Raritan, NJ - December 18, 2015 -Janssen Pharmaceuticals, Inc. (Janssen) announced today that the company has entered into a definitive collaboration and license agreement with Bavarian Nordic to leverage their MVA-BN® technology, jointly with Janssen's own AdVac® technology, in the development and commercialization of a heterologous prime-boost vaccine for the treatment of Human Papillomavirus (HPV) chronic infections which can lead to cancer. Under this agreement, Janssen will conduct all clinical development and, subject to regulatory approval, will be responsible for registration, distribution and commercialization of the potential combination vaccine worldwide.
Despite a recent focus on the prevention of infection for certain HPV types, a large population remains at risk of HPV-related cancers. Janssen will leverage the prime-boost approach, similar to that used in its Ebola vaccine regimen which is currently in Phase 3 clinical trials. This approach has shown to induce a strong and longer-lasting immune response, demonstrated by both increased antibodies and T cell responses. The goal is to develop a therapeutic vaccine which aims to intercept HPV infection-related disease, particularly in women and men who are diagnosed with HPV early, by enhancing the ability of the immune system to treat chronic infections and prevent progression to cancer.
"HPV carries a significant disease burden, which can be addressed by intercepting disease progression and treating the viral infection," says Johan Van Hoof, M.D., Global Head, Infectious Diseases and Vaccines, Janssen. "We are bringing together our technology with that of Bavarian Nordic to develop a potentially first-in-class HPV vaccine which could advance human health by reducing the number of new cancer cases and associated deaths."
HPV-related cancers, which occur when a chronic infection of some HPV types cause changes to infected cells, are responsible for over 650 thousand cases globally1 each year. HPV is the primary cause of cervical cancer and certain types of head and neck cancer, in addition to several rare cancers.
With over 300 million estimated infections among men and women annually, HPV is the most prevalent sexually transmitted disease in the world.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding a new collaboration and product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in new product development, including uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Global Burden of Human Papillomavirus and Related Diseases, Forman et al, Vaccine, July 2012
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