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Press Release

Bavarian Nordic Announces Agreement with Janssen for the Development of Vaccine Regimens against HIV-1 and Hepatitis B

Bavarian Nordic A/S
Posted on: 27 Jul 17
  • Deal builds on ongoing collaboration to develop vaccines for Human Papillomavirus (HPV) and Ebola
  • Total potential agreement value up to $879 million USD including upfront, equity investment and milestone payments
  • Development efforts will employ both companies' technologies to tackle hepatitis B and human immunodeficiency virus
  • As a consequence of the agreement, the Company raises its expectations for the year-end cash preparedness from approximately DKK 2,400 million to approximately DKK 2,600 million. The expectations for full year revenues and result are maintained.

COPENHAGEN, Denmark, July 27, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced an additional worldwide exclusive license and collaboration agreement with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). This new collaboration grants Janssen the exclusive rights to Bavarian Nordic's MVA-BN ® technology for two additional programs, targeting vaccines against hepatitis B virus (HBV) and the human immunodeficiency virus (HIV-1).

Under the terms of the agreement, Janssen will provide an upfront payment of $10 million USD, and Johnson & Johnson Innovation - JJDC, Inc. will provide $33 million USD in an equity investment by subscription of new Bavarian Nordic shares. Additionally, Bavarian Nordic will be eligible to receive milestone payments based upon the achievement of specified development, regulatory and sales milestones upto a total of $836 million USD, in addition to tiered royalties on future sales.

"We are very excited about this additional collaboration with Janssen, and proud to deploy our MVA-platform in the fight against two diseases with such an enormous impact on global health," said Paul Chaplin, President & CEO of Bavarian Nordic. "This agreement builds upon the science and data we have seen to date, which has shown the potential that a combination of our two platforms could serve many patients in a wide range of disease areas. We welcome this expansion of what has already been a fantastic relationshipbetween our two companies."

With the addition of programs targeting HBV and HIV-1, the companies are now collaborating on four product development programs combining Bavarian Nordic's MVA-BN technology with Janssen's AdVac ® technology platform. In October 2014, Janssen licensed MVA-BN for use in a heterologous prime-boost Ebola vaccine regimen. Subsequently, Janssen has evaluated MVA-BN in additional disease targets, leading to a second license for HPV in December 2015. Similar to prior agreements, Janssen will be responsible for all clinical development, while manufacturing of MVA-BN is retained by Bavarian Nordic.

Further details on the subscription of shares will be announced separately.

The closing of the transaction is subject to clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act. The transaction is expected to close during third quarter of 2017.

About HIV
Significant progress has been made in the global battle against HIV/AIDS, including the development of critical antiretroviral treatments and HIV prevention tools, yet the disease remains one of the greatest global health threats of our time. An estimated 37 million people are currently living with HIV-1 globally, and nearly 2 million people become newly infected each year.

About Hepatitis - B
Chronic hepatitis B virus (HBV) causes approximately 650,000 deaths worldwide from cirrhosis and liver cancer, with approximately 60 percent of hepatocellular carcinoma attributed to hepatitis B infection. Current recommended therapies are unable to cure the infection, requiring most people to continue treatment for life.

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 Investors
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

Contact Media
BMC Communications
Brad Miles
Tel: +1 646-513-3125
E-mail: bmiles@bmccommunications.com

Company Announcement no. 20 / 2017

2017-20-en


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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
HUG#2120329
GlobeNewswire
globenewswire.com

Last updated on: 28/07/2017

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