Bavarian Nordic Submits a Marketing Application for its Smallpox Vaccine to the European Medicines Agency
(Thomson Reuters ONE) -
KVISTGAARD, Denmark, March 1, 2012 - Bavarian Nordic A/S (OMX: BAVA) announced
today that it has submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for its smallpox vaccine (IMVAMUNE(®)) that will
be marketed under the trade name IMVANEX(®) in Europe. The MAA has been filed
for consideration under the centralized procedure and following a successful
review could potentially lead to the market authorization of IMVANEX(®) in
Europe (EAA countries) during 2013.
If found acceptable by EMA, IMVANEX(®) will be indicated for active immunization
against smallpox infection and disease in persons 18 years of age and older. The
indication will include individuals with immune deficiencies and skin disorders
such as those who are Human Immunodeficiency Virus (HIV) infected and those
diagnosed with Atopic Dermatitis (AD).
This submission to EMA follows the New Drug Submission (NDS) filed with Health
Canada during 2011, which is currently undergoing the review process and still
expected to result in a market approval for IMVAMUNE(®) in Canada during 2012.
"The submission of the application for Marketing Authorization for IMVANEX(®) in
Europe marks yet an important milestone for the company, and from a regulatory
point of view, things are currently progressing well. We have entered into the
registration phase in both Canada and Europe and if both applications
successfully lead to market approval for IMVAMUNE® / IMVANEX®, this will greatly
expand the market opportunities worldwide beyond the current sales to the US
government.," stated Anders Hedegaard, President & CEO of Bavarian Nordic.
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About IMVAMUNE(®) / IMVANEX(®) - smallpox vaccine candidate
IMVAMUNE(®) is positioned as a new and superior third-generation smallpox
vaccine for protection of the general population (18-55 years old). The likely
use of IMVAMUNE(®) by governments would include: individuals contraindicated for
conventional smallpox vaccines: e.g. individuals with HIV, people with atopic
dermatitis (AD) and members of their households: First-line responders
(military, police, health care workers, etc.) and the general population.
IMVAMUNE(®) has fast-track status with the US authorities and has completed
clinical Phase 2 development. Although unlicensed, the vaccine is already in
production and available for governments globally under their national emergency
rules, due to the need for a safer smallpox vaccine.
In clinical trials to date, more than 3,400 individuals have been vaccinated
with IMVAMUNE(®), which has demonstrated a favourable safety profile. The
vaccinated subjects include almost 1,000 individuals with compromised immune
systems who are currently ineligible for conventional smallpox vaccines.
The development of IMVAMUNE(®) is funded by the US government through contracts
with BARDA (Biomedical Advanced Research and Development Authority) and the NIH
(National Institutes of Health).
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's pipeline targets cancer
and infectious diseases, and includes ten development programs. In oncology, the
company's lead program is PROSTVAC(®), a therapeutic vaccine candidate for
advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial
and is being developed under a collaboration agreement with the National Cancer
Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC(®) has been tested
in nearly 600 patients. In infectious diseases, the company's lead program is
IMVAMUNE(®), a third-generation smallpox vaccine candidate that is being
developed and supplied for emergency use to the U.S. Strategic National
Stockpile under a contract with the U.S. Government. For more information, visit
www.bavarian-nordic.com
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. 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.
201202uk:
http://hugin.info/100065/R/1590315/499579.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1590315]
Unternehmensinformation / Kurzprofil:
Datum: 01.03.2012 - 08:01 Uhr
Sprache: Deutsch
News-ID 120692
Anzahl Zeichen: 5847
contact information:
Town:
Kvistgård
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 163 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Bavarian Nordic Submits a Marketing Application for its Smallpox Vaccine to the European Medicines Agency"
steht unter der journalistisch-redaktionellen Verantwortung von
Bavarian Nordic A/S (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
