GlobeNewswire

Bavarian Nordic Announces Marketing and Distribution Agreement with Dynavax to Launch HEPLISAV B® Hepatitis B Vaccine in Germany

Share

COPENHAGEN, Denmark, May 27 2021 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) has entered a partnership with Dynavax Technologies Corporation (Nasdaq: DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines for the marketing and distribution of their HEPLISAV B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] Hepatitis B vaccine in Germany with an expected launch in the fourth quarter of 2021.

In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. HEPLISAV B is the only FDA- and EC-approved hepatitis B vaccine with a two-dose schedule for adults that is completed in one month.

HEPLISAV B will complement and strengthen Bavarian Nordic’s commercial portfolio by leveraging its existing marketing and distribution network in Germany, which, in addition to the Company’s own vaccines for rabies and tick-borne encephalitis, also will include Valneva’s vaccines for Japanese Encephalitis and cholera as part of the mutual marketing and distribution agreement entered last year. The strong overlap with the existing target audience within general practitioners, occupational health groups and travel medicine specialists provides a good strategic fit and clear commercial synergies for the dedicated sales force, Bavarian Nordic has established in Germany.

Ryan Spencer, Chief Executive Officer of Dynavax, commented: “We are excited to work with Bavarian Nordic on the commercialization of HEPLISAV B in Germany. Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, hepatitis B can be prevented with effective vaccination. With a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, HEPLISAV B provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.”

Paul Chaplin, President and CEO of Bavarian Nordic, commented: “We are pleased to expand our commercial footprint in the largest EU market by adding a complementary product to our marketing and distribution and we look forward to assisting Dynavax in a successful market entry in Europe later this year.”

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

About HEPLISAV B
HEPLISAV B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV B.

Important EU/EEA Product Information
HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

The use of HEPLISAV B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

For full E.U. Prescribing Information for HEPLISAV B, click here.

Important EU/EEA Safety information
Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.
Immunocompromised persons may have a diminished immune response to HEPLISAV B.

Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

Important U.S. Product Information
HEPLISAV B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

For full U.S. Prescribing Information for HEPLISAV B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV B. Hepatitis B has a long incubation period. HEPLISAV B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing its CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, MVABEA®, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. 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. 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
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

Company Announcement no. 19 / 2021

i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm
ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm
iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf
iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

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

Wood Mackenzie Scales Data Analytics Across the Energy Transition by Adding Quinbrook as a Lens Power Development Partner21.6.2021 13:00:00 CEST | Press release

Lens® decision intelligence platform connects the dots across a rapidly changing energy landscape LONDON/HOUSTON/SINGAPORE, June 21, 2021 (GLOBE NEWSWIRE) -- Wood Mackenzie, the leading provider of commercial intelligence for the world’s natural resources sector, today welcomes Quinbrook Infrastructure Partners as a development partner for the industry-leading Lens decision intelligence platform. With its analytics-ready power and renewables data integrated into a single platform, Lens Power enables organisations to maximise investment opportunities in clean energy and be on the forefront of the energy transition. Wood Mackenzie, a Verisk business (Nasdaq:VRSK), is collaborating with early adopters to design a power solution that provides a holistic understanding of what is happening in the world of energy, allowing organisations to analyse, screen and value assets or companies quickly and confidently to improve profitability and minimise risk. Global Power Generation Assets byEnergy S

Rovio Entertainment, Moomin Characters and Gutsy Animations enter into a long-term partnership21.6.2021 12:30:00 CEST | Press release

Rovio Entertainment Corporation Press Release Rovio Entertainment, Moomin Characters and Gutsy Animations enter into a long-term partnership Iconic Finnish brands will join forces to create joyful content for years to come. Rovio becomes an exclusive partner for Moomin based mobile games. ESPOO - Finland, June 21, 2021- Rovio Entertainment Corporation, the creator of Angry Birds, has entered into a long-term partnership with Moomin Characters and Gutsy Animation. Rovio will have the rights to develop and publish Moomin IP based games for any platform, with exclusive rights for all mobile platforms. Rovio will also become a minority shareholder in Gutsy Animations, the creator of the Moominvalley 3D animation series through an equity investment of 2.5 million euros and a convertible loan of 2.5 million euros. Moomin has a very high brand awareness particularly in Japan, which is one of the biggest gaming markets in the world. The length of the partnership is six years, with a possible e

Incap Corporation: INCAP’S FACTORIES IN INDIA CONTINUE OPERATIONS WITH REDUCED CAPACITY. INCAP’S PREVIOUSLY ANNOUNCED OUTLOOK FOR 2021 REMAINS UNCHANGED.21.6.2021 11:30:00 CEST | Press release

Incap Corporation 21 June 2021 at 12:30 p.m. (EEST) Stock Exchange Release Insider information INCAP’SFACTORIES IN INDIACONTINUE OPERATIONS WITH REDUCED CAPACITY. INCAP’S PREVIOUSLY ANNOUNCED OUTLOOK FOR 2021 REMAINS UNCHANGED. Karnataka state continues the fight against the coronavirus pandemic extending the measures taken to limit for instance social gatherings. The lock-down in Karnataka has been extended until 5 July 2021. However, the state government has given a number of concessions indicating a phased opening up in the coming weeks. Incap’s permission to operate its factories is still in force and the company continues to operate with somewhat reduced capacity following the government guidelines. The closure and the partial operations of the factories in India do not have an impact on the company’s outlook for 2021 published on 21 April 2021. Incap’s previously announced outlook for 2021: Incap estimates that its revenue, operating profit (EBIT) and adjusted operating profit (E

Progress on Brunel share buyback program 202121.6.2021 11:00:00 CEST | Press release

Amsterdam, 21 June 2021 – Brunel International N.V. (Brunel; BRNL), reports the transaction details for the period 14 June 2021 through 18 June 2021 related to its share buyback program announced on 1 June 2021 for an amount up to EUR 1,977,000, and started on 3 June 2021 in order to meet obligations under its performance share plan for senior management (excluding Board of Directors). Detailed information including all individual transactions can be found on https://www.brunelinternational.net/en/share-buyback-program. DateTotal shares repurchasedAverage purchase priceTotal consideration 14/06/2021 8,286 € 11.6138 € 96,231.95 15/06/2021 14,103 € 11.5806 € 163,321.20 16/06/2021 14,861 € 11.5029 € 170,944.60 17/06/2021 10,184 € 11.3922 € 116,018.16 18/06/2021 12,935 € 11.2274 € 145,226.42 Total60,369€ 11.4586€ 691,742.33 This press release contains inside information as meant in clause 7 of the Market Abuse Regulation. Attachment Press Release Share Buyback 2021 progress

Scientific Beta releases new inflation-friendly indices21.6.2021 10:36:33 CEST | Press release

Press Release - Boston, London, Nice, Paris, Singapore, Tokyo, June 21, 2021 Scientific Beta releases new inflation-friendly indices Equity inflation indices are Scientific Beta’s first suite of macroeconomic factor indices Scientific Beta has announced the release of inflation-friendly indices, the Scientific Beta US Inflation indices, its first suite of macroeconomic factor indices. The inflation indices provide long-term equity performance with additional inflation protection compared to a traditional cap-weighted equity index. These indices correspond to a genuinely important subject for institutional investment, because in the event of inflation they procure a higher asset value (surplus) that could offset the impact of inflation on the revenue needs of future pensioners. This capacity to produce strong conditional performance does not result in a high level of tracking error with respect to the cap-weighted benchmark, like with many indices, and ultimately in poor unconditional p

Inbjudan till HMS Networks telefonkonferens för det andra kvartalet 202121.6.2021 10:15:00 CEST | Pressemelding

HMS Networks AB (publ) offentliggör sin rapport för det andra kvartalet 2021 onsdagen den 14 juli 2021 kl. 08.00. Samma dag kl. 09.00 arrangeras en telefonkonferens för press och aktiemarknad, där VD och koncernchef Staffan Dahlström samt finanschef Joakim Nideborn presenterar rapporten. Presentationen hålls på engelska och följs direkt via telefon eller internet. De bilder som används under presentationen kommer att finnas tillgängliga på HMS webbplats före telefonkonferensen. För att delta i telefonkonferensen, ring in eller följ webbpresentationen via länken nedan. SE: +46 8 566 426 93 UK: +44 3333 009 263 US: +16 467 224 956 Länk till webbsändningen Presentation och inspelning av telefonkonferensen kommer sedan att finnas tillgängligt på HMS webbsida. https://www.hms-networks.com/sv/aktieagare För mer information, kontakta: Staffan Dahlström, VD HMS, +46 (0)35 17 29 01 Joakim Nideborn, Finanschef HMS, +46 (0)35 710 6983 HMS Networks AB (publ) är en marknadsledande leverantör av lös

Invitation to HMS Networks’ second quarter 2021 conference call21.6.2021 10:15:00 CEST | Press release

HMS Networks AB (publ) will release its second quarter report 2021 on Wednesday July 14, 2021, at 08.00 CET. On the same day, at 09.00 CET, a conference call will be held for press and analysts, where President and CEO Staffan Dahlström and CFO Joakim Nideborn present the report. The presentation will be held in English and is followed live by telephone or the internet. Slides used in the presentation will be made available on HMS’ website prior to the telephone conference. To participate in the telephone conference, please call or follow the online presentation via the link below. SE: +46 8 566 426 93 UK: +44 3333 009 263 US: +16 467 224 956 Link to webcast The presentation and recording of the telephone conference will be available on HMS’ website after the call. https://www.hms-networks.com/ir For more information, please contact: Staffan Dahlström, CEO HMS, +46 (0)35 17 29 01 Joakim Nideborn, CFO HMS, +46 (0)35 710 6983 HMS Networks AB (publ) is a market-leading provider of solutio