Johnson & Johnson (J&J) and Crucell, NV, announced that J&J, through its subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc, and Crucell have entered into a strategic collaboration focusing on the discovery, development and commercialization of monoclonal antibodies and vaccines for the treatment and prevention of influenza and other infectious and non-infectious diseases.

The immediate focus of the collaboration will be the development and commercialization of a universal monoclonal antibody product (flu-mAb) for the treatment and prevention of influenza. The focus of the long-term innovation collaboration will be on new discovery programmes leading to the development and commercialization of a universal influenza vaccine as well as the development of monoclonal antibodies and/or vaccines directed against up to three other infectious and non-infectious disease targets.

Johnson & Johnson, through its affiliate JHC Nederland B.V., has also purchased 14.6 million newly issued ordinary shares of Crucell, representing approximately 18% of Crucell's outstanding ordinary shares, for an aggregate purchase price of € 301.8 million. In addition, the companies have agreed to development milestones and royalty payments based on the successful development and commercialization of products in connection with the collaboration.

Under the flu-mAb collaboration, Crucell and Ortho-McNeil-Janssen Pharmaceuticals or its affiliates will share responsibilities to develop a universal flu-mAb product targeting all influenza A strains, including H1N1 strains (which cause seasonal flu and the current pandemic) and the H5N1 or avian strain ('bird flu'). Crucell will be responsible for research and development through Phase IIa of the influenza antibodies it has already discovered, as well as newly discovered influenza antibodies that emerge from the collaboration. Ortho-McNeil-Janssen Pharmaceuticals or its affiliates will be responsible for late-stage development of the flu-mAb product from Phase Ilb onward.

Under the long-term innovation collaboration, Ortho-McNeil-Janssen Pharmaceuticals or its affiliates and Crucell will jointly work to discover and develop a universal flu vaccine for the prevention of influenza, as well as antibody and/or vaccine products against up to three additional infectious or non-infectious disease targets to be selected after exploratory research.

Both collaborations will leverage the vaccine/antibody know-how and technology platforms of Crucell and the broad scientific and development expertise of Ortho-McNeil-Janssen Pharmaceuticals and its affiliates.

Ortho-McNeil-Janssen Pharmaceuticals will hold commercialization rights for products resulting from both collaborations in all countries throughout the world with the exception of the European Union and certain additional European countries, where Crucell will retain commercialization rights. Ortho-McNeil-Janssen Pharmaceuticals' commercialization rights for products emerging from the innovation collaboration may be expanded worldwide if Crucell elects not to contribute toward development.

Influenza causes significant morbidity and mortality worldwide. In 2008 alone, some 14 million people in the industrialized world were diagnosed with influenza, with millions more being diagnosed in developing regions. Annual flu epidemics are thought to result in 3-5 million cases of severe illness and result in more than 350 thousand deaths every year around the world.

"Despite significant advances in prevention and treatment, influenza remains a major health threat, and each year, vaccines must be formulated to address the current influenza strain," said Paul Stoffels, Global Head, Pharmaceuticals Research and Development, Johnson & Johnson. "A universal antibody or vaccine that protects against a broad range of strains would be an important advance in helping doctors and nurses manage the annual influenza season and control acute epidemic and pandemic outbreaks. We are excited about this collaboration with Crucell because it provides us access to antibody and vaccine know-how and technology and expands our ability to offer preventive health care solutions for unmet medical needs."

Crucell's chief executive officer, Ronald Brus, said: "Crucell's innovative technologies for the discovery, development and manufacture of antibody products and vaccines provide avenues to develop much-needed medical solutions for global health threats. We are delighted that this collaboration with Johnson & Johnson will strengthen and facilitate our efforts to bring innovation to global health. It provides an avenue to accelerate Crucell's existing 'flu-mAb' programme, which has already demonstrated the potential to deliver an antibody product for the prevention and treatment of any type of influenza strain."

In connection with the equity investment, Crucell and JHC Nederland have entered into a shareholder agreement setting forth certain rights and restrictions of JHC Nederland as a shareholder, which includes a 3-year standstill requiring Crucell's consent for an increase of JHC Nederland's interest in Crucell (subject to customary exceptions), a 3-month lock-up on transfers of the shares (subject to customary exceptions) and certain other provisions. The shareholder agreement will be described in more detail in the prospectus which will be issued by Crucell in connection with the listing of the shares issued to JHC Nederland.

On August 18, 2009, Crucell announced that it had received a US National Institutes of Health (NIH) contract aimed at advancing the development of monoclonal antibodies for the treatment of seasonal and pandemic influenza. The contract provides funding of up to $40.7 million, with additional options worth a further $28.4 million that may be triggered at the discretion of the NIH, bringing the potential total award amount to $69.1 million. This funding will be used for Crucell's work in the flu-mAb collaboration announced today between Crucell and Ortho-McNeil-Janssen Pharmaceuticals to expedite the potential availability of a universal antibody product for the treatment and prevention of influenza in humans.

The transaction is expected to have an estimated dilutive impact of $0.02 to $0.04 on Johnson & Johnson's 2009 adjusted earnings per share.

Crucell is a global biopharmaceutical company focused on research, development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases.