from HHS for Fulfilling Contract Milestones
6. The Omega-3 Industry Leader, Croda Health Care, selects Neptune Technologies Ingredients for New Essentially Brand
7. Millipore Launches an Interactive Biological Pathway Tool Using GeneGos Manually Curated Pathway Maps
8. Cardiovascular Side Effects of Pioglitazone and Rosiglitazone Linked to Vascular and Energy Pathways by Genomas Clinical Study
9. GEN Reports Growing Focus on PI3-Kinase Pathway in Cancer Research
10. Debiopharm and Aurigene Sign Licensing Agreement for the Development and Commercialisation of Debio 0617, a Novel Inhibitor of an Undisclosed Oncology Pathway
11. Frost & Sullivan Awards Genpathway 2008 Healthcare Innovation Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... According to Jeff Howell, Partner of Nidea Corporate ... development in Downtown Toronto is expanding at a blistering ... storeys of new development last week (including three new ... the Toronto skyline for the foreseeable future in a ... new development. , As the Toronto city council met ...
(Date:9/15/2014)... UPTON, NYHeat drives classical phase transitionsthink solid, ... happen when the temperature drops. If phase ... where quantum mechanics reigns, subtle fluctuations can ... from the U.S. Department of Energy,s Brookhaven ... explored this frigid landscape of absolute zero ...
(Date:9/15/2014)... United States (PRWEB) September 16, 2014 ... Inhibitors, Cancer Vaccines, and Adoptive T-cell Therapies is ... This report focuses on the three principal types ... of research and development in cancer immunotherapy (which ... inhibitors, Therapeutic anticancer vaccines and Adoptive cellular immunotherapy. ...
(Date:9/15/2014)... SAN JOSE, Calif. , Sept. 15, 2014 ... for Proposals (RFP) for flexible, printed product demonstrators ... conducts a two-stage RFP process with pre-proposals due ... in January 2015.  Funds for proposals ultimately selected ... (ARL) and have a significant cost share by ...
Breaking Biology Technology:ITRA Global Reports Downtown Toronto Real Estate Development is in High Gear 2ITRA Global Reports Downtown Toronto Real Estate Development is in High Gear 3Elusive quantum transformations found near absolute zero 2Elusive quantum transformations found near absolute zero 3Cancer Immunotherapy Market: Immune Checkpoint Inhibitors, Cancer Vaccines, and Adoptive T-cell Therapies 2Cancer Immunotherapy Market: Immune Checkpoint Inhibitors, Cancer Vaccines, and Adoptive T-cell Therapies 3Cancer Immunotherapy Market: Immune Checkpoint Inhibitors, Cancer Vaccines, and Adoptive T-cell Therapies 4Cancer Immunotherapy Market: Immune Checkpoint Inhibitors, Cancer Vaccines, and Adoptive T-cell Therapies 5FlexTech Alliance Issues 2015 Request for Proposals in Flexible, Printed Electronics 2
... (OTC Bulletin Board: MNCN), an innovative, global wellness solutions company, ... the OTC Bulletin Board under the symbol "MNCN." The Company,s ... , "The move to the OTC Bulletin Board will ... investors and help improve our trading liquidity," said Patrick Sheridan, ...
... DOR BioPharma, Inc. (OTC Bulletin Board: DORB) ... announced today that it has received a European ... technology for the improved oral delivery of drugs. ... Reverse Micelle Compositions and Uses Thereof" covers lipid ...
... July 8 iZumi Bio, Inc. and Pierian, Inc. ... company, iPierian, Inc. Building on the iZumi infrastructure and ... cellular reprogramming to change the paradigm of drug discovery. ... development of new therapeutics using induced pluripotent stem (iPS) ...
Cached Biology Technology:DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology 2DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology 3DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology 4DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology 5iZumi Bio and Pierian Merge to Form iPierian to Advance Cellular Reprogramming 2iZumi Bio and Pierian Merge to Form iPierian to Advance Cellular Reprogramming 3iZumi Bio and Pierian Merge to Form iPierian to Advance Cellular Reprogramming 4iZumi Bio and Pierian Merge to Form iPierian to Advance Cellular Reprogramming 5iZumi Bio and Pierian Merge to Form iPierian to Advance Cellular Reprogramming 6
(Date:9/16/2014)... XL pipeline (KXL) would likely increase oil sands extraction, ... by the non-profit organization Near Zero. The results are ... and includes both supporters and opponents of the pipeline. ... could lead to significantly higher greenhouse gas emissions, with ... , "This report examines three main scenarios discussed ...
(Date:9/16/2014)... DURHAM, N.H. From the salmon-rich waters of Southeast ... Coast to Downeast Maine,s lobster, lumber and tourist towns, ... their views about coastal environments divide along political lines. ... University of New Hampshire sociologists published this month in ... "We found a lot of environment-related differences from place ...
(Date:9/16/2014)... 2014  Valencell, Inc., a leader in performance biometric ... 18 "Showcase Companies" representing North Carolina,s ... Tech Venture Conference on September 16-17 th at ... Raleigh, North Carolina . Valencell,s President ... during the "Digital Health Spotlight Sector" on how the ...
Breaking Biology News(10 mins):Keystone XL would likely raise oil sands production and greenhouse gas emissions 2Politics divide coastal residents' views of environment, UNH research finds 2Politics divide coastal residents' views of environment, UNH research finds 3Valencell, Inc. Selected as 'Showcase Company' at CED Tech Venture Conference 2014 2
... researchers will embark on an unconventional approach to DNA research ... for the ideas to explore scientific frontiers. Chemist Patrick ... were the youngest researchers chosen among several hundred applicants. They ... a senior scientist, growth biology Prof. Rod Hill. The ...
... A long-term field and DNA study by the ... University of Miami, Field Museum of Chicago and others ... Bimini islands, Bahamas, tend to stay near their coastal ... typically focuses on baby sharks confined to shallow habitats, ...
... produced more cheaply using nanoparticle "inks" that allow them ... sides of buildings or rooftops to absorb electricity-producing sunlight. ... chemical engineer, is hoping to cut costs to one-tenth ... process for solar cells gas-phase deposition in a ...
Cached Biology News:Idaho researchers win grant to explore DNA frontier 2Scientists shed new light on behavior of shark 'tweens' and 'teenagers' 2Scientists shed new light on behavior of shark 'tweens' and 'teenagers' 3Lower-cost solar cells to be printed like newspaper, painted on rooftops 2
All serum is collected from U.S.D.A. fryers and broilers. Pricing: $15/unit for 1 - 10 units; $12/unit for 11 - 50 units...
Whole blood is collected from healthy pigs (mixed breed, either sex) at the time of slaughter, refrigerated within 6 hours, processed within 24 hours and frozen at -20ºC....
Human/Mouse/Rat Keap1 MAb (Clone 333116) Protein Family: Transcription Factor Regulators...
Collected from sexually mature, mixed sex, mixed breed guinea pigs. Pricing: $120/unit for 1 - 10 units...
Biology Products: