Bavarian Nordic Announces Submission of European Marketing Authorisation Applications for Investigational Ebola Vaccine Regimen
COPENHAGEN, Denmark, November 7, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that its partner Janssen Pharmaceutical Companies of Johnson & Johnson have submitted Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) seeking licensure for an investigational Ebola vaccine regimen for the prevention of Ebola Virus Disease (EVD) caused by Zaire ebolavirus. Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN® Filo). In September 2019, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted an Accelerated Assessment, which will shorten the review time for these applications.
The vaccine regimen includes Ad26.ZEBOV as the first dose, which is based on Janssen’s AdVac® technology, and MVA-BN® Filo as the second dose, which is based on Bavarian Nordic’s MVA-BN® technology and is administered approximately eight weeks later. The MAAs are supported by data from Phase 1, 2 and 3 clinical studies evaluating the safety and immunogenicity of the vaccine regimen in adults and children, preclinical studies, and immunobridging analyses. To date, more than 6,500 volunteers across the U.S., Europe and Africa have participated in over 10 clinical studies of the vaccine.
Janssen also has ongoing discussions with the U.S. Food and Drug Administration (FDA) to define the required data set for filing of the Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway and is also working in collaboration with the World Health Organization (WHO) to enable registration of the Ebola vaccine regimen in African countries.
On October 31, 2019, Janssen announced it will provide up to 500,000 regimens of its investigational vaccine to the Democratic Republic of Congo (DRC) for use in a new clinical trial organized by the DRC government and global health stakeholders in an effort to contain the country’s Ebola outbreak.
“We congratulate Janssen on this important milestone in the development of a much-needed vaccine to fight Ebola, and we are proud to support the process to ensure a successful regulatory review,” said Paul Chaplin, President and CEO of Bavarian Nordic. “We are excited about the prospects of yet another approved product coming from our pipeline, building on our validated MVA-BN platform technology.”
Upon EMA approval of the MVA-BN Filo vaccine, Bavarian Nordic would be eligible to receive a milestone payment of USD 10 million under the license agreement with Janssen.
In 2014, in response to the Ebola epidemic in West Africa, Johnson & Johnson accelerated the development of a preventive Ebola vaccine regimen with multiple global partners across the U.S., Europe and Africa. The regimen (Ad26.ZEBOV, MVA-BN-Filo) uses a combination of two vaccines based on AdVac® technology from Janssen, and MVA-BN® technology from Bavarian Nordic. The first dose primes the immune system, and the second aims to enhance the duration of the immune response. These vaccines both use a viral vector approach, where a virus is genetically modified so that it cannot replicate but is used to safely express key proteins of the target virus, in this case Ebola virus. To date, more than 6,500 individuals across the U.S., Europe and Africa have participated in multiple Janssen-sponsored and partner-led clinical studies. The available clinical data suggest that the vaccine regimen has a favorable safety profile, is well tolerated, and induces robust and durable immune responses against the Ebola virus Zaire strain. – the cause of the DRC outbreak.
Under the agreement with Janssen in 2014, Bavarian Nordic licensed MVA-BN Filo to Janssen and manufactured a significant amount of vaccines, currently stockpiled by Janssen.
The vaccine regimen was developed in a collaborative research program with the NIH and received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases, part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively. Further funding for the Ebola vaccine regimen has been provided in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA under Contract Numbers HHSO100201700013C and HHSO100201500008C.
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative therapies against infectious diseases and cancer. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates intended to unlock the power of the immune system to improve public health with a focus on high unmet medical needs. In addition to our long-standing collaboration with the U.S. government on the development and supply of medical countermeasures, including the only FDA-approved, non-replicating smallpox vaccine, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable benefit-risk profile. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.
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.
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Paddock Circle Advisors (US)
Tel: +1 781 686 9600
Company Announcement no. 23 / 2019
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Bayport Management Limited Quarterly report March 202029.5.2020 22:00:00 CEST | Press release
Please find Bayport Management Limited Quarterly report March 2020 attached. Attachments BML Quarterly Report March 2020BML Quarterly Report March 2020
Ress Life Investments A/S: Ress Life Investments A/S publishes Net Asset Value (NAV)29.5.2020 20:50:00 CEST | Press release
Ress Life Investments Holbergsgade 14, 2 tv DK-1057 Copenhagen K Denmark CVR nr. 33593163 www.resslifeinvestments.com To: Nasdaq Copenhagen Date: 29 May 2020 Corporate Announcement 22/2020 Ress Life Investments A/S publishes Net Asset Value (NAV). Ress Life Investments A/S publishes the Net Asset Value (NAV) per share and performance data as of 15 May 2020. NAV per share in USD: 1955.92 NAV per share in EUR: 1811.38 The performance during the first half of May was 0.01% in USD. The year-to-date net performance is -0.15% in USD. Assets under management (AUM) was 184.6 million US dollars. Questions related to this announcement can be made to the company's AIF-manager, Resscapital AB. Contact person: Gustaf Hagerud firstname.lastname@example.org Tel + 46 8 545 282 27 Note: The terms for subscription of shares, minimum subscription amount and redemption of shares are provided in the Articles of Association, Information Brochure and in the Key Investment Information Document (KIID) availabl
Eastern Property Holdings Limited (EPH):First quarter 2020 Financial Update29.5.2020 19:45:23 CEST | Press release
29 May 2020, Road Town, Tortola, BVI KEY EVENTS In March 2020, the Company received EUR 204.7 million by issuance of subordinated notes to its two largest shareholders at an interest rate of 3.5% p.a. The management intends to use the funds for the acquisition of properties in Western Europe in order to further strengthen the Group’s business and follow its strategy to invest in premium quality income producing commercial property assets in Europe.Arbat sales have been continued: a few more apartments and parking lots were sold in Q1 2020.Leases with the Company’s top tenants (Chanel and Richemont Group) have been extended.As a subsequent event, in April 2020 the Company acquired 89.9% of interest in the Nhow Hotel in Berlin, Germany. The property had been completed in 2010 and comprises approximately 20,160 sqm, including 304 rooms, 86 underground & 39 surface parking spaces, a spa, restaurant and two music studios. FINANCIAL HIGHLIGHTS The Company’s rental properties demonstrate stab
Arion Bank: Transactions of primary insiders / financially connected parties29.5.2020 16:58:35 CEST | Press release
Please see announcements attached. Attachments BBL VII ehfBrekkuás ehf
AB Linas Agro Group performance and financial results for 9-month period of FY 2019/2029.5.2020 16:30:07 CEST | Press release
Consolidated revenue was 9.6 % less and totaled EUR 476 million. Sales volume reached 1.67 million tons of various products and was 3.2% less as compared to previous year. The gross profit reached EUR 27.1 million and was 11,8 % higher than a year before. Consolidated EBITDA was 74 % higher and amounted to EUR 11.8 million. The operating profit was EUR 2.9 million (last year there was an operating loss of EUR 1.2 million). Profit before taxes amounted to EUR 0.67 million (compared to a loss of EUR 3.6 million in the previous year). Net profit attributable to the Group amounted to EUR 0.64 million (previous year there was a loss of EUR 3.5 million). A brief comment by Finance Director Mažvydas Šileika: Trade in grains, oilseeds and feedstuffs has been affected by the pandemic as the borders of the countries were closed, and the value of some stocks that haven’t been sold before quarantine has declined during the quarantine. Sales fell 16% to EUR 305 million. However, the operating profi
Conditions for Riksbank Bid Procedures SEK Municipal Bonds29.5.2020 16:20:00 CEST | Press release
Bid procedure on 2 June 2020, Municipalities and Regions Bonds:Fixed-rate Bonds issued in SEK by Municipalities or Regions with maturity in 2023. The following issuers are accepted for delivery: Borås Kommun Göteborgs Kommun Jönköpings Kommun Nacka Kommun Norrköpings Kommun Skåne Läns Landsting Stockholms Kommun Stockholms Läns Landsting Sundsvalls Kommun Vellinge Kommun Delivery may not be made in Bonds purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Specific terms, i.e. the purchase may not have been made after 22 May 2020.Bids:Bids are made to tel 08-696 69 70 and confirmed in writing by a filled-in Bid form by e-mail to EOL@riksbank.se.Bid date:Tuesday 2 June 2020Bid time:1000-1100 hours (CEST) on the Bid dateRequested volume: (corresponding nominal amount)SEK 750 +/- 750 millionHighest permitted bid volume: (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed