23 nov: USA: Ordreindgang på varige goder overrasker markant positivt
23 nov: Bavarian melder om fuldt hus i studie af koppevaccine
23-11-2016 15:23:05

Bavarian Nordic Completes Enrollment of Phase 3 Non-inferiority Study of IMVAMUNE® Smallpox Vaccine

Relateret indhold
16 nov - 
Torsdagens aktier: Genmab og GN forrest i bedste dag si..
16 nov - 
Torsdagens aktier: Genmab og GN førte an i bedste C20-d..
16 nov - 
Aktier/middag: Genmab og GN topper grønt C20 - børsdebu..
Relateret debat
11:26 - 
Æren som klovn i cirkus EI kan du ikke løb..
11:10 - 
Jeg kritisere også Pandora og Vestas som du kunne læse ..
11:03 - 
Baron Von Pladderhoved har tabt mange penge på Ba..

  • Second and final Phase 3 study to support a U.S. registration of liquid-frozen IMVAMUNE

COPENHAGEN, Denmark, November 23, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the completion of enrollment of a Phase 3 clinical study designed to demonstrate non-inferiority between its investigational, non-replicating smallpox vaccine, IMVAMUNE and ACAM2000, the current U.S. licensed, and replicating smallpox vaccine. This is the second and final study agreed with the U.S. Food and Drug Administration (FDA) to support the registration of liquid-frozen IMVAMUNE. The first study, a lot consistency study in 4,000 healthy individuals, was successfully completed in 2015.

The Phase 3 non-inferiority study enrolled 440 subjects at a U.S. military garrison in South Korea led by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in collaboration with the U.S. Defense Health Agency. All subjects will have completed the study within second quarter of 2017, and top line data is anticipated in the second half of 2017.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: "Completion of enrolment of this study represents a significant milestone in the collaboration between Bavarian Nordic, and multiple federal agencies. IMVAMUNE has served as the cornerstone for our Company over the past decade and we will continue to work with the U.S. Government to meet their stated goal of protecting 66 million Americans who are in need of a safer smallpox vaccine. We look forward reporting these data and working with the authorities in the process towards U.S. licensure."

Bavarian Nordic has to-date delivered 28 million doses of liquid-frozen IMVAMUNE to the U.S. Strategic National Stockpile.

Federal funding acknowledgments

The Phase 3 study comparing the safety and immunogenicity of IMVAMUNE to ACAM2000 has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200700034C

About Bavarian Nordic

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company's live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its partner Janssen are developing an Ebola vaccine regimen, which has been fast-tracked, with the backing of worldwide health authorities, and a vaccine for the prevention and treatment of HPV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

Forward-looking statements

This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contacts

Rolf Sass Sørensen

Vice President Investor Relations (EU)

Tel: +45 61 77 47 43

Seth Lewis

Vice President Investor Relations (US)

Tel: +1 978 341 5271

Company Announcement no. 30 / 2016

2016-30-en


This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Bavarian Nordic A/S via Globenewswire

Vedhæftet fil: 771658.pdf

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
19 nov
BAVA
Som lovet har der været ro fra mine kommentar siden på denne i en lange periode. Jeg tror på der vil..
11
16 nov
BAVA
Lad nu være med at falde til hans niveau.
6
16 nov
BAVA
Baronen er til børnefødselsdag hos EddieC. Lige nu leger de gæt og grimasser og får cola og popcorn...
6
17 nov
BAVA
Ovenpå gårsdagens stigning på flotte 8,56%, falder kursen idag med 2,88% i et generelt surt marked, ..
4
18 nov
BAVA
Jeg håber ikke at der er nogle her på siden, der følger det vrøvl der kommer fra din person.
2
09:39
BAVA
Enkommentar, jeg har haft samme tanke, .. BMS er iøjeblikket ved at kigge resultaterne igennem, og d..
1
18 nov
BAVA
bakkah: syntes dit indlag er fint, har solgt i 257 og køber igen 240, tror den siver igen. det var j..
1
16 nov
BAVA
Du udleverer dig selv Baron... Gang på gang på gang!
1
16 nov
BAVA
Næmli - status quo for mig - ind i 243 ud i 236 - og så ind i 232 og ud i 240 - resultat - NUL men i..
1
16 nov
BAVA
Ja, august har ret. Det nemmeste er dog i virkeligheden at ignorere ham. De har et fremragende ords..
1

NTR tror på millionoverskud efter fremgang i shippingforretning

20-11-2017 15:06:36
Selv om der bliver holdt igen med investeringerne i shippingbranchen, har NTR Holding kunne løfte resultaterne i 2017.Selskabet, der tjener penge på at sælge sikkerhedsudstyr til shippingbranchen via selskabet Daniamant, kommer ud af årets første ni måneder med et overskud før skat på 3,5 mio. kr., hvilket er en stigning fra 0,8 mio. kr. i samme periode året før.Omsætningen er steget til 63,7 mio...

Mærsk/Equita: Sænker kursmål til 13.000 kr. fra 14.000

20-11-2017 14:38:43
Analytikerne i den italienske investeringsbank Equita har sænket anbefalingen af Mærsk-aktien til 13.000 kr. fra 14.000 kr.Det fremgår af Bloomberg News.Anbefalingen "hold" fastholdes.Nedjusteringen lægger ikke hindringer i vejen for en positiv mandag for Mærsk-aktien, der stiger 0,4 pct. for A-aktiens vedkommende til 10.050 kr., mens B-aktien i toppen af C20-indekset løftes 1,0 pct. til 10.370 kr..

Novo/ABM: GLP-1-markedet kan komme i fokus på kapitalmarkedsdag

20-11-2017 10:35:04
Der er lagt op til bred gennemgang af Novo Nordisks forretnings- og udviklingsaktiviteter på selskabets kapitalmarkedsdag tirsdag, og vanen tro næppe nye finansielle målsætninger.Det vurderer analytiker i Alm. Brand Markets Michael Friis Jørgensen forud for tirsdagens investormøde, der i år er henlagt til Måløv.- Jeg kan på ingen måde se Novo gå væk fra sin målsætning om at vokse 5 pct. i gennemsn..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Vestas/Goldman: Skærer knap en tredjedel af kursmålet
2
Aktier/middag: Usikkerhed spøger igen om Vestas og sender aktien ned
3
Vestas skaber frygt blandt underleverandørerne - citat
4
Mandagens aktier: Novo steg på forventning - Vestas ned på usikkerhed
5
Aktier/åbning: Goldman puffer til Vestas i svagt marked

Relaterede aktiekurser

Bavarian Nordic A/S 251,00 -0,6% Fald i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2017  Disclaimer Privatlivspolitik
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
20. november 2017 23:55:58
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20171108.1 - EUROWEB6 - 2017-11-20 23:55:58 - 2017-11-20 23:55:58 - 1 - Website: OKAY