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 up to 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 relationship between 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.
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.
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
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Tel: +1 646-513-3125
Company Announcement no. 20 / 2017